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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)
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
Secondary ID [1] 0 0
K-321-303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fuchs Endothelial Corneal Dystrophy 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [2] 0 0
Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Timepoint [2] 0 0
Baseline to Week 12
Secondary outcome [3] 0 0
Central corneal Endothelial Cell Density (ECD) (cells/mm2) at Week 12
Timepoint [3] 0 0
Week 12

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Dr. Greg Moloney - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Nebraska
Country [5] 0 0
United States of America
State/province [5] 0 0
New Mexico
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Dakota
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Oregon
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Wisconsin
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Denmark
State/province [13] 0 0
Capital
Country [14] 0 0
Denmark
State/province [14] 0 0
Central Jutland
Country [15] 0 0
Germany
State/province [15] 0 0
Baden-Württemberg
Country [16] 0 0
Germany
State/province [16] 0 0
Bayern
Country [17] 0 0
Germany
State/province [17] 0 0
Nordrhein-Westfalen
Country [18] 0 0
Germany
State/province [18] 0 0
Saarland
Country [19] 0 0
Spain
State/province [19] 0 0
Asturias
Country [20] 0 0
Spain
State/province [20] 0 0
Barcelona
Country [21] 0 0
Spain
State/province [21] 0 0
Córdoba
Country [22] 0 0
Spain
State/province [22] 0 0
Girona
Country [23] 0 0
United Kingdom
State/province [23] 0 0
London, City Of
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Merseyside
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Tyne And Wear

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kowa Research Institute, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A study to assess the safety and efficacy of K-321 in participants with FECD after
simultaneous cataract surgery and descemetorhexis.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05826353
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Shona Pendse, MD, MMSc
Address 0 0
Kowa Pharma Development Co.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Director, Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
919-433-1621
Fax 0 0
Email 0 0
StudyRecruitment@KowaUS.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05826353