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

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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).

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

Details

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

Criteria

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