Dry Eye DiseasePhase 1MTPNCT05497479
Study Evaluating Techniques for Measuring Tear Production
A Phase 1 study testing 0.003% AR-15512 to be administered in both eyes in people with Dry Eye Disease, run by Aerie Pharmaceuticals at 1 site in United States.
Trial summary
This will be a vehicle-controlled, masked, randomized study conducted at a single site in the United States. All participants enrolled will have Dry Eye Disease (DED). The study will consist of 2 Visits. At Visit 1, eligibility will be assessed at Screening. 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 to be administered in both eyes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2021to 10 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Have used, and/or desired to use artificial tears for DED symptoms within 6 months prior to Visit 1
- Within the last year from Visit 1, have a documented Schirmer test with or without topical anesthesia score ≥ 2 and ≤ 10 mm/5 min
- Within the last year from Visit 1, have documented symptoms of DED
- Corrected Visual Acuity (Snellen) 20/200 or better in both
Who cannot join
- Use of artificial tears within 2 hours prior to Visit 1
- Use of ocular cyclosporine or other prescription ophthalmic solution for DED (e.g., Restasis®, Cequa®, Xiidra®) within 30 days of Visit 1 or anticipated use during the study period.
- Regular use of any topical ocular non-DED medication or use of a topical ocular non-DED medication within 2 hours of Visit 1
- Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study
- Punctal or intracanalicular plug present in either eyelid or anticipated plug insertion or occlusion at any time during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Research Foundation
Newport Beach, California, 92663
About this study
Official title: A Phase 1 Study Evaluating Techniques for Measuring Tear Production
This will be a vehicle-controlled, masked, randomized study conducted at a single site in the United States. All participants enrolled will have Dry Eye Disease (DED). The study will consist of 2 Visits. At Visit 1, eligibility will be assessed at Screening. All eligible subjects will then be enrolled and randomized to one of two treatment groups (1:1): active (0.003% AR-15512) or control (AR-15512 vehicle). Subjects in each treatment group will then be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test.
- Conditions
- Dry Eye Disease
- Being tested
- 0.003% AR-15512 to be administered in both eyes, Vehicle to be administered in both eyes
- 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 to be administered in both eyesDrug
Two rounds of Schirmer tests, performed without anesthetic (per randomization), before and after instillation of 0.003% AR-15512
Vehicle to be administered in both eyesDrug
Two rounds of Schirmer tests, performed without anesthetic, before and after instillation of Vehicle
0.003% AR-15512 to be administered in both eyesDrug
Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of 0.003% AR-15512
Vehicle to be administered in both eyesDrug
Two rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of Vehicle
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Schirmer test with no anesthetic | Experimental | Both eyes will be treated. Receives: Drug: 0.003% AR-15512 to be administered in both eyes; Drug: Vehicle to be administered in both eyes |
| Treatment with Schirmer test with anesthetic | Experimental | Both eyes will be treated. Receives: Drug: 0.003% AR-15512 to be administered in both eyes; Drug: Vehicle to be administered in both eyes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unanesthetized Schirmer test
Proportion of subjects ≥ 10 mm increase in unanesthetized Schirmer score
Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score indicates a better outcome.
Measured: Day 1
Unanesthetized Schirmer test
Mean change in Unanesthetized Schirmer score
Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean change indicates a better outcome.
Measured: Day 1
Unanesthetized Schirmer test
Mean Unanesthetized Schirmer score
Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean value indicates a better outcome.
Measured: Day 1
Anesthetized Schirmer test
Proportion of subjects ≥ 10 mm increase in anesthetized Schirmer score
Schirmer strips placed with anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score indicates a better outcome.
Measured: Day 1
Anesthetized Schirmer test
Mean change in anesthetized Schirmer score.
Schirmer strips placed without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean change indicates a better outcome.
Measured: Day 1
Anesthetized Schirmer test
Mean anesthetized Schirmer score
Schirmer strips placed with anesthesia, in both eyes measure the amount of tear wetting over 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean value indicates a better outcome.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start9 Dec 2021
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All eligible subjects will be enrolled and randomized (1:1) to one of two treatment groups: active (0.003% AR-15512) or control (AR-15512 vehicle). Following enrollment, subjects in the two treatment groups will each be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerie Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle S Senchyna, PhD, Study director, Aerie Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497479
- Sponsor's protocol ID
- 21-110-A
- Acronym
- MTP
- Status last verified
- Aug 2022
- First submitted
- 26 Jul 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- 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 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Evaluating Techniques for Measuring Tear Production
- ClinicalTrials.gov ID
- NCT05497479
- Acronym / sponsor ID
- MTP / 21-110-A
- Conditions
- Dry Eye Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
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 vehicle-controlled, masked, randomized study conducted at a single site in the United States. All participants enrolled will have Dry Eye Disease (DED). The study will consist of 2 Visits. At Visit 1, eligibility will be assessed at Screening. All eligible subjects will then be enrolled and randomized to one of two treatment groups (1:1): active (0.003% AR-15512) or control (AR-15512 vehicle). Subjects in each treatment group will then be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All eligible subjects will be enrolled and randomized (1:1) to one of two treatment groups: active (0.003% AR-15512) or control (AR-15512 vehicle). Following enrollment, subjects in the two treatment groups will each be randomized 1:1 to which Visit (Visit 1 or 2) anesthetic will be used with the Schirmer test.
| Arm | Type | Receives |
|---|---|---|
| Treatment with Schirmer test with no anesthetic | Experimental | Drug: 0.003% AR-15512 to be administered in both eyes, Drug: Vehicle to be administered in both eyesBoth eyes will be treated. |
| Treatment with Schirmer test with anesthetic | Experimental | Drug: 0.003% AR-15512 to be administered in both eyes, Drug: Vehicle to be administered in both eyesBoth eyes will be treated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have used, and/or desired to use artificial tears for DED symptoms within 6 months prior to Visit 1
- Within the last year from Visit 1, have a documented Schirmer test with or without topical anesthesia score ≥ 2 and ≤ 10 mm/5 min
- Within the last year from Visit 1, have documented symptoms of DED
- Corrected Visual Acuity (Snellen) 20/200 or better in both
Key exclusion criteria (5 listed)
- Use of artificial tears within 2 hours prior to Visit 1
- Use of ocular cyclosporine or other prescription ophthalmic solution for DED (e.g., Restasis®, Cequa®, Xiidra®) within 30 days of Visit 1 or anticipated use during the study period.
- Regular use of any topical ocular non-DED medication or use of a topical ocular non-DED medication within 2 hours of Visit 1
- Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study
- Punctal or intracanalicular plug present in either eyelid or anticipated plug insertion or occlusion at any time 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 to be administered in both eyesTwo rounds of Schirmer tests, performed without anesthetic (per randomization), before and after instillation of 0.003% AR-15512 | Drug | Treatment with Schirmer test with no anesthetic |
| Vehicle to be administered in both eyesTwo rounds of Schirmer tests, performed without anesthetic, before and after instillation of Vehicle | Drug | Treatment with Schirmer test with no anesthetic |
| 0.003% AR-15512 to be administered in both eyesTwo rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of 0.003% AR-15512 | Drug | Treatment with Schirmer test with anesthetic |
| Vehicle to be administered in both eyesTwo rounds of Schirmer tests, performed with anesthetic (per randomization), before and after instillation of Vehicle | Drug | Treatment with Schirmer test with anesthetic |
Primary outcome
Unanesthetized Schirmer test
Time frame: Day 1
Proportion of subjects ≥ 10 mm increase in unanesthetized Schirmer score Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score indicates a better outcome.
Unanesthetized Schirmer test
Time frame: Day 1
Mean change in Unanesthetized Schirmer score Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean change indicates a better outcome.
Unanesthetized Schirmer test
Time frame: Day 1
Mean Unanesthetized Schirmer score Schirmer strips placed, without anesthesia, in both eyes measure the amount of tear wetting over 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean value indicates a better outcome.
Anesthetized Schirmer test
Time frame: Day 1
Proportion of subjects ≥ 10 mm increase in anesthetized Schirmer score Schirmer strips placed with anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. An ≥ 10 mm score indicates a better outcome.
Anesthetized Schirmer test
Time frame: Day 1
Mean change in anesthetized Schirmer score. Schirmer strips placed without anesthesia, in both eyes measure the amount of tear wetting over a 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean change indicates a better outcome.
Anesthetized Schirmer test
Time frame: Day 1
Mean anesthetized Schirmer score Schirmer strips placed with anesthesia, in both eyes measure the amount of tear wetting over 5 minute period, measured in whole millimeters to a maximum score of 35 mm. A greater mean value indicates a better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- 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.
Michelle S Senchyna, PhD study director
Aerie Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.003% AR-15512 to be administered in both eyes in people with Dry Eye Disease, run by Aerie Pharmaceuticals at 1 site 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 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Unanesthetized Schirmer test (time frame: Day 1). The study lists 6 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 11 Aug 2022; AzTrials last refreshed its copy on 3 Nov 2026.