Open Actively Recruiting

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)

About

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 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
30 Years
Maximum Age
75 Years

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.

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Share:
Study Stats
Protocol No.
22-000912
Category
Eye/Ocular Disorders
Contact
Golshan Latifiyaghin
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05376176
For detailed technical eligibility, visit ClinicalTrials.gov.