Phase 2
N=40
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
Bottom Line
View on ClinicalTrials.gov: NCT04498169 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Sep 2022
Primary outcome: Primary: Central Corneal Thickness (CCT) — -28.4; -20.1 µm — p=0.0021
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Netarsudil Ophthalmic (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aerie Pharmaceuticals
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Central Corneal Thickness (CCT) |
-28.4; -20.1 | 0.0021 sig |
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 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)
Data sourced from ClinicalTrials.gov (NCT04498169). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.