Conditions: Dry Eye Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 332
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the safety of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye as assessed by ocular and non-ocular adverse events when administered BID for approximately 1 year.

Detailed description:

Arms:
arm 1: Placebo arm 2: Active

Interventions: intervention 1: Lifitegrast intervention 2: Placebo
Intervention descriptions: intervention 1: Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: \~1 year intervention 2: Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: \~1 year

Protocol document: