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)
Completed · Phase 2 · Has a placebo group
Conditions studied: Fuchs Endothelial Corneal Dystrophy
In brief
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.
Key facts
- Study ID
- NCT05376176
- Run by
- Santen Inc.
- People needed
- 86
- Starts
- 2022-05-19
- Expected to finish
- 2025-05-26
- Last updated by the study team
- 2026-08-07
Who can join
Age: 30 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female diagnosed with FECD.
You may not qualify if…
- 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.
Where it is running
- Stein Eye Institution UCLA — Los Angeles, California, United States
- Price Vision Group — Indianapolis, Indiana, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Tauber Eye Center — Kansas City, Missouri, United States
- Comprehensive Eye Care, Ltd — Washington, Missouri, United States
- Metropolitan Eye Research and Surgery Center — Palisades Park, New Jersey, United States
- Devers Eye Institute — Portland, Oregon, United States
- Scott Christie and Associates — Cranberry Township, Pennsylvania, United States
- UPMC — Pittsburgh, Pennsylvania, United States
- Houston Eye Associates — Houston, Texas, United States
- Fondation Ophtalmologique Adolphe de Rothschild — Paris, France
- University Hospital of Saint-Etienne — Saint-Etienne, France
- Medical Research Foundation — Chennai, Tamil Nadu, India
- Suven Clinical Research CenterL V Prasad Eye Institute — Banjara Hills, Telangana, India
Full record on ClinicalTrials.gov
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