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NCT05285644 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Safety and Efficacy of AR-15512
A Phase 3 study, sponsored by Aerie Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 465
- Enrollment target
NCT05285644: Completed Phase 3 study, sponsored by Aerie Pharmaceuticals.
NCT05285644 is a Phase 3 study that has completed, run by Aerie Pharmaceuticals. The registered enrollment target is 465 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05285644, a Phase 3 study, has completed, sponsored by Aerie Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 465 participants
- Enrollment target
Study 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). 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.
Primary Outcome
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.
Interventions
- DRUG 0.003% AR-15512 ophthalmic solution
- DRUG AR-15512 vehicle ophthalmic solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 465 participants |
| Start Date | 2022-05-09 |
| Est. Completion | 2023-07-24 |
| Phase | Phase 3 |
What the finished NCT05285644 record still lists
NCT05285644 is an interventional study that assigns participants to a tested intervention. The registered 465 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which 0.003% AR-15512 ophthalmic solution is the first listed.
NCT05285644 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05285644 about?
NCT05285644 is a clinical study titled "Study Evaluating the Safety and Efficacy of AR-15512". 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...
What is the current status of trial NCT05285644?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 465 participants. The study started on 2022-05-09. Estimated completion is 2023-07-24.
What interventions are being tested in trial NCT05285644?
The interventions under investigation include: 0.003% AR-15512 ophthalmic solution (DRUG), AR-15512 vehicle ophthalmic solution (DRUG).
Who is sponsoring clinical trial NCT05285644?
This trial is sponsored by Aerie Pharmaceuticals, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05285644's enrollment target sits among peer trials
465 819th of 2000 higher than 1,180 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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