Status:
COMPLETED
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)
Lead Sponsor:
Shire
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 3 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2010
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00926185
Start Date
August 3 2009
End Date
February 18 2010
Last Update
August 9 2021
Active Locations (5)
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1
The Eye Care Group
Waterbury, Connecticut, United States, 06708
2
Central Maine Eye Care
Lewiston, Maine, United States, 04243
3
Ora, Inc. (two locations)
Andover, Massachusetts, United States, 01840
4
Mundorf Eye Center
Charlotte, North Carolina, United States, 28204