Status:
COMPLETED
Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)
Lead Sponsor:
Shire
Conditions:
Keratoconjunctivitis Sicca
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
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 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)
Key Trial Info
Start Date :
August 29 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2012
Estimated Enrollment :
588 Patients enrolled
Trial Details
Trial ID
NCT01421498
Start Date
August 29 2011
End Date
April 28 2012
Last Update
June 11 2021
Active Locations (13)
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1
OPUS-1 Investigational Site
Waterbury, Connecticut, United States, 06708
2
OPUS-1 Investigational Site
Louisville, Kentucky, United States, 40405
3
OPUS-1 Investigational Site
Augusta, Maine, United States, 04330
4
OPUS-1 Investigational Site
Lewiston, Maine, United States, 04243