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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)

Primary Purpose

Fuchs Endothelial Corneal Dystrophy

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
STN1010904 ophthalmic suspension 0.03% BID
STN1010904 ophthalmic suspension 0.1% BID
Placebo (Vehicle) BID
Sponsored by
Santen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fuchs Endothelial Corneal Dystrophy

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Price Vision GroupRecruiting
  • Mayo ClinicRecruiting
  • Tauber Eye CenterRecruiting
  • Comprehensive Eye Care, LtdRecruiting
  • Metropolitan Eye Research and Surgery CenterRecruiting
  • Devers Eye InstituteRecruiting
  • UPMCRecruiting
  • Houston Eye AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

STN1010904 ophthalmic suspension 0.03% BID

STN1010904 ophthalmic suspension 0.1% BID

Placebo Vehicle BID

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18
Change from baseline in BCVA with contrast level of 10% at Month 18
Change from baseline in contrast sensitivity with glare light at Month 18

Secondary Outcome Measures

Best corrected visual acuity (BCVA) with contrast level of 100% at all post-baseline visits
BCVA with contrast level of 10% at all post-baseline visits
Contrast sensitivity with glare light at all post-baseline visits
Contrast sensitivity without glare light at all post-baseline visits

Full Information

First Posted
May 11, 2022
Last Updated
September 19, 2023
Sponsor
Santen Inc.
Collaborators
ActualEyes Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05376176
Brief Title
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)
Acronym
PHANTOM
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2022 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.
Collaborators
ActualEyes Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs Endothelial Corneal Dystrophy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STN1010904 ophthalmic suspension 0.03% BID
Arm Type
Experimental
Arm Title
STN1010904 ophthalmic suspension 0.1% BID
Arm Type
Experimental
Arm Title
Placebo Vehicle BID
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
STN1010904 ophthalmic suspension 0.03% BID
Intervention Description
0.03% STN1010904 ophthalmic suspension BID
Intervention Type
Drug
Intervention Name(s)
STN1010904 ophthalmic suspension 0.1% BID
Intervention Description
0.1% STN1010904 ophthalmic suspension BID
Intervention Type
Drug
Intervention Name(s)
Placebo (Vehicle) BID
Intervention Description
Placebo (vehicle) BID
Primary Outcome Measure Information:
Title
Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18
Time Frame
at 18 month
Title
Change from baseline in BCVA with contrast level of 10% at Month 18
Time Frame
at 18 month
Title
Change from baseline in contrast sensitivity with glare light at Month 18
Time Frame
at 18 month
Secondary Outcome Measure Information:
Title
Best corrected visual acuity (BCVA) with contrast level of 100% at all post-baseline visits
Time Frame
up to month 18
Title
BCVA with contrast level of 10% at all post-baseline visits
Time Frame
up to month 18
Title
Contrast sensitivity with glare light at all post-baseline visits
Time Frame
up to month 18
Title
Contrast sensitivity without glare light at all post-baseline visits
Time Frame
up to month 18

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Santen Inc Clinical Operations
Phone
+1 415-268-9100
Email
clinicaltrials@santen.com
Facility Information:
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
Tauber Eye Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Name
Comprehensive Eye Care, Ltd
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Individual Site Status
Recruiting
Facility Name
Metropolitan Eye Research and Surgery Center
City
Palisades Park
State/Province
New Jersey
ZIP/Postal Code
07650
Country
United States
Individual Site Status
Recruiting
Facility Name
Devers Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Name
UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025-1697
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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)

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