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Completed

NCT Number: NCT05495269

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

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.

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Key information

Conditions

Sturge-Weber Syndrome Angiomatosis Cardiovascular Diseases Eye Diseases Glaucoma Hemangioma Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue Nervous System Diseases Neurocutaneous Syndromes Ocular Hypertension Vascular Diseases

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke Eye Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QLS-101 ophthalmic solution, 2.0 %

Drug

ophthalmic solution in a single use dropper vial

Other names: QLS-101

Primary outcomes

  1. Ocular safety

    Time frame: Over 28 days

    Incidence of ocular treatment emergent adverse events (TEAEs)

  2. Systemic safety

    Time frame: Over 28 days

    Incidence of systemic TEAEs

Secondary outcomes

  1. Ocular hypotensive effectiveness

    Time frame: 28 days

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

Sponsors and collaborators

Lead sponsor

Qlaris Bio, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2022
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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