Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation and Pain
NCT ID: NCT02793817
Last Updated: 2020-12-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
520 participants
INTERVENTIONAL
2016-06-30
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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KPI-121 1.0% Ophthalmic Suspension
dosed BID
KPI-121 1% Ophthalmic Suspension dosed BID
Vehicle of KPI-121 Ophthalmic Suspension
dosed BID
Vehicle of KPI-121 Ophthalmic Suspension dosed BID
Interventions
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KPI-121 1% Ophthalmic Suspension dosed BID
Vehicle of KPI-121 Ophthalmic Suspension dosed BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
In Investigator's opinion, potential postoperative Snellen Distance VA by pinhole method of at least 20/200 in study eye.
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; severe/serious systemic disease or uncontrolled medical condition that in judgment of Investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening or 18 days following surgery.
* In the opinion of 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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Arizona Eye Center
Chandler, Arizona, United States
Cornea and Cataract Consultants of CA
Phoenix, Arizona, United States
Sall Research Medical Center
Artesia, California, United States
Orange County Ophthalmology
Garden Grove, California, United States
Lugene Eye Institute
Glendale, California, United States
Inland Eye Specialists
Hemet, California, United States
United Medical Research Institute
Inglewood, California, United States
LoBue Laser and Eye Medical Center
Murrieta, California, United States
Pendleton Eye Center
Oceanside, California, United States
North Bay Eye Associates, Inc.
Petaluma, 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
Eye Center of Northern Colorado, PC
Fort Collins, Colorado, United States
Eye Associates of Fort Myers
Fort Myers, Florida, United States
Levenson Eye Associates
Jacksonville, Florida, United States
Shettle Eye Research, Inc
Largo, Florida, United States
International Research Center
Tampa, Florida, United States
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, United States
Jacksoneye, S. C.
Lake Villa, Illinois, United States
The Eye Care Institute
Louisville, Kentucky, United States
Great Lakes Eye Care
Saint Joseph, Michigan, United States
Minnesota Eye Consultants, PA
Bloomington, Minnesota, United States
Comprehensive Eye Care, Ltd. / Vision Research Institute, LLC
Washington, Missouri, United States
Abrams Eye Institute
Las Vegas, Nevada, United States
Duke University Eye Center
Durham, North Carolina, United States
Apex Eye
Cincinnati, Ohio, United States
Roseburg Research Associates, LLC
Roseburg, Oregon, United States
Eye Care Specialists
Kingston, Pennsylvania, United States
Carolina Cataract & Laser Center
Ladson, South Carolina, United States
Carolina Eyecare Physicians, LLC
Mt. Pleasant, South Carolina, United States
Texan Eye, PA / Keystone Research, Ltd
Austin, Texas, United States
The Cataract & Glaucoma Center
El Paso, Texas, United States
Houston Eye Associates
Houston, Texas, United States
Kozlovsky Delay & Winter Eye Consultants, LLC Corona Research
San Antonio, Texas, 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-005
Identifier Type: -
Identifier Source: org_study_id