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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05495269

Enrollment

Registered

2022-08-10

Start date

2022-11-23

Completion date

2023-03-20

Last updated

2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Ocular Hypertension, Sturge-Weber Syndrome

Brief summary

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.

Interventions

DRUGQLS-101 ophthalmic solution, 2.0 %

ophthalmic solution in a single use dropper vial

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open-label, single treatment

Eligibility

Sex/Gender

ALL

Age

12 Years to 19 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026