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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04250207
Registration number
NCT04250207
Ethics application status
Date submitted
16/01/2020
Date registered
31/01/2020
Date last updated
22/09/2022
Titles & IDs
Public title
Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis
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Scientific title
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
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Secondary ID [1]
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K-321-201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fuchs' Endothelial Corneal Dystrophy
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - K-321 Solution
Treatment: Drugs - Placebo Solution
Experimental: K-321 QID - K-321 Ophthalmic Solution Dose A
Experimental: K-321 BID - K-321 Ophthalmic Solution Dose B
Placebo Comparator: Placebo - Vehicle Solution Dose
Treatment: Drugs: K-321 Solution
K-321 solution drops
Treatment: Drugs: Placebo Solution
Placebo solution drops for K-321
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Corneal Central ECD Measure at 12 weeks
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Assessment method [1]
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Change in Central Endothelial Cell Density
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Timepoint [1]
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12 Weeks
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Secondary outcome [1]
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Safety Assessment
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Assessment method [1]
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Number of participants with at least one adverse event
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Timepoint [1]
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52 Weeks
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/06/2022
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Sample size
Target
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Accrual to date
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Final
65
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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Sydney Eye Hospital - Sydney
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Recruitment hospital [2]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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2000 - Sydney
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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Illinois
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Indiana
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Massachusetts
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Michigan
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Minnesota
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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Ohio
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Oregon
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United States of America
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Pennsylvania
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Denmark
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Capital
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Denmark
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Aarhus
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Germany
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Bayern
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Germany
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Saarland
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Spain
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Asturias
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Spain
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State/province [18]
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Barcelona
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Country [19]
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Spain
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State/province [19]
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Córdoba
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Kowa Research Institute, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of this study is to investigate the effect of K-321 in patients with Fuchs
endothelial corneal dystrophy (FECD) after descemetorhexis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04250207
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Shona Pendse, MD, MMSc
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Address
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Kowa Pharma Development Co.
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Fax
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04250207
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