Pilot, single-site, prospective study of QLS-111 0.015 % in subjects with NPDR, OAG or NTG
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.
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.
Sequential
QLS-111 Ophthalmic Solution (0.015%)
DrugQLS-111 (0.015%) administered BID for 7 days OU.
QLS-111 Ophthalmic Solution (0.075%)
DrugQLS-111 (0.075%) administered BID for 7 days OU. Follows the 7 days where QLS-111 (0.015%) is administered.
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.
Ocular safety
Ocular safety will be assessed by review of the following: • Ocular adverse events (AEs)
Systemic safety
Systemic safety will be assessed by review of the following: • Systemic AEs
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