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A Pilot Study For Efficacy And Safety Of Glanatec® Opthalmic Solution 0.4% On Corneal Edema And Endothelial Cell Counts In Subjects With Fuchs Endothelial Dystrophy Undergoing Descemet Stripping Without Endothelial Keratoplasty
In brief, the objective of this study is to investigate whether the drug Glanatec ® which is approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs endothelial dystrophy who have had a descemet stripping procedure without endothelial keratoplasty. While some limited data exists as a proof of concept in in vitro or animal studies, and Glanatec® has been successfully used in a recently published case series for this indication, there is insufficient data to show that this drug can be effectively used for corneal cell clearing while maintaining patient safety. The goal of the study is to provide sufficient proof of concept for the use of this drug in patients with FED whose only treatment alternative is to undergo corneal transplant.
Age
18 - 91 years
Sex
ALL
Healthy Volunteers
No
NorthShore University HealthSystem
Glenview, Illinois, United States
Start Date
December 6, 2017
Primary Completion Date
December 1, 2021
Completion Date
December 1, 2021
Last Updated
August 11, 2021
30
ESTIMATED participants
Ripasudil hydrochloride hydrate 0.4% ophthalmic solution
DRUG
Lead Sponsor
Marian Macsai, MD
Data Source & Attribution
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