A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease
Status:
Completed
Trial end date:
2021-07-20
Target enrollment:
Participant gender:
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. All
subjects will be exposed to the Controlled Adverse Environment (CAE®) at the Screening,
Baseline, Day 28 and Day 84 visits. Only subjects who qualify based on inclusion/exclusion
criteria, will be enrolled in the study and randomized at a 1:1:1 ratio within each site, to
receive AR-15512 0.0014%, AR-15512 0.003% or AR-15512 vehicle to be administered as 1 drop in
each eye twice daily for 84 days.