Masked, Randomized, Single-site, Crossover Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101 Dosed for 14 Days in Adult Subjects With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)

QC-203

Safety and tolerability study of 2 concentrations of QLS-101 for adult subjects with Sturge Weber Syndrome (SWS)-related glaucoma due to elevated episcleral venous pressure (EVP).

2021-10-19

2022-06-06

2022-08-01

Completed

Early phase I

3

Inclusion Criteria: * Diagnosed with SWS. * Elevated intraocular pressure (IOP) * Willing to continue current dosing regimen of IOP-lowering medications * Willing to refrain from contact lens use in the study eye. Exclusion Criteria: * IOP with variability of \> 4 mm Hg * Expected to undergo IOP-lowering surgery * Incisional or laser surgery of any type * Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis * A 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 Visit 1

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Patients take 2 different doses of investigational product at distinct treatment periods. Dose is masked.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Masked investigational product labeling.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 3, 'type': 'ACTUAL'}}

2023-03-27