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

• Status: Completed
• Trial end date: 2015-10-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Lifitegrast; Ophthalmic Solutions

Criteria

Inclusion Criteria:

• Patient-reported history of Dry Eye Disease in both eyes.

• Use of over the counter artificial tears within the past 30 days.

• A negative urine pregnancy test for females and willingness to use adequate birth control throughout the study.

• Able and willing to comply with all study procedures.

Exclusion Criteria:

• Presence of an ocular condition that could affect the study parameters such as active ocular infections, ocular inflammation, glaucoma, or diabetic retinopathy;.

• Unwilling to stop wearing contact lenses during the study.

• LASIK or other ocular surgical procedures within 12 months prior to or during the study.

• Use of prohibited medications

• Significant medical conditions that could affect the study parameters.