Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
332 participants
INTERVENTIONAL
2012-10-16
2014-03-03
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
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: \~1 year
Lifitegrast
Active
Lifitegrast
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: \~1 year
Interventions
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Lifitegrast
Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: \~1 year
Placebo
Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: \~1 year
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
* 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 24h prior to Visit 1 and for some duration during the study
* 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 prohibited medications during the appropriate pre-study washout period and at any time during the study unless otherwise specified
* 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
* 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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SONATA Investigational Site
Artesia, California, United States
SONATA Investigational Site
Hemet, California, United States
SONATA Investigational Site
Laguna Hills, California, United States
SONATA Investigational Site
Lancaster, California, United States
SONATA Investigational Site
Montebello, California, United States
SONATA Investigational Site
Parker, Colorado, United States
SONATA Investigational Site
Boynton Beach, Florida, United States
SONATA Investigational Site
Roswell, Georgia, United States
SONATA Investigational Site
Hoffman Estates, Illinois, United States
SONATA Investigational Site
Edgewood, Kentucky, United States
SONATA Investigational Site
Lexington, Kentucky, United States
SONATA Investigational Site
Stillwater, Minnesota, United States
SONATA Investigational Site
Pennington, New Jersey, United States
SONATA Investigational Site
Woodland Park, New Jersey, United States
SONATA Investigational Site
Rochester, New York, United States
SONATA Investigational Site
Rockville Centre, New York, United States
SONATA Investigational Site
Charlotte, North Carolina, United States
SONATA Investigational Site
High Point, North Carolina, United States
SONATA Investigational Site
Cleveland, Ohio, United States
SONATA Investigational Site
Doylestown, Pennsylvania, United States
SONATA Investigational Site
Mt. Pleasant, South Carolina, United States
SONATA Investigational Site
Chattanooga, Tennessee, United States
SONATA Investigational Site
Houston, Texas, United States
Countries
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References
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Donnenfeld ED, Karpecki PM, Majmudar PA, Nichols KK, Raychaudhuri A, Roy M, Semba CP. Safety of Lifitegrast Ophthalmic Solution 5.0% in Patients With Dry Eye Disease: A 1-Year, Multicenter, Randomized, Placebo-Controlled Study. Cornea. 2016 Jun;35(6):741-8. doi: 10.1097/ICO.0000000000000803.
Other Identifiers
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1118-DRY-400
Identifier Type: -
Identifier Source: org_study_id
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