CompletedPhase 2

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)

United States86 participantsStarted 2022-05-19

Plain-language 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.

Who can participate

Age range30 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18

Timeframe: at 18 month

Change from baseline in BCVA with contrast level of 10% at Month 18

Timeframe: at 18 month

Change from baseline in contrast sensitivity with glare light at Month 18

Timeframe: at 18 month

Trial details

NCT IDNCT05376176

SponsorSanten Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-26

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