A Phase 3 interventional study of Ripasudil and Placebo in Fuchs' Endothelial Dystrophy and Cataract, sponsored by Singapore Eye Research Institute. Recruiting at 1 site in Singapore. Open to participants aged 50 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-01-29.
Sponsored by Singapore Eye Research Institute · Phase 3, Interventional, and Prevention
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.
Patients with Fuch's Corneal Endothelial Dystrophy and undergoing femtosecond laser-assisted cataract surgery will be recruited for this study. They will be randomly assigned into treatment or placebo group.
The investigators hypothesize that the ROCK inhibitor ripasudil 0.4% helps maintain corneal endothelial functional integrity and reduce cell loss after cataract surgery in patients with FED.
To test the hypothesis, the investigators plan to conduct a randomized clinical trial which aims to:
92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.
Browse Fuchs' Endothelial Dystrophy studies →Singapore Eye Research Institute is the lead sponsor of 27 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will be asked to instill Glanatec Ophthalmic Solution (containing Ripasadil 0.4%) 4 times a day for 1 month following cataract removal surgery.
Drug: Ripasudil
Participants in this group will be asked to instill saline solution 4 times a day for 1 month following cataract removal surgery.
Other: Placebo
Glanatec Ophthalmic Solution 0.4% W/V with ripasudil hydrochloride hydrate as active ingredient is currently being used by patients with ocular hypertension or open-angle glaucoma. Inhibition of Rho kinase to facilitate aqueous outflow from the conventional outflow pathway via the trabecular meshwork and Schlemm's canal has been suggested as the IOP-lowering mechanism of action by ripasudil.
Also known as: Glanatec
Saline eye drops
Average endothelial cell density (ECD) is higher in participants in treatment group than participants in placebo.
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.
Time frame: 3 months
To monitor for conjunctival hyperemia in participants in treatment group.
The Cornea and Contact Lens Research Unit (CCLRU) grading scale will be used as an objective assessment guideline for grading conjunctival hyperaemia. The investigators will grade the conjunctival hyperemia This assessment will be done pre-surgery, Week 1, Week 2, Week 3, 1 month, 3 months post-surgery.
Time frame: 3 months
Plan to share: No
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Studies of the drug tested here: K-115
Fuchs' Endothelial Dystrophy →
Singapore Eye Research Institute