At a glance
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A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease (COMET-1)
In Brief
A Phase 2 clinical trial evaluating AR-15512 Ophthalmic Solution and AR-15512 Ophthalmic Solution Vehicle for Dry Eye Disease. Completed, enrolled 369 participants across 15 sites.
Detailed 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.
Study Details
Timeline
Interventions
Ophthalmic solution administered via topical ocular instillation in one of two dose concentrations: 0.0014% (lower dose) or 0.003% (higher dose)
Ophthalmic solution vehicle administered via topical ocular instillation