QLS-111-FDC preservative-free eye drops to lower eye pressure in open-angle glaucoma or ocular hypertension
A Masked, Randomized, Prospective Study of QLS-111-FDC in Subjects With Open-Angle Glaucoma or Ocular Hypertension
This 14-day test will see if preservative-free QLS-111-FDC eye drops lower intraocular pressure better than preservative-free latanoprost in adults with open-angle glaucoma or ocular hypertension.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Qlaris Bio, Inc. Industry-sponsored |
| Locations | 1 site (Largo, Florida) |
| Trial ID | NCT07354516 on ClinicalTrials.gov |
What this trial studies
This is a 14-day, randomized, double-masked, active-controlled study comparing an investigational preservative-free fixed-dose combination (QLS-111-FDC) with preservative-free latanoprost in adults with mild to moderate open-angle glaucoma or ocular hypertension. Participants undergo a run-in with preservative-free latanoprost and must have an 08:00 IOP of ≥19 mmHg at qualification to be randomized. The study is multicenter with five visits and measures IOP-lowering effect along with safety and tolerability. Outcomes focus on short-term IOP reduction and adverse events with the investigational fixed-dose combination.
Who should consider this trial
Good fit: Adults with mild to moderate open-angle glaucoma or ocular hypertension, visual acuity of 20/200 or better in each eye, and an 08:00 IOP ≥19 mmHg after a preservative-free latanoprost run-in are ideal candidates.
Not a fit: Patients with narrow or closed angles, recent intraocular surgery, active ocular disease other than mild–moderate OAG/OHT, prior nonresponse to topical prostaglandin analogs, extreme corneal thickness, or uncontrolled systemic disease are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the preservative-free fixed-dose combination could lower eye pressure effectively with the convenience of a single drop and reduced preservative exposure.
How similar studies have performed: Other preservative-free prostaglandin-based treatments and some fixed-dose combinations have shown IOP-lowering benefits, but this specific QLS-111-FDC formulation is investigational and not yet proven in larger trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Largo, Florida
- Shettle Eye Research — Largo, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Lisa Brandano
- Email: lbrandano@qlaris.bio
- Phone: 9789302103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.