Rhopressa for Corneal Edema Associated With Fuchs Dystrophy

Study Overview
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Brief Summary
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The study objective is to determine whether use of Rhopressa improves the ability of corneal endothelial cells to maintain appropriate corneal hydration in patients with Fuchs endothelial corneal dystrophy (FECD), which could help delay or prevent the need for a corneal transplant.

Official Title
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Prospective Randomized Study to Determine Whether Use of Rhopressa™ Can Ameliorate Corneal Edema Associated With Fuchs Dystrophy

Conditions
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Fuchs Endothelial Dystrophy

Intervention / Treatment
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* Drug: Netarsudil Ophthalmic Solution
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age Male or female patient diagnosed with FECD and corneal edema evident by slit lamp exam and/or corneal tomography. Patient is able and willing to administer eye drops. Patient is able to comprehend and has signed the Informed Consent form. Exclusion Criteria: Active intraocular inflammation, corneal ulceration, keratitis, or conjunctivitis. Known sensitivity to any of the ingredients in the study medications. Abnormal eyelid function. History of herpetic keratitis. History of non-compliance with using prescribed medication. Current or planned pregnancy within the study duration. Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study. Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Netarsudil<br>A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night. | Drug: Netarsudil Ophthalmic Solution<br>* Netarsudil eye drops instilled once daily<br>* Other names: Rhopressa;|
| Placebo Comparator: Placebo<br>A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night. | Drug: Placebo<br>* Placebo eye drops instilled once daily<br>* Other names: Rhopressa vehicle without active ingredient;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Central Corneal Thickness | Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Corrected Distance Visual Acuity (CDVA) | Change in CDVA (lines read on the eye chart at 3 months minus lines read at baseline) | 3 months |