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Active, Not Recruiting

NCT Number: NCT07354516

Study of QLS-111-FDC in 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shettle Eye Research

Largo, Florida, 33773, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QLS-111-FDC

Combination Product

QLS-111-FDC, a PF FDC administered by topical ophthalmic (TO) application for 14 days in the evening (QPM) in both eyes (OU).

Latanoprost (0.005%)

Drug

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

Other names: latanoprost ophthalmic solution 0.005%, PF

Primary outcomes

  1. Change from baseline in IOP

    Time frame: Over 15 days

    Change from baseline in IOP, lowering of IOP compared to baseline is desirable outcome.

Secondary outcomes

  1. Ocular safety and tolerability

    Time frame: Over 15 days

    Incidence of ocular adverse events

  2. Ocular comfort

    Time frame: Over 15 days

    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.

Sponsors and collaborators

Lead sponsor

Qlaris Bio, Inc.

Industry

Registry information

Official study title

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

Acronym: Firecrest

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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