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

February 21, 2026 updated by: Qlaris Bio, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in blood flow to the posterior segment of the eye.
Time Frame: Days 1 through 22
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ocular safety
Time Frame: Days 1 through 22

Ocular safety will be assessed by review of the following:

• Ocular adverse events (AEs)
Days 1 through 22
Systemic safety
Time Frame: Days 1 through 22

Systemic safety will be assessed by review of the following:

• Systemic AEs
Days 1 through 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qlaris Bio, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Barbara M Wirostko, MD, Qlaris Bio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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