MedTrace Logo

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)

NCT05826353 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-01-22

No results posted yet for this study

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

DRUG

Ripasudil

K-321 ophthalmic solution

DRUG

Placebo

Placebo ophthalmic solution

Sponsors & Collaborators

  • Kowa Research Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Shona Pendse, MD, MMSc · Kowa Pharma Development Co.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-11
Primary Completion
2025-01-17
Completion
2025-10-24
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05826353 on ClinicalTrials.gov