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

Glaucoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05495269
• Other study ID #: QC-205
• Status: Completed
• Phase: Phase 2
• Start date: November 23, 2022
• Est. completion date: March 20, 2023

Study information

• Verified date: March 2023
• Source: Qlaris Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: March 20, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

Inclusion Criteria:

• Between 12 and 19 years of age at Screening.

• Diagnosed with SWS

• Elevated IOP

• Willing to continue current dosing regimen of IOP-lowering medications

• Able to provide informed consent and follow study instructions

Exclusion Criteria:

• Expected to undergo IOP-lowering surgery

• Incisional or laser surgery of any type 4 months prior to study

• Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis, 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 study

• Patient cannot be applanated or tolerate IOP measurements

• Patient is pregnant or lactating

• Uncontrolled systemic disease that can interfere with study participation

• Inability to self-dose or identify a caregiver for all study eye drop administration

Related Conditions & MeSH terms

• Brain Stem Infarctions
• Glaucoma
• Ocular Hypertension
• Sturge-Weber Syndrome
• Syndrome

Intervention

Drug:
• QLS-101 ophthalmic solution, 2.0 %
ophthalmic solution in a single use dropper vial

Locations

Country	Name	City	State
United States	Duke Eye Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Qlaris Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular safety	Incidence of ocular treatment emergent adverse events (TEAEs)	Over 28 days
Primary	Systemic safety	Incidence of systemic TEAEs	Over 28 days
Secondary	Ocular hypotensive effectiveness	Mean change in intraocular pressure (IOP) (mmHg and % change) from baseline following 28 days dosing with QLS-101	28 days