Dry Eye DiseasePhase 3COMET-4NCT05493111
A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512
A Phase 3 study testing 0.003% AR-15512 ophthalmic solution in people with Dry Eye Disease, run by Aerie Pharmaceuticals at 10 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of topical ophthalmic 0.003% AR-15512 compared to its vehicle dosed twice daily (BID) in subjects with dry eye disease (DED) for 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- 0.003% AR-15512 ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 10 sitesUnited States
- Study dates
- 1 Nov 2022to 28 Feb 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous history of Dry Eye Disease (DED) within the previous 12 months of the Baseline visit.
- Have used or desired to use artificial tears for DED symptoms within 3 months prior to the Baseline visit.
- Corrected visual acuity as specified in the protocol at the Baseline visit.
- Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history, and vital signs (heart rate and blood pressure) at the Baseline visit.
Who cannot join
- History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety.
- Current evidence of other significant ophthalmic disease requiring topical medication (e.g. glaucoma, ocular hypertension) which may interfere with vision (e.g., cataract, macular degeneration) or other disease which the investigator believes may interfere with study findings or interpretation.
- Use of contact lenses in either eye within 7 days prior to the Baseline visit or planned use during the study.
- Use of medications as specified in the protocol.
- Use of lid heating therapy (i.e., LipiFlow®, iLUX®) or Meibomian gland probing/therapeutic expression within 6 months prior to the Baseline visit or anticipated during the study.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Arizona Eye Center
Chandler, Arizona, 85225
Global Research Management
Glendale, California, 91204
Macy Eye Center
Los Angeles, California, 90048
Piedmont Eye Center
Lynchburg, Virginia, 24502
SightMD
Manhasset, New York, 11030
University Eye Specialists
Maryville, Tennessee, 37803
Eye Research Foundation
Newport Beach, California, 92663
Shultz Vision
Northridge, California, 91325
Periman Eye Institute
Seattle, Washington, 98119
Arizona Eye Institute
Sun City, Arizona, 85351
About this study
Official title: A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-4)
The purpose of this study is to evaluate the safety of topical ophthalmic 0.003% AR-15512 compared to its vehicle dosed twice daily (BID) in subjects with dry eye disease (DED) for 12 months.
Read the detailed description
At the end of the Screening Visit, subjects will undergo a protocol-specified washout period for prohibited prior and concomitant therapies. At the Baseline Visit, subjects who qualify based on inclusion/exclusion criteria will be enrolled in the study and randomized in a 2:1 ratio to receive 0.003% AR-15512 or AR-15512 Vehicle administered as 1 drop in each eye twice a day for 365 days (12 months). At the end of the Day 365 visit, subjects will exit the study.
Aerie Pharmaceuticals was acquired by Alcon on November 22, 2022.
- Conditions
- Dry Eye Disease
- Being tested
- 0.003% AR-15512 ophthalmic solution, AR-15512 vehicle ophthalmic solution
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.003% AR-15512 ophthalmic solutionDrug
Active ingredients administered via topical ocular instillation
AR-15512 vehicle ophthalmic solutionDrug
Inactive ingredients administered via topical ocular instillation
| Study group | Role | What they receive |
|---|---|---|
| 0.003% AR-15512 | Experimental | 0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 365 days Receives: Drug: 0.003% AR-15512 ophthalmic solution |
| AR-15512 Vehicle | Placebo comparator | AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 365 days Receives: Drug: AR-15512 vehicle ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Treatment-Emergent Adverse Events by Preferred Term With Incidence Greater Than 2 Percent
A treatment-emergent adverse event was defined as any event that occurred or worsened on or after the day randomized study intervention was initiated. At each study visit, subjects were verbally asked by clinic staff to report any changes to any aspect of their ocular health. Ocular treatment-emergent adverse events reported by the subject or observed by the investigator were summarized by preferred term for overall incidence calculation. This was a subject-based assessment.
Measured: Day 1 post-treatment, up to Day 365
Mean Change From Baseline in Heart Rate at Each Study Visit
Heart rate was measured using manual or automated methods and recorded in beats per minute (bpm). Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit
Systolic blood pressure was measured using an appropriate sphygmomanometer and recorded in millimeters mercury (mmHg). Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit
Diastolic blood pressure was measured using an appropriate sphygmomanometer and recorded in millimeters mercury (mmHg). Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Mean Change From Baseline in Overall Average Endothelial Cell Density at Day 365
Cell density in the central corneal endothelium was assessed using specular microscopy imaging. Overall average cell density was calculated as the average of the average cell densities of three images and was measured in cells per millimeter squared (cells/mm^2). A negative change from baseline represents a less desirable outcome.
Measured: Baseline (Day 1 pretreatment), Day 365
Percentage of Subjects With 10 Percent or More Decrease From Baseline in Overall Average Endothelial Cell Density at Study Exit
Cell density in the central corneal endothelium was assessed using specular microscopy imaging. Overall average cell density was calculated as the average of the average cell densities of three images and was measured in cells per millimeter squared (cells/mm^2). A decrease from baseline represents a less desirable outcome.
Measured: Baseline (Day 1 pretreatment), Study Exit (Day 365, early termination visit, or unscheduled visit)
Mean Change From Baseline in Hematology by Visit - Basophil Level
A small volume of blood was collected and sent to a laboratory for analysis. Basophil level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Basophils to Leukocytes Ratio Reported in Percentage of Cells
A small volume of blood was collected and sent to a laboratory for analysis. The basophils to leukocytes ratio was reported as the absolute number of basophils divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Eosinophil Level
A small volume of blood was collected and sent to a laboratory for analysis. Eosinophil level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Eosinophils to Leukocytes Ratio Reported in Percentage of Cells
A small volume of blood was collected and sent to a laboratory for analysis. The eosinophils to leukocytes ratio was reported as the absolute number of eosinophils divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Concentration Level
A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte mean corpuscular hemoglobin concentration level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Level
A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte mean corpuscular hemoglobin level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Volume
A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte mean corpuscular volume was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Erythrocyte Level
A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Erythrocyte Distribution Width Reported as Percentage of Variation of Cells
A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte distribution width was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Hematocrit Level
A small volume of blood was collected and sent to a laboratory for analysis. Hematocrit level was reported as the volume of red blood cells in liters (L) divided by the volume of blood in L. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Hemoglobin Level
A small volume of blood was collected and sent to a laboratory for analysis. Hemoglobin level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Leukocyte Level
A small volume of blood was collected and sent to a laboratory for analysis. Leukocyte level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Lymphocyte Level
A small volume of blood was collected and sent to a laboratory for analysis. Lymphocyte level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells
A small volume of blood was collected and sent to a laboratory for analysis. The lymphocytes to leukocytes ratio was reported as the absolute number of lymphocytes divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Monocyte Level
A small volume of blood was collected and sent to a laboratory for analysis. Monocyte level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Monocytes to Leukocytes Ratio Reported in Percentage of Cells
A small volume of blood was collected and sent to a laboratory for analysis. The monocytes to leukocytes ratio was reported as the absolute number of monocytes divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Neutrophil Level
A small volume of blood was collected and sent to a laboratory for analysis. Neutrophil level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Neutrophils to Leukocytes Ratio Reported in Percentage of Cells
A small volume of blood was collected and sent to a laboratory for analysis. The neutrophils to leukocytes ratio was reported as the absolute number of neutrophils divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Platelet Level
A small volume of blood was collected and sent to a laboratory for analysis. Platelet level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Hematology by Visit - Mean Platelet Volume
A small volume of blood was collected and sent to a laboratory for analysis. Platelet volume was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Chemistry by Visit - Alanine Aminotransferase Level
A small volume of blood was collected and sent to a laboratory for analysis. Alanine aminotransferase level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Chemistry by Visit - Albumin Level
A small volume of blood was collected and sent to a laboratory for analysis. Albumin level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Chemistry by Visit - Alkaline Phosphatase Level
A small volume of blood was collected and sent to a laboratory for analysis. Alkaline phosphatase level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Chemistry by Visit - Aspartate Aminotransferase Level
A small volume of blood was collected and sent to a laboratory for analysis. Aspartate aminotransferase level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Chemistry by Visit - Calcium Level
A small volume of blood was collected and sent to a laboratory for analysis. Calcium level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Chemistry by Visit - Creatinine Level
A small volume of blood was collected and sent to a laboratory for analysis. Creatinine level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Chemistry by Visit - Globulin Level
A small volume of blood was collected and sent to a laboratory for analysis. Globulin level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Chemistry by Visit - Potassium Level
A small volume of blood was collected and sent to a laboratory for analysis. Potassium level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Chemistry by Visit - Protein Level
A small volume of blood was collected and sent to a laboratory for analysis. Protein level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Chemistry by Visit - Sodium Level
A small volume of blood was collected and sent to a laboratory for analysis. Sodium level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Chemistry by Visit - Triglyceride Level
A small volume of blood was collected and sent to a laboratory for analysis. Triglyceride level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Chemistry by Visit - Urea Nitrogen Level
A small volume of blood was collected and sent to a laboratory for analysis. Urea nitrogen level was measured. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Urinalysis by Visit - Specific Gravity Level
A small volume of blood was collected and sent to a laboratory for analysis. Specific gravity level was calculated by dividing the sample's density by the density of water. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Change From Baseline in Urinalysis by Visit - pH Level
A small volume of urine was collected and sent to a laboratory for analysis. The pH scale ranges from 0 (most acidic) to 14 (most alkaline), with 7 as neutral. Minimal change from the start of the study indicates a better outcome.
Measured: Baseline (Day 1 pretreatment), Day 180, Day 365
Mean Best Corrected Visual Acuity (BCVA) Letter Score by Visit
Visual acuity with correction in place (spectacles or a trial frame with lenses) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts (original or modified) at a distance of 10 feet. Each line on the ETDRS chart typically has five letters, and each letter correctly identified adds to the overall score. ETDRS letter scores range from 0 to 100, with each letter correctly identified representing a score of 1. A perfect score of 100 is achieved when all 70 letters on the chart are correctly identified. 85 letters correctly identified corresponds to normal distance eyesight.
Measured: Baseline (Day 1 pretreatment), Day 365
Mean Corrected Visual Acuity in LogMar by Visit
Visual acuity with correction in place (spectacles or a trial frame with lenses) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts (original or modified) at a distance of 10 feet. Each line on the ETDRS chart typically has five letters, and each letter correctly identified adds to the overall score. The overall letter score was converted to Logarithmic minimum angle of resolution (LogMAR). LogMAR scores typically range from -0.3 to 1.0, where zero represents normal vision, negative values indicate better than normal vision, and positive values indicate poorer than normal vision.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to lid erythema (redness of the eyelid) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to lid edema (swelling of the eyelid) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to conjunctiva hyperemia (increased amount of blood in the conjunctiva) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to conjunctiva edema (swelling of the conjunctiva) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to cornea staining/erosion were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to cornea edema (swelling of the cornea) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to cells in the anterior chamber (the fluid-filled space located in the front of the eye between the cornea and the iris) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to anterior chamber flare (a visible clouding of the the fluid-filled space located in the front of the eye between the cornea and the iris) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to lens opacity (a clouding of the eye's natural lens) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Mean Total Ocular Staining Score by Visit
Total corneal (fluorescein) staining score ranges between 0 and 5. Total conjunctival staining score is collected as the sum of lissamine green staining nasal and temporal scores and ranges between 0 and 10 per eye. Total ocular staining score is collected as the sum of total corneal and conjunctival scores (0 to 15) with a maximum possible score of 15 per eye. A higher total score indicates greater staining (or worse condition).
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Mean Intraocular Pressure by Visit
Intraocular pressure was measured using Goldmann applanation tonometry and measured in millimeters mercury (mmHg). Values between 10mmHg and 20mmHg are considered normal eye pressure.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous
An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the vitreous (the clear gel that fills the space between the lens and the retina of the eyeball) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina
An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the retina (the light-sensitive tissue lining the back of the eye that converts light into electrical signals the brain then interprets as images) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula
An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the macula (the round area at the center of the retina that provides central vision) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve
An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the optic nerve (the nerve that transmits visual information from the retina to the brain) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid
An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the choroid (the layer of blood vessels and connective tissue between the white of the eye and retina) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Measured: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Nov 2022
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scientific Advisor, CRD, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493111
- Sponsor's protocol ID
- AR-15512-LTSS
- Acronym
- COMET-4
- Status last verified
- Jul 2025
- First submitted
- 26 Jul 2022
- Last updated
- 13 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-4)
- ClinicalTrials.gov ID
- NCT05493111
- Acronym / sponsor ID
- COMET-4 / AR-15512-LTSS
- Conditions
- Dry Eye Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 9 Aug 2022 (actual)
- Results
- Posted 13 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of topical ophthalmic 0.003% AR-15512 compared to its vehicle dosed twice daily (BID) in subjects with dry eye disease (DED) for 12 months.
Detailed description
At the end of the Screening Visit, subjects will undergo a protocol-specified washout period for prohibited prior and concomitant therapies. At the Baseline Visit, subjects who qualify based on inclusion/exclusion criteria will be enrolled in the study and randomized in a 2:1 ratio to receive 0.003% AR-15512 or AR-15512 Vehicle administered as 1 drop in each eye twice a day for 365 days (12 months). At the end of the Day 365 visit, subjects will exit the study.
Aerie Pharmaceuticals was acquired by Alcon on November 22, 2022.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.003% AR-15512 | Experimental | Drug: 0.003% AR-15512 ophthalmic solution0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 365 days |
| AR-15512 Vehicle | Placebo comparator | Drug: AR-15512 vehicle ophthalmic solutionAR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 365 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previous history of Dry Eye Disease (DED) within the previous 12 months of the Baseline visit.
- Have used or desired to use artificial tears for DED symptoms within 3 months prior to the Baseline visit.
- Corrected visual acuity as specified in the protocol at the Baseline visit.
- Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history, and vital signs (heart rate and blood pressure) at the Baseline visit.
Key exclusion criteria (5 listed)
- History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety.
- Current evidence of other significant ophthalmic disease requiring topical medication (e.g. glaucoma, ocular hypertension) which may interfere with vision (e.g., cataract, macular degeneration) or other disease which the investigator believes may interfere with study findings or interpretation.
- Use of contact lenses in either eye within 7 days prior to the Baseline visit or planned use during the study.
- Use of medications as specified in the protocol.
- Use of lid heating therapy (i.e., LipiFlow®, iLUX®) or Meibomian gland probing/therapeutic expression within 6 months prior to the Baseline visit or anticipated during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.003% AR-15512 ophthalmic solutionActive ingredients administered via topical ocular instillation | Drug | 0.003% AR-15512 |
| AR-15512 vehicle ophthalmic solutionInactive ingredients administered via topical ocular instillation | Drug | AR-15512 Vehicle |
Primary outcome
Ocular Treatment-Emergent Adverse Events by Preferred Term With Incidence Greater Than 2 Percent
Time frame: Day 1 post-treatment, up to Day 365
A treatment-emergent adverse event was defined as any event that occurred or worsened on or after the day randomized study intervention was initiated. At each study visit, subjects were verbally asked by clinic staff to report any changes to any aspect of their ocular health. Ocular treatment-emergent adverse events reported by the subject or observed by the investigator were summarized by preferred term for overall incidence calculation. This was a subject-based assessment.
Mean Change From Baseline in Heart Rate at Each Study Visit
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Heart rate was measured using manual or automated methods and recorded in beats per minute (bpm). Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Systolic Blood Pressure at Each Study Visit
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Systolic blood pressure was measured using an appropriate sphygmomanometer and recorded in millimeters mercury (mmHg). Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Diastolic Blood Pressure at Each Study Visit
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Diastolic blood pressure was measured using an appropriate sphygmomanometer and recorded in millimeters mercury (mmHg). Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Overall Average Endothelial Cell Density at Day 365
Time frame: Baseline (Day 1 pretreatment), Day 365
Cell density in the central corneal endothelium was assessed using specular microscopy imaging. Overall average cell density was calculated as the average of the average cell densities of three images and was measured in cells per millimeter squared (cells/mm^2). A negative change from baseline represents a less desirable outcome.
Percentage of Subjects With 10 Percent or More Decrease From Baseline in Overall Average Endothelial Cell Density at Study Exit
Time frame: Baseline (Day 1 pretreatment), Study Exit (Day 365, early termination visit, or unscheduled visit)
Cell density in the central corneal endothelium was assessed using specular microscopy imaging. Overall average cell density was calculated as the average of the average cell densities of three images and was measured in cells per millimeter squared (cells/mm^2). A decrease from baseline represents a less desirable outcome.
Mean Change From Baseline in Hematology by Visit - Basophil Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Basophil level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Basophils to Leukocytes Ratio Reported in Percentage of Cells
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. The basophils to leukocytes ratio was reported as the absolute number of basophils divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Eosinophil Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Eosinophil level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Eosinophils to Leukocytes Ratio Reported in Percentage of Cells
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. The eosinophils to leukocytes ratio was reported as the absolute number of eosinophils divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Concentration Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte mean corpuscular hemoglobin concentration level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Hemoglobin Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte mean corpuscular hemoglobin level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Erythrocyte Mean Corpuscular Volume
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte mean corpuscular volume was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Erythrocyte Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Erythrocyte Distribution Width Reported as Percentage of Variation of Cells
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Erythrocyte distribution width was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Hematocrit Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Hematocrit level was reported as the volume of red blood cells in liters (L) divided by the volume of blood in L. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Hemoglobin Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Hemoglobin level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Leukocyte Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Leukocyte level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Lymphocyte Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Lymphocyte level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Lymphocytes to Leukocytes Ratio Reported in Percentage of Cells
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. The lymphocytes to leukocytes ratio was reported as the absolute number of lymphocytes divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Monocyte Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Monocyte level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Monocytes to Leukocytes Ratio Reported in Percentage of Cells
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. The monocytes to leukocytes ratio was reported as the absolute number of monocytes divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Neutrophil Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Neutrophil level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Neutrophils to Leukocytes Ratio Reported in Percentage of Cells
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. The neutrophils to leukocytes ratio was reported as the absolute number of neutrophils divided by the absolute number of leukocytes multiplied by 100. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Platelet Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Platelet level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Hematology by Visit - Mean Platelet Volume
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Platelet volume was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Chemistry by Visit - Alanine Aminotransferase Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Alanine aminotransferase level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Chemistry by Visit - Albumin Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Albumin level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Chemistry by Visit - Alkaline Phosphatase Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Alkaline phosphatase level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Chemistry by Visit - Aspartate Aminotransferase Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Aspartate aminotransferase level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Chemistry by Visit - Calcium Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Calcium level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Chemistry by Visit - Creatinine Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Creatinine level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Chemistry by Visit - Globulin Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Globulin level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Chemistry by Visit - Potassium Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Potassium level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Chemistry by Visit - Protein Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Protein level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Chemistry by Visit - Sodium Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Sodium level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Chemistry by Visit - Triglyceride Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Triglyceride level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Chemistry by Visit - Urea Nitrogen Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Urea nitrogen level was measured. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Urinalysis by Visit - Specific Gravity Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of blood was collected and sent to a laboratory for analysis. Specific gravity level was calculated by dividing the sample's density by the density of water. Minimal change from the start of the study indicates a better outcome.
Mean Change From Baseline in Urinalysis by Visit - pH Level
Time frame: Baseline (Day 1 pretreatment), Day 180, Day 365
A small volume of urine was collected and sent to a laboratory for analysis. The pH scale ranges from 0 (most acidic) to 14 (most alkaline), with 7 as neutral. Minimal change from the start of the study indicates a better outcome.
Mean Best Corrected Visual Acuity (BCVA) Letter Score by Visit
Time frame: Baseline (Day 1 pretreatment), Day 365
Visual acuity with correction in place (spectacles or a trial frame with lenses) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts (original or modified) at a distance of 10 feet. Each line on the ETDRS chart typically has five letters, and each letter correctly identified adds to the overall score. ETDRS letter scores range from 0 to 100, with each letter correctly identified representing a score of 1. A perfect score of 100 is achieved when all 70 letters on the chart are correctly identified. 85 letters correctly identified corresponds to normal distance eyesight.
Mean Corrected Visual Acuity in LogMar by Visit
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Visual acuity with correction in place (spectacles or a trial frame with lenses) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts (original or modified) at a distance of 10 feet. Each line on the ETDRS chart typically has five letters, and each letter correctly identified adds to the overall score. The overall letter score was converted to Logarithmic minimum angle of resolution (LogMAR). LogMAR scores typically range from -0.3 to 1.0, where zero represents normal vision, negative values indicate better than normal vision, and positive values indicate poorer than normal vision.
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Erythema
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to lid erythema (redness of the eyelid) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lid Edema
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to lid edema (swelling of the eyelid) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Hyperemia
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to conjunctiva hyperemia (increased amount of blood in the conjunctiva) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Conjunctiva Edema
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to conjunctiva edema (swelling of the conjunctiva) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Staining/Erosion
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to cornea staining/erosion were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Cornea Edema
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to cornea edema (swelling of the cornea) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Cells
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to cells in the anterior chamber (the fluid-filled space located in the front of the eye between the cornea and the iris) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Anterior Chamber Flare
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to anterior chamber flare (a visible clouding of the the fluid-filled space located in the front of the eye between the cornea and the iris) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Number of Subjects With Clinically Significant Biomicroscopy Findings as Determined by the Investigator at Each Study Visit - Lens Opacity
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
An eye exam (slit lamp biomicroscopy) was performed by the investigator at each study visit. Findings related to lens opacity (a clouding of the eye's natural lens) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Mean Total Ocular Staining Score by Visit
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Total corneal (fluorescein) staining score ranges between 0 and 5. Total conjunctival staining score is collected as the sum of lissamine green staining nasal and temporal scores and ranges between 0 and 10 per eye. Total ocular staining score is collected as the sum of total corneal and conjunctival scores (0 to 15) with a maximum possible score of 15 per eye. A higher total score indicates greater staining (or worse condition).
Mean Intraocular Pressure by Visit
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
Intraocular pressure was measured using Goldmann applanation tonometry and measured in millimeters mercury (mmHg). Values between 10mmHg and 20mmHg are considered normal eye pressure.
Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Vitreous
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the vitreous (the clear gel that fills the space between the lens and the retina of the eyeball) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Retina
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the retina (the light-sensitive tissue lining the back of the eye that converts light into electrical signals the brain then interprets as images) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Macula
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the macula (the round area at the center of the retina that provides central vision) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Optic Nerve
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the optic nerve (the nerve that transmits visual information from the retina to the brain) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Number of Subjects With Clinically Significant Change From Baseline in Dilated Fundus Exam Results by Visit - Choroid
Time frame: Baseline (Day 1 pretreatment), Day 14, Day 90, Day 180, Day 270, Day 365
An examination of the back of the eye (dilated fundus exam) was performed by the investigator. Findings related to the choroid (the layer of blood vessels and connective tissue between the white of the eye and retina) were graded as Normal or Abnormal. Abnormal findings were categorized as clinically significant (CS) or not clinically significant (NCS). CS findings were defined at those that may interfere with study parameters or otherwise confound the data as determined by the investigator.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scientific Advisor, CRD study director
Alcon Research, LLC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.003% AR-15512 ophthalmic solution in people with Dry Eye Disease, run by Aerie Pharmaceuticals at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Treatment-Emergent Adverse Events by Preferred Term With Incidence Greater Than 2 Percent (time frame: Day 1 post-treatment, up to Day 365). The study lists 58 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.