Conditions: Keratoconjunctivitis Sicca Dry Eye Disease
Keywords: ophthalmic delivery Dry Eye
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 588
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Lifitegrast arm 2: Placebo

Interventions: intervention 1: Lifitegrast intervention 2: Placebo
Intervention descriptions: intervention 1: Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks intervention 2: Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks

Protocol document: