STN1010904 Eye Drops for Fuchs' Dystrophy

(PHANTOM Trial)

Recruiting at 14 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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing an eye drop solution called STN1010904 on people with Fuchs Endothelial Corneal Dystrophy (FECD). The goal is to see if these eye drops can help improve or stabilize their cornea condition.

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.

What data supports the effectiveness of the drug STN1010904 eye drops for Fuchs' Dystrophy?

Research on a similar eye drop delivery system using mucoadhesive nanoparticles showed that it can prolong the retention of drugs on the eye surface, allowing for effective treatment with lower doses and potentially fewer side effects. This suggests that STN1010904, if using a similar delivery method, might also be effective for eye conditions like Fuchs' Dystrophy by improving drug retention and reducing dosage frequency. ^{1 2 3 4 5}

How is the drug STN1010904 unique for treating 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 severe enough to require a corneal transplant. Unlike other treatments, it is being tested in different concentrations to determine its effectiveness in reducing corneal edema (swelling) associated with the disease. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Prolonged Ocular Retention of Mucoadhesive Nanoparticle Eye Drop Formulation Enables Treatment of Eye Diseases Using Significantly Reduced Dosage. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The Efficiency of Cyclosporine A-Eluting Contact Lenses for the Treatment of Dry Eye. [2020]

3. France pubmed.ncbi.nlm.nih.gov

[Galenic and analytic development of tacrolimus 0.06% eye drops]. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Preparation of 0.05% FK506 suspension eyedrops and its pharmacokinetics after topical ocular administration. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

An Updated Systematic Review With Meta-Analysis Of Randomized Trials On Topical Cyclosporin A For Dry-Eye Disease. [2022]

6. Poland pubmed.ncbi.nlm.nih.gov

[Changes in corneal structure observed with confocal microscopy during Fuchs endothelial dystrophy]. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Randomized, Double-Masked, Pilot Study of Netarsudil 0.02% Ophthalmic Solution for Treatment of Corneal Edema in Fuchs Dystrophy. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

[Mixed corneal dystrophy]. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

CTG18.1 Expansion in TCF4 Increases Likelihood of Transplantation in Fuchs Corneal Dystrophy. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Selecting Fuchs patients for drug trials involving endothelial cell proliferation. [2018]