Back to resultsStudy to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension).
Primary Purpose
Primary Open Angle Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
QLS-101
Timolol Maleate
Sponsored by
About this trial
This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring elevated intraocular pressure
Eligibility Criteria
Inclusion Criteria:
- Visual acuity +1.0 logMAR or better
- Willing to give informed consent
- Ability to washout from current intraocular pressure lowering medications -
Exclusion Criteria:
- Severe glaucomatous damage
- Previous glaucoma intraocular or laser surgery
- Refractive surgery
- Ocular infection or inflammation
Sites / Locations
- Dixon Eye Care
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
QLS-101 0.5%
QLS-101 1%
QLS-101 2%
Timolol Maleate 0.5% preservative free ophthalmic solution
Arm Description
Outcomes
Primary Outcome Measures
Ocular safety
Number of participants with treatment-related adverse events will be monitored
Secondary Outcome Measures
Ocular hypotensive efficacy
Number of participants with intraocular pressure reduction from baseline will be calculated.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04830397
Brief Title
Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension).
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
February 17, 2022 (Actual)
Study Completion Date
February 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qlaris Bio, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluating the safety and tolerability of QLS-101 versus timolol maleate ophthalmic solution in glaucoma or ocular hypertension.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Ocular Hypertension
Keywords
elevated intraocular pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QLS-101 0.5%
Arm Type
Experimental
Arm Title
QLS-101 1%
Arm Type
Experimental
Arm Title
QLS-101 2%
Arm Type
Experimental
Arm Title
Timolol Maleate 0.5% preservative free ophthalmic solution
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
QLS-101
Intervention Description
Ophthalmic solution 1x daily
Intervention Type
Drug
Intervention Name(s)
Timolol Maleate
Intervention Description
Ophthalmic solution 1x daily
Primary Outcome Measure Information:
Title
Ocular safety
Description
Number of participants with treatment-related adverse events will be monitored
Time Frame
100 days
Secondary Outcome Measure Information:
Title
Ocular hypotensive efficacy
Description
Number of participants with intraocular pressure reduction from baseline will be calculated.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Visual acuity +1.0 logMAR or better
Willing to give informed consent
Ability to washout from current intraocular pressure lowering medications -
Exclusion Criteria:
Severe glaucomatous damage
Previous glaucoma intraocular or laser surgery
Refractive surgery
Ocular infection or inflammation
Facility Information:
Facility Name
Dixon Eye Care
City
Albany
State/Province
Georgia
ZIP/Postal Code
31701
Country
United States
12. IPD Sharing Statement
Links:
URL
https://qlaris.bio
Description
Company website, pipeline
Learn more about this trial
Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension).
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