Clinical trial · Interventional
A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101
Masked, Randomized, Single-site, Crossover Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101 Dosed for 14 Days in Adult Subjects With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
NCT04947124CI-TRIAL-00084874completedPhase 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)
Safety and tolerability study of 2 concentrations of QLS-101 for adult subjects with Sturge Weber Syndrome (SWS)-related glaucoma due to elevated episcleral venous pressure (EVP).
Conditions
Conditions (4)
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 | — |
| Glaucoma Congenital | — | UNRESOLVED | — |
| Ocular Hypertension | — | UNRESOLVED | — |
| Sturge-Weber Syndrome (SWS) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QLS-101ophthalmic solution 1% | Drug | — | UNRESOLVED |
| QLS-101ophthalmic solution 2% | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1% QLS-101
- description
- dosed once a day for 14 days as either first or second dosing period per randomization
- interventionNames
- Drug: QLS-101ophthalmic solution 1%
- type
- EXPERIMENTAL
- label
- 2% QLS-101
- description
- dosed once a day for 14 as either first or second dosing period per randomization
- interventionNames
- Drug: QLS-101ophthalmic solution 2%
Primary outcomes (5)
- measure
- Ocular adverse events (AEs)
- timeFrame
- 56 days, including a 14-day washout
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with SWS. * Elevated intraocular pressure (IOP) * Willing to continue current dosing regimen of IOP-lowering medications * Willing to refrain from contact lens use in the study eye. Exclusion Criteria: * IOP with variability of \> 4 mm Hg * Expected to undergo IOP-lowering surgery * Incisional or laser surgery of any type * Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis * A 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 Visit 1
References
Publications (0)
Data not yet available
No reference posted for this study.