Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension).
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
1 other identifier
interventional
84
1 country
1
Brief Summary
Evaluating the safety and tolerability of QLS-101 versus timolol maleate ophthalmic solution in glaucoma or ocular hypertension.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2021
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2021
CompletedStudy Start
First participant enrolled
March 31, 2021
CompletedFirst Posted
Study publicly available on registry
April 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2022
CompletedJanuary 17, 2025
January 1, 2025
11 months
March 30, 2021
January 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ocular safety
Number of participants with treatment-related adverse events will be monitored
100 days
Secondary Outcomes (1)
Ocular hypotensive efficacy
28 days
Study Arms (4)
QLS-101 0.5%
EXPERIMENTALQLS-101 1%
EXPERIMENTALQLS-101 2%
EXPERIMENTALTimolol Maleate 0.5% preservative free ophthalmic solution
ACTIVE COMPARATORInterventions
Ophthalmic solution 1x daily
Eligibility Criteria
You may qualify if:
- Visual acuity +1.0 logMAR or better
- Willing to give informed consent
- Ability to washout from current intraocular pressure lowering medications -
You may not qualify if:
- Severe glaucomatous damage
- Previous glaucoma intraocular or laser surgery
- Refractive surgery
- Ocular infection or inflammation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qlaris Bio, Inc.lead
Study Sites (1)
Dixon Eye Care
Albany, Georgia, 31701, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2021
First Posted
April 5, 2021
Study Start
March 31, 2021
Primary Completion
February 17, 2022
Study Completion
February 17, 2022
Last Updated
January 17, 2025
Record last verified: 2025-01