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

• Status: Not yet recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qlaris Bio, Inc.
• Treatments: Ophthalmic Solutions

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