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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/NCT05826353
Registration number
NCT05826353
Ethics application status
Date submitted
6/04/2023
Date registered
24/04/2023
Date last updated
25/01/2024
Titles & IDs
Public title
A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)
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Scientific title
A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Administration With Two-Week Gradual Dose Taper Phase and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Subjects With Fuchs Endothelial Corneal Dystrophy
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Secondary ID [1]
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K-321-303
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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 - Ripasudil
Treatment: Drugs - Placebo
Experimental: K-321 - K-321 ophthalmic solution four times daily (QID) for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase
Placebo Comparator: Placebo - Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase
Treatment: Drugs: Ripasudil
K-321 ophthalmic solution
Treatment: Drugs: Placebo
Placebo ophthalmic solution
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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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Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
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Assessment method [1]
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Timepoint [1]
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Baseline to Week 12
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Secondary outcome [1]
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Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
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Assessment method [1]
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Timepoint [1]
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Baseline to Week 12
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Secondary outcome [2]
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Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
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Assessment method [2]
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Timepoint [2]
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Baseline to Week 12
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Secondary outcome [3]
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Central corneal Endothelial Cell Density (ECD) (cells/mm2) at Week 12
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Assessment method [3]
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Central corneal endothelial cell images will be captured by non-contact specular microscopy.
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Timepoint [3]
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Week 12
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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 the 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
- Is a female subject of childbearing potential and any of the following is true:
1. is pregnant or lactating/breastfeeding, or
2. is not surgically sterile, not post-menopausal (no menses for the previous 12
months), or not practicing an effective method of birth control as determined by
the Investigator (eg, oral contraceptives, double barrier methods, hormonal
injectable or implanted contraceptives, tubal ligation, or partner with
vasectomy)
- Meet any other exclusion criteria outlined in the 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 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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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
11/05/2023
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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
1/01/2025
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Dr. Greg Moloney - Sydney
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Recruitment postcode(s) [1]
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2000 - Sydney
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Florida
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Michigan
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Nebraska
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New Mexico
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New York
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North Dakota
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Ohio
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Ontario
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Denmark
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Capital
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Denmark
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Central Jutland
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Germany
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Baden-Württemberg
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Germany
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Bayern
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Germany
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Nordrhein-Westfalen
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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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Barcelona
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Spain
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Córdoba
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Spain
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Girona
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United Kingdom
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London, City Of
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United Kingdom
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Merseyside
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United Kingdom
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Tyne And Wear
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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
A study to assess the safety and efficacy of K-321 in participants with FECD after
simultaneous cataract surgery and descemetorhexis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05826353
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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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Email
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Contact person for public queries
Name
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Director, Clinical Operations
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Address
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Phone
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919-433-1621
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05826353
Download to PDF