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)

NCT05376176 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 101090401IN
• Study Type: interventional
• Target: 86
• Locations: 3 countries
• Sites: 15

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.

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

  This measure evaluates the change in Best Corrected Visual Acuity (BCVA) with a contrast level of 100% from baseline to the 18-month mark. BCVA is assessed using standardized visual acuity charts, and the results are expressed in logMAR units. The baseline score is determined prior to the first dose at Visit 2, and if unavailable, the last observed measurement before the first dose is used. The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.

  The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.

• Change From Baseline in BCVA With Contrast Level of 10% at Month 18

  This measure evaluates the change in Best Corrected Visual Acuity (BCVA) with a contrast level of 10% from baseline to the 18-month mark. BCVA is assessed using standardized visual acuity charts, and the results are expressed in logMAR units. The baseline score is determined prior to the first dose at Visit 2, and if unavailable, the last observed measurement before the first dose is used. The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.

  The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.

• Change From Baseline in Contrast Sensitivity With Glare Light at Month 18

  This measure evaluates the change in contrast sensitivity under glare conditions from baseline to Month 18. Baseline is defined as the measurement obtained prior to the first dose at Visit 2, or the last available pre-dose measurement if Visit 2 data are unavailable. The change is calculated as the difference between the Month 18 value and the baseline value. AULCSF is calculated using the below steps: Measure contrast sensitivity (CS) at several spatial frequencies (cpd, cycles per degree). For example, at spatial frequencies of 3, 6, 12, 18. Convert the corresponding contrast sensitivity to log10 scale. Convert spatial frequencies to log10 scale. For example, log10(3), log10(6), log10(12), log10(18). Calculate the area using trapezoidal rule. Therefore, the actual measurement of AULCSF is log CS × log(cpd). For simplification, we referred to this as log scale. Higher AULCSF indicates better contrast sensitivity and better visual function.

  The change is calculated as the difference between the AULCSF at the 18-month visit and the baseline score.

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% BID DRUG

0.03% STN1010904 ophthalmic suspension BID

STN1010904 ophthalmic suspension 0.03% BID

Placebo (Vehicle) BID DRUG

Placebo (vehicle) BID

Placebo Vehicle BID

STN1010904 ophthalmic suspension 0.1% BID DRUG

0.1% STN1010904 ophthalmic suspension BID

STN1010904 ophthalmic suspension 0.1% BID

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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.

Sponsors & Collaborators

• Santen Inc.: lead
• ActualEyes, Inc.: collaborator

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, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Director of R&D Quality Management
• Organization: Santen Inc

evelyn.chikere@santen.com

15106851794

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: August 7, 2026
• Results First Posted: August 7, 2026

Record last verified: 2026-08

Locations

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