Open
Actively Recruiting
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)
About
Brief 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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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.
Join this Trial
Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
22-000912
Category
Eye/Ocular Disorders
Principal Investigator
Contact
Location
- UCLA Westwood