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

Qlaris Bio

Status and phase: Completed; Phase 2

Conditions: Glaucoma Congenital; Glaucoma; Ocular Hypertension; Sturge-Weber Syndrome (SWS)

Treatments: Drug: QLS-101ophthalmic solution 2%; Drug: QLS-101ophthalmic solution 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT04947124

QC-203

Details and patient eligibility

About

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).

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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3 participants in 2 patient groups

1% QLS-101

Experimental group

Description:

dosed once a day for 14 days as either first or second dosing period per randomization

Treatment:

Drug: QLS-101ophthalmic solution 1%

2% QLS-101

Experimental group

Description:

dosed once a day for 14 as either first or second dosing period per randomization

Treatment:

Drug: QLS-101ophthalmic solution 2%