Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

Summary

This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo (vehicle) in patients with keratoconjunctivitis sicca (dry eye disease).

Timeline

Start

2014-09

Primary completion

2015-05

Completion

2015-05

Outcome

Met primary endpoint

release “Compared to the vehicle, OTX-101 showed statistically significant improvement in the primary end point in the trial.” sunpharma.com ↗

Drugs

Indications