Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)

Phase 3 Completed 588 enrolled Shire

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of the study is to evaluate the efficacy of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in the treatment of Dry Eye. The safety and tolerability of SAR 1118 Ophthalmic Solution (5.0%) compared to placebo in subjects with dry eye when administered BID for 12 weeks will also be evaluated.

Timeline

Start: 2011-08-29
Primary completion: 2012-04-28
Completion: 2012-04-28

Outcome

Mixed primary results

paper The study met the primary objective efficacy ICSS end point in demonstrating superiority of lifitegrast compared with placebo (P = 0.0007). PMID 24289915 ↗

paper The study did not meet the co-primary subjective VR-OSDI measure (P = 0.7894). PMID 24289915 ↗

Publications

Results Sheppard JD, Torkildsen GL, Lonsdale JD, D'Ambrosio FA Jr, McLaurin EB, Eiferman RA, Kennedy KS, Semba CP; OPUS-1 Study Group. Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: results of the OPUS-1 phase 3 study. Ophthalmology. 2014 Feb;121(2):475-83. doi: 10.1016/j.ophtha.2013.09.015. Epub 2013 Nov 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lifitegrast	Unknown	5 %	Topical