A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye.

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

Details

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

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

• Artificial tear use within the past 30 days

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 first visit and for the duration of the study

• 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 prohibited medications at any time during the study unless otherwise specified

• Any significant 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 first visit, and/or any other ocular surgical procedure within 12 months prior to first visit; 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)