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A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

A Randomized, Open-Label, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Dosing Regimens of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

NCT04498169•Aerie Pharmaceuticals

View on ClinicalTrials.gov

Summary

Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adults aged 18 years or older
•2. Documented diagnosis of FCD
•3. Evidence of central corneal edema, in at least one eye, at the Screening and Baseline Visit, in the eligible eye(s)
•4. Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the eligible eye(s)

Exclusion Criteria

•1. FCD so advanced that, in the opinion of the Investigator, surgery would likely be required in the study eligible eye(s) within the study period
•2. Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation
•3. History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)

Locations (12)

Orange County Ophthalmology

Garden Grove, California, United States

Harvard Eye Associates

Laguna Hills, California, United States

Cincinnati Eye Institute

Edgewood, Kentucky, United States

Advance Eye Associates

South Dartmouth, Massachusetts, United States

Chu Vision Institute

Bloomington, Minnesota, United States

Minnesota Eye Care

Minnetonka, Minnesota, United States

Ophthalmology Associates

St Louis, Missouri, United States

Vance Thompson Vision

West Fargo, North Dakota, United States

Comprehensive Eye Care

Westerville, Ohio, United States

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Key Dates

Start Date

September 17, 2020

Primary Completion Date

August 11, 2021

Completion Date

August 11, 2021

Last Updated

September 15, 2022

Enrollment

ACTUAL participants

Conditions

Corneal Edema

Interventions

Netarsudil Ophthalmic

DRUG

Netarsudil Ophthalmic

DRUG

The Belgian Endothelial Surgical Transplant of the Cornea

NCT05436665

Corneal EdemaCorneal Endothelial Disorder+3 more

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RECRUITING

Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema

NCT06983652

Corneal DiseasesCorneal Scars and Opacities+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 15, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

Inclusion Criteria

Exclusion Criteria

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