Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04250207




Registration number
NCT04250207
Ethics application status
Date submitted
16/01/2020
Date registered
31/01/2020
Date last updated
5/11/2024

Titles & IDs
Public title
Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis
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
Secondary ID [1] 0 0
K-321-201
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 - 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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Central Corneal Endothelial Cell Density (ECD) at Week 12
Timepoint [1] 0 0
Baseline to Week 12
Secondary outcome [1] 0 0
Central Corneal ECD From Baseline to Each Subsequent Visit
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [2] 0 0
Change From Baseline in Central Corneal Thickness
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [3] 0 0
Time to Achievement of no Corneal Oedema of Study Eye
Timepoint [3] 0 0
Baseline to Week 52
Secondary outcome [4] 0 0
Proportion of Patients Who Achieved Central Corneal ECD of 700 Cells/mm2 or More at Each Visit
Timepoint [4] 0 0
Baseline to Week 52
Secondary outcome [5] 0 0
Time to Achieve Central Corneal ECD 700 Cells/mm2 or More
Timepoint [5] 0 0
Up to 52 Weeks
Secondary outcome [6] 0 0
Number of Patients Who Achieved Corneal Thickness Less Than or Equal to Baseline Corneal Thickness
Timepoint [6] 0 0
Baseline up to 52 Weeks
Secondary outcome [7] 0 0
Proportion of Patients Who Achieve No Corneal Oedema of Study Eye by Visit
Timepoint [7] 0 0
Baseline to Week 52
Secondary outcome [8] 0 0
Time to Return of Corneal Thickness to Less Than or Equal to Baseline Cornea Thickness
Timepoint [8] 0 0
Baseline up to Week 52
Secondary outcome [9] 0 0
Percent Change of Central Corneal Thickness From Baseline to Each Subsequent Visit
Timepoint [9] 0 0
Baseline to Week 52

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

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/06/2022
Sample size
Target
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Sydney Eye Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
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
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New Mexico
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
Denmark
State/province [13] 0 0
Capital
Country [14] 0 0
Denmark
State/province [14] 0 0
Aarhus
Country [15] 0 0
Germany
State/province [15] 0 0
Bayern
Country [16] 0 0
Germany
State/province [16] 0 0
Saarland
Country [17] 0 0
Spain
State/province [17] 0 0
Asturias
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
Córdoba

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT04250207