NCT07354516

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
2mo left

Started Mar 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

January 17, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 18, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

January 17, 2026

Last Update Submit

March 18, 2026

Conditions

OAG - Open-Angle GlaucomaOHT - Ocular Hypertension

Keywords

glaucomaintraocular pressure (IOP)eye drops

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in IOP

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

    Over 15 days

Secondary Outcomes (2)

  • Ocular safety and tolerability

    Over 15 days

  • Ocular comfort

    Over 15 days

Study Arms (2)

QLS-111-FDC ophthalmic solution

EXPERIMENTAL

QLS-111-FDC, PF FDC

Combination Product: QLS-111-FDC

Latanoprost ophthalmic solution

ACTIVE COMPARATOR

PF latanoprost 0.005%

Drug: Latanoprost (0.005%)

Interventions

QLS-111-FDCCOMBINATION_PRODUCT

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

QLS-111-FDC ophthalmic solution
Latanoprost (0.005%)DRUG

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

Also known as: latanoprost ophthalmic solution 0.005%, PF
Latanoprost ophthalmic solution

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shettle Eye Research

Largo, Florida, 33773, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular HypertensionGlaucoma

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Barbara M Wirostko, MD

    Qlaris Bio, Inc.

    STUDY DIRECTOR

Central Study Contacts

Lisa Brandano

CONTACT

9789302103lbrandano@qlaris.bio

Lauryl Hargreaves

CONTACT

lhargreaves@qlaris.bio

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
IP is packaged and labeled in a masked fashion
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2026

First Posted

January 21, 2026

Study Start

March 18, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)