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NCT05497479 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating Techniques for Measuring Tear Production
A Phase 1 study of Dry Eye Disease, sponsored by Aerie Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05497479: Completed Phase 1 study of Dry Eye Disease, sponsored by Aerie Pharmaceuticals.
NCT05497479 is a Phase 1 study of Dry Eye Disease that has completed, run by Aerie Pharmaceuticals. The registered enrollment target is 40 participants, below the 254-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05497479, a Phase 1 study of Dry Eye Disease, has completed, sponsored by Aerie Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG 0.003% AR-15512 to be administered in both eyes
- DRUG Vehicle to be administered in both eyes
Study Locations (1)
California
- Eye Research Foundation - Newport Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-12-09 |
| Est. Completion | 2021-12-10 |
| Phase | Phase 1 |
What the finished NCT05497479 record still lists
NCT05497479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 254-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Dry Eye Disease appearing as the primary indexed condition, and to 2 interventions - of which 0.003% AR-15512 to be administered in both eyes is the first listed.
NCT05497479 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05497479 about?
NCT05497479 is a clinical study titled "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 enroll...
What is the current status of trial NCT05497479?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2021-12-09. Estimated completion is 2021-12-10.
What conditions does trial NCT05497479 study?
This clinical trial studies the following conditions: Dry Eye Disease.
What interventions are being tested in trial NCT05497479?
The interventions under investigation include: 0.003% AR-15512 to be administered in both eyes (DRUG), Vehicle to be administered in both eyes (DRUG).
Who is sponsoring clinical trial NCT05497479?
This trial is sponsored by Aerie Pharmaceuticals, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05497479 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dry Eye Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05497479's enrollment target sits among peer trials
40 30th of 33 higher than 4 of 33 other Dry Eye Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dry Eye Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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