Health TrialsbyHealthPanel

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

ConditionsOAG - Open-Angle GlaucomaOHT - Ocular Hypertension
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorQlaris Bio, Inc.

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: QLS-111-FDC ophthalmic solutionExperimental treatment 1 intervention
Group B: Latanoprost ophthalmic solutionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in IOP

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

Time frame
Over 15 days

Secondary outcomes

1

Ocular safety and tolerability

Incidence of ocular adverse events

Time frame
Over 15 days
2

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.

Time frame
Over 15 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qlaris Bio, Inc.

Lead sponsor

Source ClinicalTrials.gov
Apply now