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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04947124

Enrollment

Registered

2021-07-01

Start date

2021-10-19

Completion date

2022-08-01

Last updated

2025-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Glaucoma Congenital, Ocular Hypertension, Sturge-Weber Syndrome (SWS)

Keywords

Sturge-Weber Syndrome, Glaucoma, Elevated Intraocular pressure (IOP)

Brief summary

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).

Detailed description

Masked, randomized, single site, crossover study to compare 2 concentrations of QLS-101. Subjects will be randomized to one of 2 concentrations of QLS-101 for the first 14 days of daily dosing, and after a 14-day washout period they will be crossed over to the other concentration for another 14 days of daily dosing. Dose assignment is masked to patient and investigator.

Interventions

DRUGQLS-101ophthalmic solution 1%

QLS-101ophthalmic solution 1.0%

DRUGQLS-101ophthalmic solution 2%

QLS-101ophthalmic solution 2.0%

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Masking description

Masked investigational product labeling.

Intervention model description

Patients take 2 different doses of investigational product at distinct treatment periods. Dose is masked.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Ocular adverse events (AEs)	56 days, including a 14-day washout	Standard safety endpoint, ocular AEs, (including elevated IOP)
Visual acuity	56 days, including a 14-day washout	Standard safety endpoint, best corrected visual acuity, Snellen score, change from baseline
Enhance depth imaging optical coherence tomography (EDI-OCT)	56 days, including a 14-day washout	Standard safety endpoint, EDI-OCT, corneal thickness
Slit lamp exam	56 days, including a 14-day washout	Standard safety endpoint, slit lamp exam, abnormalities, changes from baseline
Dilated fundus exam	56 days, including a 14-day washout	Fundus exam, abnormalities, changes from baseline

Secondary

Measure	Time frame	Description
Ocular hypotensive efficacy	14 days after each dosing timepoint is completed	Mean change in IOP from baseline following 14 days dosing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026