Single-site Pilot Study Evaluating the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusion and Vessel Dilation ((PENGUIN))

An Exploratory, Pilot, Single-site Study to Evaluate the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusion and Vessel Dilation

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

Study Overview

• Status: Recruiting
• Conditions: Open-angle Glaucoma (OAG); Normal Tension Glaucoma (NTG); Non-proliferative Diabetic Retinopathy (NPDR)
• Intervention / Treatment: Drug: QLS-111 Ophthalmic Solution (0.015%); Drug: QLS-111 Ophthalmic Solution (0.075%)

Detailed Description

Pilot, single-site, prospective study of BID OU dosing of QLS-111 0.015 % for 7 days followed by QLS-111 0.075% BID OU in subjects with NPDR, OAG or NTG. Both eyes (OU) will be dosed. The study is comprised of 4 visits including Screening/Baseline visit, 2 Treatment Period visits over 14 days of IP dosing, and a Post-Treatment visit.

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lisa Brandano; Phone Number: 978-930-2103; Email: lbrandano@qlaris.bio

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94303
      • Recruiting
      • Stanford University, Dept. of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of mild to moderate OAG, mild to moderate NTG, or stable NPDR in at least one eye.
• Corrected visual acuity in each eye +1.0 logMAR or better by early treatment diabetic retinopathy study (ETDRS) in each eye (equivalent to 20/200).
• Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

• History of active ocular disease other than mild to moderate OAG, mild to moderate NTG, or stable NPDR.
• Patient is using more than 1 ocular hypotensive topical medication for intraocular pressure (IOP) control (prior MIGS and/or laser trabeculoplasty to control IOP is allowed if done at least 3 months from Screening (Visit 1).
• Use of TO β-blockers (i.e. timolol) within 3 months prior to Screening.
• Is noncompliant with current ocular anti-hypotensive medications and/or unwilling to be compliant throughout the study.
• Clinically significant severe retinal disease in either eye that will require treatment during the study (e.g., proliferative diabetic retinopathy, exudative, or severe non-exudative macular degeneration). NOTE: background diabetic retinopathy (BDR) as required for the NPDR subjects is allowed if in the Investigator's opinion the BDR is stable and is expected to remain stable during the duration of the study.
• Anti-VEGF or TO steroid treatment within 3 months prior to Screening or expected treatment while participating in this study. Prior diabetic macular edema (DME) history is allowed if adequately controlled with treatment (anti-VEGFs and steroids not within last 3 months prior to Screening), regimen is stable, and not expected to change during the study. - Corneal pathologic changes preventing reliable measurement (e.g., scarring, opacity, edema, and bullae) in either eye that would inhibit accurate IOP measurements.
• Previously diagnosed, clinically significant systemic or psychiatric disease (e.g., myasthenia gravis, hepatic, renal, endocrine, pulmonary, or cardiovascular disorders) which might compromise the study results or subject safety. For the purpose of this study previously diagnosed, clinically significant renal disease that should be excluded from enrollment will be defined as Stages 3-5 kidney disease and/or an estimated glomerular filtration rate (eGFR) of ≤59.
• Use of calcium channel blockers.
• Labile hypertension and/or hypotension that is inadequately controlled,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QLS-111 Ophthalmic Solution, 2 concentrations (0.015% and 0.075%, concurrent) dosed BID for 7 days; QLS-111 Ophthalmic Solution, 2 concentrations (0.015% and 0.075%) dosed BID for 7 days (taken 12-hour intervals) OU.	Drug: QLS-111 Ophthalmic Solution (0.015%); QLS-111 (0.015%) administered BID for 7 days OU.; Drug: QLS-111 Ophthalmic Solution (0.075%); QLS-111 (0.075%) administered BID for 7 days OU. Follows the 7 days where QLS-111 (0.015%) is administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in blood flow to the posterior segment of the eye.	Ocular imaging will be collected at study visits at baseline, treatment period , and 1 week post-treatment and to evaluate change from baseline in retinal vessel diameter and blood flow.	Days 1 through 22

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular safety	Ocular safety will be assessed by review of the following: • Ocular adverse events (AEs)	Days 1 through 22
Systemic safety	Systemic safety will be assessed by review of the following: • Systemic AEs	Days 1 through 22

Collaborators and Investigators

• Sponsor: Qlaris Bio, Inc.
• Investigators: Study Director: Barbara M Wirostko, MD, Qlaris Bio

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: January 17, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 21, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: glaucoma; diabetic retinopathy; vessel dilation
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Optic Nerve Diseases; Retinal Diseases; Ocular Hypertension; Diabetic Retinopathy; Glaucoma; Glaucoma, Open-Angle; Low Tension Glaucoma
• Other Study ID Numbers: QC-111-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No