Clinical trial · Interventional
Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
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)
NCT05495269CI-TRIAL-00084876completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glaucoma | — | UNRESOLVED | — |
| Ocular Hypertension | — | UNRESOLVED | — |
| Sturge-Weber Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QLS-101 ophthalmic solution, 2.0 % | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QLS-101, 2.0%
- description
- Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes
- interventionNames
- Drug: QLS-101 ophthalmic solution, 2.0 %
Primary outcomes (2)
- measure
- Ocular safety
- timeFrame
- Over 28 days
- description
- Incidence of ocular treatment emergent adverse events (TEAEs)
- measure
- Systemic safety
- timeFrame
- Over 28 days
- description
- Incidence of systemic TEAEs
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.