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STN1010904 Eye Drops for Fuchs' Dystrophy (PHANTOM Trial)

Phase 2

Recruiting

Research Sponsored by Santen Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female diagnosed with FECD

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 18 month

Awards & highlights

PHANTOM Trial Summary

This trial is testing a new eye drop medication for people with a specific corneal dystrophy. The study will last 18 months and compare the new medication to a placebo.

Who is the study for?

This trial is for men and women diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD). It's not open to pregnant or breastfeeding women, nor to those who have had certain eye surgeries like corneal transplants in the affected eye.Check my eligibility

What is being tested?

The study tests two strengths of STN1010904 ophthalmic suspension (0.03% and 0.1%), given twice daily against a placebo, over an 18-month period with nine visits, to see how well they work and their safety in treating FECD.See study design

What are the potential side effects?

While specific side effects are not listed here, typical ones from ophthalmic suspensions may include eye irritation, discomfort, redness, blurred vision, dry eyes or allergic reactions.

PHANTOM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with Fuchs' Endothelial Corneal Dystrophy (FECD).

PHANTOM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 18 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 18 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 18 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in BCVA with contrast level of 10% at Month 18

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

Change from baseline in contrast sensitivity with glare light at Month 18

Secondary outcome measures

BCVA with contrast level of 10% at all post-baseline visits

Best corrected visual acuity (BCVA) with contrast level of 100% at all post-baseline visits

Contrast sensitivity with glare light at all post-baseline visits

+1 more

PHANTOM Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: STN1010904 ophthalmic suspension 0.1% BIDExperimental Treatment1 Intervention

Group II: STN1010904 ophthalmic suspension 0.03% BIDExperimental Treatment1 Intervention

Group III: Placebo Vehicle BIDPlacebo Group1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Santen Inc.Lead Sponsor

34 Previous Clinical Trials

4,489 Total Patients Enrolled

ActualEyes Inc.UNKNOWN

Media Library

Placebo (Vehicle) Clinical Trial Eligibility Overview. Trial Name: NCT05376176 — Phase 2

Fuchs' Dystrophy Research Study Groups: STN1010904 ophthalmic suspension 0.03% BID, STN1010904 ophthalmic suspension 0.1% BID, Placebo Vehicle BID

Fuchs' Dystrophy Clinical Trial 2023: Placebo (Vehicle) Highlights & Side Effects. Trial Name: NCT05376176 — Phase 2

Placebo (Vehicle) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05376176 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can patients sign up for this trial right now?

"Yes, this information is accurate. The study's most recent update was on 6/15/2022 and it is actively seeking participants, as first reported on 5/19/2022."

Answered by AI

Are there any harmful effects to STN1010904 ophthalmic suspension 0.1% BID use?

"This is a Phase 2 trial, meaning that while there are some data supporting safety, none support efficacy. As such, our team Power has given it a score of 2 in terms of safety."

Answered by AI

Is this study open to patients who are below the age of 80?

"People aged 30 to 75 are eligible for this specific clinical trial. In contrast, there is one ongoing clinical trial for people under 18 and eighteen different trials for seniors above the age of 65."

Answered by AI

How many people are being given the chance to try this new treatment?

"That is correct. The clinical trial in question, which was first advertised on May 19th, is still looking for participants. As of right now, they are 80 patients short of their goal, across 2 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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)

2022. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05376176.