PHANTOM: 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)

• Sponsor: Santen Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05376176
• Collaborator: ActualEyes Inc. (Other)
• Enrollment: 80
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 33.4
• Patients Per Site: 40
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fuchs Endothelial Corneal Dystrophy	Drug: STN1010904 ophthalmic suspension 0.03% BID; Drug: STN1010904 ophthalmic suspension 0.1% BID; Drug: Placebo (Vehicle) BID	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 19, 2022
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: Placebo Vehicle BID	Drug: Placebo (Vehicle) BID; Placebo (vehicle) BID

Outcome Measures

Primary Outcome Measures

1. Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18 [at 18 month]

2. Change from baseline in BCVA with contrast level of 10% at Month 18 [at 18 month]

3. Change from baseline in contrast sensitivity with glare light at Month 18 [at 18 month]

Secondary Outcome Measures

1. Best corrected visual acuity (BCVA) with contrast level of 100% at all post-baseline visits [up to month 18]

2. BCVA with contrast level of 10% at all post-baseline visits [up to month 18]

3. Contrast sensitivity with glare light at all post-baseline visits [up to month 18]

4. Contrast sensitivity without glare light at all post-baseline visits [up to month 18]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Price Vision Group	Indianapolis	Indiana	United States	46260
2	Houston Eye Associates	Houston	Texas	United States	77025-1697

Sponsors and Collaborators

• Santen Inc.
• ActualEyes Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Santen Inc.
• ClinicalTrials.gov Identifier: NCT05376176
• Other Study ID Numbers: 101090401IN
• First Posted: May 17, 2022
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy

Study Results

No Results Posted as of Jun 21, 2022