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)

Santen Inc.86 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fuchs Endothelial Corneal Dystrophy

Interventions

STN1010904 ophthalmic suspension 0.03% BIDDRUG

0.03% STN1010904 ophthalmic suspension BID

STN1010904 ophthalmic suspension 0.1% BIDDRUG

0.1% STN1010904 ophthalmic suspension BID

Placebo (Vehicle) BIDDRUG

Placebo (vehicle) BID

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (15)

Stein Eye Institution UCLA

Los Angeles, California, United States

Price Vision Group

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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

Time frame: at 18 month

Change from baseline in BCVA with contrast level of 10% at Month 18

Time frame: at 18 month

Change from baseline in contrast sensitivity with glare light at Month 18

Time frame: at 18 month

Secondary Outcomes

Best corrected visual acuity (BCVA) with contrast level of 100% at all post-baseline visits

Time frame: up to month 18

BCVA with contrast level of 10% at all post-baseline visits

Time frame: up to month 18

Contrast sensitivity with glare light at all post-baseline visits

Time frame: up to month 18

Contrast sensitivity without glare light at all post-baseline visits

Time frame: up to month 18

Data from ClinicalTrials.gov

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