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

Study Locations

  • United States
    • 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
Drug: QLS-101 ophthalmic solution, 2.0 %
ophthalmic solution in a single use dropper vial
Other Names:
  • QLS-101

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

Qlaris Bio, Inc.

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

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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