The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 Ophthalmic Solution in lowering intraocular pressure (IOP) in subjecs with ocular hypertension or open-angle glaucoma. Subjects will be randomized in a 1:1 ratio to NCX 470 0.1% or to latanoprost 0.005% to be administered to both eyes once daily in the evening for up to 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
696
NCX 470 Ophthalmic Solution, 0.1%
Latanoprost Ophthalmic Solution, 0.005%
Change from baseline IOP
Mean IOP change from time-matched baseline at 8AM and 4PM time points at the Week 2, Week 6 and Month 3 Visits in the study eye
Time frame: Up to 3 months
Change from baseline in diurnal IOP
Mean diurnal IOP change from baseline at the Week 2, Week 6 and Month 3 Visits in the study eye
Time frame: Up to 3 months
Frequency and incidence of treatment-emergent adverse events
Number and percentage of subjects with ocular and non-ocular treatment-emergent adverse events
Time frame: 12 months
Rate of discontinuation
Percentage of subjects in each treatment group who discontinue study participation
Time frame: 12 months
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