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A Study to Evaluate Safety and Tolerability of QLS-101 in NTG

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: NCT04857827
Recruitment Status : Completed
First Posted : April 23, 2021
Last Update Posted : October 10, 2022
Sponsor:
Information provided by (Responsible Party):
Qlaris Bio, Inc.

Study Description
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Brief Summary:
A randomized active-controlled multi-site double-masked 28 day study to evaluate the safety and tolerability of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with normal tension glaucoma

Condition or disease Intervention/treatment Phase
Normal Tension Glaucoma Drug: QLS-101 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the IP identity until after the final database is locked. IPs will be provided in identical-appearing pouches to maintain masking.
Primary Purpose: Treatment
Official Title: A Randomized Active-controlled Study to Evaluate Safety and Tolerability of QLS-101 Versus Timolol Preservative Free Ophthalmic Solution in Subjects With Normal Tension Glaucoma
Actual Study Start Date : September 15, 2021
Actual Primary Completion Date : August 26, 2022
Actual Study Completion Date : August 26, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: QLS-101 ophthalmic solution 1.0%
Ophthalmic solution one time daily for 14 days (These patients will administer 2.0% QLS-101 for last 14 days of the study).
 Drug: QLS-101
Ophthalmic solution once daily dosing for 14 days followed by 14 days of twice daily dosing.
Active Comparator: Timolol maleate PF 0.5% ophthalmic solution
Ophthalmic solution once daily dosing for 14 days followed by 14 days of twice daily dosing.
 Drug: QLS-101
Ophthalmic solution once daily dosing for 14 days followed by 14 days of twice daily dosing.
Experimental: QLS-101 ophthalmic solution 2%
Ophthalmic solution once daily dosing for 14 days followed by 14 days of twice daily dosing.
 Drug: QLS-101
Ophthalmic solution once daily dosing for 14 days followed by 14 days of twice daily dosing.


Outcome Measures
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Primary Outcome Measures :
  1. Ocular safety [ Time Frame: 86 days ]
    Number of participants with treatment-related adverse events will be monitored


Secondary Outcome Measures :
  1. Ocular hypotensive efficacy [ Time Frame: 14 days ]
    Number of participants with intraocular pressure reduction from baseline will be calculated


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:

  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. All secondary glaucomas
  2. Previous glaucoma intraocular or laser surgery (selective laser trabeculoplasty permitted when done 18 months or longer from Screening)
  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): NCT04857827


Locations
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United States, South Dakota
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108
Sponsors and Collaborators
Qlaris Bio, Inc.
Investigators
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Study Chair: Qlaris Bio Wellesley, MA
More Information
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Additional Information:

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Responsible Party: Qlaris Bio, Inc.
ClinicalTrials.gov Identifier: NCT04857827    
Other Study ID Numbers: QC-202
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: October 10, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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.:
low tension glaucoma
glaucoma
Additional relevant MeSH terms:
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Glaucoma
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases