An Exploratory, Pilot, Single-site Study to Evaluate the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusion and Vessel Dilation
Qlaris Bio, Inc.
Summary
Pilot, single-site, prospective study of QLS-111 0.015 % in subjects with NPDR, OAG or NTG
Description
Pilot, single-site, prospective study of BID OU dosing of QLS-111 0.015 % for 7 days followed by QLS-111 0.075% BID OU in subjects with NPDR, OAG or NTG. Both eyes (OU) will be dosed. The study is comprised of 4 visits including Screening/Baseline visit, 2 Treatment Period visits over 14 days of IP dosing, and a Post-Treatment visit.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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/…
Interventions
- DrugQLS-111 Ophthalmic Solution (0.015%)
QLS-111 (0.015%) administered BID for 7 days OU.
- DrugQLS-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.
Location
- Stanford University, Dept. of OphthalmologyPalo Alto, California