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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  

Dry Eye Disease Clinical Trial

Official title:
A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease (COMET-1)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04498182
Study type Interventional
Source Aerie Pharmaceuticals
Contact
Status Completed
Phase Phase 2
Start date November 10, 2020
Completion date July 20, 2021
View Details
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