About this trial
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.
Eligibility criteria
Qualifiers
• Ability to understand read and sign the informed consent form.
Age between 30 and <91 years
Ability to understand and follow instructions and study procedures
Willingness to comply with all study procedures and be available for the duration of the study
Disqualifiers
• Uncontrolled glaucoma (IOP >25 mmHg)
Presence of secondary corneal pathology such as infective or autoimmune keratitis
Advanced corneal stromal edema defined as the presence of haze, bullae, or DM folds on slit-lamp biomicroscopy
History of herpes simplex virus or cytomegalovirus keratitis
Trial design
Treatments tested in this trial
- Ripasudil hydrochloride hydrate 0.4% ophthalmic solution
Treatment groups
Sponsors and collaborators
Marian Macsai, MD
Lead sponsor
Endeavor Health
Sponsor institution