Back to resultsA Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy (Fuchs)
Primary Purpose
Corneal Edema
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Netarsudil Ophthalmic
Netarsudil Ophthalmic
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Edema focused on measuring Corneal Edema, Fuchs Corneal Dystrophy, Netarsudil Ophthalmic Solution
Eligibility Criteria
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)
Sites / Locations
- Orange County Ophthalmology
- Harvard Eye Associates
- Cincinnati Eye Institute
- Advance Eye Associates
- Chu Vision Institute
- Minnesota Eye Care
- Ophthalmology Associates
- Vance Thompson Vision
- Comprehensive Eye Care
- Vance Thompson Vision
- Houston Eye Associates
- Virginia Eye Consultants
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Once Daily Netarsudil Ophthalmic Solution
Twice Daily Netarsudil Ophthalmic Solution
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Central Corneal Thickness (CCT)
Mean change from baseline in CCT by ultrasound pachymetry
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04498169
Brief Title
A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 17, 2020 (Actual)
Primary Completion Date
August 11, 2021 (Actual)
Study Completion Date
August 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerie Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Edema
Keywords
Corneal Edema, Fuchs Corneal Dystrophy, Netarsudil Ophthalmic Solution
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Once Daily Netarsudil Ophthalmic Solution
Arm Type
Experimental
Arm Description
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.
Arm Title
Twice Daily Netarsudil Ophthalmic Solution
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Netarsudil Ophthalmic
Other Intervention Name(s)
Rhopressa®
Intervention Description
Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
Netarsudil Ophthalmic
Other Intervention Name(s)
Rhopressa®
Intervention Description
Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
Primary Outcome Measure Information:
Title
Central Corneal Thickness (CCT)
Description
Mean change from baseline in CCT by ultrasound pachymetry
Time Frame
Baseline & 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Senchyna, Ph.D.
Organizational Affiliation
Aerie Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Orange County Ophthalmology
City
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Harvard Eye Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Cincinnati Eye Institute
City
Edgewood
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Advance Eye Associates
City
South Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02748
Country
United States
Facility Name
Chu Vision Institute
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55420
Country
United States
Facility Name
Minnesota Eye Care
City
Minnetonka
State/Province
Minnesota
ZIP/Postal Code
55305
Country
United States
Facility Name
Ophthalmology Associates
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Vance Thompson Vision
City
W. Fargo
State/Province
North Dakota
ZIP/Postal Code
58078
Country
United States
Facility Name
Comprehensive Eye Care
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43082
Country
United States
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36327101
Citation
Lindstrom RL, Lewis AE, Holland EJ, Sheppard JD, Hovanesian JA, Senchyna M, Hollander DA. Phase 2, Randomized, Open-Label Parallel-Group Study of Two Dosing Regimens of Netarsudil for the Treatment of Corneal Edema Due to Fuchs Corneal Dystrophy. J Ocul Pharmacol Ther. 2022 Dec;38(10):657-663. doi: 10.1089/jop.2022.0069. Epub 2022 Nov 3.
Results Reference
derived
Learn more about this trial
A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
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