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NCT04498182 · ClinicalTrials.gov registry record · Phase 2
A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease
A Phase 2 study, sponsored by Aerie Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 369
- Enrollment target
NCT04498182: Completed Phase 2 study, sponsored by Aerie Pharmaceuticals.
NCT04498182 is a Phase 2 study that has completed, run by Aerie Pharmaceuticals. The registered enrollment target is 369 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (177% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04498182, a Phase 2 study, has completed, sponsored by Aerie Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 369 participants
- Enrollment target
Study Summary
This is a Phase 2b, multicenter, vehicle-controlled, double-masked, randomized study. All subjects enrolled will have dry eye disease. The study consists of Screening and Baseline visits to determine eligibility, followed by efficacy assessments at Day 14 (Visit 3), 28 (Visit 4) and 84 (Visit 5/Study Exit). Safety will be assessed at all study visits.
Primary Outcome
Ocular discomfort was assessed using a Visual Analogue Scale (VAS) that ranged from 0 millimeters (mm) (no ocular discomfort) to 100 mm (maximum ocular discomfort). Ocular discomfort was assessed at Baseline prior to CAE exposure and at Day 28 prior to CAE exposure. The Day 28 value was subtracted from the Baseline value. A more negative change value indicates a better outcome. This was a subject based assessment, and subject assigned a single score for both eyes. This is a co-primary endpoint.
Interventions
- DRUG AR-15512 Ophthalmic Solution
- DRUG AR-15512 Ophthalmic Solution Vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 369 participants |
| Start Date | 2020-10-26 |
| Est. Completion | 2021-07-17 |
| Phase | Phase 2 |
What the finished NCT04498182 record still lists
NCT04498182 is an interventional study that assigns participants to a tested intervention. The registered 369 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (177% higher).
The record links to 0 conditions, and to 2 interventions - of which AR-15512 Ophthalmic Solution is the first listed.
NCT04498182 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04498182 about?
NCT04498182 is a clinical study titled "A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease". This is a Phase 2b, multicenter, vehicle-controlled, double-masked, randomized study. All subjects enrolled will have dry eye disease. The study consists of Screening and Baseline visits to determine eligibility, followed by efficacy assessments at Day 14 (Visit 3), 28 (Visit 4) and 84 (Visit 5/Stud...
What is the current status of trial NCT04498182?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 369 participants. The study started on 2020-10-26. Estimated completion is 2021-07-17.
What interventions are being tested in trial NCT04498182?
The interventions under investigation include: AR-15512 Ophthalmic Solution (DRUG), AR-15512 Ophthalmic Solution Vehicle (DRUG).
Who is sponsoring clinical trial NCT04498182?
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 NCT04498182's enrollment target sits among peer trials
369 121st of 2000 higher than 1,880 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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