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)

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).

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma; Glaucoma Congenital; Sturge-Weber Syndrome (SWS)
• Intervention / Treatment: Drug: QLS-101ophthalmic solution 1%; Drug: QLS-101ophthalmic solution 2%

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1% QLS-101; dosed once a day for 14 days as either first or second dosing period per randomization	Drug: QLS-101ophthalmic solution 1%; QLS-101ophthalmic solution 1.0%; Other Names: QLS-101
Experimental: 2% QLS-101; dosed once a day for 14 as either first or second dosing period per randomization	Drug: QLS-101ophthalmic solution 2%; QLS-101ophthalmic solution 2.0%; Other Names: QLS-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Standard safety endpoint, best corrected visual acuity, Snellen score, change from baseline	56 days, including a 14-day washout
Enhance depth imaging optical coherence tomography (EDI-OCT)	Standard safety endpoint, EDI-OCT, corneal thickness	56 days, including a 14-day washout
Slit lamp exam	Standard safety endpoint, slit lamp exam, abnormalities, changes from baseline	56 days, including a 14-day washout
Dilated fundus exam	Fundus exam, abnormalities, changes from baseline	56 days, including a 14-day washout
Ocular adverse events (AEs)	Standard safety endpoint, ocular AEs, (including elevated IOP)	56 days, including a 14-day washout

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular hypotensive efficacy	Mean change in IOP from baseline following 14 days dosing	14 days after each dosing timepoint is completed

Collaborators and Investigators

• Sponsor: Qlaris Bio, Inc.
• Investigators: Study Director: B. Wirostko, M.D., Qlaris Bio, Inc.

Publications and helpful links

Helpful Links

• Qlaris Bio website, pipeline page

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Actual): June 6, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: June 8, 2021
• First Submitted That Met QC Criteria: June 23, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Glaucoma; Sturge-Weber Syndrome; Elevated Intraocular pressure (IOP)
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Neoplasms by Histologic Type; Disease; Infant, Newborn, Diseases; Eye Diseases; Brain Infarction; Brain Ischemia; Infarction; Necrosis; Congenital Abnormalities; Neurocutaneous Syndromes; Neoplasms, Vascular Tissue; Ischemia; Stroke; Angiomatosis; Hemangioma; Eye Abnormalities; Glaucoma, Open-Angle; Syndrome; Glaucoma; Ocular Hypertension; Klippel-Trenaunay-Weber Syndrome; Brain Stem Infarctions; Sturge-Weber Syndrome; Hydrophthalmos; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: QC-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No