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QLS-111 + Latanoprost for Open-Angle Glaucoma

Phase 2
Recruiting
Research Sponsored by Qlaris Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days

Summary

"This trial is studying the safety and effectiveness of QLS-111 in combination with latanoprost for reducing eye pressure in patients with open-angle glaucoma or ocular hypertension."

Who is the study for?
This trial is for people aged 12 or older with mild to moderate open-angle glaucoma (OAG) or ocular hypertension (OHT). Participants must have seen a decrease in eye pressure after previous treatment and be willing to continue using latanoprost during the study. They should also have an eye pressure of ≥19 mmHg at specific times before joining.
What is being tested?
The Qlaris Phase 2 study is testing different strengths of QLS-111 eye drops, combined with a prostaglandin analog called latanoprost, to see if they are safe and can effectively lower the pressure inside the eyes of patients with OAG or OHT.
What are the potential side effects?
Possible side effects may include discomfort in the eyes, redness, possible changes in vision, and potential allergic reactions. The exact side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinically significant change in blood pressure
Clinically significant change in findings on fundus exam
Clinically significant change in findings on slit lamp exam
+4 more
Secondary study objectives
CFB in IOP at various timepoints in the study eye
Change from baseline (CFB) of mean diurnal IOP in the study eye

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: QLS-111 ophthalmic solutionExperimental Treatment3 Interventions
Qlaris' IP, QLS-111 ophthalmic solution, provided in 3 concentrations (0.015%, 0.03%, and 0.075%), preservative free (PF), single-use units, masked.
Group II: Placebo comparator: Vehicle ophthalmic solutionPlacebo Group1 Intervention
Inactive control (0.00%), PF, single-use units, masked.

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Who is running the clinical trial?

Qlaris Bio, Inc.Lead Sponsor
6 Previous Clinical Trials
239 Total Patients Enrolled
Lisa BrandanoStudy DirectorQlaris Bio, Inc.
3 Previous Clinical Trials
145 Total Patients Enrolled
~32 spots leftby Nov 2025
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