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Clinical trial

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

ID
Name
K-321-303
Description
A study to assess the safety and efficacy of K-321 in participants with FECD after simultaneous cataract surgery and descemetorhexis.
Trial arms
Trial start
2023-05-11
Estimated PCD
2024-06-01
Trial end
2025-01-01
Status
Recruiting
Phase
Early phase I
Treatment
Ripasudil
K-321 ophthalmic solution
Arms:
K-321
Other names:
K-321
Placebo
Placebo ophthalmic solution
Arms:
Placebo
Size
100
Primary endpoint
Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks
Baseline to Week 12
Eligibility criteria
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. 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-04-18

1 organization

1 product

1 drug

1 indication

Organization
Kowa Research Institute
Product
Ripasudil
Indication
Fuchs Endothelial Corneal Dystrophy
Drug
Varlilumab