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)

Phase 2

Active, not recruiting

• Conditions: Fuchs Endothelial Corneal Dystrophy
• Interventions: Drug: STN1010904 ophthalmic suspension 0.1% BID; Drug: Placebo (Vehicle) BID; Drug: STN1010904 ophthalmic suspension 0.03% BID

• Registration Number: NCT05376176
• Lead Sponsor: Santen Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-11
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-17
• Study Start: 2022-05-19
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STN1010904 ophthalmic suspension 0.1% BID	STN1010904 ophthalmic suspension 0.1% BID	-
Placebo Vehicle BID	Placebo (Vehicle) BID	-
STN1010904 ophthalmic suspension 0.03% BID	STN1010904 ophthalmic suspension 0.03% BID	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (15)

Scott Christie and Associates; 🇺🇸 Cranberry Township, Pennsylvania, United States

University Hospital of Saint-Etienne; 🇫🇷 Saint-Étienne, France

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

Houston Eye Associates; 🇺🇸 Houston, Texas, United States

Medical Research Foundation; 🇮🇳 Chennai, Tamil Nadu, India

Metropolitan Eye Research and Surgery Center; 🇺🇸 Palisades Park, New Jersey, United States

Suven Clinical Research CenterL V Prasad Eye Institute; 🇮🇳 Banjara Hills, Telangana, India

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Stein Eye Institution UCLA; 🇺🇸 Los Angeles, California, United States

Price Vision Group; 🇺🇸 Indianapolis, Indiana, United States

Tauber Eye Center; 🇺🇸 Kansas City, Missouri, United States

Devers Eye Institute; 🇺🇸 Portland, Oregon, United States

Comprehensive Eye Care, Ltd; 🇺🇸 Washington, Missouri, United States

Fondation Ophtalmologique Adolphe de Rothschild; 🇫🇷 Paris, France