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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2025-07-15

No results posted yet for this 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.

Conditions

  • Fuchs Endothelial Corneal Dystrophy

Interventions

DRUG

STN1010904 ophthalmic suspension 0.03% BID

0.03% STN1010904 ophthalmic suspension BID

DRUG

STN1010904 ophthalmic suspension 0.1% BID

0.1% STN1010904 ophthalmic suspension BID

DRUG

Placebo (Vehicle) BID

Placebo (vehicle) BID

Sponsors & Collaborators

  • ActualEyes Inc.

    collaborator UNKNOWN

  • Santen Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-19
Primary Completion
2025-05-26
Completion
2025-05-26
FDA Drug
Yes

Countries

  • United States
  • France
  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05376176 on ClinicalTrials.gov