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
Status: Completed
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:
• Male or female diagnosed with FECD.
Locations
United States
California
Stein Eye Institution UCLA
Los Angeles
Indiana
Price Vision Group
Indianapolis
Maryland
Johns Hopkins University
Baltimore
Minnesota
Mayo Clinic
Rochester
Missouri
Tauber Eye Center
Kansas City
Comprehensive Eye Care, Ltd
Washington
New Jersey
Metropolitan Eye Research and Surgery Center
Palisades Park
Oregon
Devers Eye Institute
Portland
Pennsylvania
Scott Christie and Associates
Cranberry Township
UPMC
Pittsburgh
Texas
Houston Eye Associates
Houston
Other Locations
France
Fondation Ophtalmologique Adolphe de Rothschild
Paris
University Hospital of Saint-Etienne
Saint-etienne
India
Suven Clinical Research CenterL V Prasad Eye Institute
Banjara Hills
Medical Research Foundation
Chennai
Time Frame
Start Date: 2022-05-19
Completion Date: 2025-05-26
Participants
Target number of participants: 86
Treatments
Experimental: STN1010904 ophthalmic suspension 0.03% BID
Experimental: STN1010904 ophthalmic suspension 0.1% BID
Placebo_comparator: Placebo Vehicle BID
Related Therapeutic Areas
Sponsors
Collaborators: ActualEyes Inc.
Leads: Santen Inc.