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Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
Phase 2
Waitlist Available
Led By Sharon Freedman, M.D.
Research Sponsored by Qlaris Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new treatment called QLS-101 for adolescents with Sturge-Weber Syndrome who have high eye pressure. The medicine is applied to both eyes every morning for about a month to help reduce the pressure.
Eligible Conditions
- Ocular Hypertension
- Sturge-Weber Syndrome
- Glaucoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Ocular safety
Systemic safety
Secondary study objectives
Ocular hypotensive effectiveness
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: QLS-101, 2.0%Experimental Treatment1 Intervention
Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
QLS-101 ophthalmic solution, 2.0 %
2022
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
Qlaris Bio, Inc.Lead Sponsor
6 Previous Clinical Trials
285 Total Patients Enrolled
4 Trials studying Ocular Hypertension
195 Patients Enrolled for Ocular Hypertension
Sharon Freedman, M.D.Principal InvestigatorDuke Eye Center