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)

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Fuchs Endothelial Corneal Dystrophy

Intervention / Treatment
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* Drug: STN1010904 ophthalmic suspension 0.03% BID
* Drug: STN1010904 ophthalmic suspension 0.1% BID
* Drug: Placebo (Vehicle) BID


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STN1010904 ophthalmic suspension 0.03% BID<br> | Drug: STN1010904 ophthalmic suspension 0.03% BID<br>* 0.03% STN1010904 ophthalmic suspension BID<br>|
| Experimental: STN1010904 ophthalmic suspension 0.1% BID<br> | Drug: STN1010904 ophthalmic suspension 0.1% BID<br>* 0.1% STN1010904 ophthalmic suspension BID<br>|
| Placebo Comparator: Placebo Vehicle BID<br> | Drug: Placebo (Vehicle) BID<br>* Placebo (vehicle) BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18 |  | at 18 month | 
| 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 | 

Secondary Outcome Measures

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