QLS-111-FDC for Glaucoma
(Firecrest 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive QLS-111-FDC or PF latanoprost for 14 days to evaluate IOP-lowering effect, safety, and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
QLS-111-FDC, PF FDC
PF latanoprost 0.005%
Find a Clinic Near You
Who Is Running the Clinical Trial?
Qlaris Bio, Inc.
Lead Sponsor
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 ...
2.
ophthalmologytimes.com
ophthalmologytimes.com/view/qlaris-bio-announces-positive-data-from-2-clinical-trials-investigating-qls-111-in-patients-with-primary-open-angle-glaucoma-and-ocular-hypertensionQlaris 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 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.