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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04947124
Recruitment Status : Recruiting
First Posted : July 1, 2021
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
Qlaris Bio, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Sturge-Weber Syndrome (SWS) Glaucoma Glaucoma Congenital Ocular Hypertension Drug: QLS-101ophthalmic solution 1% Drug: QLS-101ophthalmic solution 2% Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Patients take 2 different doses of investigational product at distinct treatment periods. Dose is masked.
Masking: Double (Participant, Investigator)
Masking Description: Masked investigational product labeling.
Primary Purpose: Treatment
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)
Actual Study Start Date : October 19, 2021
Estimated Primary Completion Date : February 11, 2022
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1% QLS-101
dosed once a day for 14 days as either first or second dosing period per randomization
 Drug: QLS-101ophthalmic solution 1%
QLS-101ophthalmic solution 1.0%
Other Name: QLS-101
Experimental: 2% QLS-101
dosed once a day for 14 as either first or second dosing period per randomization
 Drug: QLS-101ophthalmic solution 2%
QLS-101ophthalmic solution 2.0%
Other Name: QLS-101


Outcome Measures
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Primary Outcome Measures :
  1. Ocular AEs [ Time Frame: 56 days, including a 14-day washout ]
    Standard safety endpoint, ocular AEs, (including elevated IOP)

  2. Visual acuity [ Time Frame: 56 days, including a 14-day washout ]
    Standard safety endpoint, best corrected visual acuity, Snellen score, change from baseline

  3. Enhance depth imaging optical coherence tomography (EDI-OCT) [ Time Frame: 56 days, including a 14-day washout ]
    Standard safety endpoint, EDI-OCT, corneal thickness

  4. Slit lamp exam [ Time Frame: 56 days, including a 14-day washout ]
    Standard safety endpoint, slit lamp exam, abnormalities, changes from baseline

  5. Dilated fundus exam [ Time Frame: 56 days, including a 14-day washout ]
    Fundus exam, abnormalities, changes from baseline


Secondary Outcome Measures :
  1. Ocular hypotensive efficacy [ Time Frame: 14 days after each dosing timepoint is completed ]
    Mean change in IOP from baseline following 14 days dosing


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04947124


Contacts
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Contact: Cheryl St John 9789302103 cstjohn@qlaris.bio
Contact: Lisa Brandano 978-930-2103 lbrandano@qlaris.bio

Locations
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United States, North Carolina
Duke Eye Center Recruiting
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Qlaris Bio, Inc.
More Information
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Additional Information:

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Responsible Party: Qlaris Bio, Inc.
ClinicalTrials.gov Identifier: NCT04947124    
Other Study ID Numbers: QC-203
First Posted: July 1, 2021    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qlaris Bio, Inc.:
Sturge-Weber Syndrome
Glaucoma
Elevated IOP
Additional relevant MeSH terms:
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Sturge-Weber Syndrome
Brain Stem Infarctions
Glaucoma
Ocular Hypertension
Hydrophthalmos
Klippel-Trenaunay-Weber Syndrome
Syndrome
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Infarction
Ischemia
Necrosis
Angiomatosis
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Neurocutaneous Syndromes
Eye Abnormalities
Glaucoma, Open-Angle