Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in normal tension glaucoma patients.
A randomized, active-controlled, multi-site, double-masked, pilot study to evaluate the safety and tolerability of QLS-111 0.015% versus Timolol maleate ophthalmic preservative free (PF) 0.5% ophthalmic solution in subjects with NTG. Primary objective is to evaluate the ocular and systemic safety and tolerability of QLS-111 0.015% compared to active control (Timolol). Secondary objective is to evaluate the ocular hypotensive efficacy of QLS-111 0.015% with once daily evening (QPM) and twice daily (BID) dosing versus Timolol with QPM dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
QLS-111 ophthalmic solution 0.015% applied QPM OU for 7 days followed by BID dosing OU for 7 days, to constitute a 14-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
Timolol BID: Timolol Maleate PF 0.5% Ophthalmic Solution (Timolol) with BID dosing OU will be administered up to 14 days. All IP for this study will be supplied masked in PF single use vials.
Seoul National University Hospital
Seoul, South Korea
RECRUITINGIncidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)
Ocular safety and tolerability: (AEs)
Time frame: 14 days
Clinically significant change in visual acuity
Ocular safety and tolerability: visual acuity
Time frame: 14 days
Clinically significant change in findings on slit lamp exam
Ocular safety and tolerability: dilated biomicroscopy of eye to observe clinically significant changes from baseline
Time frame: 14 days
Clinically significant change in findings on fundus exam
Ocular safety and tolerability: dilated ophthalmoscopy to observe clinically significant changes from baseline in posterior segment of eye
Time frame: 14 days
Incidence of systemic TEAEs
Systemic safety and tolerability: AEs
Time frame: 14 days
Clinically significant changes in blood pressure (BP)
Systemic safety and tolerability: vital sign, measuring systolic and diastolic blood pressure
Time frame: 14 days
Clinically significant changes in heart rate (HR)
Systemic safety and tolerability: vital signs
Time frame: 14 days
Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye
Ocular hypotensive efficacy: diurnal IOP CFB
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Time frame: 14 days
CFB in IOP at various timepoints in the study eye
Ocular hypotensive efficacy: IOP CFB for multiple timepoints throughout the day
Time frame: 14 days