← Back to all trials
Completed
NCT07354516
Study of QLS-111-FDC in Open-Angle Glaucoma or Ocular Hypertension
Conditions: OAG - Open-Angle Glaucoma, OHT - Ocular Hypertension
Sex: All
Ages: 12 Years – N/A
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 64
Sponsor: Qlaris Bio, Inc.
Location: Shettle Eye Research Largo Florida
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 \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.
Source: ClinicalTrials.gov (NCT07354516). StuddyBuddy aggregates publicly available trial information.