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NCT05493111 · ClinicalTrials.gov registry record · Phase 3
A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512
A Phase 3 study, sponsored by Aerie Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 275
- Enrollment target
NCT05493111: Completed Phase 3 study, sponsored by Aerie Pharmaceuticals.
NCT05493111 is a Phase 3 study that has completed, run by Aerie Pharmaceuticals. The registered enrollment target is 275 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05493111, a Phase 3 study, has completed, sponsored by Aerie Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 275 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG 0.003% AR-15512 ophthalmic solution
- DRUG AR-15512 vehicle ophthalmic solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2022-11-01 |
| Est. Completion | 2024-02-28 |
| Phase | Phase 3 |
What the finished NCT05493111 record still lists
NCT05493111 is an interventional study that assigns participants to a tested intervention. The registered 275 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 (64% lower).
The record links to 0 conditions, and to 2 interventions - of which 0.003% AR-15512 ophthalmic solution is the first listed.
NCT05493111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05493111 about?
NCT05493111 is a clinical study titled "A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512". 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.
What is the current status of trial NCT05493111?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 275 participants. The study started on 2022-11-01. Estimated completion is 2024-02-28.
What interventions are being tested in trial NCT05493111?
The interventions under investigation include: 0.003% AR-15512 ophthalmic solution (DRUG), AR-15512 vehicle ophthalmic solution (DRUG).
Who is sponsoring clinical trial NCT05493111?
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 NCT05493111's enrollment target sits among peer trials
275 1206th of 2000 higher than 794 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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