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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-19

Study Completion Date

2022-08-01

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).

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Masked investigational product labeling.

Study Groups

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1% QLS-101

dosed once a day for 14 days as either first or second dosing period per randomization

Group Type EXPERIMENTAL

QLS-101ophthalmic solution 1%

Intervention Type DRUG

QLS-101ophthalmic solution 1.0%

2% QLS-101

dosed once a day for 14 as either first or second dosing period per randomization

Group Type EXPERIMENTAL

QLS-101ophthalmic solution 2%

Intervention Type DRUG

QLS-101ophthalmic solution 2.0%

Interventions

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QLS-101ophthalmic solution 1%

QLS-101ophthalmic solution 1.0%

Intervention Type DRUG

QLS-101ophthalmic solution 2%

QLS-101ophthalmic solution 2.0%

Intervention Type DRUG

Other Intervention Names

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QLS-101 QLS-101

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No