CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
K-321 Solution +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04250207
NCT04250207Phase 2Completed

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

Kowa Research Institute, Inc.·interventional·Posted Jan 31, 2020·Updated Nov 5, 2024

In Brief

A Phase 2 clinical trial evaluating K-321 Solution and Placebo Solution for Fuchs' Endothelial Corneal Dystrophy. Completed, enrolled 65 participants across 29 sites in 5 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Denmark, Germany, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 31, 2020
Enrollment StartJun 23, 2020
Primary CompletionSep 22, 2021
Study CompletionJun 27, 2022
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.4 years ago

Interventions

K-321 Solutiondrug

K-321 solution drops

Placebo Solutiondrug

Placebo solution drops for K-321