Open-angle Glaucoma (OAG)Phase 2NCT06249152
Qlaris Study of QLS-111 in Combination With a PGA for OAG and/or OHT Patients
A Phase 2 study testing QLS-111, 0.015%, QLS-111, 0.030% and QLS-111, 0.075% in people with Open-angle Glaucoma (OAG) and Ocular Hypertension (OHT), run by Qlaris Bio, Inc. at 1 site in United States.
Trial summary
Qlaris Phase 2 clinical study investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in combination with latanoprost in open-angle glaucoma (OAG) and/or ocular hypertension (OHT) patients. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Open-angle Glaucoma (OAG), Ocular Hypertension (OHT), Glaucoma
- What is being tested?
- QLS-111, 0.015%, QLS-111, 0.030% and QLS-111, 0.075%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2024to 20 Dec 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 12 years or older
- Able and willing provide signed informed consent (assent)
- mild to moderate OAG or OHT in at least one eye and current or previous treatment with PGA. Exhibits decrease (i.e., >20% from reported pre- treatment) in intraocular pressure (IOP). Patient is willing to continue latanoprost throughout the study.
- IOP ≥19 mmHg at 08:00 hour (H) at qualification visits prior to randomization
Who cannot join
- History of active ocular disease other than mild to moderate OAG/OHT
- Nonresponse to and/or noncompliant with PGA treatment
- Use of other topical ocular medications with exception of the PGA which the patient will use throughout the study
- Moderate to severe glaucomatous damage in either eye
- Previous glaucoma intraocular surgery in either eye (e.g., trabeculectomy, tubes, cyclodestructive procedures, diode) with exception of selective laser trabeculoplasty (SLT) if done less than 12 months from screening, trabecular meshwork minimally invasive glaucoma surgery (MIGS) when combined with cataract surgery and done less than 12 months from screening.
- significant ocular trauma, or intraocular surgery (e.g., cataract extraction/intraocular lens insertion) or extensive retinal laser treatment, refractive surgery in either eye.
Show all 11Show fewer
- Ocular infection, inflammation (e.g., uveitis), moderate to severe blepharitis/meibomitis and/or severe keratoconjunctivitis sicca in either eye at screening, history of herpes simplex keratitis, in either eye.
- Clinically significant retinal disease in either eye
- Clinically significant systemic or psychiatric disease
- Participation in any investigational study within 30 days prior to screening
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Double-masked, Vehicle-controlled, Randomized Study to Evaluate the Safety and Tolerability of QLS-111 Versus Vehicle in Combination With Latanoprost Treatment in Subjects With Open-angle Glaucoma and/or Ocular Hypertension
Qlaris Phase 2 clinical study investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in combination with latanoprost in open-angle glaucoma (OAG) and/or ocular hypertension (OHT) patients.
Read the detailed description
Pilot, double-masked, vehicle-controlled, randomized, prospective parallel study of 14-day once daily evening (QPM) dosing, followed by 14-day twice daily (BID) dosing of an investigational product (IP), QLS-111, or vehicle as concomitant therapy with monotherapy latanoprost a PGA treatment that is administered QPM. Both eyes (OU) will be dosed. The study is comprised of seven (7) visits and approximately 28 days of IP dosing.
- Being tested
- QLS-111, 0.015%, QLS-111, 0.030%, QLS-111, 0.075%, QLS-111 vehicle ophthalmic solution
- Keywords
- Qlaris, OAG, Glaucoma, PGA therapy, Apteryx I, OHT, latanoprost
- 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.
QLS-111, 0.015%Drug
Also called QLS-111
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
QLS-111, 0.030%Drug
Also called QLS-111
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
QLS-111, 0.075%Drug
Also called QLS-111
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
QLS-111 vehicle ophthalmic solutionDrug
Also called Vehicle, inactive control
Vehicle drops applied QPM for 14 days the BID for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: QLS-111 ophthalmic solution | Experimental | Qlaris' IP, QLS-111 ophthalmic solution, provided in 3 concentrations (0.015%, 0.03%, and 0.075%), preservative free (PF), single-use units, masked. Receives: Drug: QLS-111, 0.015%; Drug: QLS-111, 0.030%; Drug: QLS-111, 0.075% |
| Placebo comparator: Vehicle ophthalmic solution | Placebo comparator | Inactive control (0.00%), PF, single-use units, masked. Receives: Drug: QLS-111 vehicle ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ocular treatment-emergent adverse events (TEAEs)
Ocular safety and tolerability
Measured: 28 days
Clinically significant change in visual acuity
Ocular safety and tolerability
Measured: 28 days
Clinically significant change in findings on slit lamp exam
Ocular safety and tolerability
Measured: 28 days
Clinically significant change in findings on fundus exam
Ocular safety and tolerability
Measured: 28 days
Incidence of systemic (TEAEs)
Systemic safety and tolerability
Measured: 28 days
Clinically significant change in blood pressure
Systemic safety and tolerability
Measured: 28 days
Clinically significant change in heart rate
Systemic safety and tolerability
Measured: 28 days
Secondary outcomes (2)
Change from baseline (CFB) of mean diurnal IOP in the study eye
Ocular hypotensive efficacy: diurnal IOP
Measured: 28 days
CFB in IOP at various timepoints in the study eye
Ocular hypotensive efficacy: CFB for multiple timepoints
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 posted8 Feb 2024
- Study start21 Apr 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open-angle Glaucoma (OAG)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 14-day QPM dosing followed by 14-day BID dosing of QLS-111 (3 concentrations versus vehicle in combination with latanoprost. Dosing is OU.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 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
- NCT06249152
- Sponsor's protocol ID
- QC-111-203
- Other IDs
- Apteryx
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2024
- 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 Pilot, Double-masked, Vehicle-controlled, Randomized Study to Evaluate the Safety and Tolerability of QLS-111 Versus Vehicle in Combination With Latanoprost Treatment in Subjects With Open-angle Glaucoma and/or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT06249152
- Acronym / sponsor ID
- QC-111-203
- Keywords
- Qlaris, OAG, Glaucoma, PGA therapy, Apteryx I, OHT, latanoprost
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Qlaris Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 8 Feb 2024 (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 study investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in combination with latanoprost in open-angle glaucoma (OAG) and/or ocular hypertension (OHT) patients.
Detailed description
Pilot, double-masked, vehicle-controlled, randomized, prospective parallel study of 14-day once daily evening (QPM) dosing, followed by 14-day twice daily (BID) dosing of an investigational product (IP), QLS-111, or vehicle as concomitant therapy with monotherapy latanoprost a PGA treatment that is administered QPM. Both eyes (OU) will be dosed. The study is comprised of seven (7) visits and approximately 28 days of IP 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 14-day QPM dosing followed by 14-day BID dosing of QLS-111 (3 concentrations versus vehicle in combination with latanoprost. Dosing is OU.
| Arm | Type | Receives |
|---|---|---|
| Experimental: QLS-111 ophthalmic solution | Experimental | Drug: QLS-111, 0.015%, Drug: QLS-111, 0.030%, Drug: QLS-111, 0.075%Qlaris' IP, QLS-111 ophthalmic solution, provided in 3 concentrations (0.015%, 0.03%, and 0.075%), preservative free (PF), single-use units, masked. |
| Placebo comparator: Vehicle ophthalmic solution | Placebo comparator | Drug: QLS-111 vehicle ophthalmic solutionInactive control (0.00%), PF, single-use units, masked. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 12 years or older
- Able and willing provide signed informed consent (assent)
- mild to moderate OAG or OHT in at least one eye and current or previous treatment with PGA. Exhibits decrease (i.e., >20% from reported pre- treatment) in intraocular pressure (IOP). Patient is willing to continue latanoprost throughout the study.
- IOP ≥19 mmHg at 08:00 hour (H) at qualification visits prior to randomization
Key exclusion criteria (11 listed)
- History of active ocular disease other than mild to moderate OAG/OHT
- Nonresponse to and/or noncompliant with PGA treatment
- Use of other topical ocular medications with exception of the PGA which the patient will use throughout the study
- Moderate to severe glaucomatous damage in either eye
- Previous glaucoma intraocular surgery in either eye (e.g., trabeculectomy, tubes, cyclodestructive procedures, diode) with exception of selective laser trabeculoplasty (SLT) if done less than 12 months from screening, trabecular meshwork minimally invasive glaucoma surgery (MIGS) when combined with cataract surgery and done less than 12 months from screening.
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-111, 0.015%Also: QLS-111QLS-111 eyedrops applied QPM for 14 days the BID for 14 days. | Drug | Experimental: QLS-111 ophthalmic solution |
| QLS-111, 0.030%Also: QLS-111QLS-111 eyedrops applied QPM for 14 days the BID for 14 days. | Drug | Experimental: QLS-111 ophthalmic solution |
| QLS-111, 0.075%Also: QLS-111QLS-111 eyedrops applied QPM for 14 days the BID for 14 days. | Drug | Experimental: QLS-111 ophthalmic solution |
| QLS-111 vehicle ophthalmic solutionAlso: Vehicle, inactive controlVehicle drops applied QPM for 14 days the BID for 14 days. | Drug | Placebo comparator: Vehicle ophthalmic solution |
Primary outcome
Incidence of ocular treatment-emergent adverse events (TEAEs)
Time frame: 28 days
Ocular safety and tolerability
Clinically significant change in visual acuity
Time frame: 28 days
Ocular safety and tolerability
Clinically significant change in findings on slit lamp exam
Time frame: 28 days
Ocular safety and tolerability
Clinically significant change in findings on fundus exam
Time frame: 28 days
Ocular safety and tolerability
Incidence of systemic (TEAEs)
Time frame: 28 days
Systemic safety and tolerability
Clinically significant change in blood pressure
Time frame: 28 days
Systemic safety and tolerability
Clinically significant change in heart rate
Time frame: 28 days
Systemic safety and tolerability
2 secondary outcomes
Change from baseline (CFB) of mean diurnal IOP in the study eye
Time frame: 28 days
CFB in IOP at various timepoints in the study eye
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 20 Jan 2025.
- Company website, pipelineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Open-angle Glaucoma (OAG)
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Recruiting
Safety and Effectiveness of the VisiPlate Aqueous Shunt in Patients With Refractory Open-Angle Glaucoma
Open Angle Glaucoma (OAG)
RecruitingObservational study
iDose TR Administration in an Office-Based Surgery Setting
Open Angle Glaucoma (OAG), Ocular Hypertension (OHT)
RecruitingPhase 1/2
REGN22530 for Adults With Primary Open Angle Glaucoma or Ocular Hypertension
Primary Open Angle Glaucoma (POAG), Ocular Hypertension (OHT)
RecruitingObservational study
A Study to Assess Brillouin Hydration Mapping for the Evaluation of Ocular Tissues and Diseases
Fuchs Endothelial Corneal Dysfunction, Open Angle Glaucoma (OAG)
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 QLS-111, 0.015%, QLS-111, 0.030% and QLS-111, 0.075% in people with Open-angle Glaucoma (OAG) and Ocular Hypertension (OHT), 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 11 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 treatment-emergent adverse events (TEAEs) (time frame: 28 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.