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

Primary Purpose

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

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

QLS-101ophthalmic solution 1%

QLS-101ophthalmic solution 2%

About this trial

This is an interventional treatment trial for Sturge-Weber Syndrome (SWS) focused on measuring Sturge-Weber Syndrome, Glaucoma, Elevated Intraocular pressure (IOP)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Duke Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

1% QLS-101

2% QLS-101

Arm Description

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

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

Outcomes

Primary Outcome Measures

Ocular adverse events (AEs)

Standard safety endpoint, ocular AEs, (including elevated IOP)

Visual acuity

Standard safety endpoint, best corrected visual acuity, Snellen score, change from baseline

Enhance depth imaging optical coherence tomography (EDI-OCT)

Standard safety endpoint, EDI-OCT, corneal thickness

Slit lamp exam

Standard safety endpoint, slit lamp exam, abnormalities, changes from baseline

Dilated fundus exam

Fundus exam, abnormalities, changes from baseline

Secondary Outcome Measures

Ocular hypotensive efficacy

Mean change in IOP from baseline following 14 days dosing

Full Information

NCT ID

NCT04947124

First Posted

June 8, 2021

Last Updated

March 22, 2023

Sponsor

Qlaris Bio, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04947124

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 19, 2021 (Actual)

Primary Completion Date

June 6, 2022 (Actual)

Study Completion Date

August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Qlaris Bio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

ParticipantInvestigator

Masking Description

Masked investigational product labeling.

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1% QLS-101

Arm Type

Experimental

Arm Description

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

Arm Title

2% QLS-101

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

QLS-101ophthalmic solution 1%

Other Intervention Name(s)

QLS-101

Intervention Description

QLS-101ophthalmic solution 1.0%

Intervention Type

Drug

Intervention Name(s)

QLS-101ophthalmic solution 2%

Other Intervention Name(s)

QLS-101

Intervention Description

QLS-101ophthalmic solution 2.0%

Primary Outcome Measure Information:

Title

Ocular adverse events (AEs)

Description

Standard safety endpoint, ocular AEs, (including elevated IOP)

Time Frame