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Rho Kinase Inhibitor

K-321 Eye Drops for Fuchs' Dystrophy

Phase 3
Recruiting
Research Sponsored by Kowa Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights
Pivotal Trial

Summary

This trial is testing K-321 to help people with an eye condition called FECD recover after a corneal procedure. The treatment aims to support the growth and repair of eye cells.

Who is the study for?
This trial is for adults over 18 with Fuchs Endothelial Corneal Dystrophy (FECD) who have not had cataract surgery in the last 90 days. Women must not be pregnant, breastfeeding, or of childbearing potential unless using effective birth control or are surgically sterile/post-menopausal.
What is being tested?
The study tests K-321 eye drops' safety and effectiveness on patients with FECD after a procedure called descemetorhexis. Participants will either receive Ripasudil (K-321) or a placebo to compare outcomes.
What are the potential side effects?
While specific side effects for K-321 aren't detailed here, common side effects from similar eye drop treatments include eye irritation, discomfort, redness, blurred vision, and possible allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Central corneal ECD at Week 12

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: K-321Experimental Treatment1 Intervention
K-321 ophthalmic solution four times daily (QID) for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase
Group II: PlaceboPlacebo Group1 Intervention
Placebo ophthalmic solution QID for 12 weeks followed by a two-week gradual dose taper phase and 38-week follow-up phase
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ripasudil
2022
Completed Phase 3
~340

Find a Location

Who is running the clinical trial?

Kowa Research Institute, Inc.Lead Sponsor
45 Previous Clinical Trials
16,236 Total Patients Enrolled
Shona Pendse, MD, MMScStudy ChairKowa Pharma Development Co.
5 Previous Clinical Trials
714 Total Patients Enrolled

Media Library

Ripasudil (Rho Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05795699 — Phase 3
Fuchs' Dystrophy Research Study Groups: Placebo, K-321
Fuchs' Dystrophy Clinical Trial 2023: Ripasudil Highlights & Side Effects. Trial Name: NCT05795699 — Phase 3
Ripasudil (Rho Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05795699 — Phase 3
~40 spots leftby Oct 2025
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