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

Phase 2

Completed

• Conditions: Sturge-Weber Syndrome (SWS); Glaucoma; Glaucoma Congenital; Ocular Hypertension
• Interventions: Drug: QLS-101ophthalmic solution 1%; Drug: QLS-101ophthalmic solution 2%

• Registration Number: NCT04947124
• Lead Sponsor: Qlaris Bio, Inc.

Brief Summary

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).

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 Timeline

• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-07-01
• Study Start: 2021-10-19
• Primary Completion: 2022-06-06
• Study Completion: 2022-08-01
• Disposition First Submitted: 2023-03-21
• Disposition First Posted: 2023-03-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1% QLS-101	QLS-101ophthalmic solution 1%	dosed once a day for 14 days as either first or second dosing period per randomization
2% QLS-101	QLS-101ophthalmic solution 2%	dosed once a day for 14 as either first or second dosing period per randomization

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Ocular hypotensive efficacy	14 days after each dosing timepoint is completed	Mean change in IOP from baseline following 14 days dosing

Trial Locations

Locations (1)

Duke Eye Center; 🇺🇸 Durham, North Carolina, United States