Qlaris Phase 2 clinical study investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in combination with latanoprost in open-angle glaucoma (OAG) and/or ocular hypertension (OHT) patients.
Pilot, double-masked, vehicle-controlled, randomized, prospective parallel study of 14-day once daily evening (QPM) dosing, followed by 14-day twice daily (BID) dosing of an investigational product (IP), QLS-111, or vehicle as concomitant therapy with monotherapy latanoprost a PGA treatment that is administered QPM. Both eyes (OU) will be dosed. The study is comprised of seven (7) visits and approximately 28 days of IP dosing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
QLS-111 eyedrops applied QPM for 14 days the BID for 14 days.
Berkeley Eye Center
Houston, Texas, United States
Incidence of ocular treatment-emergent adverse events (TEAEs)
Ocular safety and tolerability
Time frame: 28 days
Clinically significant change in visual acuity
Ocular safety and tolerability
Time frame: 28 days
Clinically significant change in findings on slit lamp exam
Ocular safety and tolerability
Time frame: 28 days
Clinically significant change in findings on fundus exam
Ocular safety and tolerability
Time frame: 28 days
Incidence of systemic (TEAEs)
Systemic safety and tolerability
Time frame: 28 days
Clinically significant change in blood pressure
Systemic safety and tolerability
Time frame: 28 days
Clinically significant change in heart rate
Systemic safety and tolerability
Time frame: 28 days
Change from baseline (CFB) of mean diurnal IOP in the study eye
Ocular hypotensive efficacy: diurnal IOP
Time frame: 28 days
CFB in IOP at various timepoints in the study eye
Ocular hypotensive efficacy: CFB for multiple timepoints
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Vehicle drops applied QPM for 14 days the BID for 14 days.
Time frame: 28 days