This study is in progress, not accepting new patients

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)

a study on Fuchs Endothelial Corneal Dystrophy Fuchs' Dystrophy

Summary

Eligibility
for people ages 30-75 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

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.

Official Title

A Phase IIa, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, 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) - PHANTOM Study

Keywords

Fuchs Endothelial Corneal Dystrophy, Hereditary Corneal Dystrophies, Fuchs' Endothelial Dystrophy, STN1010904 ophthalmic suspension 0.03% BID, STN1010904 ophthalmic suspension 0.1% BID

Eligibility

You can join if…

Open to people ages 30-75

  • Male or female diagnosed with FECD.

You CAN'T join 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.

Locations

  • Stein Eye Institution UCLA
    Los Angeles California 90095 United States
  • Devers Eye Institute
    Portland Oregon 97210 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Santen Inc.
ID
NCT05376176
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated