Fuchs Endothelial Corneal DystrophyPhase 2PHANTOMNCT05376176

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)

A Phase 2 study testing STN1010904 ophthalmic suspension 0.03% BID and STN1010904 ophthalmic suspension 0.1% BID in people with Fuchs Endothelial Corneal Dystrophy, run by Santen Inc. at 15 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 75 years
Conditions the study is for: Fuchs Endothelial Corneal Dystrophy
What is being tested?: STN1010904 ophthalmic suspension 0.03% BID and STN1010904 ophthalmic suspension 0.1% BID
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 86 participants
Where: 15 sitesin 3 countries
Study dates: 19 May 2022to 26 May 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female diagnosed with FECD.

Who cannot join

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.

Trial locations and contacts

15 sites in 3 countries.

Country

City, postcode or hospital

15 sites in 3 countries

United States11 sites

Johns Hopkins University
Baltimore, Maryland, 21287
Scott Christie and Associates
Cranberry Township, Pennsylvania, 16066
Houston Eye Associates
Houston, Texas, 77025-1697
Price Vision Group
Indianapolis, Indiana, 46260
Tauber Eye Center
Kansas City, Missouri, 64111
Stein Eye Institution UCLA
Los Angeles, California, 90095
Metropolitan Eye Research and Surgery Center
Palisades Park, New Jersey, 07650
UPMC
Pittsburgh, Pennsylvania, 15213
Devers Eye Institute
Portland, Oregon, 97210
Mayo Clinic
Rochester, Minnesota, 55905
Comprehensive Eye Care, Ltd
Washington, Missouri, 63090

Other trials in United States

France2 sites

Fondation Ophtalmologique Adolphe de Rothschild
Paris, 75019
University Hospital of Saint-Etienne
Saint-Etienne, 42055

Other trials in France

India2 sites

Suven Clinical Research CenterL V Prasad Eye Institute
Banjara Hills, Telangana, 500034
Medical Research Foundation
Chennai, Tamil Nadu, 600 006

Other trials in India

About this study

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

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.

Conditions: Fuchs Endothelial Corneal Dystrophy
Being tested: STN1010904 ophthalmic suspension 0.03% BID, STN1010904 ophthalmic suspension 0.1% BID, Placebo (Vehicle) BID
Medical subject headings: Fuchs' Endothelial Dystrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

STN1010904 ophthalmic suspension 0.03% BIDDrug
0.03% STN1010904 ophthalmic suspension BID
STN1010904 ophthalmic suspension 0.1% BIDDrug
0.1% STN1010904 ophthalmic suspension BID
Placebo (Vehicle) BIDDrug
Placebo (vehicle) BID

Study groups in NCT05376176
Study group	Role	What they receive
STN1010904 ophthalmic suspension 0.03% BID	Experimental	Not described Receives: Drug: STN1010904 ophthalmic suspension 0.03% BID
STN1010904 ophthalmic suspension 0.1% BID	Experimental	Not described Receives: Drug: STN1010904 ophthalmic suspension 0.1% BID
Placebo Vehicle BID	Placebo comparator	Not described Receives: Drug: Placebo (Vehicle) BID

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Best Corrected Visual Acuity (BCVA) With Contrast Level of 100% at Month 18
This measure evaluates the change in Best Corrected Visual Acuity (BCVA) with a contrast level of 100% from baseline to the 18-month mark. BCVA is assessed using standardized visual acuity charts, and the results are expressed in logMAR units. The baseline score is determined prior to the first dose at Visit 2, and if unavailable, the last observed measurement before the first dose is used. The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
Measured: The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
Change From Baseline in BCVA With Contrast Level of 10% at Month 18
This measure evaluates the change in Best Corrected Visual Acuity (BCVA) with a contrast level of 10% from baseline to the 18-month mark. BCVA is assessed using standardized visual acuity charts, and the results are expressed in logMAR units. The baseline score is determined prior to the first dose at Visit 2, and if unavailable, the last observed measurement before the first dose is used. The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
Measured: The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
Change From Baseline in Contrast Sensitivity With Glare Light at Month 18
This measure evaluates the change in contrast sensitivity under glare conditions from baseline to Month 18. Baseline is defined as the measurement obtained prior to the first dose at Visit 2, or the last available pre-dose measurement if Visit 2 data are unavailable. The change is calculated as the difference between the Month 18 value and the baseline value.
AULCSF is calculated using the below steps:
Measure contrast sensitivity (CS) at several spatial frequencies (cpd, cycles per degree). For example, at spatial frequencies of 3, 6, 12, 18.
Convert the corresponding contrast sensitivity to log10 scale. Convert spatial frequencies to log10 scale. For example, log10(3), log10(6), log10(12), log10(18).
Calculate the area using trapezoidal rule. Therefore, the actual measurement of AULCSF is log CS × log(cpd). For simplification, we referred to this as log scale. Higher AULCSF indicates better contrast sensitivity and better visual function.
Measured: The change is calculated as the difference between the AULCSF at the 18-month visit and the baseline score.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 May 202226 May 2025

First posted17 May 2022
Study start19 May 2022
Primary completion26 May 2025
Study completion26 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Fuchs Endothelial Corneal DystrophyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05376176
Sponsor's protocol ID: 101090401IN
Acronym: PHANTOM
Status last verified: Aug 2026
First submitted: 11 May 2022
Last updated: 7 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
Fuchs, Fuchs Dystrophy
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingPhase 2
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Fuchs
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder

All Fuchs Endothelial Corneal Dystrophy trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05376176
Acronym / sponsor ID: PHANTOM / 101090401IN
Conditions: Fuchs Endothelial Corneal Dystrophy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: Santen Inc.Industry (pharma, biotech, devices)
Collaborators: ActualEyes, Inc.
Study start: 19 May 2022 (actual)
Primary completion: 26 May 2025 (actual)
Study completion: 26 May 2025 (actual)
First posted: 17 May 2022 (actual)
Results: Posted 7 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
STN1010904 ophthalmic suspension 0.03% BID	Experimental	Drug: STN1010904 ophthalmic suspension 0.03% BID
STN1010904 ophthalmic suspension 0.1% BID	Experimental	Drug: STN1010904 ophthalmic suspension 0.1% BID
Placebo Vehicle BID	Placebo comparator	Drug: Placebo (Vehicle) BID

Who may qualify

Ages: 30 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Male or female diagnosed with FECD.

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
STN1010904 ophthalmic suspension 0.03% BID0.03% STN1010904 ophthalmic suspension BID	Drug	STN1010904 ophthalmic suspension 0.03% BID
STN1010904 ophthalmic suspension 0.1% BID0.1% STN1010904 ophthalmic suspension BID	Drug	STN1010904 ophthalmic suspension 0.1% BID
Placebo (Vehicle) BIDPlacebo (vehicle) BID	Drug	Placebo Vehicle BID

Primary outcome

Change From Baseline in Best Corrected Visual Acuity (BCVA) With Contrast Level of 100% at Month 18
Time frame: The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
This measure evaluates the change in Best Corrected Visual Acuity (BCVA) with a contrast level of 100% from baseline to the 18-month mark. BCVA is assessed using standardized visual acuity charts, and the results are expressed in logMAR units. The baseline score is determined prior to the first dose at Visit 2, and if unavailable, the last observed measurement before the first dose is used. The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
Change From Baseline in BCVA With Contrast Level of 10% at Month 18
Time frame: The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
This measure evaluates the change in Best Corrected Visual Acuity (BCVA) with a contrast level of 10% from baseline to the 18-month mark. BCVA is assessed using standardized visual acuity charts, and the results are expressed in logMAR units. The baseline score is determined prior to the first dose at Visit 2, and if unavailable, the last observed measurement before the first dose is used. The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.
Change From Baseline in Contrast Sensitivity With Glare Light at Month 18
Time frame: The change is calculated as the difference between the AULCSF at the 18-month visit and the baseline score.
This measure evaluates the change in contrast sensitivity under glare conditions from baseline to Month 18. Baseline is defined as the measurement obtained prior to the first dose at Visit 2, or the last available pre-dose measurement if Visit 2 data are unavailable. The change is calculated as the difference between the Month 18 value and the baseline value. AULCSF is calculated using the below steps: Measure contrast sensitivity (CS) at several spatial frequencies (cpd, cycles per degree). For example, at spatial frequencies of 3, 6, 12, 18. Convert the corresponding contrast sensitivity to log10 scale. Convert spatial frequencies to log10 scale. For example, log10(3), log10(6), log10(12), log10(18). Calculate the area using trapezoidal rule. Therefore, the actual measurement of AULCSF is log CS × log(cpd). For simplification, we referred to this as log scale. Higher AULCSF indicates better contrast sensitivity and better visual function.

Results and safety

Results posted to the registry on 7 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
STN1010904 Ophthalmic Suspension 0.03% BID	32	22
STN1010904 Ophthalmic Suspension 0.1% BID	32	22
Placebo Vehicle BID	22	19

Primary outcome: Change From Baseline in Best Corrected Visual Acuity (BCVA) With Contrast Level of 100% at Month 18

Time frame: The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.. Mean (Standard Error). Unit: LogMAR

Measure	Placebo Vehicle BID n = 22	STN1010904 Ophthalmic Suspension 0.03% BID n = 31	STN1010904 Ophthalmic Suspension 0.1% BID n = 29
Value	0.026 (0.0203)	0.039 (0.0176)	0.042 (0.0181)

Population analysed: As the analysis is conducted using the Full Analysis Set, the number of participants does not necessarily correspond to that presented in the Participant Flow.

Primary outcome: Change From Baseline in BCVA With Contrast Level of 10% at Month 18

Time frame: The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.. Mean (Standard Error). Unit: LogMAR

Measure	Placebo Vehicle BID n = 22	STN1010904 Ophthalmic Suspension 0.03% BID n = 31	STN1010904 Ophthalmic Suspension 0.1% BID n = 29
Value	-0.014 (0.0336)	-0.005 (0.0294)	0.085 (0.0302)

Population analysed: As the analysis is conducted using the Full Analysis Set, the number of participants does not necessarily correspond to that presented in the Participant Flow.

Primary outcome: Change From Baseline in Contrast Sensitivity With Glare Light at Month 18

Time frame: The change is calculated as the difference between the AULCSF at the 18-month visit and the baseline score.. Mean (Standard Error). Unit: log CS × log(cpd)

Measure	Placebo Vehicle BID n = 22	STN1010904 Ophthalmic Suspension 0.03% BID n = 31	STN1010904 Ophthalmic Suspension 0.1% BID n = 29
Value	0.060 (0.0479)	0.078 (0.0420)	-0.067 (0.0434)

Population analysed: As the analysis is conducted using the Full Analysis Set, the number of participants does not necessarily correspond to that presented in the Participant Flow.

Adverse events

Time frame: Adverse events were collected from informed consent through the final visit (subject withdrawal or up to 18 months after treatment initiation).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
STN1010904 Ophthalmic Suspension 0.03% BID	0 of 33 (0%)	17 of 33 (51.5%)	0 of 33
STN1010904 Ophthalmic Suspension 0.1% BID	1 of 32 (3.1%)	23 of 32 (71.9%)	0 of 32
Placebo Vehicle BID	1 of 21 (4.8%)	8 of 21 (38.1%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Fuchs Endothelial Corneal Dystrophy

Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
Fuchs, Fuchs Dystrophy
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingPhase 2
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Fuchs
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

15 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, France, India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Best Corrected Visual Acuity (BCVA) With Contrast Level of 100% at Month 18 (time frame: The change is calculated as the difference between the BCVA score at the 18-month visit and the baseline score.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05376176.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.