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

Summary

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

Timeline

Start

2014-11-06

Primary completion

2015-10-05

Completion

2015-10-05

Outcome

Met primary endpoint

registry Placebo vs Lifitegrast; p =0.0007; Treatment Effect 7.16 (95% CI 3.04 to 11.28) NCT02284516 ↗

paper At day 84, lifitegrast-treated participants experienced significantly greater improvement from baseline in EDS versus those receiving placebo PMID 28079022 ↗

release “OPUS-3, a phase 3 trial, met primary endpoint, demonstrating significant improvement in patient-reported symptoms from baseline to day 84” takeda.com ↗

Publications

• Holland EJ, Jackson MA, Donnenfeld E, Piccolo R, Cohen A, Barabino S, Rolando M, Figueiredo FC. Efficacy of Lifitegrast Ophthalmic Solution, 5.0%, in Patients With Moderate to Severe Dry Eye Disease: A Post Hoc Analysis of 2 Randomized Clinical Trials. JAMA Ophthalmol. 2021 Nov 1;139(11):1200-1208. doi: 10.1001/jamaophthalmol.2021.3943.
• Holland EJ, Luchs J, Karpecki PM, Nichols KK, Jackson MA, Sall K, Tauber J, Roy M, Raychaudhuri A, Shojaei A. Lifitegrast for the Treatment of Dry Eye Disease: Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3). Ophthalmology. 2017 Jan;124(1):53-60. doi: 10.1016/j.ophtha.2016.09.025. Epub 2016 Oct 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lifitegrast	Unknown	5 %	Other

Indications