CompletedPhase 2

A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

United States40 participantsStarted 2020-09-17

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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)

What they're measuring

Central Corneal Thickness (CCT)

Timeframe: Baseline & 4 weeks

Trial details

NCT IDNCT04498169

SponsorAerie Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-11

Results submitted2022-08-10

View on ClinicalTrials.gov More Corneal Edema trials