Study of QLS-111-FDC in Open-Angle Glaucoma or Ocular Hypertension (NCT07354516) | Clinical Trial Compass
RecruitingPhase 2/3
Study of QLS-111-FDC in Open-Angle Glaucoma or Ocular Hypertension
United States60 participantsStarted 2026-03-18
Plain-language 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).
Who can participate
Age range12 Years
SexALL
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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.