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

Sponsor

Qlaris Bio, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05495269

Collaborator

(none)

Enrollment

Arm

5.9

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sturge-Weber Syndrome Glaucoma Ocular Hypertension	Drug: QLS-101 ophthalmic solution, 2.0 %	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open-label, single treatmentOpen-label, single treatment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: QLS-101, 2.0% Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes	Drug: QLS-101 ophthalmic solution, 2.0 % ophthalmic solution in a single use dropper vial

Arm

Intervention/Treatment

Experimental: QLS-101, 2.0%

Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes

Drug: QLS-101 ophthalmic solution, 2.0 %

ophthalmic solution in a single use dropper vial

Outcome Measures

Primary Outcome Measures

Ocular safety [Over 28 days]
Incidence of ocular treatment emergent adverse events (TEAEs)
Systemic safety [Over 28 days]
Incidence of systemic TEAEs

Secondary Outcome Measures

Ocular hypotensive effectiveness [28 days]
Mean change in IOP (mmHg and % change) from baseline following 28 days dosing with QLS-101

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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