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

Qlaris Bio, Inc.3 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

QLS-101ophthalmic solution 1%DRUG

QLS-101ophthalmic solution 1.0%

QLS-101ophthalmic solution 2%DRUG

QLS-101ophthalmic solution 2.0%

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with SWS. * Elevated intraocular pressure (IOP) * Willing to continue current dosing regimen of IOP-lowering medications * Willing to refrain from contact lens use in the study eye. Exclusion Criteria: * IOP with variability of \> 4 mm Hg * Expected to undergo IOP-lowering surgery * Incisional or laser surgery of any type * Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis * A 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 Visit 1

Locations (1)

Duke Eye Center

Durham, North Carolina, United States