Status:
COMPLETED
A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
Lead Sponsor:
Aerie Pharmaceuticals
Conditions:
Corneal Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04498169
Start Date
September 17 2020
End Date
August 11 2021
Last Update
September 15 2022
Active Locations (12)
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1
Orange County Ophthalmology
Garden Grove, California, United States, 92843
2
Harvard Eye Associates
Laguna Hills, California, United States, 92653
3
Cincinnati Eye Institute
Edgewood, Kentucky, United States, 41017
4
Advance Eye Associates
South Dartmouth, Massachusetts, United States, 02748