A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
NCT ID: NCT04498169
Last Updated: 2022-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2020-09-17
2021-08-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Netarsudil Ophthalmic
Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
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.
Netarsudil Ophthalmic
Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
Interventions
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Netarsudil Ophthalmic
Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
Netarsudil Ophthalmic
Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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Aerie Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Michelle Senchyna, Ph.D.
Role: STUDY_DIRECTOR
Aerie Pharmaceuticals Inc.
Locations
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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
Houston Eye Associates
Houston, Texas, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AR-13324-CS210
Identifier Type: -
Identifier Source: org_study_id
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