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

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Status and phase

Completed

Phase 2

Conditions

Sturge-Weber Syndrome

Glaucoma

Ocular Hypertension

Treatments

Drug: QLS-101 ophthalmic solution, 2.0 %

Study type

Interventional

Funder types

Industry

Identifiers

NCT05495269

QC-205

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

12 to 19 years old

Volunteers

No Healthy Volunteers

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