Rhopressa for Corneal Edema Associated With Fuchs Dystrophy

Price Vision Group

Status and phase: Completed; Phase 3; Phase 2

Conditions: Fuchs Endothelial Dystrophy

Treatments: Drug: Placebo; Drug: Netarsudil Ophthalmic Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04051463

2019-007

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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29 participants in 2 patient groups, including a placebo group

Netarsudil

Active Comparator group

Description:

A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night.

Treatment:

Drug: Netarsudil Ophthalmic Solution

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo