NCT02284516

A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3)

A Phase 3, Multicenter, Randomized, Double-masked, and Placebo-controlled Study Evaluating the Efficacy and Safety of a 5.0% Concentration of Lifitegrast Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye Disease and History of Recent Artificial Tear Use

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 711 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy and safety of Lifitegrast in subjects with dry eye disease and a recent history of artificial tear use.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	Lifitegrast	Lifitegrast Ophthalmic Solution 5%, BID for 84 days
DRUG	Placebo	Placebo to match active treatment, BID for 84 days

Timeline

• Start date: 2014-11-06
• Primary completion: 2015-10-05
• Completion: 2015-10-05
• First posted: 2014-11-06
• Last updated: 2021-06-11
• Results posted: 2017-03-15

Locations

41 sites across 1 country: United States