- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04250207
Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis
September 20, 2022 updated by: Kowa Research Institute, Inc.
A Double-Masked, Randomised, Placebo-Controlled, Parallel-Group, 12 Week, Phase 2 Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Patients With Fuchs Endothelial Corneal Dystrophy
The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Sydney, New South Wales, Australia, 2000
- Sydney Eye Hospital
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South Australia
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Adelaide, South Australia, Australia, 5000
- Royal Adelaide Hospital
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Aarhus, Denmark, 8200
- Aarhus Universitetshospital
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Capital
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Glostrup, Capital, Denmark, 2600
- Rigshospitalet - Glostrup
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Bayern
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Erlangen, Bayern, Germany, 91054
- Universitätsklinikum Erlangen
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Saarland
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Homburg, Saarland, Germany, 66421
- Universität des Saarlandes
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Barcelona, Spain, 8035
- Instituto de Microcirugia Ocular
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Córdoba, Spain, 14012
- Hospital La Arruzafa
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Asturias
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Oviedo, Asturias, Spain, 33012
- Instituto Ophthalmologic Fernandez Vega
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Barcelona
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Badalona, Barcelona, Spain, 08916
- Hospital Universitario Germans Trias i Pujol
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California
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Los Angeles, California, United States, 90095
- Jules Stein Eye Institute
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Palo Alto, California, United States, 94304
- Byers Eye Institute at Stanford
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Sacramento, California, United States, 95817
- UC Davis Eye Center
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Sacramento, California, United States, 98515
- Sacramento Eye Consultants
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Florida
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Fort Myers, Florida, United States, 33907
- Gorovoy MD Eye Specialists
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Gainesville, Florida, United States, 32605
- UF Health Eye Center
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Illinois
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Hoffman Estates, Illinois, United States, 60169
- Chicago Cornea Consultants Ltd
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Orland Park, Illinois, United States, 60467
- Arbor Centers For Eyecare
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Indiana
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Indianapolis, Indiana, United States, 46260
- Price Vision Group
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts Eye and Ear Infirmary
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Michigan
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Ann Arbor, Michigan, United States, 48105
- W Kellogg Eye Center
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Minnesota
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Bloomington, Minnesota, United States, 55431
- Minnesota Eye Consultants
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New Mexico
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Albuquerque, New Mexico, United States, 87109
- Eye Associates of New Mexico
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New York
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New York, New York, United States, 10017
- NY Langone Health
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Ohio
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Cincinnati, Ohio, United States, 45242
- Cincinnati Eye Institute
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Oregon
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Portland, Oregon, United States, 97210
- Devers Eye Institute
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Portland, Oregon, United States, 97239
- Casey Eye Institute - OHSU
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Pennsylvania
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Bala-Cynwyd, Pennsylvania, United States, 19004
- Vantage EyeCare, LLC
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Pittsburgh, Pennsylvania, United States, 15213
- UPMC Eye Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Is at least 18 years old at the screening visit (Visit 1).
- Has a diagnosis of FECD at Visit 1.
- Meet all other inclusion criteria outlined in clinical study protocol.
Exclusion Criteria:
- Has a study eye with a history of cataract surgery within 90 days of Visit 1.
- Has a study eye with a history of any previous ocular surgery other than for cataract.
- Meet any other exclusion criteria outlined in clinical study protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: K-321 QID
K-321 Ophthalmic Solution Dose A
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K-321 solution drops
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Experimental: K-321 BID
K-321 Ophthalmic Solution Dose B
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K-321 solution drops
Placebo solution drops for K-321
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Placebo Comparator: Placebo
Vehicle Solution Dose
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Placebo solution drops for K-321
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Corneal Central ECD Measure at 12 weeks
Time Frame: 12 Weeks
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Change in Central Endothelial Cell Density
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12 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Assessment
Time Frame: 52 Weeks
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Number of participants with at least one adverse event
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52 Weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Shona Pendse, MD, MMSc, Kowa Pharma Development Co.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 23, 2020
Primary Completion (Actual)
September 22, 2021
Study Completion (Actual)
June 27, 2022
Study Registration Dates
First Submitted
January 16, 2020
First Submitted That Met QC Criteria
January 29, 2020
First Posted (Actual)
January 31, 2020
Study Record Updates
Last Update Posted (Actual)
September 22, 2022
Last Update Submitted That Met QC Criteria
September 20, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- K-321-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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