Primary Open Angle GlaucomaPhase 2NCT04830397
Study to Evaluate QLS-101 Compared to Timolol Maleate Eye Drops in Subjects With High Eye Pressure (Glaucoma or Ocular Hypertension).
A Phase 2 study testing QLS-101 and Timolol Maleate in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Qlaris Bio, Inc. at 1 site in United States.
Trial summary
Evaluating the safety and tolerability of QLS-101 versus timolol maleate ophthalmic solution in glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- QLS-101 and Timolol Maleate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2021to 17 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Visual acuity +1.0 logMAR or better
- Willing to give informed consent
- Ability to washout from current intraocular pressure lowering medications -
Who cannot join
- Severe glaucomatous damage
- Previous glaucoma intraocular or laser surgery
- Refractive surgery
- Ocular infection or inflammation
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- QLS-101, Timolol Maleate
- Keywords
- elevated intraocular pressure
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS-101Drug
Ophthalmic solution 1x daily
Timolol MaleateDrug
Ophthalmic solution 1x daily
| Study group | Role | What they receive |
|---|---|---|
| QLS-101 0.5% | Experimental | Not described Receives: Drug: QLS-101 |
| QLS-101 1% | Experimental | Not described Receives: Drug: QLS-101 |
| QLS-101 2% | Experimental | Not described Receives: Drug: QLS-101 |
| Timolol Maleate 0.5% preservative free ophthalmic solution | Active comparator | Not described Receives: Drug: Timolol Maleate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular safety
Number of participants with treatment-related adverse events will be monitored
Measured: 100 days
Secondary outcomes (1)
Ocular hypotensive efficacy
Number of participants with intraocular pressure reduction from baseline will be calculated.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start31 Mar 2021
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qlaris Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830397
- Sponsor's protocol ID
- QC-201
- Status last verified
- Jan 2025
- First submitted
- 30 Mar 2021
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04830397
- Acronym / sponsor ID
- QC-201
- Conditions
- Primary Open Angle Glaucoma, Ocular Hypertension
- Keywords
- elevated intraocular pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Qlaris Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QLS-101 0.5% | Experimental | Drug: QLS-101 |
| QLS-101 1% | Experimental | Drug: QLS-101 |
| QLS-101 2% | Experimental | Drug: QLS-101 |
| Timolol Maleate 0.5% preservative free ophthalmic solution | Active comparator | Drug: Timolol Maleate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Visual acuity +1.0 logMAR or better
- Willing to give informed consent
- Ability to washout from current intraocular pressure lowering medications -
Key exclusion criteria (4 listed)
- Severe glaucomatous damage
- Previous glaucoma intraocular or laser surgery
- Refractive surgery
- Ocular infection or inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLS-101Ophthalmic solution 1x daily | Drug | QLS-101 0.5%, QLS-101 1%, QLS-101 2% |
| Timolol MaleateOphthalmic solution 1x daily | Drug | Timolol Maleate 0.5% preservative free ophthalmic solution |
Primary outcome
Ocular safety
Time frame: 100 days
Number of participants with treatment-related adverse events will be monitored
1 secondary outcome
Ocular hypotensive efficacy
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Company website, pipelineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QLS-101 and Timolol Maleate in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Qlaris Bio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular safety (time frame: 100 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.