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RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

Study of QLS-111-FDC 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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

COMBINATION_PRODUCT

QLS-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).

DRUG

Latanoprost (0.005%)

PF latanoprost administered by TO application for 14 days QPM OU.

Locations (1)

Shettle Eye Research
Largo, Florida, United States