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

Phase 2

Completed

• Conditions: Sturge-Weber Syndrome; Glaucoma; Ocular Hypertension
• Interventions: Drug: QLS-101 ophthalmic solution, 2.0 %

• Registration Number: NCT05495269
• Lead Sponsor: Qlaris Bio, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Study Start: 2022-11-23
• Primary Completion: 2023-01-25
• Status Verified: 2023-03
• Study Completion: 2023-03-20
• Disposition First Submitted: 2023-03-21
• Last Update Submitted: 2023-03-22
• Disposition First Posted: 2023-03-27
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QLS-101, 2.0%	QLS-101 ophthalmic solution, 2.0 %	Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes

Primary Outcome Measures

Name	Time	Method
Systemic safety	Over 28 days	Incidence of systemic TEAEs
Ocular safety	Over 28 days	Incidence of ocular treatment emergent adverse events (TEAEs)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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