Back to resultsSafety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
Primary Purpose
Sturge-Weber Syndrome, Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
QLS-101 ophthalmic solution, 2.0 %
Sponsored by
About this trial
This is an interventional treatment trial for Sturge-Weber Syndrome
Eligibility Criteria
Inclusion Criteria:
- Between 12 and 19 years of age at Screening.
- Diagnosed with SWS
- Elevated IOP
- Willing to continue current dosing regimen of IOP-lowering medications
- Able to provide informed consent and follow study instructions
Exclusion Criteria:
- Expected to undergo IOP-lowering surgery
- Incisional or laser surgery of any type 4 months prior to study
- Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis, 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 study
- Patient cannot be applanated or tolerate IOP measurements
- Patient is pregnant or lactating
- Uncontrolled systemic disease that can interfere with study participation
- Inability to self-dose or identify a caregiver for all study eye drop administration
Sites / Locations
- Duke Eye Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
QLS-101, 2.0%
Arm Description
Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes
Outcomes
Primary Outcome Measures
Ocular safety
Incidence of ocular treatment emergent adverse events (TEAEs)
Systemic safety
Incidence of systemic TEAEs
Secondary Outcome Measures
Ocular hypotensive effectiveness
Mean change in intraocular pressure (IOP) (mmHg and % change) from baseline following 28 days dosing with QLS-101
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05495269
Brief Title
Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
Official Title
Pilot, Open-label Study of Safety and Tolerability of QLS-101 in Adolescents 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
November 23, 2022 (Actual)
Primary Completion Date
January 25, 2023 (Actual)
Study Completion Date
March 20, 2023 (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
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Open-label study of an investigational product (IP), QLS-101, with 28-day every morning (QAM) dosing to both eyes (OU) in adolescents with SWS who have clinical evidence of glaucoma and/or ocular hypertension (OHT) related to SWS elevated EVP in at least one eye.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sturge-Weber Syndrome, Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open-label, single treatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QLS-101, 2.0%
Arm Type
Experimental
Arm Description
Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes
Intervention Type
Drug
Intervention Name(s)
QLS-101 ophthalmic solution, 2.0 %
Other Intervention Name(s)
QLS-101
Intervention Description
ophthalmic solution in a single use dropper vial
Primary Outcome Measure Information:
Title
Ocular safety
Description
Incidence of ocular treatment emergent adverse events (TEAEs)
Time Frame
Over 28 days
Title
Systemic safety
Description
Incidence of systemic TEAEs
Time Frame
Over 28 days
Secondary Outcome Measure Information:
Title
Ocular hypotensive effectiveness
Description
Mean change in intraocular pressure (IOP) (mmHg and % change) from baseline following 28 days dosing with QLS-101
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between 12 and 19 years of age at Screening.
Diagnosed with SWS
Elevated IOP
Willing to continue current dosing regimen of IOP-lowering medications
Able to provide informed consent and follow study instructions
Exclusion Criteria:
Expected to undergo IOP-lowering surgery
Incisional or laser surgery of any type 4 months prior to study
Ocular infection, inflammation, clinically significant blepharitis or conjunctivitis, 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 study
Patient cannot be applanated or tolerate IOP measurements
Patient is pregnant or lactating
Uncontrolled systemic disease that can interfere with study participation
Inability to self-dose or identify a caregiver for all study eye drop administration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Freedman, M.D.
Organizational Affiliation
Duke Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
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