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QLS-111 Ophthalmic Solution for Glaucoma

((PENGUIN) Trial)

LB
Overseen ByLisa Brandano
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Qlaris Bio, Inc.
Must not be taking: TO β-blockers, Anti-VEGF, Steroids, Calcium channel blockers
Disqualifiers: Severe retinal disease, Systemic disease, others
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?

Pilot, single-site, prospective study of QLS-111 0.015 % in subjects with NPDR, OAG or NTG

Who Is on the Research Team?

BM

Barbara M Wirostko, MD

Principal Investigator

Qlaris Bio

Are You a Good Fit for This Trial?

This trial is for individuals with mild to moderate open-angle glaucoma (OAG), normal-tension glaucoma (NTG), or stable non-proliferative diabetic retinopathy (NPDR) in at least one eye. Participants must have a corrected visual acuity of 20/200 or better and be able to consent and follow study instructions.

Inclusion Criteria

I have been diagnosed with a certain type of glaucoma or stable eye disease in at least one eye.
My vision is 20/200 or better in both eyes.
I am willing and able to follow the study's rules and sign the consent form.

Timeline for a Trial Participant

Screening/Baseline

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

Treatment

Participants receive QLS-111 Ophthalmic Solution, 2 concentrations (0.015% and 0.075%) dosed BID for 7 days

14 days
2 visits (in-person)

Post-Treatment

Participants are monitored for safety and effectiveness after treatment

1 week
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • QLS-111 Ophthalmic Solution

Trial Overview

The study is testing two concentrations of QLS-111 Ophthalmic Solution, 0.015% and 0.075%, to evaluate their effects on blood flow and vessel dilation in the back part of the eye among patients with certain types of glaucoma or diabetic retinopathy.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: QLS-111 Ophthalmic Solution, 2 concentrations (0.015% and 0.075%, concurrent) dosed BID for 7 daysExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Qlaris Bio, Inc.

Lead Sponsor

Trials
7
Recruited
250+

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