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NCT Number: NCT05376176

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)

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.

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Key information

Conditions

Fuchs Endothelial Corneal Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fondation Ophtalmologique Adolphe de Rothschild, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

STN1010904 ophthalmic suspension 0.03% BID

Drug

0.03% STN1010904 ophthalmic suspension BID

STN1010904 ophthalmic suspension 0.1% BID

Drug

0.1% STN1010904 ophthalmic suspension BID

Placebo (Vehicle) BID

Drug

Placebo (vehicle) BID

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Santen Inc.

Industry

Collaborators

  • ActualEyes, Inc.

Registry information

Official study 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

Acronym: PHANTOM

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 17, 2022
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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