NCT05376176

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2022

Typical duration for phase_2

Geographic Reach
3 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 17, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

May 19, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2025

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

3 years

First QC Date

May 11, 2022

Last Update Submit

July 10, 2025

Conditions

Fuchs Endothelial Corneal Dystrophy

Outcome Measures

Primary Outcomes (3)

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

    at 18 month

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

    at 18 month

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

    at 18 month

Secondary Outcomes (4)

  • Best corrected visual acuity (BCVA) with contrast level of 100% at all post-baseline visits

    up to month 18

  • BCVA with contrast level of 10% at all post-baseline visits

    up to month 18

  • Contrast sensitivity with glare light at all post-baseline visits

    up to month 18

  • Contrast sensitivity without glare light at all post-baseline visits

    up to month 18

Study Arms (3)

STN1010904 ophthalmic suspension 0.03% BID

EXPERIMENTAL
Drug: STN1010904 ophthalmic suspension 0.03% BID

STN1010904 ophthalmic suspension 0.1% BID

EXPERIMENTAL
Drug: STN1010904 ophthalmic suspension 0.1% BID

Placebo Vehicle BID

PLACEBO COMPARATOR
Drug: Placebo (Vehicle) BID

Interventions

STN1010904 ophthalmic suspension 0.03% BIDDRUG

0.03% STN1010904 ophthalmic suspension BID

STN1010904 ophthalmic suspension 0.03% BID
STN1010904 ophthalmic suspension 0.1% BIDDRUG

0.1% STN1010904 ophthalmic suspension BID

STN1010904 ophthalmic suspension 0.1% BID
Placebo (Vehicle) BIDDRUG

Placebo (vehicle) BID

Placebo Vehicle BID

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female diagnosed with FECD.

You may not qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Stein Eye Institution UCLA

Los Angeles, California, 90095, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Comprehensive Eye Care, Ltd

Washington, Missouri, 63090, United States

Location

Metropolitan Eye Research and Surgery Center

Palisades Park, New Jersey, 07650, United States

Location

Devers Eye Institute

Portland, Oregon, 97210, United States

Location

Scott Christie and Associates

Cranberry Township, Pennsylvania, 16066, United States

Location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Houston Eye Associates

Houston, Texas, 77025-1697, United States

Location

Fondation Ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

University Hospital of Saint-Etienne

Saint-Etienne, 42055, France

Location

Medical Research Foundation

Chennai, Tamil Nadu, 600 006, India

Location

Suven Clinical Research CenterL V Prasad Eye Institute

Banjara Hills, Telangana, 500034, India

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Corneal Dystrophies, HereditaryCorneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 17, 2022

Study Start

May 19, 2022

Primary Completion

May 26, 2025

Study Completion

May 26, 2025

Last Updated

July 15, 2025

Record last verified: 2025-07

Locations

IN(2)US(11)FR(2)