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NCT04498169 Clinical Trial

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

Corneal Edema Clinical Trial

— Fuchs  

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04498169
Other study ID # AR-13324-CS210
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 17, 2020
Est. completion date August 11, 2021

Study information
Verified date August 2022
Source Aerie Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date August 11, 2021
Est. primary completion date August 11, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Netarsudil Ophthalmic
Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
• Netarsudil Ophthalmic
Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution

Locations
Country Name City State
United States Chu Vision Institute Bloomington Minnesota
United States Cincinnati Eye Institute Edgewood Kentucky
United States Orange County Ophthalmology Garden Grove California
United States Houston Eye Associates Houston Texas
United States Harvard Eye Associates Laguna Hills California
United States Minnesota Eye Care Minnetonka Minnesota
United States Virginia Eye Consultants Norfolk Virginia
United States Ophthalmology Associates Saint Louis Missouri
United States Vance Thompson Vision Sioux Falls South Dakota
United States Advance Eye Associates South Dartmouth Massachusetts
United States Vance Thompson Vision W. Fargo North Dakota
United States Comprehensive Eye Care Westerville Ohio

Sponsors (1)
Lead Sponsor Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Central Corneal Thickness (CCT) Mean change from baseline in CCT by ultrasound pachymetry Baseline & 4 weeks
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