← Back to Search

Other

QLS-111 ophthalmic solution for 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 days

Awards & highlights

Study Summary

"This trial is testing a new drug called QLS-111 to see if it is safe and effective in lowering eye pressure in patients with glaucoma or high eye pressure."

Who is the study for?

This trial is for people aged 12 or older with primary open-angle glaucoma (POAG) or ocular hypertension (OHT). They must have a best corrected visual acuity of 20/200 or better and documented high eye pressure. Participants need to understand the study and agree to join by signing a consent form.Check my eligibility

What is being tested?

The Qlaris Phase 2 study tests different strengths of QLS-111 eye drops against a vehicle solution to see if they are safe, tolerable, and effective in lowering eye pressure in patients with POAG or OHT.See study design

What are the potential side effects?

Possible side effects may include discomfort in the eyes, redness, itching, potential vision changes, or other local reactions related to the use of ophthalmic solutions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

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 findings on fundus exam

Clinically significant change in findings on slit lamp exam

Clinically significant change in visual acuity

+4 more

Secondary outcome measures

CFB in IOP at various timepoints in the study eye

Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: QLS-111 ophthalmic solutionExperimental Treatment3 Interventions

Qlaris' investigational product, QLS-111 ophthalmic solution, provided in 3 concentrations for this study (0.015%, 0.03%. and 0.075%), single use vials, masked, and preservative free (PF).

Group II: QLS-111 ophthalmic vehicle solutionPlacebo Group1 Intervention

Inactive control (0.00%). QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Qlaris Bio, Inc.Lead Sponsor

6 Previous Clinical Trials

287 Total Patients Enrolled

6 Trials studying Glaucoma

287 Patients Enrolled for Glaucoma

Lisa BrandanoStudy DirectorQlaris Bio, Inc.

3 Previous Clinical Trials

193 Total Patients Enrolled

2 Trials studying Glaucoma

168 Patients Enrolled for Glaucoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available openings for new participants in this research study?

"Indeed, as per the information found on clinicaltrials.gov, this trial is actively seeking participants. It was initially posted on March 15th, 2024 and last updated on March 16th, 2024. The study aims to enroll a total of 60 individuals from one designated site."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical research study?

"Indeed, information from clinicaltrials.gov shows that this research endeavor is actively seeking candidates. The trial was first listed on March 15th, 2024, and most recently revised on March 16th, 2024. It aims to recruit a total of 60 participants at a single site."

Answered by AI

What is the safety profile of QLS-111 ophthalmic solution in individuals receiving treatment?

"According to our evaluation at Power, the safety rating for QLS-111 ophthalmic solution is a 2 on the scale due to its Phase 2 trial status. This suggests that while some safety data exists, no evidence of efficacy has been observed yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Qlaris Phase 2 Study of QLS-111 in POAG and/or OHT Patients

2024. "Qlaris Phase 2 Study of QLS-111 in POAG and/or OHT Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06016972.