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

NCT ID: NCT05495269

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-23
• Study Completion Date: 2023-03-20

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.

Conditions

Sturge-Weber Syndrome; Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QLS-101, 2.0%

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

Group Type: EXPERIMENTAL

QLS-101 ophthalmic solution, 2.0 %

Intervention Type: DRUG

ophthalmic solution in a single use dropper vial

Interventions

QLS-101 ophthalmic solution, 2.0 %

ophthalmic solution in a single use dropper vial

Intervention Type: DRUG

Other Intervention Names

QLS-101

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qlaris Bio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Freedman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke Eye Center

Locations

Duke Eye Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

QC-205

Identifier Type: -

Identifier Source: org_study_id