- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05495269
Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
March 22, 2023 updated by: Qlaris Bio, Inc.
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lisa Brandano
- Phone Number: 978-930-2103
- Email: lbrandano@qlaris.bio
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke Eye Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: QLS-101, 2.0%
Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes
|
ophthalmic solution in a single use dropper vial
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ocular safety
Time Frame: Over 28 days
|
Incidence of ocular treatment emergent adverse events (TEAEs)
|
Over 28 days
|
Systemic safety
Time Frame: Over 28 days
|
Incidence of systemic TEAEs
|
Over 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ocular hypotensive effectiveness
Time Frame: 28 days
|
Mean change in intraocular pressure (IOP) (mmHg and % change) from baseline following 28 days dosing with QLS-101
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 23, 2022
Primary Completion (Actual)
January 25, 2023
Study Completion (Actual)
March 20, 2023
Study Registration Dates
First Submitted
August 2, 2022
First Submitted That Met QC Criteria
August 8, 2022
First Posted (Actual)
August 10, 2022
Study Record Updates
Last Update Posted (Actual)
March 27, 2023
Last Update Submitted That Met QC Criteria
March 22, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Eye Diseases
- Disease
- Brain Ischemia
- Infarction
- Stroke
- Brain Infarction
- Hemangioma
- Neoplasms, Vascular Tissue
- Neurocutaneous Syndromes
- Angiomatosis
- Glaucoma
- Ocular Hypertension
- Syndrome
- Klippel-Trenaunay-Weber Syndrome
- Sturge-Weber Syndrome
- Brain Stem Infarctions
- Pharmaceutical Solutions
- Ophthalmic Solutions
Other Study ID Numbers
- QC-205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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