Normal Tension Glaucoma (NTG)Phase 2NCT04857827
A Study to Evaluate Safety and Tolerability of QLS-101 in NTG
A Phase 2 study testing QLS-101 and Timolol maleate PF 0.5% ophthalmic solution in people with Normal Tension Glaucoma (NTG), run by Qlaris Bio, Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Normal Tension Glaucoma (NTG)
- What is being tested?
- QLS-101 and Timolol maleate PF 0.5% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 26 Aug 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
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
About this study
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)
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
- Conditions
- Normal Tension Glaucoma (NTG)
- Being tested
- QLS-101, Timolol maleate PF 0.5% ophthalmic solution
- Keywords
- low tension glaucoma (LTG), glaucoma
- Medical subject headings
- Low Tension Glaucoma, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS-101Drug
Also called QLS-101 ophthalmic solution
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
Timolol maleate PF 0.5% ophthalmic solutionDrug
Also called Timolol
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
| Study group | Role | What they receive |
|---|---|---|
| QLS-101 ophthalmic solution 1.0% | Experimental | Ophthalmic solution once daily (QD) dosing in both eyes (OU) for 14 days followed by 14 days of twice daily (BID) dosing. Receives: Drug: QLS-101 |
| Timolol maleate PF 0.5% ophthalmic solution | Active comparator | Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing. Receives: Drug: Timolol maleate PF 0.5% ophthalmic solution |
| QLS-101 ophthalmic solution 2.0% | Experimental | Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing. Receives: Drug: QLS-101 |
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: 86 days
Secondary outcomes (1)
Ocular hypotensive efficacy
Number of participants with intraocular pressure reduction from baseline will be calculated
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start15 Sep 2021
- Primary completion26 Aug 2022
- Study completion26 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Tension Glaucoma (NTG)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qlaris Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- B. Wirostko, M.D., Study director, Qlaris Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857827
- Sponsor's protocol ID
- QC-202
- Status last verified
- Jan 2025
- First submitted
- 20 Apr 2021
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04857827
- Acronym / sponsor ID
- QC-202
- Conditions
- Normal Tension Glaucoma (NTG)
- Keywords
- low tension glaucoma (LTG), glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Qlaris Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 26 Aug 2022 (actual)
- Study completion
- 26 Aug 2022 (actual)
- First posted
- 23 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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QLS-101 ophthalmic solution 1.0% | Experimental | Drug: QLS-101Ophthalmic solution once daily (QD) dosing in both eyes (OU) for 14 days followed by 14 days of twice daily (BID) dosing. |
| Timolol maleate PF 0.5% ophthalmic solution | Active comparator | Drug: Timolol maleate PF 0.5% ophthalmic solutionOphthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing. |
| QLS-101 ophthalmic solution 2.0% | Experimental | Drug: QLS-101Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing. |
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)
- 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
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-101Also: QLS-101 ophthalmic solutionOphthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing. | Drug | QLS-101 ophthalmic solution 1.0%, QLS-101 ophthalmic solution 2.0% |
| Timolol maleate PF 0.5% ophthalmic solutionAlso: TimololOphthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing. | Drug | Timolol maleate PF 0.5% ophthalmic solution |
Primary outcome
Ocular safety
Time frame: 86 days
Number of participants with treatment-related adverse events will be monitored
1 secondary outcome
Ocular hypotensive efficacy
Time frame: 14 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 20 Jan 2025.
- company websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
B. Wirostko, M.D. study director
Qlaris Bio, Inc.
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 PF 0.5% ophthalmic solution in people with Normal Tension Glaucoma (NTG), 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 20 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: 86 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 20 Jan 2025.