STN1010904 Eye Drops for Fuchs' Dystrophy

(PHANTOM Trial)

No longer recruiting at 15 trial locations

Overseen By Santen Inc Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Santen Inc.

Disqualifiers: Pregnant, Lactating, Ocular surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 18 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests eye drops to determine their effectiveness for individuals with Fuchs' Dystrophy, a condition affecting the cornea that can lead to vision problems. The study compares two different strengths of STN1010904 eye drops against a placebo to assess their effectiveness and safety. Participants must visit the study site nine times over 18 months. The trial seeks individuals diagnosed with Fuchs' Dystrophy who have not undergone surgery in the eye being studied. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that STN1010904 eye drops are under investigation as a treatment for Fuchs' Dystrophy. In earlier studies, researchers tested two doses—0.03% and 0.1%—to assess safety. These studies evaluated the effects of the eye drops on vision and corneal health, the clear front part of the eye.

Results so far indicate that the eye drops are generally well-tolerated, with most participants experiencing no serious side effects. However, a few individuals reported minor side effects, such as temporary eye irritation.

As these trials remain in the early stages, researchers are closely monitoring safety. This careful observation ensures the treatment's safety before wider use. Overall, the current findings are encouraging for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about STN1010904 eye drops for Fuchs' Dystrophy because they offer a potentially innovative approach to treating this degenerative eye condition. Unlike current treatments, which typically involve corneal transplants or managing symptoms with hypertonic saline drops, STN1010904 uses a novel ophthalmic suspension that may help improve vision by directly targeting the corneal endothelium. The two concentrations being tested, 0.03% and 0.1%, allow for flexibility in dosing and could provide more effective and convenient options for patients. This treatment could ultimately transform the management of Fuchs' Dystrophy by potentially delaying the need for surgical intervention.

What evidence suggests that STN1010904 eye drops could be an effective treatment for Fuchs' Dystrophy?

This trial will evaluate STN1010904 eye drops as a treatment for Fuchs' Dystrophy, a condition affecting the cornea. Participants will receive either STN1010904 ophthalmic suspension at 0.03% or 0.1% strength, or a placebo vehicle. Research has shown that STN1010904 might be promising, with early results suggesting potential improvements in vision and corneal health. This is significant as it offers a non-surgical option, whereas current treatments often require surgery. Ongoing studies aim to better understand the effectiveness and safety of these drops. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Exclusion Criteria

I have had eye surgery for FECD.

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive STN1010904 ophthalmic suspension (0.03% or 0.1%) or placebo, twice daily for 18 months

18 months

9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo (Vehicle)
• STN1010904 ophthalmic suspension 0.03%
• STN1010904 ophthalmic suspension 0.1%

Trial Overview 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.

How Is the Trial Designed?

Group I: STN1010904 ophthalmic suspension 0.1% BID Experimental Treatment 1 Intervention

Group II: STN1010904 ophthalmic suspension 0.03% BID Experimental Treatment 1 Intervention

Group III: Placebo Vehicle BID Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Santen Inc.

Lead Sponsor

Trials

35

Recruited

4,600+

ActualEyes Inc.

Collaborator

Trials

1

Recruited

80+

Citations

1. withpower.com withpower.com/trial/phase-2-fuchs-endothelial-dystrophy-4-2022-1a557?lat=36.65114&lng=-97.3517

STN1010904 Eye Drops for Fuchs' Dystrophy STN1010904 eye drops are a novel treatment option for Fuchs' Dystrophy, offering a non-surgical approach that may help manage the condition before it becomes ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20538064

Clinical Trials The purpose of this study is to assess the effectiveness and safety of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing, when ...

3. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/fuchs-dystrophy

Fuchs' Dystrophy clinical trials at University of California Health This is a Phase IIa study to assess efficacy and safety of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when ...

4. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/fuchs'-dystrophy

Fuchs' Dystrophy Clinical Trials The purpose of this study is to assess the effectiveness and safety of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing, when compared ...

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-stn1010904-eye-drops-for-patients-with-fuchs-endothelial-corneal-dystrophy/

Study on the Effectiveness and Safety of STN1010904 Eye ... The purpose of the study is to assess how well the STN1010904 eye drops work in improving vision and the health of the cornea in people with Fuchs Endothelial ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11034696/

Therapeutic future of Fuchs endothelial corneal dystrophy A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects ...

7. journals.lww.com journals.lww.com/tjop/fulltext/2024/14010/therapeutic_future_of_fuchs_endothelial_corneal.3.aspx

Therapeutic future of Fuchs endothelial corneal dystrophy:... A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs ...