NCT04947124

A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101

Masked, Randomized, Single-site, Crossover Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101 Dosed for 14 Days in Adult Subjects With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Qlaris Bio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Safety and tolerability study of 2 concentrations of QLS-101 for adult subjects with Sturge Weber Syndrome (SWS)-related glaucoma due to elevated episcleral venous pressure (EVP).

Detailed description

Masked, randomized, single site, crossover study to compare 2 concentrations of QLS-101. Subjects will be randomized to one of 2 concentrations of QLS-101 for the first 14 days of daily dosing, and after a 14-day washout period they will be crossed over to the other concentration for another 14 days of daily dosing. Dose assignment is masked to patient and investigator.

Conditions

• Sturge-Weber Syndrome (SWS)
• Glaucoma
• Glaucoma Congenital
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	QLS-101ophthalmic solution 1%	QLS-101ophthalmic solution 1.0%
DRUG	QLS-101ophthalmic solution 2%	QLS-101ophthalmic solution 2.0%

Timeline

• Start date: 2021-10-19
• Primary completion: 2022-06-06
• Completion: 2022-08-01
• First posted: 2021-07-01
• Last updated: 2025-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study