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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
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
16,246 Total Patients Enrolled
Shona Pendse, MD, MMScStudy ChairKowa Pharma Development Co.
5 Previous Clinical Trials
724 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Fuchs' Endothelial Corneal Dystrophy.I am a woman who can have children and am using effective birth control.I had cataract surgery on one eye within the last 90 days.I am pregnant or breastfeeding.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: K-321
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.