A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye Conducted in a Controlled Adverse Environment (CAE)

Phase 2 Completed 230 enrolled Shire

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.

Timeline

Start: 2009-08-03
Primary completion: 2010-02-18
Completion: 2010-02-18

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

registry analysis (unspecified test); Lifitegrast 0.1% vs Placebo; p = 0.9381; Treatment Effect 0.06 (95% CI -0.26 to 0.39); Dunnett's test NCT00926185 ↗

registry analysis (unspecified test); Lifitegrast 1.0% vs Placebo; p = 0.3585; Treatment Effect 0.20 (95% CI -0.13 to 0.53); Dunnett's test NCT00926185 ↗

registry analysis (unspecified test); Lifitegrast 5.0% vs Placebo; p = 0.1375; Treatment Effect 0.27 (95% CI -0.06 to 0.60); Dunnett's test NCT00926185 ↗

Publications

Semba CP, Torkildsen GL, Lonsdale JD, McLaurin EB, Geffin JA, Mundorf TK, Kennedy KS, Ousler GW. A phase 2 randomized, double-masked, placebo-controlled study of a novel integrin antagonist (SAR 1118) for the treatment of dry eye. Am J Ophthalmol. 2012 Jun;153(6):1050-60.e1. doi: 10.1016/j.ajo.2011.11.003. Epub 2012 Feb 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lifitegrast	Unknown	0.1 %	Topical
Subject	Lifitegrast	Unknown	1 %	Topical
Subject	Lifitegrast	Unknown	5 %	Topical