Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)

• Status: Completed
• Trial end date: 2012-04-28
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

• Willing and able to read, sign, and date the informed consent and HIPAA documents

• Willing and able to comply with all study procedures

• Be at least 18 years of age

• Patient-reported history of dry eye in both eyes

• Demonstrate a positive response when exposed to the Controlled Adverse Environment model

• A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period

Exclusion Criteria:

• Any ocular condition that, in the opinion of the Investigator, could affect study parameters including, but not limited to, active ocular infection, ocular inflammation, glaucoma, and/or diabetic retinopathy

• Unwilling to avoid wearing contact lenses for 7 days prior to and for duration of the study period

• Any blood donation or significant loss of blood within 56 days of Visit 1

• Any history of immunodeficiency disorder, positive HIV, hepatitis B, C, or evidence of acute active hepatitis A (anti-HAV IgM), or organ or bone marrow transplant.

• Use of any topical ophthalmic preparations (including artificial tear substitutes) 72 hrs prior to Visit 1 and during the study

• Any significant chronic illness that could interfere with study parameters

• History of laser-assisted in situ keratomileusis (LASIK) or similar type of corneal refractive surgery within 12 months prior to Visit 1, and/or any other ocular surgical procedure within 12 months prior to Visit 1; or any scheduled ocular surgical procedure during the study period.

• Known history of alcohol and/or drug abuse

• Subjects with Dry eye secondary to scarring or destruction of conjunctival goblet cells (as with Vitamin A deficiency)