Status:
COMPLETED
Study Evaluating the Safety and Efficacy of AR-15512 (COMET-3)
Lead Sponsor:
Aerie Pharmaceuticals
Conditions:
Dry Eye Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief 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)...
Detailed Description
At the end of the Screening Visit, all qualified subjects will be assigned to administer one drop of AR-15512 Vehicle twice a day to both eyes for approximately 14 days (vehicle run-in period). After ...
Eligibility Criteria
Inclusion
- Key
- Signs and symptoms of dry eye disease (DED) at the Screening and Baseline visits;
- Corrected visual acuity of +0.70 logarithm Minimum angle of resolution (LogMAR) or better in both eyes at Screening and Baseline visits;
- Other protocol-specified inclusion criteria may apply.
- Key
Exclusion
- History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety;
- Regular use of lid hygiene within 14 days prior to the Screening visit or any planned use during the study;
- Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study;
- Medication use as specified in the protocol;
- History or presence of significant systemic disease;
- Other protocol-specified exclusion criteria may apply.
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2023
Estimated Enrollment :
467 Patients enrolled
Trial Details
Trial ID
NCT05360966
Start Date
July 18 2022
End Date
October 17 2023
Last Update
July 23 2025
Active Locations (23)
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1
Reeve Woods Eye Center
Chico, California, United States, 95926
2
NVision Clinical Research, LLC
Fullerton, California, United States, 92835
3
Eye Research Foundation
Newport Beach, California, United States, 92663
4
Shultz Vision
Northridge, California, United States, 91325