Non-proliferative Diabetic Retinopathy (NPDR)Phase 2(PENGUIN)NCT07354477
Single-site Pilot Study Evaluating the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusion and Vessel Dilation
A Phase 2 study testing QLS-111 Ophthalmic Solution (0.015%) and QLS-111 Ophthalmic Solution (0.075%) in people with Non-proliferative Diabetic Retinopathy (NPDR) and Open-angle Glaucoma (OAG), run by Qlaris Bio, Inc. at 1 site in United States.
Trial summary
Pilot, single-site, prospective study of QLS-111 0.015 % in subjects with NPDR, OAG or NTG Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-proliferative Diabetic Retinopathy (NPDR), Open-angle Glaucoma (OAG), Normal Tension Glaucoma (NTG)
- What is being tested?
- QLS-111 Ophthalmic Solution (0.015%) and QLS-111 Ophthalmic Solution (0.075%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2026to Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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,
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University, Dept. of Ophthalmology
Palo Alto, California, 94303
About this study
Official title: 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
Read the 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.
- Conditions
- Non-proliferative Diabetic Retinopathy (NPDR), Open-angle Glaucoma (OAG), Normal Tension Glaucoma (NTG)
- Being tested
- QLS-111 Ophthalmic Solution (0.015%), QLS-111 Ophthalmic Solution (0.075%)
- Keywords
- glaucoma, diabetic retinopathy, vessel dilation
- Medical subject headings
- Glaucoma, Open-Angle, Low Tension Glaucoma, Glaucoma, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS-111 Ophthalmic Solution (0.015%)Drug
QLS-111 (0.015%) administered BID for 7 days OU.
QLS-111 Ophthalmic Solution (0.075%)Drug
QLS-111 (0.075%) administered BID for 7 days OU. Follows the 7 days where QLS-111 (0.015%) is administered.
| Study group | Role | What they receive |
|---|---|---|
| QLS-111 Ophthalmic Solution, 2 concentrations (0.015% and 0.075%, concurrent) dosed BID for 7 days | Experimental | QLS-111 Ophthalmic Solution, 2 concentrations (0.015% and 0.075%) dosed BID for 7 days (taken 12-hour intervals) OU. Receives: Drug: QLS-111 Ophthalmic Solution (0.015%); Drug: QLS-111 Ophthalmic Solution (0.075%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 1 through 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start20 Feb 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-proliferative Diabetic Retinopathy (NPDR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qlaris Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara M Wirostko, MD, Study director, Qlaris Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354477
- Sponsor's protocol ID
- QC-111-205
- Acronym
- (PENGUIN)
- Status last verified
- Sep 2026
- First submitted
- 22 Dec 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory, Pilot, Single-site Study to Evaluate the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusion and Vessel Dilation
- ClinicalTrials.gov ID
- NCT07354477
- Acronym / sponsor ID
- (PENGUIN) / QC-111-205
- Conditions
- Non-proliferative Diabetic Retinopathy (NPDR), Open-angle Glaucoma (OAG), Normal Tension Glaucoma (NTG)
- Keywords
- glaucoma, diabetic retinopathy, vessel dilation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Qlaris Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot, single-site, prospective study of QLS-111 0.015 % in subjects with NPDR, OAG or NTG
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS-111 Ophthalmic Solution, 2 concentrations (0.015% and 0.075%, concurrent) dosed BID for 7 days | Experimental | Drug: QLS-111 Ophthalmic Solution (0.015%), Drug: QLS-111 Ophthalmic Solution (0.075%)QLS-111 Ophthalmic Solution, 2 concentrations (0.015% and 0.075%) dosed BID for 7 days (taken 12-hour intervals) OU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLS-111 Ophthalmic Solution (0.015%)QLS-111 (0.015%) administered BID for 7 days OU. | Drug | QLS-111 Ophthalmic Solution, 2 concentrations (0.015% and 0.075%, concurrent) dosed BID for 7 days |
| 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. | Drug | QLS-111 Ophthalmic Solution, 2 concentrations (0.015% and 0.075%, concurrent) dosed BID for 7 days |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara M Wirostko, MD study director
Qlaris Bio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QLS-111 Ophthalmic Solution (0.015%) and QLS-111 Ophthalmic Solution (0.075%) in people with Non-proliferative Diabetic Retinopathy (NPDR) and Open-angle Glaucoma (OAG), run by Qlaris Bio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in blood flow to the posterior segment of the eye. (time frame: Days 1 through 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.