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NCT05360966 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)
A Phase 3 study of Dry Eye Disease, sponsored by Aerie Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 467
- Enrollment target
- 20
- Study locations
NCT05360966: Completed Phase 3 study of Dry Eye Disease, sponsored by Aerie Pharmaceuticals.
NCT05360966 is a Phase 3 study of Dry Eye Disease that has completed, run by Aerie Pharmaceuticals. The registered enrollment target is 467 participants, above the 241-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (94% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05360966, a Phase 3 study of Dry Eye Disease, has completed, sponsored by Aerie Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 467 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG 0.003% AR-15512 ophthalmic solution
- DRUG AR-15512 vehicle ophthalmic solution
Study Locations (20)
California
- Reeve Woods Eye Center - Chico
- NVision Clinical Research, LLC - Fullerton
- Eye Research Foundation - Newport Beach
- Shultz Vision - Northridge
- NVision Clinical Research, LLC - Torrance
Massachusetts
- Andover Eye Associates - Andover
- Boston Vision - Milford
- Andover Eye Associates - Raynham - Raynham
North Carolina
- Oculus Research - Garner
- Wilmington Eye - Leland
- Pure Ophthalmic Research - Mint Hill
Illinois
- Jackson Eye - Lake Villa
- Wyse Eyecare - Northbrook
Florida
- Argus Research Center - Cape Coral
Indiana
- Pankratz Eye Institute - Columbus
Nevada
- AdvanceMed Clinical Research - Las Vegas
New York
- NVision Clinical Research, LLC - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 467 participants |
| Start Date | 2022-07-18 |
| Est. Completion | 2023-10-17 |
| Phase | Phase 3 |
What the finished NCT05360966 record still lists
NCT05360966 is an interventional study that assigns participants to a tested intervention. The registered 467 participants enrollment target is mid-sized for trials with a published cap, above the 241-participant average among 33 other Dry Eye Disease trials with a reported enrollment target (94% higher).
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 ophthalmic solution is the first listed.
NCT05360966 names 20 study sites across 11 states, led by California, Massachusetts, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05360966 about?
NCT05360966 is a clinical study titled "Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)". 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 NCT05360966?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 467 participants. The study started on 2022-07-18. Estimated completion is 2023-10-17.
What conditions does trial NCT05360966 study?
This clinical trial studies the following conditions: Dry Eye Disease.
What interventions are being tested in trial NCT05360966?
The interventions under investigation include: 0.003% AR-15512 ophthalmic solution (DRUG), AR-15512 vehicle ophthalmic solution (DRUG).
Who is sponsoring clinical trial NCT05360966?
This trial is sponsored by Aerie Pharmaceuticals, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05360966 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05360966's enrollment target sits among peer trials
467 5th of 33 higher than 29 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.
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