Status:
COMPLETED
A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease
Lead Sponsor:
Aerie Pharmaceuticals
Conditions:
Dry Eye Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
At the end of the Screening Visit, all qualified subjects will be assigned to administer AR-15512 vehicle twice a day to both eyes for 14 days (vehicle run-in period). After the vehicle run-in period,...
Eligibility Criteria
Inclusion
- Key
- Previous history of dry eye disease (DED) within the previous 6 months;
- Have used and/or desired to use artificial tears for DED symptoms within 2 months prior to the Screening visit;
- Signs and symptoms of DED at the Screening and Baseline visits;
- Best Corrected Visual Acuity (BCVA) of 20/200 (+0.70 LogMAR) or better in both eyes at both the 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;
- Current evidence of other significant ophthalmic diseases which, in the opinion of the investigator, may interfere with study findings or interpretation;
- Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study;
- Regular use of ocular medications or nutritional supplements as specified in the protocol within 30 days prior to the Screening visit;
- Positive pregnancy test at Screening or Baseline visits or currently breastfeeding.
- Other protocol-specified exclusion criteria may apply.
Key Trial Info
Start Date :
October 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2021
Estimated Enrollment :
369 Patients enrolled
Trial Details
Trial ID
NCT04498182
Start Date
October 26 2020
End Date
July 17 2021
Last Update
August 28 2024
Active Locations (15)
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1
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States, 85032
2
Eye Research Foundation
Newport Beach, California, United States, 92663
3
Vision Institute
Colorado Springs, Colorado, United States, 80907
4
Midwest Cornea Associates, LLC
Carmel, Indiana, United States, 46290