NCT05528172

A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery

A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Treatment and 14-week Extension, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and efficacy of K-321 in subjects after cataract surgery

Conditions

• Corneal Edema After Cataract Surgery

Interventions

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

Timeline

• Start date: 2022-08-04
• Primary completion: 2023-06-22
• Completion: 2023-06-22
• First posted: 2022-09-06
• Last updated: 2024-05-24

Locations

45 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study