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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

Study Summary

This trial will look at a new treatment for a type of eye disease and its safety and effectiveness.

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.Check my eligibility

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.See study design

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

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 ECD 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

Do I qualify?Apply below to find out

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: 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

Frequently Asked Questions

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

How hazardous is K-321 to patients' health?

"Our team evaluated K-321's safety using a scale of 1 to 3 and gave it the highest rating because this is an advanced Phase 3 trial with multiple rounds of data substantiating its efficacy as well as its safety."

Answered by AI

What is the aggregate figure of participants in this clinical research?

"Affirmative. Clinicaltrials.gov lists this clinical trial as active and recruiting patients, which commenced on March 30th 2023 and has since been updated. 100 participants are required to be recruited from two separate sites."

Answered by AI

Are there any vacancies in this clinical trial for those seeking treatment?

"Affirmative. On clinicaltrials.gov, the facts demonstrate that this experiment is enlisting participants at present. It was initially advertised on March 30th 2023 and refreshed most recently on April 5th 2023. To meet its research criteria, it requires 100 individuals from two medical sites to join the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)

2023. "A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05795699.

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