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NCT Number: NCT04947124

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

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).

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Key information

Conditions

Sturge-Weber Syndrome (SWS) Angiomatosis Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Abnormalities Eye Diseases Glaucoma Glaucoma Congenital Glaucoma, Open-Angle Hemangioma Hydrophthalmos Infant, Newborn, Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Vascular Tissue Nervous System Diseases Neurocutaneous Syndromes Ocular Hypertension Sturge-Weber Syndrome Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Duke Eye Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

QLS-101ophthalmic solution 1%

Drug

QLS-101ophthalmic solution 1.0%

Other names: QLS-101

QLS-101ophthalmic solution 2%

Drug

QLS-101ophthalmic solution 2.0%

Other names: QLS-101

Primary outcomes

  1. Ocular adverse events (AEs)

    Time frame: 56 days, including a 14-day washout

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

  2. Visual acuity

    Time frame: 56 days, including a 14-day washout

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

  3. Enhance depth imaging optical coherence tomography (EDI-OCT)

    Time frame: 56 days, including a 14-day washout

    Standard safety endpoint, EDI-OCT, corneal thickness

  4. Slit lamp exam

    Time frame: 56 days, including a 14-day washout

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

  5. Dilated fundus exam

    Time frame: 56 days, including a 14-day washout

    Fundus exam, abnormalities, changes from baseline

Secondary outcomes

  1. Ocular hypotensive efficacy

    Time frame: 14 days after each dosing timepoint is completed

    Mean change in IOP from baseline following 14 days dosing

Sponsors and collaborators

Lead sponsor

Qlaris Bio, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 1, 2021
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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