A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye Conducted in a Controlled Adverse Environment (CAE)
Completed · Phase 2 · Has a placebo group
Conditions studied: Dry Eye
In brief
The purpose of this study is to evaluate the efficacy of three different concentrations (0.1%, 1.0%, 5.0%) of SAR 1118 Ophthalmic Solution compared to placebo in the treatment of dry eye.
Key facts
- Study ID
- NCT00926185
- Run by
- Shire
- People needed
- 230
- Starts
- 2009-08-03
- Expected to finish
- 2010-02-18
- Last updated by the study team
- 2021-08-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed Informed Consent Form and HIPAA document
- 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 tear substitutes) 72 hrs prior to screening assessments and through the entire study period
- 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
Where it is running
- The Eye Care Group — Waterbury, Connecticut, United States
- Central Maine Eye Care — Lewiston, Maine, United States
- Ora, Inc. (two locations) — Andover, Massachusetts, United States
- Mundorf Eye Center — Charlotte, North Carolina, United States
- Total Eye Care, P.A. — Memphis, Tennessee, United States
Full record on ClinicalTrials.gov
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