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) (PHANTOM)

August 5, 2026 updated by: Santen Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild
      • Saint-Etienne, France, 42055
        • University Hospital of Saint-Etienne
  • India
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 006
        • Medical Research Foundation
    • Telangana
      • Banjara Hills, Telangana, India, 500034
        • Suven Clinical Research CenterL V Prasad Eye Institute
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Stein Eye Institution UCLA
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Price Vision Group
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Tauber Eye Center
      • Washington, Missouri, United States, 63090
        • Comprehensive Eye Care, Ltd
    • New Jersey
      • Palisades Park, New Jersey, United States, 07650
        • Metropolitan Eye Research and Surgery Center
    • Oregon
      • Portland, Oregon, United States, 97210
        • Devers Eye Institute
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Scott Christie and Associates
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC
    • Texas
      • Houston, Texas, United States, 77025-1697
        • Houston Eye Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Vehicle BID
Drug: Placebo (Vehicle) BID
Placebo (vehicle) BID
Experimental: STN1010904 ophthalmic suspension 0.03% BID
Drug: STN1010904 ophthalmic suspension 0.03% BID
0.03% STN1010904 ophthalmic suspension BID
Experimental: STN1010904 ophthalmic suspension 0.1% BID
Drug: STN1010904 ophthalmic suspension 0.1% BID
0.1% STN1010904 ophthalmic suspension BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Best Corrected Visual Acuity (BCVA) With Contrast Level of 100% at Month 18
Time Frame: The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
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
Time Frame: The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
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
Time Frame: The change is calculated as the difference between the AULCSF at the 18-month visit and the baseline score.

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.

Secondary Outcome Measures

Outcome Measure
Time Frame
Best corrected visual acuity (BCVA) with contrast level of 100% at all post-baseline visits
Time Frame: up to month 18
up to month 18
BCVA with contrast level of 10% at all post-baseline visits
Time Frame: up to month 18
up to month 18
Contrast sensitivity with glare light at all post-baseline visits
Time Frame: up to month 18
up to month 18
Contrast sensitivity without glare light at all post-baseline visits
Time Frame: up to month 18
up to month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santen Inc.

Collaborators

ActualEyes, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2022

Primary Completion (Actual)

May 26, 2025

Study Completion (Actual)

May 26, 2025

Study Registration Dates

First Submitted

May 11, 2022

First Submitted That Met QC Criteria

May 11, 2022

First Posted (Actual)

May 17, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101090401IN

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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