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QLS-111-FDC for Glaucoma

(Firecrest Trial)

LH
LB
Overseen ByLisa Brandano
Age: Any Age
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Qlaris Bio, Inc.
Must be taking: PF latanoprost
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye drop, QLS-111-FDC, to determine its safety and effectiveness in lowering eye pressure in individuals with open-angle glaucoma or ocular hypertension, conditions that can lead to vision loss. Researchers aim to compare this new treatment's safety and efficacy to latanoprost, an existing medication for high eye pressure. Individuals diagnosed with mild to moderate open-angle glaucoma or ocular hypertension and an eye pressure of at least 19 mmHg may qualify for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in eye care.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not use other topical eye medications for 30 days before starting. It doesn't specify about other medications, but you should discuss with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that QLS-111-FDC, a treatment tested for glaucoma and high eye pressure, has promising safety results from earlier studies. These studies found that QLS-111, a component of the treatment, is safe and well-tolerated by patients. Patients did not report any serious side effects, indicating no harmful reactions occurred. Additionally, the treatment did not cause significant eye redness, a common issue with some treatments. Overall, based on current research, this combination treatment appears to be a safe option.12345

Why do researchers think this study treatment might be promising for glaucoma?

Unlike the standard treatment for glaucoma, which often includes medications like Latanoprost that lower eye pressure, QLS-111-FDC offers a new approach. Researchers are excited about QLS-111-FDC because it combines multiple active ingredients into a single ophthalmic solution, potentially enhancing effectiveness and convenience for patients. This novel formulation aims to provide better pressure control and longer-lasting effects, which could mean fewer side effects and improved management of glaucoma.

What evidence suggests that this trial's treatments could be effective for glaucoma?

Research has shown that QLS-111-FDC may help lower eye pressure in people with open-angle glaucoma or ocular hypertension. In this trial, participants will receive either QLS-111-FDC or Latanoprost. Studies found that combining QLS-111 with latanoprost can reduce eye pressure by up to 3.6 mmHg more than latanoprost alone. This suggests it might be more effective at lowering eye pressure, which is crucial for treating these conditions. The treatment aids the eye's drainage system in relieving pressure. These findings suggest that QLS-111-FDC could be a strong option for managing eye pressure in affected individuals.23567

Who Is on the Research Team?

BM

Barbara M Wirostko, MD

Principal Investigator

Qlaris Bio, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate open-angle glaucoma or ocular hypertension in at least one eye, who have an eye pressure of 19 mmHg or higher after using preservative-free latanoprost. Participants must not have other serious eye diseases, recent eye surgery, uncontrolled health conditions, or be pregnant.

Inclusion Criteria

My eye pressure is 19 mmHg or higher after using PF latanoprost.
I have been diagnosed with mild to moderate open-angle glaucoma or ocular hypertension.
BCVA 1.0 logMAR or better in each eye (equivalent to 20/200)

Exclusion Criteria

I have had serious eye diseases, not just mild or moderate glaucoma or high eye pressure.
I have used topical prostaglandin eye drops without much improvement.
Central corneal thickness in either eye <470 or >630 μm
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive QLS-111-FDC or PF latanoprost for 14 days to evaluate IOP-lowering effect, safety, and tolerability

2 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

  • Latanoprost
  • QLS-111-FDC

Trial Overview

The study compares a new preservative-free combination eye drop (QLS-111-FDC) to standard latanoprost drops to see which lowers eye pressure better and how safe they are. Participants are randomly assigned to each group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: QLS-111-FDC ophthalmic solutionExperimental Treatment1 Intervention
Group II: Latanoprost ophthalmic solutionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Qlaris Bio, Inc.

Lead Sponsor

Trials
7
Recruited
250+

Citations

Preclinical Evaluation of Safety and Efficacy of QLS-111

QLS-111, administered in combination with timolol, or in preservative-free FDC with latanoprost, lowered IOP by up to an additional 2.4 mmHg compared to effects ...

Qlaris Bio announces positive data from 2 clinical trials ...

Results showed that QLS-111 added to latanoprost dosed once daily in the evening drove up to 3.2 mmHg greater reduction in IOP as compared to ...

Qlaris Bio announces development of fixed-dose ...

Clinical studies have demonstrated that treatment with QLS‑111 provides significant IOP lowering, maintains normal vascular integrity, and is ...

NCT06249152 | Qlaris Study of QLS-111 in Combination ...

Qlaris Phase 2 clinical study investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in combination with latanoprost in open-angle ...

Qlaris Bio Announces Positive Topline Data From Two ...

QLS-111 met all primary and secondary endpoints in the Osprey and Apteryx studies. QLS-111 added to latanoprost drove up to 3.6 mmHg greater reduction in IOP ...

Preclinical Evaluation of Safety and Efficacy of QLS-111

QLS-111 at 0.5 mM (0.015%) showed the greatest IOP reduction of 4.9 ± 0.7 mmHg in normotensive mice. QLS-111 lowered episcleral venous pressure (EVP) but did ...

Preclinical Evaluation of Safety and Efficacy of QLS-111

Results: QLS-111 at 0.5 mM (0.015%) showed the greatest IOP reduction of 4.9 ± 0.7 mmHg in normotensive mice. QLS-111 lowered episcleral venous ...