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Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes

ophthalmic solution in a single use dropper vial

QLS-101 ophthalmic solution, 2.0 %

Sharon Freedman, M.D.

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.

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

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)

Incidence of ocular treatment emergent adverse events (TEAEs)

Mean change in intraocular pressure (IOP) (mmHg and % change) from baseline following 28 days dosing with QLS-101

Qlaris Bio, Inc.

Hydrophthalmos

Congenital Abnormalities

Eye Abnormalities

Glaucoma, Open-Angle

Infant, Newborn, Diseases

Glaucoma, Congenital

dosed once a day for 14 days as either first or second dosing period per randomization

dosed once a day for 14 as either first or second dosing period per randomization

QLS-101ophthalmic solution 1%

QLS-101ophthalmic solution 2%

B. Wirostko, M.D.

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).

Masked, randomized, single site, crossover study to compare 2 concentrations of QLS-101. Subjects will be randomized to one of 2 concentrations of QLS-101 for the first 14 days of daily dosing, and after a 14-day washout period they will be crossed over to the other concentration for another 14 days of daily dosing. Dose assignment is masked to patient and investigator.

Patients take 2 different doses of investigational product at distinct treatment periods. Dose is masked.

A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101

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)

Standard safety endpoint, ocular AEs, (including elevated IOP)

Standard safety endpoint, best corrected visual acuity, Snellen score, change from baseline

Standard safety endpoint, EDI-OCT, corneal thickness

Standard safety endpoint, slit lamp exam, abnormalities, changes from baseline

Fundus exam, abnormalities, changes from baseline

Mean change in IOP from baseline following 14 days dosing

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)	NCT05495269	Sturge-Weber Sy... Glaucoma Ocular Hyperten...	QLS-101 ophthal...	12 Years - 19 Years	Qlaris Bio, Inc.
A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101	NCT04947124	Sturge-Weber Sy... Glaucoma Glaucoma Congen... Ocular Hyperten...	QLS-101ophthalm... QLS-101ophthalm...	18 Years -	Qlaris Bio, Inc.

Spots Global Cancer Trial Database for ocular hypertension