QLS-111 eye drops to improve back-of-eye blood flow and widen eye blood vessels
An Exploratory, Pilot, Single-site Study to Evaluate the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusion and Vessel Dilation
This trial will test QLS-111 eye drops to see if they improve blood flow and dilate vessels in people with mild-to-moderate open-angle glaucoma, normal-tension glaucoma, or stable non-proliferative diabetic retinopathy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qlaris Bio, Inc. Industry-sponsored |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT07354477 on ClinicalTrials.gov |
What this trial studies
This is a pilot, single-site, prospective Phase 2 study at Stanford testing topical QLS-111 given to both eyes twice daily. Participants will receive 0.015% QLS-111 BID for 7 days followed by 0.075% QLS-111 BID for 7 more days, with four clinic visits including screening/baseline, two treatment visits, and a post-treatment visit. The study will measure posterior ocular perfusion and vessel dilation to determine short-term vascular effects of the drug. Safety and tolerability will also be monitored during the 14-day dosing period.
Who should consider this trial
Good fit: Ideal candidates are adults with mild-to-moderate open-angle glaucoma or normal-tension glaucoma, or with stable non-proliferative diabetic retinopathy, who have corrected visual acuity of 20/200 or better in each eye and can attend visits at the study site.
Not a fit: Patients with clinically significant severe retinal disease requiring treatment, those using more than one topical ocular hypotensive medication, recent use of topical beta-blockers, or poor compliance with eye medications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, QLS-111 could improve retinal and posterior ocular blood flow and vessel diameter, which might help preserve vision or slow disease progression in affected patients.
How similar studies have performed: This vascular-targeting topical approach is relatively novel for improving posterior perfusion, with limited and mixed clinical evidence from prior small studies of vasoactive ocular agents.
Eligibility criteria
Show full inclusion / exclusion criteria
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,
Where this trial is running
Palo Alto, California
- Stanford University, Dept. of Ophthalmology — Palo Alto, California, United States (Recruiting)
Study contacts
- Study coordinator: Lisa Brandano
- Email: lbrandano@qlaris.bio
- Phone: 978-930-2103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.