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Experimental: QLS-111 ophthalmic solution 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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinically significant change in blood pressure
Clinically significant change in findings on fundus exam
Clinically significant change in findings on slit lamp exam
+4 moreSecondary outcome measures
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
299 Total Patients Enrolled
Lisa BrandanoStudy DirectorQlaris Bio, Inc.
3 Previous Clinical Trials
205 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the ophthalmic solution known as Experimental: QLS-111 received approval from the FDA?
"Our team at Power has appraised the safety of Experimental: QLS-111 ophthalmic solution to be a 2 on our scale. This rating stems from it being in Phase 2, where some data supports its safety while efficacy evidence is lacking."
Answered by AI
Are there any ongoing opportunities for patients to participate in this medical study?
"As per clinicaltrials.gov, this trial is presently seeking candidates. The initial posting was on April 8, 2024, with the latest update made on April 5, 2024."
Answered by AI
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