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

Summary

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

Timeline

Start

2020-06-23

Primary completion

2021-09-22

Completion

2022-06-27

Outcome

Met primary endpoint

registry analysis (superiority test); K-321 QID vs Placebo; p = 0.0065; Other (Wilcoxon Rank Sum Test) NCT04250207 ↗

registry analysis (superiority test); K-321 BID vs Placebo; p = 0.0344; Other (Wilcoxon Rank Sum Test) NCT04250207 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ripasudil	Small molecule	—	Topical

Indications