NCT05495269CompletedPhase 2
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Qlaris Bio, Inc.
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Systemic safety
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 19 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
QLS-101, 2.0%
Experimental
Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes
Intervention: QLS-101 ophthalmic solution, 2.0 % (Drug)
Outcomes
Primary Outcomes
Systemic safety
Time Frame: Over 28 days
Incidence of systemic TEAEs
Ocular safety
Time Frame: Over 28 days
Incidence of ocular treatment emergent adverse events (TEAEs)
Secondary Outcomes
- Ocular hypotensive effectiveness(28 days)
Investigators
Study Sites (1)
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