A Study to Determine the Safety and Tolerability of 2 Concentrations of QLS-101

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

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

Intervention / Treatment
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* Drug: QLS-101ophthalmic solution 1%
* Drug: QLS-101ophthalmic solution 2%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients take 2 different doses of investigational product at distinct treatment periods. Dose is masked.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1% QLS-101<br>dosed once a day for 14 days as either first or second dosing period per randomization | Drug: QLS-101ophthalmic solution 1%<br>* QLS-101ophthalmic solution 1.0%<br>* Other names: QLS-101;|
| Experimental: 2% QLS-101<br>dosed once a day for 14 as either first or second dosing period per randomization | Drug: QLS-101ophthalmic solution 2%<br>* QLS-101ophthalmic solution 2.0%<br>* Other names: QLS-101;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sturge-Weber Syndrome, Glaucoma, Elevated Intraocular pressure (IOP)