NCT07354516 Study of QLS-111-FDC in Open-Angle Glaucoma or Ocular Hypertension
| NCT ID | NCT07354516 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Qlaris Bio, Inc. |
| Condition | OAG - Open-Angle Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-03-18 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2026-03-18 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.
Contact & Investigator
Barbara M Wirostko, MD
STUDY DIRECTOR
Qlaris Bio, Inc.
Frequently Asked Questions
Who can join the NCT07354516 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying OAG - Open-Angle Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07354516 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07354516 currently recruiting?
Yes, NCT07354516 is actively recruiting participants. Contact the research team at lbrandano@qlaris.bio for enrollment information.
Where is the NCT07354516 trial being conducted?
This trial is being conducted at Largo, United States.
Who is sponsoring the NCT07354516 clinical trial?
NCT07354516 is sponsored by Qlaris Bio, Inc.. The principal investigator is Barbara M Wirostko, MD at Qlaris Bio, Inc.. The trial plans to enroll 60 participants.