Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis
NCT ID: NCT04250207
Last Updated: 2024-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
65 participants
INTERVENTIONAL
2020-06-23
2022-06-27
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-321 QID
K-321 Ophthalmic Solution Dose A
K-321 Solution
K-321 solution drops
K-321 BID
K-321 Ophthalmic Solution Dose B
K-321 Solution
K-321 solution drops
Placebo Solution
Placebo solution drops for K-321
Placebo
Vehicle Solution Dose
Placebo Solution
Placebo solution drops for K-321
Interventions
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K-321 Solution
K-321 solution drops
Placebo Solution
Placebo solution drops for K-321
Eligibility Criteria
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Inclusion Criteria
* Has a diagnosis of FECD at Visit 1.
Exclusion Criteria
* Has a study eye with a history of any previous ocular surgery other than for cataract.
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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Shona Pendse, MD, MMSc
Role: STUDY_CHAIR
Kowa Pharma Development Co.
Locations
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Jules Stein Eye Institute
Los Angeles, California, United States
Byers Eye Institute at Stanford
Palo Alto, California, United States
UC Davis Eye Center
Sacramento, California, United States
Sacramento Eye Consultants
Sacramento, California, United States
Gorovoy MD Eye Specialists
Fort Myers, Florida, United States
UF Health Eye Center
Gainesville, Florida, United States
Chicago Cornea Consultants Ltd
Hoffman Estates, Illinois, United States
Arbor Centers For Eyecare
Orland Park, Illinois, United States
Price Vision Group
Indianapolis, Indiana, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
W Kellogg Eye Center
Ann Arbor, Michigan, United States
Minnesota Eye Consultants
Bloomington, Minnesota, United States
Eye Associates of New Mexico
Albuquerque, New Mexico, United States
NY Langone Health
New York, New York, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Devers Eye Institute
Portland, Oregon, United States
Casey Eye Institute - OHSU
Portland, Oregon, United States
Vantage EyeCare, LLC
Bala-Cynwyd, Pennsylvania, United States
UPMC Eye Center
Pittsburgh, Pennsylvania, United States
Sydney Eye Hospital
Sydney, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Rigshospitalet - Glostrup
Glostrup Municipality, Capital, Denmark
Aarhus Universitetshospital
Aarhus, , Denmark
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
Universität des Saarlandes
Homburg, Saarland, Germany
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Instituto Ophthalmologic Fernandez Vega
Oviedo, Principality of Asturias, Spain
Instituto de Microcirugia Ocular
Barcelona, , Spain
Hospital La Arruzafa
Córdoba, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol: Ver. 1.0
Document Type: Study Protocol: Ver. 2.0
Document Type: Statistical Analysis Plan: Ver. 1.0
Document Type: Statistical Analysis Plan: Ver. 2.0
Document Type: Statistical Analysis Plan: Ver. 2.0 Addendum
Other Identifiers
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K-321-201
Identifier Type: -
Identifier Source: org_study_id
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