A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease
NCT ID: NCT05403827
Last Updated: 2025-01-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
644 participants
INTERVENTIONAL
2022-07-03
2023-12-05
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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K-161
K-161 Ophthalmic Solution
K-161
K-161 Ophthalmic Solution
Placebo
Vehicle Solution
Placebo
Vehicle Solution
Interventions
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K-161
K-161 Ophthalmic Solution
Placebo
Vehicle Solution
Eligibility Criteria
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Inclusion Criteria
* Have a reported history of dry eye disease in both eyes and a history of eye drop use for dry eye symptom
Exclusion Criteria
* Have a history of corneal refractive surgery and/or any other ocular surgical procedure within 12 months
18 Years
ALL
No
Sponsors
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Kowa Research Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Andrey E. Belous, MD, PhD
Role: STUDY_CHAIR
Kowa Pharma Development Co.
Locations
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The University of Alabama at Birmingham School of Optometry, Clinical Eye Research Center
Birmingham, Alabama, United States
Trinity Research Group
Dothan, Alabama, United States
Cornea and Cataract Consultants of Arizona
Phoenix, Arizona, United States
Citrus Valley Eyecare / Premiere Practice Management, LLC
Covina, California, United States
Orange County Ophthalmology Medical Group
Garden Grove, California, United States
Global Research Management
Glendale, California, United States
Inland Eye Specialists
Hemet, California, United States
United Medical Research Institute
Inglewood, California, United States
Premiere Practice Management, LLC
Los Angeles, California, United States
North Valley Eye Medical Group, Inc
Mission Hills, California, United States
LoBue Laser and Eye Medical Center
Murrieta, California, United States
Eye Research Foundation, Inc.
Newport Beach, California, United States
Pendleton Eye Center
Oceanside, California, United States
Martel Eye Medical Group
Rancho Cordova, California, United States
Sierra Clinical Trial Research Organization
Santa Ana, California, United States
Premiere Practice Management, LLC
Torrance, California, United States
Wolstan and Goldberg Eye Associates
Torrance, California, United States
Vision Institute
Colorado Springs, Colorado, United States
Corneal Consultants of Colorado dba Colorado Eye Consultants
Littleton, Colorado, United States
Segal Drug Trials
Delray Beach, Florida, United States
Bowden Eye & Associates
Jacksonville, Florida, United States
Shettle Eye Research, Inc.
Largo, Florida, United States
International Research Center
Tampa, Florida, United States
Dixophthal, PC.
Albany, Georgia, United States
Edwin Yoshio Endo, OD & Associates & Interns
‘Aiea, Hawaii, United States
Chicago Cornea Consultants
Hoffman Estates, Illinois, United States
Jones Eye Clinic and Surgery Center
Sioux City, Iowa, United States
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, United States
Midwest Vision Research Foundation at Pepose Vision Institute
Chesterfield, Missouri, United States
Tauber Eye Center
Kansas City, Missouri, United States
Tekwani Vision Center
St Louis, Missouri, United States
Ophthalmology Associates
St Louis, Missouri, United States
Comprehensive Eye Care, Ltd.
Washington, Missouri, United States
Wellish Vision Institute
Las Vegas, Nevada, United States
Asheville Eye Associates
Asheville, North Carolina, United States
Oculus Research
Garner, North Carolina, United States
Wake Forest Health Network, LLC
High Point, North Carolina, United States
Insight Research Clinic, LLC dba EyeCare Professionals
Powell, Ohio, United States
Conestoga Eye PC
Lancaster, Pennsylvania, United States
Associates in Ophthalmology Ltd
West Mifflin, Pennsylvania, United States
West Bay Eye Associates
Warwick, Rhode Island, United States
Total Eye Care, PA
Memphis, Tennessee, United States
Advancing Vision Research
Smyrna, Tennessee, United States
Keystone Research
Austin, Texas, United States
Hill Country Eye Center
Cedar Park, Texas, United States
Southwest Eye Institute
El Paso, Texas, United States
Lake Travis Eye and Laser Center/Revolution Research
Lakeway, Texas, United States
R and R Eye Research, LLC
San Antonio, Texas, United States
DCT-Shah Research, LLC dba Discovery Clinical Trials
San Antonio, Texas, United States
Northern Virginia Ophthalmology Associates
Falls Church, Virginia, United States
Virginia Eye Consultants, Inc.
Norfolk, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol: Initial
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Statistical Analysis Plan: Ver 1.0
Document Type: Statistical Analysis Plan: ver 1.0 Addendum
Other Identifiers
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K-161-3.01
Identifier Type: -
Identifier Source: org_study_id
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