Back to resultsA Study to Evaluate Safety and Tolerability of QLS-101 in NTG
Primary Purpose
Normal Tension Glaucoma (NTG)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
QLS-101
Timolol maleate PF 0.5% ophthalmic solution
Sponsored by
About this trial
This is an interventional treatment trial for Normal Tension Glaucoma (NTG) focused on measuring low tension glaucoma (LTG), glaucoma
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:
- All secondary glaucomas
- Previous glaucoma intraocular or laser surgery (selective laser trabeculoplasty permitted when done 18 months or longer from Screening)
- Refractive surgery
- Ocular infection or inflammation
Sites / Locations
- Vance Thompson Vision
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
QLS-101 ophthalmic solution 1.0%
Timolol maleate PF 0.5% ophthalmic solution
QLS-101 ophthalmic solution 2.0%
Arm Description
Ophthalmic solution once daily (QD) dosing in both eyes (OU) for 14 days followed by 14 days of twice daily (BID) dosing.
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
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
NCT04857827
Brief Title
A Study to Evaluate Safety and Tolerability of QLS-101 in NTG
Official Title
A Randomized Active-controlled Study to Evaluate Safety and Tolerability of QLS-101 Versus Timolol Preservative Free (PF) Ophthalmic Solution in Subjects With Normal Tension Glaucoma (NTG)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
August 26, 2022 (Actual)
Study Completion Date
August 26, 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Normal Tension Glaucoma (NTG)
Keywords
low tension glaucoma (LTG), glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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 investigational product (IP) identity until after the final database is locked. IPs will be provided in identical-appearing pouches to maintain masking.
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QLS-101 ophthalmic solution 1.0%
Arm Type
Experimental
Arm Description
Ophthalmic solution once daily (QD) dosing in both eyes (OU) for 14 days followed by 14 days of twice daily (BID) dosing.
Arm Title
Timolol maleate PF 0.5% ophthalmic solution
Arm Type
Active Comparator
Arm Description
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
Arm Title
QLS-101 ophthalmic solution 2.0%
Arm Type
Experimental
Arm Description
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
Intervention Type
Drug
Intervention Name(s)
QLS-101
Other Intervention Name(s)
QLS-101 ophthalmic solution
Intervention Description
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
Intervention Type
Drug
Intervention Name(s)
Timolol maleate PF 0.5% ophthalmic solution
Other Intervention Name(s)
Timolol
Intervention Description
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
Primary Outcome Measure Information:
Title
Ocular safety
Description
Number of participants with treatment-related adverse events will be monitored
Time Frame
86 days
Secondary Outcome Measure Information:
Title
Ocular hypotensive efficacy
Description
Number of participants with intraocular pressure reduction from baseline will be calculated
Time Frame
14 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:
All secondary glaucomas
Previous glaucoma intraocular or laser surgery (selective laser trabeculoplasty permitted when done 18 months or longer from Screening)
Refractive surgery
Ocular infection or inflammation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B. Wirostko, M.D.
Organizational Affiliation
Qlaris Bio, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Vance Thompson Vision
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://qlaris.bio
Description
company website
Learn more about this trial
A Study to Evaluate Safety and Tolerability of QLS-101 in NTG
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