Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related … (NCT05495269) | Clinical Trial Compass
CompletedPhase 2
Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
United States2 participantsStarted 2022-11-23
Plain-language 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.
Who can participate
Age range12 Years – 19 Years
SexALL
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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