A Masked, Randomized, Prospective Study of QLS-111-FDC in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Qlaris Bio, Inc.
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).
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
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Combination ProductQLS-111-FDC
QLS-111-FDC, a PF FDC administered by topical ophthalmic (TO) application for 14 days in the evening (QPM) in both eyes (OU).
- DrugLatanoprost (0.005%)
PF latanoprost administered by TO application for 14 days QPM OU.
Location
- Shettle Eye ResearchLargo, Florida