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)

Fuchs Endothelial Corneal Dystrophy Clinical Trial

— PHANTOM  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05376176
• Other study ID #: 101090401IN
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 19, 2022
• Est. completion date: May 30, 2025

Study information

• Verified date: May 2024
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: May 30, 2025
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Dystrophies, Hereditary
• Fuchs Endothelial Corneal Dystrophy
• Fuchs' Endothelial Dystrophy

Intervention

Drug:
• STN1010904 ophthalmic suspension 0.03% BID
0.03% STN1010904 ophthalmic suspension BID
• STN1010904 ophthalmic suspension 0.1% BID
0.1% STN1010904 ophthalmic suspension BID
• Placebo (Vehicle) BID
Placebo (vehicle) BID

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris
France	University Hospital of Saint-Etienne	Saint-Étienne
India	Suven Clinical Research CenterL V Prasad Eye Institute	Banjara Hills	Telangana
India	Medical Research Foundation	Chennai	Tamil Nadu
United States	Johns Hopkins University	Baltimore	Maryland
United States	Scott Christie and Associates	Cranberry Township	Pennsylvania
United States	Houston Eye Associates	Houston	Texas
United States	Price Vision Group	Indianapolis	Indiana
United States	Tauber Eye Center	Kansas City	Missouri
United States	Stein Eye Institution UCLA	Los Angeles	California
United States	Metropolitan Eye Research and Surgery Center	Palisades Park	New Jersey
United States	UPMC	Pittsburgh	Pennsylvania
United States	Devers Eye Institute	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Comprehensive Eye Care, Ltd	Washington	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Santen Inc.	ActualEyes Inc.

Countries where clinical trial is conducted

United States,  France,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18		at 18 month
Primary	Change from baseline in BCVA with contrast level of 10% at Month 18		at 18 month
Primary	Change from baseline in contrast sensitivity with glare light at Month 18		at 18 month
Secondary	Best corrected visual acuity (BCVA) with contrast level of 100% at all post-baseline visits		up to month 18
Secondary	BCVA with contrast level of 10% at all post-baseline visits		up to month 18
Secondary	Contrast sensitivity with glare light at all post-baseline visits		up to month 18
Secondary	Contrast sensitivity without glare light at all post-baseline visits		up to month 18