Rhopressa for Corneal Edema Associated With Fuchs Dystrophy

Phase 2

Completed

• Conditions: Fuchs Endothelial Dystrophy
• Interventions: Drug: Netarsudil Ophthalmic Solution; Drug: Placebo

• Registration Number: NCT04051463
• Lead Sponsor: Price Vision Group

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-05
• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-09
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Results First Submitted: 2021-08-27
• Results First Submitted QC: 2021-08-28
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Results First Posted: 2021-09-24
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Netarsudil	Netarsudil Ophthalmic Solution	A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night.
Placebo	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change in Central Corneal Thickness	1 month	Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline

Secondary Outcome Measures

Name	Time	Method
Change in Corrected Distance Visual Acuity (CDVA)	3 months	Change in CDVA (lines read on the eye chart at 3 months minus lines read at baseline)

Trial Locations

Locations (1)

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States