NCT04250207

Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Kowa Research Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis.

Conditions

• Fuchs' Endothelial Corneal Dystrophy

Interventions

Type	Name	Description
DRUG	K-321 Solution	K-321 solution drops
DRUG	Placebo Solution	Placebo solution drops for K-321

Timeline

• Start date: 2020-06-23
• Primary completion: 2021-09-22
• Completion: 2022-06-27
• First posted: 2020-01-31
• Last updated: 2024-11-05
• Results posted: 2024-11-05

Locations

29 sites across 5 countries: United States, Australia, Denmark, Germany, Spain

Regulatory

• FDA-regulated drug study