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)

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Inc.
• Collaborator: ActualEyes Inc.

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.