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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
Pivotal Trial

Summary

This trial tests K-321 to see if it helps people recover better after cataract surgery. It focuses on ensuring the treatment is safe and effective for these patients.

Eligible Conditions
  • Swelling of the cornea

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Central Corneal Endothelial Cell Density (ECD) at Week 12
Secondary study objectives
Change in Best-Corrected Visual Acuity (BCVA)
Change in Central Corneal ECD
Change in Corneal Thickness
+6 more

Awards & Highlights

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

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

Find a Location

Who is running the clinical trial?

Kowa Research Institute, Inc.Lead Sponsor
45 Previous Clinical Trials
16,015 Total Patients Enrolled
Shona Pendse, MD, MMScStudy ChairKowa Pharma Development Co.
5 Previous Clinical Trials
493 Total Patients Enrolled
~99 spots leftby Dec 2025
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