Safety and Efficacy of KPI-121 Compared to Placebo in Subjects With Dry Eye Disease
NCT ID: NCT02819284
Last Updated: 2021-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
909 participants
INTERVENTIONAL
2016-06-30
2017-09-30
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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KPI-121 0.25% Ophthalmic Suspension
KPI-121 0.25% Ophthalmic Suspension
Vehicle of KPI-121 0.25% Ophthalmic Suspension
Vehicle of KPI-121 0.25% Ophthalmic Suspension
Interventions
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KPI-121 0.25% Ophthalmic Suspension
Vehicle of KPI-121 0.25% Ophthalmic Suspension
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of glaucoma, IOP\>21 mmHg at the screening or randomization visits, or being treated for glaucoma in either eye.
* Diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within 30 days prior to screening.
* In the opinion of the Investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.
18 Years
ALL
No
Sponsors
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Kala Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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UAB School of Optometry
Birmingham, Alabama, United States
Arizona Eye Center
Chandler, Arizona, United States
NEA Baptist Clinic
Jonesboro, Arkansas, United States
Sall Research Medical Center
Artesia, California, United States
Milton M. Hom, OD, FAAO
Azusa, California, United States
Family Eye Care Center
Campbell, California, United States
Orange County Ophthalmology
Garden Grove, California, United States
Lugene Eye Institute
Glendale, California, United States
The Gavin Herbert Eye Institute
Irvine, California, United States
Macy Eye Center
Los Angeles, California, United States
Advanced Vision Care
Los Angeles, California, United States
North Valley Eye Medical Group
Mission Hills, California, United States
Eye Research Foundation
Newport Beach, California, United States
Arch Health Partners
Poway, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Shasta Eye Medical Group, Inc
Redding, California, United States
West Coast Eye Care Associates
San Diego, California, United States
Wolstan & Goldberg Eye Associates
Torrance, California, United States
Michael K Tran, M.D., Inc.
Westminster, California, United States
Hernando Eye Institute
Brooksville, Florida, United States
Central Florida Eye Associates
Lakeland, Florida, United States
Shettle Eye Research, Inc
Largo, Florida, United States
International Eye Associates PA
Ormond Beach, Florida, United States
Perez Eye Center/International Research Center
Tampa, Florida, United States
Eye Care Centers Management, Inc. (Clayton Eye Center)
Morrow, Georgia, United States
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, United States
Price Vision Group
Indianapolis, Indiana, United States
John-Kenyon American Eye Institute
New Albany, Indiana, United States
Cincinnati Eye Institute
Edgewood, Kentucky, United States
Koffler Vision Group
Lexington, Kentucky, United States
The Eye Care Institute
Louisville, Kentucky, United States
Taustine Eye Center
Louisville, Kentucky, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Minnesota Eye Consultants, PA
Bloomington, Minnesota, United States
Tauber Eye Center
Kansas City, Missouri, United States
Tekwani Vision Center
St Louis, Missouri, United States
Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC
Washington, Missouri, United States
Abrams Eye Institute
Las Vegas, Nevada, United States
Raymond Fong, MDPC
New York, New York, United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States
Cornerstone Eye Care
High Point, North Carolina, United States
James D Branch MD
Winston-Salem, North Carolina, United States
Comprehensive Eye Care of Central Ohio
Westerville, Ohio, United States
Drs. Fine, Hoffman & Sims, LLC
Eugene, Oregon, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Bucci Laser Vision Institute
Wilkes-Barre, Pennsylvania, United States
Chattanooga Eye Institute, P.C.
Chattanooga, Tennessee, United States
Total Eye Care, PA
Memphis, Tennessee, United States
Toyos Clinic
Nashville, Tennessee, United States
Texan Eye, PA / Keystone Research, Ltd
Austin, Texas, United States
The Cataract and Glaucoma Center
El Paso, Texas, United States
Houston Eye Associates
Houston, Texas, United States
Advanced Laser Vision & Surgical Institute, Intouch Clinical Research Center
Houston, Texas, United States
Whitsett Vision Group
Houston, Texas, United States
The Ocular Surface Institute (TOSI), University of Houston
Houston, Texas, United States
Brazosport Eye Institute
Lake Jackson, Texas, United States
Kozlovsky Delay & Winter Eye Consultants, LLC
San Antonio, Texas, United States
Hoopes Vision
Draper, Utah, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Regional Eye Associates
Morgantown, West Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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KPI-121-C-007
Identifier Type: -
Identifier Source: org_study_id
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