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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

Is at least 18 years old at the screening visit (Visit 1)

Has a diagnosis of FECD at Visit 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 12

Awards & highlights

Study Summary

This trial tests a new eye drug to treat FECD after eye surgery.

Who is the study for?

This trial is for adults over 18 with Fuchs Endothelial Corneal Dystrophy (FECD) who are undergoing cataract surgery and descemetorhexis. Participants must meet all other criteria specified in the study protocol.Check my eligibility

What is being tested?

The trial is testing K-321 eye drops to see if they're safe and effective when used after cataract surgery and descemetorhexis in patients with FECD, compared to a placebo.See study design

What are the potential side effects?

Potential side effects of K-321 eye drops may include discomfort in the eyes, redness, or changes in vision. The exact side effects will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been diagnosed with Fuchs' dystrophy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 12

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Central corneal Endothelial Cell Density (ECD) (cells/mm2) at Week 12

Time to achievement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks

Time to improvement in best corrected (distance) visual acuity (BCVA) by ETDRS letter score during the first 12 weeks

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kowa Research Institute, Inc.Lead Sponsor

44 Previous Clinical Trials

16,320 Total Patients Enrolled

Shona Pendse, MD, MMScStudy ChairKowa Pharma Development Co.

5 Previous Clinical Trials

814 Total Patients Enrolled

Media Library

Ripasudil (Rho Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05826353 — Phase 3

Fuchs' Dystrophy Research Study Groups: K-321, Placebo

Fuchs' Dystrophy Clinical Trial 2023: Ripasudil Highlights & Side Effects. Trial Name: NCT05826353 — Phase 3

Ripasudil (Rho Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05826353 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned K-321 for public consumption?

"After assessing the available data, our team at Power has assigned K-321 a score of 3 on the safety scale. This designation reflects that this Phase 3 trial offers evidence for both efficacy and multiple rounds affirming its security."

Answered by AI

Which number of participants is being admitted to the clinical trial?

"Affirmative. The information located on clinicaltrials.gov reveals that this medical trial has been actively calling for participants since the 11th of May and is still accepting applications today. Two sites are recruiting 100 individuals altogether."

Answered by AI

Is enrollment being accepted for this experiment?

"Correct. Clinicaltrials.gov confirms that this medical study, which was first posted on May 11th 2023, is actively recruiting participants. Around 100 individuals are needed from 2 separate clinical sites."

Answered by AI

Who else is applying?

What site did they apply to?

Macy Eye Center

What portion of applicants met pre-screening criteria?

Met criteria

Why did patients apply to this trial?

I have Fuchs Dystrophy and my eye is declining. I’m not as bad as some but hope to delay the progression of the disease. My father had two cornea transplants later in his life and I’m hoping to avoid that if possible.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

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)

2023. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05826353.

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