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NCT05528172
A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery
Phase 3 trial testing Ripasudil in Corneal Edema After Cataract Surgery in 331 participants. Completed in 22 June 2023.
22 June 2023
Quick facts
| Lead sponsor | Kowa Research Institute, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 331 |
| Start date | 4 August 2022 |
| Primary completion | 22 June 2023 |
| Estimated completion | 22 June 2023 |
| Sites | 45 locations across Puerto Rico, United States |
Drugs / interventions tested
- Ripasudil — full drug profile →
- Placebo
Conditions studied
- Corneal Edema After Cataract Surgery — all drugs for Corneal Edema After Cataract Surgery →
Sponsor
Kowa Research Institute, Inc. — full company profile →
Who can join
18 and older, any sex, with Corneal Edema After Cataract Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the safety and efficacy of K-321 in subjects after cataract surgery
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Exploring the Role of ROCK Inhibition in Corneal Edema Through Crosstalk Between Epithelial and Endothelial Cells.
Yi LY, Hsieh HH, Lin ZQ, Hung KF, et al · · 2024 · cited 4× · PMID 39534682 · DOI 10.1155/2024/9381303
Verify or expand the search:
- PubMed search for NCT05528172
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ripasudil
Trials testing the same drug.
- NCT05826353 — A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexi · Phase 3 · completed
- NCT05795699 — A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothel · Phase 3 · completed
- NCT05275972 — Descemet Endothelial Thickness Comparison Trial II · Phase 3 · recruiting
- NCT05636579 — Study to Assess Safety and Tolerability of Multiple Doses of EO2002 · Phase 1 · recruiting
Other Kowa Research Institute, Inc. trials
Trials by the same sponsor.
- NCT06525311 — A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis · Phase 1 · completed
- NCT05826353 — A Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Simultaneous Cataract Surgery and Descemetorhexi · Phase 3 · completed
- NCT05795699 — A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothel · Phase 3 · completed
- NCT05722262 — Study to Demonstrate the Bioequivalence of Single Oral Administration of K-001 Relative to Single Oral Coadministration · Phase 1 · completed
- NCT05327127 — Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis · Phase 2 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05528172 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kowa Research Institute, Inc.
- Last refreshed: 24 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05528172.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing