← Back to all trials
Completed
NCT05376176
A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD)
Conditions: Fuchs Endothelial Corneal Dystrophy
Sex: All
Ages: 30 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 86
Sponsor: Santen Inc.
Location: Stein Eye Institution UCLA Los Angeles California
Summary
This is a Phase IIa study to assess efficacy and safety of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD). This study will consist of a Screening Period of up to 15 days and an 18-month Double-Masked Treatment Period, including 9 individual visits to the study site.
Eligibility Criteria
Inclusion Criteria:
* Male or female diagnosed with FECD.
Exclusion Criteria:
* Females who are pregnant or lactating.
* Any ocular surgery for FECD (e.g., penetrating keratoplasty (PKP), Descemet stripping endothelial keratoplasty (DSEK), Descemet membrane endothelial keratoplasty (DMEK), Descemet stripping automated endothelial keratoplasty (DSAEK), Descemet stripping only (DSO) in the study eye.
Source: ClinicalTrials.gov (NCT05376176). StuddyBuddy aggregates publicly available trial information.
