OAG - Open-Angle GlaucomaPhase 2/3FirecrestNCT07354516
Study of QLS-111-FDC in Open-Angle Glaucoma or Ocular Hypertension
A Phase 2/3 study testing QLS-111-FDC and Latanoprost (0.005%) in people with OAG - Open-Angle Glaucoma and OHT - Ocular Hypertension, run by Qlaris Bio, Inc. at 1 site in United States.
Trial summary
Firecrest study is evaluating the intraocular pressure (IOP)-lowering effect, safety, and tolerability of Qlaris' preservative free [PF], fixed-dose combination [FDC] investigational product (IP) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- OAG - Open-Angle Glaucoma, OHT - Ocular Hypertension
- What is being tested?
- QLS-111-FDC and Latanoprost (0.005%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to 22 Jul 2026
- Phase
- Phase 2/3
- 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
- BCVA 1.0 logMAR or better in each eye (equivalent to 20/200)
- Diagnosis of mild to moderate OAG or OHT in at least one eye
- IOP ≥19 mmHg at 08:00 hour (H) at Qualification Visits following a run-in with PF latanoprost
Who cannot join
- History of active ocular disease other than mild to moderate OAG/OHT
- Prior use of any topical PGA without a clinically meaningful response
- Noncompliant with current ocular anti-hypertensive medications or unwilling to be compliant throughout the study
- Use of other topical ocular concomitant medications 30 days prior
- History of angle closure or a narrow angle, significant ocular trauma, ocular infection, uveitis, intraocular surgery in either eye.
- Central corneal thickness in either eye <470 or >630 μm
Show all 9Show fewer
- Clinically significant systemic or psychiatric disease, chronic kidney disease, or hypertension, hypotension, or diabetes that is uncontrolled.
- Participation in any investigational study within 30 days prior to Screening
- Females who are pregnant, nursing, or not using birth control.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Masked, Randomized, Prospective Study of QLS-111-FDC in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Firecrest study is evaluating the intraocular pressure (IOP)-lowering effect, safety, and tolerability of Qlaris' preservative free [PF], fixed-dose combination [FDC] investigational product (IP) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Read the detailed description
14-day prospective, double-masked, active-controlled, randomized multicenter study comparing QLS-111-FDC and PF latanoprost. Study is comprised of 5 visits.
- Being tested
- QLS-111-FDC, Latanoprost (0.005%)
- Keywords
- glaucoma, intraocular pressure (IOP), eye drops
- 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-FDCCombination product
QLS-111-FDC, a PF FDC administered by topical ophthalmic (TO) application for 14 days in the evening (QPM) in both eyes (OU).
Latanoprost (0.005%)Drug
Also called latanoprost ophthalmic solution 0.005%, PF
PF latanoprost administered by TO application for 14 days QPM OU.
| Study group | Role | What they receive |
|---|---|---|
| QLS-111-FDC ophthalmic solution | Experimental | QLS-111-FDC, PF FDC Receives: Combination Product: QLS-111-FDC |
| Latanoprost ophthalmic solution | Active comparator | PF latanoprost 0.005% Receives: Drug: Latanoprost (0.005%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in IOP
Change from baseline in IOP, lowering of IOP compared to baseline is desirable outcome.
Measured: Over 15 days
Secondary outcomes (2)
Ocular safety and tolerability
Incidence of ocular adverse events
Measured: Over 15 days
Ocular comfort
Ocular comfort following study treatment as assessed by subject and using a visual analog scale (VAS) provided by the site at the treatment period visits. Subjects will grade their ocular comfort on a scale of 0 (extremely comfortable) to 100 (extremely uncomfortable) by placing a vertical mark on the horizontal line.
Measured: Over 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start18 Mar 2026
- Primary completion22 Jul 2026
- Study completion22 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OAG - 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qlaris Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara M Wirostko, MD, Study director, Qlaris Bio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354516
- Sponsor's protocol ID
- QC-300
- Acronym
- Firecrest
- Status last verified
- Jul 2026
- First submitted
- 17 Jan 2026
- Last updated
- 29 Jul 2026
- 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 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Masked, Randomized, Prospective Study of QLS-111-FDC in Subjects With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT07354516
- Acronym / sponsor ID
- Firecrest / QC-300
- Keywords
- glaucoma, intraocular pressure (IOP), eye drops
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Qlaris Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- 22 Jul 2026 (actual)
- Study completion
- 22 Jul 2026 (actual)
- First posted
- 21 Jan 2026 (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.
Firecrest study is evaluating the intraocular pressure (IOP)-lowering effect, safety, and tolerability of Qlaris' preservative free [PF], fixed-dose combination [FDC] investigational product (IP) in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
Detailed description
14-day prospective, double-masked, active-controlled, randomized multicenter study comparing QLS-111-FDC and PF latanoprost. Study is comprised of 5 visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLS-111-FDC ophthalmic solution | Experimental | Combination Product: QLS-111-FDCQLS-111-FDC, PF FDC |
| Latanoprost ophthalmic solution | Active comparator | Drug: Latanoprost (0.005%)PF latanoprost 0.005% |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- BCVA 1.0 logMAR or better in each eye (equivalent to 20/200)
- Diagnosis of mild to moderate OAG or OHT in at least one eye
- IOP ≥19 mmHg at 08:00 hour (H) at Qualification Visits following a run-in with PF latanoprost
Key exclusion criteria (9 listed)
- History of active ocular disease other than mild to moderate OAG/OHT
- Prior use of any topical PGA without a clinically meaningful response
- Noncompliant with current ocular anti-hypertensive medications or unwilling to be compliant throughout the study
- Use of other topical ocular concomitant medications 30 days prior
- History of angle closure or a narrow angle, significant ocular trauma, ocular infection, uveitis, intraocular surgery in either eye.
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-FDCQLS-111-FDC, a PF FDC administered by topical ophthalmic (TO) application for 14 days in the evening (QPM) in both eyes (OU). | Combination product | QLS-111-FDC ophthalmic solution |
| Latanoprost (0.005%)Also: latanoprost ophthalmic solution 0.005%, PFPF latanoprost administered by TO application for 14 days QPM OU. | Drug | Latanoprost ophthalmic solution |
Primary outcome
Change from baseline in IOP
Time frame: Over 15 days
Change from baseline in IOP, lowering of IOP compared to baseline is desirable outcome.
2 secondary outcomes
Ocular safety and tolerability
Time frame: Over 15 days
Ocular comfort
Time frame: Over 15 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 29 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for OAG - Open-Angle Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
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.
Barbara M Wirostko, MD 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 2/3 study testing QLS-111-FDC and Latanoprost (0.005%) in people with OAG - Open-Angle Glaucoma and OHT - 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 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 29 Jul 2026. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change from baseline in IOP (time frame: Over 15 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 29 Jul 2026.