Status:
COMPLETED
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)
Lead Sponsor:
Santen Inc.
Collaborating Sponsors:
ActualEyes Inc.
Conditions:
Fuchs Endothelial Corneal Dystrophy
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Male or female diagnosed with FECD.
Exclusion
- 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.
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2025
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT05376176
Start Date
May 19 2022
End Date
May 26 2025
Last Update
July 15 2025
Active Locations (15)
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1
Stein Eye Institution UCLA
Los Angeles, California, United States, 90095
2
Price Vision Group
Indianapolis, Indiana, United States, 46260
3
Johns Hopkins University
Baltimore, Maryland, United States, 21287
4
Mayo Clinic
Rochester, Minnesota, United States, 55905