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

Completed · Phase 3 · Has a placebo group

Conditions studied: Keratoconjunctivitis Sicca, Dry Eye Disease

In brief

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.

Key facts

Study ID

NCT01421498

Run by

Shire

People needed

588

Starts

2011-08-29

Expected to finish

2012-04-28

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
• 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

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 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)

Where it is running

• OPUS-1 Investigational Site — Waterbury, Connecticut, United States
• OPUS-1 Investigational Site — Louisville, Kentucky, United States
• OPUS-1 Investigational Site — Augusta, Maine, United States
• OPUS-1 Investigational Site — Lewiston, Maine, United States
• OPUS-1 Investigational Site — Andover, Massachusetts, United States
• OPUS-1 Investigational Site — Lancaster, Massachusetts, United States
• OPUS-1 Investigational Site — Quincy, Massachusetts, United States
• OPUS-1 Investigational Site — Wakefield, Massachusetts, United States
• OPUS-1 Investigational Site — Winchester, Massachusetts, United States
• OPUS-1 Investigational Site — Derry, New Hampshire, United States
• OPUS-1 Investigational Site — Manchester, New Hampshire, United States
• OPUS-1 Investigational Site — Memphis, Tennessee, United States
• OPUS-1 Investigational Site — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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