Phase 2
Completed 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
Source: ClinicalTrials.gov NCT04498169 ↗
Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Sep 2022
Primary outcomePrimary: Central Corneal Thickness (CCT) — -28.4; -20.1 µm — p=0.0021
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Central Corneal Thickness (CCT) |
-28.4; -20.1 | 0.0021 sig |
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. Informational only — not medical advice.