Eligibility
18+
All Sexes
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Study Summary
The purpose of this study is to assess the safety and efficacy of K-321 in subjects after cataract surgery
Eligible Conditions
- Corneal Edema After Cataract Surgery
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 6 Secondary · Reporting Duration: Baseline to Week 26
Baseline to Week 26
Change from baseline in Best-Corrected Visual Acuity (BCVA)
Change from baseline in Central Corneal Endothelial Cell Density (ECD)
Change from baseline in Corneal Thickness
Change from baseline in Peripheral Corneal ECD
Change in Vision-related quality of life
Safety Assessment
Week 26
Change from baseline in corneal edema
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
4 Treatment Groups
Group B
1 of 4
Group A
1 of 4
Group C
1 of 4
Group D
1 of 4
Experimental Treatment
Non-Treatment Group
330 Total Participants · 4 Treatment Groups
Primary Treatment: Group B · Has Placebo Group · Phase 3
Group B
Drug
Experimental Group · 1 Intervention: Ripasudil · Intervention Types: DrugGroup A
Drug
Experimental Group · 1 Intervention: Ripasudil · Intervention Types: DrugGroup C
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugGroup D
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 26
Closest Location: Durrie Vision · Overland Park, KS
2011First Recorded Clinical Trial
1 TrialsResearching Corneal Edema After Cataract Surgery
15 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are at least 18 years old.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments