Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1)
NCT ID: NCT01421498
Last Updated: 2021-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
588 participants
INTERVENTIONAL
2011-08-29
2012-04-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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5.0% Lifitegrast
Lifitegrast
Lifitegrast
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks
Placebo
Placebo
Placebo
Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks
Interventions
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Lifitegrast
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks
Placebo
Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
18 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
Countries
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References
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Sheppard JD, Torkildsen GL, Lonsdale JD, D'Ambrosio FA Jr, McLaurin EB, Eiferman RA, Kennedy KS, Semba CP; OPUS-1 Study Group. Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: results of the OPUS-1 phase 3 study. Ophthalmology. 2014 Feb;121(2):475-83. doi: 10.1016/j.ophtha.2013.09.015. Epub 2013 Nov 26.
Other Identifiers
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1118-KCS-200
Identifier Type: -
Identifier Source: org_study_id
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