Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)

Study Overview
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Brief Summary
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Open-label study of an investigational product (IP), QLS-101, with 28-day every morning (QAM) dosing to both eyes (OU) in adolescents with SWS who have clinical evidence of glaucoma and/or ocular hypertension (OHT) related to SWS elevated EVP in at least one eye.

Official Title
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Pilot, Open-label Study of Safety and Tolerability of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)

Conditions
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Sturge-Weber Syndrome, Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: QLS-101 ophthalmic solution, 2.0 %


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 12 and 19 years of age at Screening. Diagnosed with SWS Elevated IOP Willing to continue current dosing regimen of IOP-lowering medications Able to provide informed consent and follow study instructions Exclusion Criteria: Expected to undergo IOP-lowering surgery Incisional or laser surgery of any type 4 months prior to study Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis, history of herpes simplex keratitis in either eye History of or active clinically significant ocular disease Use of topical ocular corticosteroids in the 6 weeks prior to study Patient cannot be applanated or tolerate IOP measurements Patient is pregnant or lactating Uncontrolled systemic disease that can interfere with study participation Inability to self-dose or identify a caregiver for all study eye drop administration

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label, single treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QLS-101, 2.0%<br>Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes | Drug: QLS-101 ophthalmic solution, 2.0 %<br>* ophthalmic solution in a single use dropper vial<br>* Other names: QLS-101;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular safety | Incidence of ocular treatment emergent adverse events (TEAEs) | Over 28 days | 
| Systemic safety | Incidence of systemic TEAEs | Over 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular hypotensive effectiveness | Mean change in intraocular pressure (IOP) (mmHg and % change) from baseline following 28 days dosing with QLS-101 | 28 days |