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Ripasudil Eye Drops for Cataract Surgery

Phase 3

Waitlist Available

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 baseline to week 26

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective in people who have had cataract surgery.

Eligible Conditions

Corneal Edema After Cataract Surgery

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 26 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Central Corneal Endothelial Cell Density (ECD) at Week 12

Secondary outcome measures

Change in Best-Corrected Visual Acuity (BCVA)

Change in Central Corneal ECD

Change in Corneal Thickness

+6 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Group BExperimental Treatment1 Intervention

Participants receive K-321 ophthalmic solution Four times daily(QID) for 12 Weeks followed by a 14 week follow-up period with no treatment.

Group II: Group AExperimental Treatment1 Intervention

Participants receive K-321 ophthalmic solution Four times daily(QID) for 12 Weeks followed by a 4 week follow-up period with no treatment.

Group III: Group CPlacebo Group1 Intervention

Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 4 week follow-up period with no treatment.

Group IV: Group DPlacebo Group1 Intervention

Participants will receive K-321 Placebo ophthalmic solution QID for 12 Weeks followed by a 14 week follow-up period with no treatment.

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

16,089 Total Patients Enrolled

Shona Pendse, MD, MMScStudy ChairKowa Pharma Development Co.

5 Previous Clinical Trials

583 Total Patients Enrolled

Frequently Asked Questions

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

Has Ripasudil undergone the FDA's drug approval process?

"There is both efficacy and safety data available for Ripasudil, thus it was given a score of 3."

Answered by AI

How many different research facilities are conducting this clinical trial?

"There are a total of 14 running clinical trials for this medication, which can be found at Icon Eye Care in Grand Junction, Silverstein Eye Centers, P.C. in Kansas City, Wolstan and Goldberg Eye Associates in Torrance, and other locations."

Answered by AI

What is the ceiling for how many people can join this research project?

"The sponsor, Kowa Research Institute, Inc., requires 330 patients that fit the bill in order to run this clinical trial which will take place in different states. Two locations for this study are Icon Eye Care in Grand Junction, Colorado and Silverstein Eye Centers, P.C. in Kansas City, Missouri."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery

2022. "A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05528172.

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