Safety and Efficacy of KPI-121 in Subjects With Dry Eye Disease
NCT ID: NCT02813265
Last Updated: 2021-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
918 participants
INTERVENTIONAL
2016-06-30
2017-10-31
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, Intraocular Pressure (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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Little Rock Eye Clinic, LLP
Little Rock, Arkansas, United States
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States
Schwartz Laser Eye Center
Scottsdale, Arizona, United States
Eyecare Arkansas, P.A.
Little Rock, Arkansas, United States
Sall Research Medical Center
Artesia, California, United States
Orange County Ophthalmology Medical Group
Garden Grove, California, United States
United Medical Research Institute
Inglewood, California, United States
North Valley Eye Medical Group
Mission Hills, California, United States
Montebello Medical Center, Inc.
Montebello, California, United States
LoBue Laser and Eye Medical Center
Murrieta, California, United States
Eye Research Foundation
Newport Beach, California, United States
Pendleton Eye Center
Oceanside, California, United States
North Bay Eye Associates, Inc.
Petaluma, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Sacramento Eye Consultants
Sacramento, California, United States
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, United States
Corneal Consultants of Colorado
Littleton, Colorado, United States
The Eye Center of Southern CT, P.C.
Hamden, Connecticut, United States
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, United States
Eye Associates of Fort Myers
Fort Myers, Florida, United States
Shettle Eye Research, Inc.
Largo, Florida, United States
Atlantic Eye Center
Palm Coast, Florida, United States
The Eye Center of North Florida
Panama City, Florida, United States
Dixon Eye Care
Albany, Georgia, United States
Jacksoneye, S. C.
Lake Villa, Illinois, United States
Midwest Cornea Associates, LLC
Indianapolis, Indiana, United States
Stiles EyeCare Excellence and Glaucoma Institute
Overland Park, Kansas, United States
Clinical Eye Research of Boston
Winchester, Massachusetts, United States
Chu Vision Institute
Bloomington, Minnesota, United States
Lifelong Vision Foundation at Pepose Vision Institute
Chesterfield, Missouri, United States
Ophthalmology Associates
St Louis, Missouri, United States
Ophthalmology Consultants, Ltd.
St Louis, Missouri, United States
Wellish Vision Institute
Las Vegas, Nevada, United States
Matossian Eye Associates
Pennington, New Jersey, United States
Rochester Ophthalmological Group, PC
Rochester, New York, United States
Cornea Consultants of Albany
Slingerlands, New York, United States
South Shore Eye Center, LLP
Wantagh, New York, United States
Mundorf Eye Center
Charlotte, North Carolina, United States
Firozvi Research, LLC / North Carolina Eye, Ear, Nose & Throat
Durham, North Carolina, United States
Eyecare Center
Raleigh, North Carolina, United States
Bergstrom Eye Research
Fargo, North Dakota, United States
Abrams Eye Center
Cleveland, Ohio, United States
Opthalamic Surgeons & Consultants of Ohio
Columbus, Ohio, United States
Apex Eye
Mason, Ohio, United States
Roseburg Research Associates, LLC
Roseburg, Oregon, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States
Conestoga Eye
Lancaster, Pennsylvania, United States
UPMC Eye Center
Pittsburgh, Pennsylvania, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Total Eye Care, PA
Memphis, Tennessee, United States
Hill Country Eye Center
Cedar Park, Texas, United States
Houston Eye Associates
Houston, Texas, United States
The Eye Clinic of Texas, Affiliate of Houston Eye Associates
League City, Texas, United States
Lake Travis Eye and Laser Center
Leander, Texas, United States
Eye Clinics of South Texas
San Antonio, Texas, United States
R and R Eye Research, LLC
San Antonio, Texas, United States
Keystone Research - Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Tanner Clinic
Layton, Utah, United States
See Clearly Vision
McLean, Virginia, United States
Virginia Eye Consultants
Norfolk, 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-006
Identifier Type: -
Identifier Source: org_study_id
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