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)

Last updated: May 13, 2024
Sponsor: Santen Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

Placebo (Vehicle) BID

STN1010904 ophthalmic suspension 0.03% BID

STN1010904 ophthalmic suspension 0.1% BID

Clinical Study ID

NCT05376176
101090401IN
  • Ages 30-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female diagnosed with FECD.

Exclusion

Exclusion Criteria:

  • Females who are pregnant or lactating.

  • Any ocular surgery for FECD (e.g., penetrating keratoplasty (PKP), Descemetstripping endothelial keratoplasty (DSEK), Descemet membrane endothelialkeratoplasty (DMEK), Descemet stripping automated endothelial keratoplasty (DSAEK),Descemet stripping only (DSO) in the study eye.

Study Design

Total Participants: 80
Treatment Group(s): 3
Primary Treatment: Placebo (Vehicle) BID
Phase: 2
Study Start date:
May 19, 2022
Estimated Completion Date:
May 30, 2025

Connect with a study center

  • Fondation Ophtalmologique Adolphe de Rothschild

    Paris, 75019
    France

    Site Not Available

  • University Hospital of Saint-Etienne

    Saint-Étienne, 42055
    France

    Site Not Available

  • Medical Research Foundation

    Chennai, Tamil Nadu 600 006
    India

    Site Not Available

  • Suven Clinical Research CenterL V Prasad Eye Institute

    Banjara Hills, Telangana 500034
    India

    Site Not Available

  • Stein Eye Institution UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • Price Vision Group

    Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Tauber Eye Center

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Comprehensive Eye Care, Ltd

    Washington, Missouri 63090
    United States

    Site Not Available

  • Metropolitan Eye Research and Surgery Center

    Palisades Park, New Jersey 07650
    United States

    Site Not Available

  • Devers Eye Institute

    Portland, Oregon 97210
    United States

    Site Not Available

  • Scott Christie and Associates

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • UPMC

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Houston Eye Associates

    Houston, Texas 77025-1697
    United States

    Site Not Available

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