NCT05495269

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Qlaris Bio, Inc. · Industry
• Sex: All
• Age: 12 Years – 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	QLS-101 ophthalmic solution, 2.0 %	ophthalmic solution in a single use dropper vial

Timeline

• Start date: 2022-11-23
• Primary completion: 2023-01-25
• Completion: 2023-03-20
• First posted: 2022-08-10
• Last updated: 2025-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study