Study of QLS-111-FDC in Open-Angle Glaucoma or Ocular Hypertension (Firecrest)

Qlaris Bio

Status and phase: Begins enrollment this month; Phase 3; Phase 2

Conditions: OHT - Ocular Hypertension; OAG - Open-Angle Glaucoma

Treatments: Combination Product: QLS-111-FDC; Drug: Latanoprost (0.005%)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07354516

QC-300

Details and patient eligibility

About

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).

Full description

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

Enrollment: 36 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups

QLS-111-FDC ophthalmic solution

Experimental group

Description:

QLS-111-FDC, PF FDC

Treatment:

Combination Product: QLS-111-FDC

Latanoprost ophthalmic solution

Active Comparator group

Description:

PF latanoprost 0.005%

Treatment:

Drug: Latanoprost (0.005%)