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

A Masked, Randomized, Prospective Study of QLS-111-FDC in Subjects With Open-Angle Glaucoma or Ocular Hypertension

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).

Study Overview

• Status: Recruiting
• Conditions: OAG - Open-Angle Glaucoma; OHT - Ocular Hypertension
• Intervention / Treatment: Combination product: QLS-111-FDC; Drug: Latanoprost (0.005%)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Lisa Brandano; Phone Number: 9789302103; Email: lbrandano@qlaris.bio
• Study Contact Backup: Name: Lauryl Hargreaves; Email: lhargreaves@qlaris.bio

Study Locations

• United States
  • Florida
    • Largo, Florida, United States, 33773
      • Recruiting
      • Shettle Eye Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLS-111-FDC ophthalmic solution; QLS-111-FDC, PF FDC	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).
Active Comparator: Latanoprost ophthalmic solution; PF latanoprost 0.005%	Drug: Latanoprost (0.005%); PF latanoprost administered by TO application for 14 days QPM OU.; Other Names: latanoprost ophthalmic solution 0.005%, PF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in IOP	Change from baseline in IOP, lowering of IOP compared to baseline is desirable outcome.	Over 15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular safety and tolerability	Incidence of ocular adverse events	Over 15 days
Ocular comfort	Ocular comfort following study treatment as assessed by subject and using a visual analog scale (VAS) provided by the site at the treatment period visits. Subjects will grade their ocular comfort on a scale of 0 (extremely comfortable) to 100 (extremely uncomfortable) by placing a vertical mark on the horizontal line.	Over 15 days

Collaborators and Investigators

• Sponsor: Qlaris Bio, Inc.
• Investigators: Study Director: Barbara M Wirostko, MD, Qlaris Bio, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: January 17, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: glaucoma; eye drops; intraocular pressure (IOP)
• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Fatty Acids; Lipids; Biological Factors; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Latanoprost
• Other Study ID Numbers: QC-300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No