NCT05826353

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)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A study to assess the safety and efficacy of K-321 in participants with FECD after simultaneous cataract surgery and descemetorhexis.

Conditions

• Fuchs Endothelial Corneal Dystrophy

Interventions

Type	Name	Description
DRUG	Ripasudil	K-321 ophthalmic solution
DRUG	Placebo	Placebo ophthalmic solution

Timeline

• Start date: 2023-05-11
• Primary completion: 2025-01-17
• Completion: 2025-10-24
• First posted: 2023-04-24
• Last updated: 2026-01-22

Locations

43 sites across 6 countries: United States, Canada, Denmark, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study