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Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension).

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04830397
Recruitment Status : Completed
First Posted : April 5, 2021
Last Update Posted : March 17, 2023
Sponsor:
Information provided by (Responsible Party):
Qlaris Bio, Inc.

Study Description
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Brief Summary:
Evaluating the safety and tolerability of QLS-101 versus timolol maleate ophthalmic solution in glaucoma or ocular hypertension.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Ocular Hypertension Drug: QLS-101 Drug: Timolol Maleate Phase 2

Detailed Description:
Multi-site study to evaluate the safety and tolerability of 3 concentrations of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Active-controlled Multi-site Double-masked Study to Evaluate the Safety and Tolerability of 3 Concentrations of QLS-101 Versus Timolol Maleate Preservative Free (PF) 0.5% Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
Actual Study Start Date : March 31, 2021
Actual Primary Completion Date : February 17, 2022
Actual Study Completion Date : February 17, 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: QLS-101 0.5% Drug: QLS-101
Ophthalmic solution 1x daily
Experimental: QLS-101 1% Drug: QLS-101
Ophthalmic solution 1x daily
Experimental: QLS-101 2% Drug: QLS-101
Ophthalmic solution 1x daily
Active Comparator: Timolol Maleate 0.5% preservative free ophthalmic solution Drug: Timolol Maleate
Ophthalmic solution 1x daily


Outcome Measures
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Primary Outcome Measures :
  1. Ocular safety [ Time Frame: 100 days ]
    Number of participants with treatment-related adverse events will be monitored


Secondary Outcome Measures :
  1. Ocular hypotensive efficacy [ Time Frame: 28 days ]
    Number of participants with intraocular pressure reduction from baseline will be calculated.


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  1. Visual acuity +1.0 logMAR or better
  2. Willing to give informed consent
  3. Ability to washout from current intraocular pressure lowering medications -

Exclusion Criteria:

  1. Severe glaucomatous damage
  2. Previous glaucoma intraocular or laser surgery
  3. Refractive surgery
  4. Ocular infection or inflammation
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): NCT04830397


Locations
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United States, Georgia
Dixon Eye Care
Albany, Georgia, United States, 31701
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: NCT04830397    
Other Study ID Numbers: QC-201
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: April 2021

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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.:
elevated intraocular pressure
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
 Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents