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

Registry ID

K-321-303

Source registry

HEALTH_CANADA

Status

Closed

Phase

PHASE3

Study type

INTERVENTIONAL

Sponsor

KOWA RESEARCH INSTITUTE, INC

Start date

2025-03-24

Completion date

2026-03-16

Last update

2023-05-29

Conditions

• FUCHS ENDOTHELIAL CORNEAL DYSTROPHY

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• 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 DESCEMETORHEXIS IN SUBJECTS WITH FUCHS ENDOTHELIAL CORNEAL DYSTROPHY

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