Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension patients.
A randomized, active- and vehicle-controlled, multi-site, double-masked study to evaluate the safety and tolerability of QLS-111 versus vehicle in subjects with primary open-angle glaucoma or ocular hypertension. Primary objective is to evaluate the ocular and systemic safety and tolerability of 3 concentrations of QLS-111 compared to vehicle control. Secondary objective is to evaluate the ocular hypotensive efficacy of 3 concentrations of QLS-111 with once daily morning (QAM), once daily evening (QPM), and twice daily (BID) dosing versus vehicle with QAM, QPM, and BID dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
63
QLS-111 ophthalmic solution, (0.015%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
QLS-111 ophthalmic solution, (0.03%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
Coastal Research Associates, LLC
Roswell, Georgia, United States
Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs)
Ocular safety and tolerability: adverse events (AEs)
Time frame: 21 days
Clinically significant change in visual acuity
Ocular safety and tolerability: visual acuity
Time frame: 21 days
Clinically significant change in findings on slit lamp exam
Ocular safety and tolerability: slit lamp
Time frame: 21 days
Clinically significant change in findings on fundus exam
Ocular safety and tolerability: fundus
Time frame: 21 days
Incidence of systemic TEAEs
Systemic safety and tolerability: AEs
Time frame: 21 days
Clinically significant changes in blood pressure (BP)
Systemic safety and tolerability: vital signs
Time frame: 21 days
Clinically significant changes in heart rate (HR)
Systemic safety and tolerability: vital signs
Time frame: 21 days
Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye
Ocular hypotensive efficacy: diurnal IOP CFB
Time frame: 21 days
CFB in IOP at various timepoints in the study eye
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
QLS-111 ophthalmic solution, (0.075%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
Vehicle ophthalmic solution applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
Ocular hypotensive efficacy: CFB for multiple timepoints throughout day
Time frame: up to 21 days