Pilot Study of Glanatec Ophthalmic Solution 0.4% for Treating Corneal Edema and Cell Counts in Fuchs Endothelial Dystrophy Patients After Descemet Stripping Without Transplant

What this Trial Is About

Researchers are studying whether the drug Glanatec4, approved in Japan for glaucoma and ocular hypertension, can be used safely and effectively in patients with Fuchs endothelial dystrophy FED who have undergone a descemet stripping procedure without endothelial keratoplasty. This study aims to provide enough proof of concept to support Glanatec4 as a treatment option for clearing corneal cells in FED patients who otherwise would need a corneal transplant. Participants receive an ophthalmic solution of Ripasudil hydrochloride hydrate 0.4%, administered either three or six times daily in the affected eye. The study is randomized and compares these two dosing schedules to evaluate the drugs effects over a 12-month period. The treatment focuses on corneal clearing and endothelial cell counts without requiring corneal transplantation. During the study, participants will be monitored through pachymetry measurements and corneal clearing assessments at 12 months, along with evaluations of visual acuity. Patients must adhere to the medication regimen and attend study visits as scheduled. The research team will track safety and effectiveness outcomes, with the total participation lasting up to one year.

Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy