Overview
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).
Description
14-day prospective, double-masked, active-controlled, randomized multicenter study comparing QLS-111-FDC and PF latanoprost. Study is comprised of 5 visits.
Eligibility
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.
