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)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fuchs Endothelial Corneal Dystrophy
• Intervention / Treatment: Drug: STN1010904 ophthalmic suspension 0.03% BID; Drug: STN1010904 ophthalmic suspension 0.1% BID; Drug: Placebo (Vehicle) BID

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Santen Inc Clinical Operations; Phone Number: +1 415-268-9100; Email: clinicaltrials@santen.com

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Recruiting
      • Price Vision Group
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • Tauber Eye Center
    • Washington, Missouri, United States, 63090
      • Recruiting
      • Comprehensive Eye Care, Ltd
  • New Jersey
    • Palisades Park, New Jersey, United States, 07650
      • Recruiting
      • Metropolitan Eye Research and Surgery Center
  • Oregon
    • Portland, Oregon, United States, 97210
      • Recruiting
      • Devers Eye Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • UPMC
  • Texas
    • Houston, Texas, United States, 77025-1697
      • Recruiting
      • Houston Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Vehicle BID	Drug: Placebo (Vehicle) BID; Placebo (vehicle) BID
Experimental: STN1010904 ophthalmic suspension 0.03% BID	Drug: STN1010904 ophthalmic suspension 0.03% BID; 0.03% STN1010904 ophthalmic suspension BID
Experimental: STN1010904 ophthalmic suspension 0.1% BID	Drug: STN1010904 ophthalmic suspension 0.1% BID; 0.1% STN1010904 ophthalmic suspension BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Santen Inc.
• Collaborators: ActualEyes Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: 101090401IN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No