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

Completed · Phase 2

Conditions studied: Sturge-Weber Syndrome, Glaucoma, Ocular Hypertension

In brief

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.

Key facts

Study ID

NCT05495269

Run by

Qlaris Bio, Inc.

People needed

2

Starts

2022-11-23

Expected to finish

2023-03-20

Last updated by the study team

2025-01-20

Who can join

Age: 12 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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