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
Overview
- Phase
- Phase 2
- Intervention
- STN1010904 ophthalmic suspension 0.03% BID
- Conditions
- Fuchs Endothelial Corneal Dystrophy
- Sponsor
- Santen Inc.
- Enrollment
- 86
- Locations
- 15
- Primary Endpoint
- Change from baseline in BCVA with contrast level of 10% at Month 18
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
STN1010904 ophthalmic suspension 0.03% BID
Intervention: STN1010904 ophthalmic suspension 0.03% BID
STN1010904 ophthalmic suspension 0.1% BID
Intervention: STN1010904 ophthalmic suspension 0.1% BID
Placebo Vehicle BID
Intervention: Placebo (Vehicle) BID
Outcomes
Primary Outcomes
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
Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% 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(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)