Dry Eye DiseasePhase 3NCT05360966
Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)
A Phase 3 study testing 0.003% AR-15512 ophthalmic solution in people with Dry Eye Disease, run by Aerie Pharmaceuticals at 23 sites in United States.
Trial summary
This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). Read more about this study
- Who is it for?
- Ages 30 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
- 467 participants
- Where
- 23 sitesUnited States
- Study dates
- 18 Jul 2022to 17 Oct 2023
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signs and symptoms of dry eye disease (DED) at the Screening and Baseline visits;
- Corrected visual acuity of +0.70 logarithm Minimum angle of resolution (LogMAR) or better in both eyes at Screening and Baseline visits;
- Other protocol-specified inclusion criteria may apply.
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;
- Regular use of lid hygiene within 14 days prior to the Screening visit or any planned use during the study;
- Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study;
- Medication use as specified in the protocol;
- History or presence of significant systemic disease;
- Other protocol-specified exclusion criteria may apply.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Keystone Research
Austin, Texas, 78731
Argus Research Center
Cape Coral, Florida, 33904
Reeve Woods Eye Center
Chico, California, 95926
Pankratz Eye Institute
Columbus, Indiana, 47203
Axis Clinicals
Dallas, Texas, 75243
Erie Retina Research
Erie, Pennsylvania, 16507
NVision Clinical Research, LLC
Fullerton, California, 92835
Oculus Research
Garner, North Carolina, 27529
Jackson Eye
Lake Villa, Illinois, 60046
AdvanceMed Clinical Research
Las Vegas, Nevada, 89123
Wilmington Eye
Leland, North Carolina, 28451
Piedmont Eye Center
Lynchburg, Virginia, 24502
Boston Vision
Milford, Massachusetts, 01757
Pure Ophthalmic Research
Mint Hill, North Carolina, 28227
Eye Research Foundation
Newport Beach, California, 92663
Wyse Eyecare
Northbrook, Illinois, 60062
Shultz Vision
Northridge, California, 91325
Andover Eye Associates - Raynham
Raynham, Massachusetts, 02767
Virginia Eye Institute
Richmond, Virginia, 23230
NVision Clinical Research, LLC
Rochester, New York, 14624
NVision Clinical Research, LLC
Torrance, California, 90505
Andover Eye Associates
Warwick, Rhode Island, 02886
About this study
Official title: A Phase 3 Study Evaluating the Safety and Efficacy of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-3)
This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of Screening (Day -14) and Baseline (Day 1) visits as well as visits at Day 7, Day 14, Day 28, and Day 90 (Study Exit) for an individual duration of participation of approximately 15 weeks.
Read the detailed description
At the end of the Screening Visit, all qualified subjects will be assigned to administer one drop of AR-15512 Vehicle twice a day to both eyes for approximately 14 days (vehicle run-in period). After the vehicle run-in period, subjects will be re-evaluated for signs and symptoms of Dry Eye Disease (DED). Subjects who requalify based on inclusion/exclusion criteria will be enrolled in the study and randomized in a 1:1 ratio to receive 0.003% AR-15512 or AR-15512 Vehicle administered as 1 drop in each eye twice a day for 90 days. At the end of the Day 90 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
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 90 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 90 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.
Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 14 in Study Eye Unanesthetized Schirmer Score
The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis.
Measured: Baseline (Day 1) pre-drop; Day 14 post-drop
Secondary outcomes (11)
Least Squares Mean Change From Baseline in Global Symptom Assessment iN Dry Eye (SANDE) Score on Day 28
The SANDE questionnaire assesses the frequency and severity of symptoms using 2 unique, 100 mm Visual Analog Scales to mark the frequency (0=rarely, 100=all the time) and severity (0=very mild, 100=very severe) of dry eye symptoms (prior to drop exposure). The 2 scores were multiplied and a square root was obtained for a resultant overall Global SANDE score of 0 to 100 where 0 represents no symptoms and 100 is maximum symptoms. A negative change indicates a better outcome. This was a subject based assessment (single score for both eyes).
Measured: Baseline (Day 1); Day 28
Least Squares Mean Change From Pre-drop Baseline Unanesthetized Schirmer Score on Post-drop Day 14 (Study Eye)
The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. The Day 14 post-drop value was compared to the Day 1 pre-drop value. A positive change indicates a better outcome. One eye (study eye) contributed data to the analysis.
Measured: Baseline (Day 1) pre-drop; Day 14 post-drop
Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 1 in Study Eye Unanesthetized Schirmer Score
The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at each subsequent study visit. The study visit value was compared to the Day 1 pre-drop value. A positive change indicates a better outcome. One eye (study eye) contributed data to the analysis.
Measured: Baseline (Day 1) pre-drop; Day 1 post-drop
Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 1 (Study Eye)
The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 1 following drop exposure. The Day 1 post-drop score was compared to the Day 1 pre-drop score. A positive change over time indicates a better outcome. One eye (study eye) contributed data to the analysis.
Measured: Baseline (Day 1) pre-drop; Day 1 post-drop
Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 90 in Study Eye Unanesthetized Schirmer Score
The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 90 following drop exposure. The Day 90 post-drop score was compared to the Day 1 pre-drop score. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis.
Measured: Baseline (Day 1) pre-drop; Day 90 post-drop
Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 90 (Study Eye)
The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 90 following drop exposure. The Day 90 post-drop score was compared to the Day 1 pre-drop score. A positive change over time indicates a better outcome. One eye (study eye) contributed data to the analysis.
Measured: Baseline (Day 1) pre-drop; Day 90 post-drop
Least Squares Mean Change From Baseline in Global SANDE Score on Day 90
The SANDE questionnaire assesses the frequency and severity of symptoms using 2 unique, 100 mm Visual Analog Scales to mark the frequency (0=rarely, 100=all the time) and severity (0=very mild, 100=very severe) of dry eye symptoms (prior to drop exposure). The 2 scores were multiplied and a square root was obtained for a resultant overall Global SANDE score of 0 to 100 where 0 represents no symptoms and 100 is maximum symptoms. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1); Day 90
Least Squares Mean Change From Baseline in SANDE Frequency Score on Day 90
The SANDE questionnaire assesses the frequency of dry eye disease symptoms. Subjects used a 100 mm Visual Analog Scale (VAS) to mark the frequency of symptoms where 0=rarely and 100=all the time. A higher SANDE frequency score indicates greater symptoms of dryness and/or irritation. The questionnaire was completed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1); Day 90
Least Squares Mean Change From Baseline in SANDE Severity Score on Day 90
The SANDE questionnaire assesses the severity of dry eye disease symptoms. Subjects used a 100 mm Visual Analog Scale (VAS) to mark the severity of symptoms where 0=very mild and 100=very severe. A higher SANDE severity score indicates greater symptoms of dryness and/or irritation. The questionnaire was completed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1); Day 90
Least Squares Mean Change From Baseline in Eye Dryness Score (EDS) on Day 90
The subject used a 100 mm Visual Analog Scale (VAS) to mark their eye dryness, where 0=no eye dryness and 100=maximum eye dryness. Eye dryness was assessed at Day 1 and Day 90 prior to drop exposure (both visits). A higher eye dryness score indicates greater dryness. The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1); Day 90
Least Squares Mean Change From Baseline in Ocular Discomfort Score (ODS) on Day 90
The subject used a 100 mm Visual Analog Scale (VAS) to mark their eye dryness, where 0=no ocular discomfort and 100 mm=maximum ocular discomfort. A higher ocular discomfort score indicates greater discomfort. Ocular discomfort was assessed at Day 1 and Day 90 prior to drop exposure (both visits). The Day 90 value was compared to the Day 1 value. A negative change indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes.
Measured: Baseline (Day 1); Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start18 Jul 2022
- Primary completion17 Oct 2023
- Study completion17 Oct 2023
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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Model description
- Qualified subjects will be enrolled in the study and randomized in a 1:1 ratio within each site to receive 0.003% AR 15512 or AR-15512 vehicle to be administered twice daily (BID) as 1 drop in each eye for 90 days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scientific Advisor, Clinical R&D, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360966
- Sponsor's protocol ID
- AR-15512-CS302
- Status last verified
- Jul 2025
- First submitted
- 2 May 2022
- Last updated
- 23 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Periman LM, Lappin CJ, McDonald MB, Coats J, Pattar GR, Okoro T, Lighthizer N, Senchyna M, Nijm LM. Improvement in Visual-Tasking Daily Living Activities and Work Productivity in Patients with Dry Eye Disease: Integrated Analysis of COMET Studies. Ophthalmol Ther. 2026 Jul 18. doi: 10.1007/s40123-026-01421-1. Online ahead of print.
PubMed 42470519Pattar GR, Wirta D, Jerkins G, Paauw J, McLaurin EB, Liu A, Evans DG, Kenyon K, Cline N, Gupta PK, Meng I, Senchyna M; COMET-2 and COMET-3 Study Groups. Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye Disease: Results of Phase 3 Pivotal COMET-2 and COMET-3 Studies. Ophthalmology. 2026 May;133(5):563-574. doi: 10.1016/j.ophtha.2025.09.018. Epub 2025 Sep 30.
PubMed 41038456
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study Evaluating the Safety and Efficacy of AR-15512, a Cold Thermoreceptor Modulator, for the Treatment of Dry Eye Disease (COMET-3)
- ClinicalTrials.gov ID
- NCT05360966
- Acronym / sponsor ID
- AR-15512-CS302
- Conditions
- Dry Eye Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Posted 23 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approximately 20 sites in the United States. All subjects enrolled will have dry eye disease (DED). The study will consist of Screening (Day -14) and Baseline (Day 1) visits as well as visits at Day 7, Day 14, Day 28, and Day 90 (Study Exit) for an individual duration of participation of approximately 15 weeks.
Detailed description
At the end of the Screening Visit, all qualified subjects will be assigned to administer one drop of AR-15512 Vehicle twice a day to both eyes for approximately 14 days (vehicle run-in period). After the vehicle run-in period, subjects will be re-evaluated for signs and symptoms of Dry Eye Disease (DED). Subjects who requalify based on inclusion/exclusion criteria will be enrolled in the study and randomized in a 1:1 ratio to receive 0.003% AR-15512 or AR-15512 Vehicle administered as 1 drop in each eye twice a day for 90 days. At the end of the Day 90 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
- Model description
- Qualified subjects will be enrolled in the study and randomized in a 1:1 ratio within each site to receive 0.003% AR 15512 or AR-15512 vehicle to be administered twice daily (BID) as 1 drop in each eye for 90 days.
| 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 90 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 90 days |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signs and symptoms of dry eye disease (DED) at the Screening and Baseline visits;
- Corrected visual acuity of +0.70 logarithm Minimum angle of resolution (LogMAR) or better in both eyes at Screening and Baseline visits;
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (6 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;
- Regular use of lid hygiene within 14 days prior to the Screening visit or any planned use during the study;
- Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study;
- Medication use as specified in the protocol;
- History or presence of significant systemic disease;
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 solutionAdministered 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
Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 14 in Study Eye Unanesthetized Schirmer Score
Time frame: Baseline (Day 1) pre-drop; Day 14 post-drop
The Schirmer test measures tear production using a filter paper placed on the lower eyelid. The amount of wetting was recorded on a scale from 0 millimeters (mm) (no tear production) to 35 mm (maximum). The test was performed at Day 1 prior to drop exposure and at Day 14 following drop exposure. An increased score represents a positive outcome. One eye (study eye) contributed data to the analysis.
11 secondary outcomes
Least Squares Mean Change From Baseline in Global Symptom Assessment iN Dry Eye (SANDE) Score on Day 28
Time frame: Baseline (Day 1); Day 28
Least Squares Mean Change From Pre-drop Baseline Unanesthetized Schirmer Score on Post-drop Day 14 (Study Eye)
Time frame: Baseline (Day 1) pre-drop; Day 14 post-drop
Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 1 in Study Eye Unanesthetized Schirmer Score
Time frame: Baseline (Day 1) pre-drop; Day 1 post-drop
Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 1 (Study Eye)
Time frame: Baseline (Day 1) pre-drop; Day 1 post-drop
Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 90 in Study Eye Unanesthetized Schirmer Score
Time frame: Baseline (Day 1) pre-drop; Day 90 post-drop
Least Squares Mean Change From Pre-drop Baseline in Unanesthetized Schirmer Score on Post-drop Day 90 (Study Eye)
Time frame: Baseline (Day 1) pre-drop; Day 90 post-drop
Least Squares Mean Change From Baseline in Global SANDE Score on Day 90
Time frame: Baseline (Day 1); Day 90
Least Squares Mean Change From Baseline in SANDE Frequency Score on Day 90
Time frame: Baseline (Day 1); Day 90
Least Squares Mean Change From Baseline in SANDE Severity Score on Day 90
Time frame: Baseline (Day 1); Day 90
Least Squares Mean Change From Baseline in Eye Dryness Score (EDS) on Day 90
Time frame: Baseline (Day 1); Day 90
Least Squares Mean Change From Baseline in Ocular Discomfort Score (ODS) on Day 90
Time frame: Baseline (Day 1); Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42470519Periman LM, Lappin CJ, McDonald MB, Coats J, Pattar GR, Okoro T, Lighthizer N, Senchyna M, Nijm LM. Improvement in Visual-Tasking Daily Living Activities and Work Productivity in Patients with Dry Eye Disease: Integrated Analysis of COMET Studies. Ophthalmol Ther. 2026 Jul 18. doi: 10.1007/s40123-026-01421-1. Online ahead of print.
- Derived from this study: PubMed 41038456Pattar GR, Wirta D, Jerkins G, Paauw J, McLaurin EB, Liu A, Evans DG, Kenyon K, Cline N, Gupta PK, Meng I, Senchyna M; COMET-2 and COMET-3 Study Groups. Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye Disease: Results of Phase 3 Pivotal COMET-2 and COMET-3 Studies. Ophthalmology. 2026 May;133(5):563-574. doi: 10.1016/j.ophtha.2025.09.018. Epub 2025 Sep 30.
- 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, Clinical R&D study director
Alcon Research, LLC
23 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 23 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 3 inclusion and 6 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 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 23 Jul 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?
Percentage of Subjects Who Achieved Equal to or Greater Than 10 Millimeter Increase From Pre-drop at Baseline to Post-drop on Day 14 in Study Eye Unanesthetized Schirmer Score (time frame: Baseline (Day 1) pre-drop; Day 14 post-drop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05360966, which also lists 2 linked publications.
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 23 Jul 2025.