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

NCT07354477 | Recruiting Phase 2 FDA Drug

• 1 other identifier: QC-111-205
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-proliferative Diabetic Retinopathy (NPDR); Open-angle Glaucoma (OAG); Normal Tension Glaucoma (NTG)

Keywords

glaucoma; diabetic retinopathy; vessel dilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Ocular safety

  Days 1 through 22

• Systemic safety

  Days 1 through 22

Study Arms (1)

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.

Drug: QLS-111 Ophthalmic Solution (0.015%); Drug: QLS-111 Ophthalmic Solution (0.075%)

Interventions

QLS-111 Ophthalmic Solution (0.015%) DRUG

QLS-111 (0.015%) administered BID for 7 days OU.

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

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Qlaris Bio, Inc.: lead

Study Sites (1)

Stanford University, Dept. of Ophthalmology

Palo Alto, California, 94303, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-Angle; Low Tension Glaucoma; Glaucoma; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Barbara M Wirostko, MD

  Qlaris Bio

  STUDY DIRECTOR

Central Study Contacts

Lisa Brandano

CONTACT

978-930-2103; lbrandano@qlaris.bio

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Study is open-label but imaging data will use a masked reviewer. Clinician reviewing the imaging data will be masked to the QLS-111 concentration and visit data when reviewing.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 21, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)