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

Completed · Phase 3 · Has a placebo group

Conditions studied: Dry Eye Disease

In brief

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.

Key facts

Study ID

NCT01743729

Run by

Shire

People needed

720

Starts

2012-12-07

Expected to finish

2013-10-01

Last updated by the study team

2021-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• OPUS-2 Investigational Site — Artesia, California, United States
• OPUS-2 Investigational Site — Hemet, California, United States
• OPUS-2 Investigational Site — Lancaster, California, United States
• OPUS-2 Investigational Site — Mission Hills, California, United States
• OPUS-2 Investigational Site — Montebello, California, United States
• OPUS-2 Investigational Site — Newport Beach, California, United States
• OPUS-2 Investigational Site — Petaluma, California, United States
• OPUS-2 Investigational SIte — Rancho Cordova, California, United States
• OPUS-2 Investigational Site — Danbury, Connecticut, United States
• OPUS-2 Investigational Site — Fort Myers, Florida, United States
• OPUS-2 Investigational Site — Hoffman Estates, Illinois, United States
• OPUS-2 Investigational Site — Indianapolis, Indiana, United States
• OPUS-2 Investigational Site — New Albany, Indiana, United States
• OPUS-2 Investigational Site — Lexington, Kentucky, United States
• OPUS-2 Investigational Site — Saint Paul, Minnesota, United States
• OPUS-2 Investigational Site — Chesterfield, Missouri, United States
• OPUS-2 Investigational Site — Des Peres, Missouri, United States
• OPUS-2 Investigational Site — Independence, Missouri, United States
• OPUS-2 Investigational Site — Kansas City, Missouri, United States
• OPUS-2 Investigational Site — Washington, Missouri, United States
• OPUS-2 Investigational Site — New York, New York, United States
• OPUS-2 Investigational Site — New York, New York, United States
• OPUS-2 Investigational Site — Wantagh, New York, United States
• OPUS-2 Investigational Site — Cleveland, Ohio, United States
• OPUS-2 Investigational Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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