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 range

12 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ocular safety

Timeframe: Over 28 days

Systemic safety

Timeframe: Over 28 days

Trial details

NCT IDNCT05495269

SponsorQlaris Bio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-25

View on ClinicalTrials.gov More Sturge-Weber Syndrome trials

Who can participate

Age range

12 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.