Clinical trial NCT05376176: 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)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Fuchs Endothelial Corneal Dystrophy
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
Collaborators: name: ActualEyes Inc.
First posted: 2022-05-17
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18
timeFrame: at 18 month
measure: Change from baseline in BCVA with contrast level of 10% at Month 18
timeFrame: at 18 month
measure: Change from baseline in contrast sensitivity with glare light at Month 18
timeFrame: at 18 month
Secondary outcomes:
measure: Best corrected visual acuity (BCVA) with contrast level of 100% at all post-baseline visits
timeFrame: up to month 18
measure: BCVA with contrast level of 10% at all post-baseline visits
timeFrame: up to month 18
measure: Contrast sensitivity with glare light at all post-baseline visits
timeFrame: up to month 18
measure: Contrast sensitivity without glare light at all post-baseline visits
timeFrame: up to month 18
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Stein Eye Institution UCLA
state: California
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: Washington
country: United States
facility: Comprehensive Eye Care, Ltd
state: Missouri
city: Palisades Park
country: United States
facility: Metropolitan Eye Research and Surgery Center
state: New Jersey
city: Portland
country: United States
facility: Devers Eye Institute
state: Oregon
city: Cranberry Township
country: United States
facility: Scott Christie and Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Saint-Étienne
country: France
facility: University Hospital of Saint-Etienne
city: Chennai
country: India
facility: Medical Research Foundation
state: Tamil Nadu
city: Banjara Hills
country: India
facility: Suven Clinical Research CenterL V Prasad Eye Institute
state: Telangana
Study officials:
References: