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) (PHANTOM)

Santen

Status and phase: Active, not recruiting; Phase 2

Conditions: Fuchs Endothelial Corneal Dystrophy

Treatments: Drug: STN1010904 ophthalmic suspension 0.1% BID; Drug: Placebo (Vehicle) BID; Drug: STN1010904 ophthalmic suspension 0.03% BID

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05376176

101090401IN

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 3 patient groups, including a placebo group

STN1010904 ophthalmic suspension 0.03% BID

Experimental group

Treatment:

Drug: STN1010904 ophthalmic suspension 0.03% BID

STN1010904 ophthalmic suspension 0.1% BID

Experimental group

Treatment:

Drug: STN1010904 ophthalmic suspension 0.1% BID

Placebo Vehicle BID

Placebo Comparator group

Treatment:

Drug: Placebo (Vehicle) BID