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

Sponsor

Aerie Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT04498169

Collaborator

(none)

Enrollment

Locations

Arms

10.8

Actual Duration (Months)

2.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Edema	Drug: Netarsudil Ophthalmic Drug: Netarsudil Ophthalmic	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 17, 2020

Actual Primary Completion Date :

Aug 11, 2021

Actual Study Completion Date :

Aug 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Once Daily Netarsudil Ophthalmic Solution One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.	Drug: Netarsudil Ophthalmic Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution Other Names: Rhopressa®
Experimental: Twice Daily Netarsudil Ophthalmic Solution One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.	Drug: Netarsudil Ophthalmic Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution Other Names: Rhopressa®

Arm

Intervention/Treatment

Experimental: Once Daily Netarsudil Ophthalmic Solution

One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.

Drug: Netarsudil Ophthalmic

Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution

Other Names:

Rhopressa®

Experimental: Twice Daily Netarsudil Ophthalmic Solution

One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.

Drug: Netarsudil Ophthalmic

Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution

Other Names:

Rhopressa®

Outcome Measures

Primary Outcome Measures

Central Corneal Thickness (CCT) [28 Days]
Mean change from baseline in CCT by ultrasound pachymetry

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation
History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Principal Investigator	Garden Grove	California	United States	92843
2	Principal Investigator	Laguna Hills	California	United States	92653
3	Principal Investigator	Hoffman Estates	Illinois	United States	60169
4	Principal Investigator	Edgewood	Kentucky	United States	41017
5	Principal Investigator	Boston	Massachusetts	United States	02114
6	Principal Investigator	South Dartmouth	Massachusetts	United States	02748
7	Principal Investigator	Bloomington	Minnesota	United States	55420
8	Principal Investigator	Minnetonka	Minnesota	United States	55305
9	Principal Investigator	Kansas City	Missouri	United States	64133
10	Principal Investigator	Saint Louis	Missouri	United States	63131
11	Principal Investigator	W. Fargo	North Dakota	United States	58078
12	Principal Investigator	Westerville	Ohio	United States	43082
13	Principal Investigator	Sioux Falls	South Dakota	United States	57108
14	Principal Investigator	Houston	Texas	United States	77025
15	Principal Investigator	Norfolk	Virginia	United States	23502