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NCT06048380
The Effects of Ripasudil in Patients With Fuchs Endothelial Corneal Dystrophy Undergoing Femtosecond Laser Assisted Cataract Surgery
Phase 3 trial testing Ripasudil in Fuchs' Endothelial Dystrophy in 120 participants. Currently enrolling.
1 July 2025
Quick facts
| Lead sponsor | Singapore Eye Research Institute |
|---|---|
| Phase | Phase 3 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 120 |
| Start date | 1 March 2025 |
| Primary completion | 1 July 2025 |
| Estimated completion | 1 July 2025 |
| Sites | 1 location across Singapore |
Drugs / interventions tested
- Ripasudil — full drug profile →
- Placebo
Conditions studied
- Fuchs' Endothelial Dystrophy — all drugs for Fuchs' Endothelial Dystrophy →
- Cataract — all drugs for Cataract →
Sponsor
Singapore Eye Research Institute
Who can join
Adults 50 to 100, any sex, with Fuchs' Endothelial Dystrophy or Cataract. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Average endothelial cell density (ECD) is higher in participants in treatment group than participants in placebo.
Time frame: 3 months
The ECD at 15 different locations of the cornea is measured with a widefield specular microscope. This assessment will be done pre-surgery, Week 1, Week 2, Week 3, 1 month, 3 months post-surgery.
Sponsor's own description
The purpose of this research is to investigate the effects of ripasudil administered as an ophthalmic solution in patients with FED after femtosecond laser assisted cataract surgery. The secondary aim is to identity the characteristics of patients who will benefit the most with the use of ripasudil based on the test results obtained from this study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06048380
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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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
- NCT05528172 — A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery · Phase 3 · completed
Other recruiting trials for Fuchs' Endothelial Dystrophy
Currently open trials in the same condition.
- NCT06261346 — Plasma Rich in Growth Factors in Corneal Endothelial Transplantation · NA · recruiting
- NCT06881771 — FECD-TRACE: Fuchs' Endothelial Corneal Dystrophy TRAjectory and Correlation With Genotype in the United Kingdom · recruiting
- 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
- NCT05436665 — The Belgian Endothelial Surgical Transplant of the Cornea · NA · recruiting
Other Singapore Eye Research Institute trials
Trials by the same sponsor.
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- NCT06967792 — Evaluation of the Safety of Terahertz Scanning System on Corneas · recruiting
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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 NCT06048380 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Singapore Eye Research Institute
- Last refreshed: 27 January 2025
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/NCT06048380.