Primary Open Angle Glaucoma (POAG)Phase 2NCT06016972
Qlaris Phase 2 Study of QLS-111 in POAG And/or OHT Patients
A Phase 2 study testing Experimental: QLS-111 ophthalmic solution, (0.015%), Experimental: QLS-111 ophthalmic solution, (0.03%) and Experimental: QLS-111 ophthalmic solution, (0.075%) in people with Primary Open Angle Glaucoma (POAG) and Primary Open Angle Glaucoma of Both Eyes, run by Qlaris Bio, Inc. at 1 site in United States.
Trial summary
Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma (POAG), Primary Open Angle Glaucoma of Both Eyes, Primary Open-Angle Glaucoma, Unspecified Eye
- What is being tested?
- Experimental: QLS-111 ophthalmic solution, (0.015%), Experimental: QLS-111 ophthalmic solution, (0.03%) and Experimental: QLS-111 ophthalmic solution, (0.075%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to 20 Aug 2024
- 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
- 18 years or older
- Able to provide written acknowledgement of giving informed consent
- Best corrected visual acuity (BCVA) 20/200 or better Bilateral POAG or OHT with documented historic IOP value(s) ≥24 mmHg, in either eye
- Post-washout IOP ≥22 mmHg in morning on Visits 2 and 3 and ≥18 mmHg at noon on Visit 2
Who cannot join
- IOP >34 mmHg
- Severe glaucomatous damage that would preclude safe washout of prescribed ocular hypotensive medications
- Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes, cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if done no earlier than 1 year from study, some minimally invasive glaucoma surgeries are allowed if done no earlier than 1 year from study)
- Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
- Use of other ophthalmic concomitant medications during the study
- Uncontrolled hypertension or hypotension
Show all 9Show fewer
- Significant systemic or psychiatric disease
- Participation in other investigational trial 30 days prior to screening or previous enrollment and treatment with Qlaris investigational product
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Coastal Research Associates, LLC
Roswell, Georgia, 30076
About this study
Official title: A Randomized, Multi-site, Double-masked Study Evaluating the Safety and Tolerability of QLS-111 Vs Vehicle in Primary Open-angle Glaucoma or Ocular Hypertension Patients
Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension patients.
Read the detailed description
A randomized, active- and vehicle-controlled, multi-site, double-masked study to evaluate the safety and tolerability of QLS-111 versus vehicle in subjects with primary open-angle glaucoma or ocular hypertension. Primary objective is to evaluate the ocular and systemic safety and tolerability of 3 concentrations of QLS-111 compared to vehicle control. Secondary objective is to evaluate the ocular hypotensive efficacy of 3 concentrations of QLS-111 with once daily morning (QAM), once daily evening (QPM), and twice daily (BID) dosing versus vehicle with QAM, QPM, and BID dosing.
- Conditions
- Primary Open Angle Glaucoma (POAG), Primary Open Angle Glaucoma of Both Eyes, Primary Open-Angle Glaucoma, Unspecified Eye, Ocular Hypertension (OHT)
- Being tested
- Experimental: QLS-111 ophthalmic solution, (0.015%), Experimental: QLS-111 ophthalmic solution, (0.03%), Experimental: QLS-111 ophthalmic solution, (0.075%), QLS-111 ophthalmic vehicle solution
- Keywords
- Qlaris, POAG, OHT, IOP, Glaucoma, Osprey
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: QLS-111 ophthalmic solution, (0.015%)Drug
Also called QLS-111
QLS-111 ophthalmic solution, (0.015%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
Experimental: QLS-111 ophthalmic solution, (0.03%)Drug
Also called QLS-111
QLS-111 ophthalmic solution, (0.03%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
Experimental: QLS-111 ophthalmic solution, (0.075%)Drug
Also called QLS-111
QLS-111 ophthalmic solution, (0.075%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
QLS-111 ophthalmic vehicle solutionOther
Also called vehicle, placebo
Vehicle ophthalmic solution applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
| Study group | Role | What they receive |
|---|---|---|
| QLS-111 ophthalmic solution | Experimental | Qlaris' investigational product, QLS-111 ophthalmic solution, provided in 3 concentrations for this study (0.015%, 0.03%. and 0.075%), single use vials, masked, and preservative free (PF). Receives: Drug: Experimental: QLS-111 ophthalmic solution, (0.015%); Drug: Experimental: QLS-111 ophthalmic solution, (0.03%); Drug: Experimental: QLS-111 ophthalmic solution, (0.075%) |
| QLS-111 ophthalmic vehicle solution | Placebo comparator | Inactive control (0.00%). QLS-111 ophthalmic vehicle solution, single use vials, masked, PF. Receives: Other: QLS-111 ophthalmic vehicle solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)
Ocular safety and tolerability: adverse events (AEs)
Measured: 21 days
Clinically significant change in visual acuity
Ocular safety and tolerability: visual acuity
Measured: 21 days
Clinically significant change in findings on slit lamp exam
Ocular safety and tolerability: slit lamp
Measured: 21 days
Clinically significant change in findings on fundus exam
Ocular safety and tolerability: fundus
Measured: 21 days
Incidence of systemic TEAEs
Systemic safety and tolerability: AEs
Measured: 21 days
Clinically significant changes in blood pressure (BP)
Systemic safety and tolerability: vital signs
Measured: 21 days
Clinically significant changes in heart rate (HR)
Systemic safety and tolerability: vital signs
Measured: 21 days
Secondary outcomes (2)
Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye
Ocular hypotensive efficacy: diurnal IOP CFB
Measured: 21 days
CFB in IOP at various timepoints in the study eye
Ocular hypotensive efficacy: CFB for multiple timepoints throughout day
Measured: up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start5 Mar 2024
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open Angle Glaucoma (POAG)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
- Model description
- Multi site double masked, vehicle-controlled, randomized, prospective parallel study of 7 days' QAM dosing, followed by 7 days' QPM dosing, and 7 days' BID dosing (7 days of dosing per regimen \[21-day treatment period\])of an investigational product (IP), QLS-111 or vehicle. Both eyes (OU) will be dosed.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qlaris Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Brandano, Study director, Qlaris Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016972
- Sponsor's protocol ID
- QC-111-201
- Other IDs
- Osprey
- Status last verified
- Jan 2025
- First submitted
- 18 Aug 2023
- 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, Multi-site, Double-masked Study Evaluating the Safety and Tolerability of QLS-111 Vs Vehicle in Primary Open-angle Glaucoma or Ocular Hypertension Patients
- ClinicalTrials.gov ID
- NCT06016972
- Acronym / sponsor ID
- QC-111-201
- Conditions
- Primary Open Angle Glaucoma (POAG), Primary Open Angle Glaucoma of Both Eyes, Primary Open-Angle Glaucoma, Unspecified Eye, Ocular Hypertension (OHT)
- Keywords
- Qlaris, POAG, OHT, IOP, Glaucoma, Osprey
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Qlaris Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 30 Aug 2023 (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.
Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension patients.
Detailed description
A randomized, active- and vehicle-controlled, multi-site, double-masked study to evaluate the safety and tolerability of QLS-111 versus vehicle in subjects with primary open-angle glaucoma or ocular hypertension. Primary objective is to evaluate the ocular and systemic safety and tolerability of 3 concentrations of QLS-111 compared to vehicle control. Secondary objective is to evaluate the ocular hypotensive efficacy of 3 concentrations of QLS-111 with once daily morning (QAM), once daily evening (QPM), and twice daily (BID) dosing versus vehicle with QAM, QPM, and BID dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi site double masked, vehicle-controlled, randomized, prospective parallel study of 7 days' QAM dosing, followed by 7 days' QPM dosing, and 7 days' BID dosing (7 days of dosing per regimen [21-day treatment period])of an investigational product (IP), QLS-111 or vehicle. Both eyes (OU) will be dosed.
| Arm | Type | Receives |
|---|---|---|
| QLS-111 ophthalmic solution | Experimental | Drug: Experimental: QLS-111 ophthalmic solution, (0.015%), Drug: Experimental: QLS-111 ophthalmic solution, (0.03%), Drug: Experimental: QLS-111 ophthalmic solution, (0.075%)Qlaris' investigational product, QLS-111 ophthalmic solution, provided in 3 concentrations for this study (0.015%, 0.03%. and 0.075%), single use vials, masked, and preservative free (PF). |
| QLS-111 ophthalmic vehicle solution | Placebo comparator | Other: QLS-111 ophthalmic vehicle solutionInactive control (0.00%). QLS-111 ophthalmic vehicle solution, single use vials, masked, PF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Able to provide written acknowledgement of giving informed consent
- Best corrected visual acuity (BCVA) 20/200 or better Bilateral POAG or OHT with documented historic IOP value(s) ≥24 mmHg, in either eye
- Post-washout IOP ≥22 mmHg in morning on Visits 2 and 3 and ≥18 mmHg at noon on Visit 2
Key exclusion criteria (9 listed)
- IOP >34 mmHg
- Severe glaucomatous damage that would preclude safe washout of prescribed ocular hypotensive medications
- Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes, cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if done no earlier than 1 year from study, some minimally invasive glaucoma surgeries are allowed if done no earlier than 1 year from study)
- Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
- Use of other ophthalmic concomitant medications during the study
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 |
|---|---|---|
| Experimental: QLS-111 ophthalmic solution, (0.015%)Also: QLS-111QLS-111 ophthalmic solution, (0.015%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials. | Drug | QLS-111 ophthalmic solution |
| Experimental: QLS-111 ophthalmic solution, (0.03%)Also: QLS-111QLS-111 ophthalmic solution, (0.03%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials. | Drug | QLS-111 ophthalmic solution |
| Experimental: QLS-111 ophthalmic solution, (0.075%)Also: QLS-111QLS-111 ophthalmic solution, (0.075%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials. | Drug | QLS-111 ophthalmic solution |
| QLS-111 ophthalmic vehicle solutionAlso: vehicle, placeboVehicle ophthalmic solution applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials. | Other | QLS-111 ophthalmic vehicle solution |
Primary outcome
Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)
Time frame: 21 days
Ocular safety and tolerability: adverse events (AEs)
Clinically significant change in visual acuity
Time frame: 21 days
Ocular safety and tolerability: visual acuity
Clinically significant change in findings on slit lamp exam
Time frame: 21 days
Ocular safety and tolerability: slit lamp
Clinically significant change in findings on fundus exam
Time frame: 21 days
Ocular safety and tolerability: fundus
Incidence of systemic TEAEs
Time frame: 21 days
Systemic safety and tolerability: AEs
Clinically significant changes in blood pressure (BP)
Time frame: 21 days
Systemic safety and tolerability: vital signs
Clinically significant changes in heart rate (HR)
Time frame: 21 days
Systemic safety and tolerability: vital signs
2 secondary outcomes
Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye
Time frame: 21 days
CFB in IOP at various timepoints in the study eye
Time frame: up to 21 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 website, pipelineLink 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.
Lisa Brandano 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 Experimental: QLS-111 ophthalmic solution, (0.015%), Experimental: QLS-111 ophthalmic solution, (0.03%) and Experimental: QLS-111 ophthalmic solution, (0.075%) in people with Primary Open Angle Glaucoma (POAG) and Primary Open Angle Glaucoma of Both Eyes, 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 4 inclusion and 9 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. Some participants in this study may receive a placebo. 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?
Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs) (time frame: 21 days). The study lists 7 primary outcomes in all. 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.