drugset / Trial / 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)

NCT05376176 ↗

Phase 2 Completed 86 enrolled Santen Inc. ActualEyes, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2022-05-19
Primary completion
2025-05-26
Completion
2025-05-26

Drugs

EvaluationDrugModalityDoseRoute
Subject STN1010904 Unknown 0.03 % —
Subject STN1010904 Unknown 0.1 % —