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)

QC-205

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.

2022-11-23

2023-01-25

2023-03-20

Completed

Early phase I

2

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label, single treatment', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2, 'type': 'ACTUAL'}}

2023-03-27