Safety Study of Lifitegrast to Treat 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 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.

Key facts

Study ID

NCT01636206

Run by

Shire

People needed

332

Starts

2012-10-16

Expected to finish

2014-03-03

Last updated by the study team

2021-06-11

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

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 24h prior to Visit 1 and for some duration during 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 during the appropriate pre-study washout period and 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 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)

Where it is running

• SONATA Investigational Site — Artesia, California, United States
• SONATA Investigational Site — Hemet, California, United States
• SONATA Investigational Site — Laguna Hills, California, United States
• SONATA Investigational Site — Lancaster, California, United States
• SONATA Investigational Site — Montebello, California, United States
• SONATA Investigational Site — Parker, Colorado, United States
• SONATA Investigational Site — Boynton Beach, Florida, United States
• SONATA Investigational Site — Roswell, Georgia, United States
• SONATA Investigational Site — Hoffman Estates, Illinois, United States
• SONATA Investigational Site — Edgewood, Kentucky, United States
• SONATA Investigational Site — Lexington, Kentucky, United States
• SONATA Investigational Site — Stillwater, Minnesota, United States
• SONATA Investigational Site — Pennington, New Jersey, United States
• SONATA Investigational Site — Woodland Park, New Jersey, United States
• SONATA Investigational Site — Rochester, New York, United States
• SONATA Investigational Site — Rockville Centre, New York, United States
• SONATA Investigational Site — Charlotte, North Carolina, United States
• SONATA Investigational Site — High Point, North Carolina, United States
• SONATA Investigational Site — Cleveland, Ohio, United States
• SONATA Investigational Site — Doylestown, Pennsylvania, United States
• SONATA Investigational Site — Mt. Pleasant, South Carolina, United States
• SONATA Investigational Site — Chattanooga, Tennessee, United States
• SONATA Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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