STN1010904 ophthalmic suspension 0.1% BID for Chandler Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Houston Eye Associates, Houston, TX
Chandler Syndrome+3 More
STN1010904 ophthalmic suspension 0.1% BID - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Chandler Syndrome
  • Fuchs' Corneal Endothelial Dystrophy (FCED)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 5 Secondary · Reporting Duration: at 18 month

at 18 month
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
up to month 18
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
Contrast sensitivity without glare light at all post-baeline visits
Contrast sensitivity without glare light at all post-baseline visits

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

STN1010904 ophthalmic suspension 0.03% BID
1 of 3
STN1010904 ophthalmic suspension 0.1% BID
1 of 3
Placebo Vehicle BID
1 of 3
Experimental Treatment
Non-Treatment Group

80 Total Participants · 3 Treatment Groups

Primary Treatment: STN1010904 ophthalmic suspension 0.1% BID · Has Placebo Group · Phase 2

STN1010904 ophthalmic suspension 0.03% BID
Drug
Experimental Group · 1 Intervention: STN1010904 ophthalmic suspension 0.03% BID · Intervention Types: Drug
STN1010904 ophthalmic suspension 0.1% BID
Drug
Experimental Group · 1 Intervention: STN1010904 ophthalmic suspension 0.1% BID · Intervention Types: Drug
Placebo Vehicle BID
Drug
PlaceboComparator Group · 1 Intervention: Placebo (Vehicle) BID · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 18 month
Closest Location: Houston Eye Associates · Houston, TX
Photo of Houston 1Photo of Houston 2Photo of Houston 3
2004First Recorded Clinical Trial
0 TrialsResearching Chandler Syndrome
38 CompletedClinical Trials

Who is running the clinical trial?

Santen Inc.Lead Sponsor
33 Previous Clinical Trials
4,531 Total Patients Enrolled
ActualEyes Inc.UNKNOWN

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.