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Not recruiting
Phase 2

QLS-111

Sponsor:

Qlaris Bio, Inc.

Code:

NCT07354477

Conditions

Non-proliferative Diabetic Retinopathy (NPDR)

Open-angle Glaucoma (OAG)

Normal Tension Glaucoma (NTG)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

QLS-111 Ophthalmic Solution (0.015%)

QLS-111 Ophthalmic Solution (0.075%)

Study Details

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)

Study ID

NCT07354477

Start date

Feb 20, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

14 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

QLS-111 Ophthalmic Solution (0.015%)

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

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.

Primary outcome measure

  • Change from Baseline in blood flow to the posterior segment of the eye. [ Time Frame: Days 1 through 22 ]

Central Contacts and Locations

More Information

Sponsor

Qlaris Bio, Inc.

Last update posted

Sep 14, 2026

Last verified

Sep, 2026

Keywords

  • glaucoma
  • diabetic retinopathy
  • vessel dilation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Qlaris Bio, Inc. on 2026-09-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.