Single-site Pilot Study Evaluating the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusi… (NCT07354477) | Clinical Trial Compass
RecruitingPhase 2
Single-site Pilot Study Evaluating the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusion and Vessel Dilation
United States14 participantsStarted 2026-02-20
Plain-language summary
Pilot, single-site, prospective study of QLS-111 0.015 % in subjects with NPDR, OAG or NTG
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
What they're measuring
1
Change from Baseline in blood flow to the posterior segment of the eye.