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CompletedNCT04830397Updated Jan 17, 2025

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

A Phase 2 interventional study of QLS-101 and Timolol Maleate in Primary Open Angle Glaucoma and Ocular Hypertension, sponsored by Qlaris Bio, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-17.

Sponsored by Qlaris Bio, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Feb 2022, 4 years 8 months ago, and no results have been posted to the registry.
Phase
Phase 2
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Primary Open Angle Glaucoma
  • Ocular Hypertension

Keywords

  • elevated intraocular pressure
03

In context

Glaucoma, Open-Angle

943 studies on the registry are indexed under Glaucoma, Open-Angle; 118 are open to participants now.

This study's enrollment of 84 is close to the median of 80 across 710 interventional studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Qlaris Bio, Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Severe glaucomatous damage
  2. Previous glaucoma intraocular or laser surgery
  3. Refractive surgery
  4. Ocular infection or inflammation
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    QLS-101 0.5%

    Drug: QLS-101

  • Experimental
    QLS-101 1%

    Drug: QLS-101

  • Experimental
    QLS-101 2%

    Drug: QLS-101

  • Active comparator
    Timolol Maleate 0.5% preservative free ophthalmic solution

    Drug: Timolol Maleate

Interventions

06

What researchers measure

Primary outcomes

  1. Ocular safety

    Number of participants with treatment-related adverse events will be monitored

    Time frame: 100 days

Secondary outcomes

  1. Ocular hypotensive efficacy

    Number of participants with intraocular pressure reduction from baseline will be calculated.

    Time frame: 28 days

07

Study locations

1 site
  • Dixon Eye Care
    Albany, Georgia 31701, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2021 to primary completion in Feb 2022, 10 months.

Of 38 industry-sponsored phase 2 interventional studies under Glaucoma, Open-Angle, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 16. This study's 10 months is close to that.

Counting every sponsor, half of 41 studies reached it within 12 months; a quarter within 7 and three quarters within 18.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2021
First posted
Apr 5, 2021
StartActual
Mar 31, 2021
Primary completionActual
Feb 17, 2022
CompletionActual
Feb 17, 2022
Last update
Jan 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04830397
Lead sponsor
Qlaris Bio, Inc.
Responsible party
Sponsor
First posted
Apr 5, 2021
Start date
Mar 31, 2021
Primary completion
Feb 17, 2022
Completion
Feb 17, 2022
Last update
Jan 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Foslevcromakalim

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Qlaris Bio, Inc.

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