The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT® Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.
After the screening examination, subjects were enrolled in the study and moved into the observation period. During the observation period, prostaglandin-analog (PGA) monotherapy was applied. After the observation period of 4 weeks or more, the baseline examination was performed. Subjects were then randomized and moved into the treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
218
Contact Alcon Japan Ltd. for Trial Locations
Tokyo, Japan
Least Squares Mean Change From Baseline in Intraocular Pressure (IOP) at 11 AM
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 11 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.
Time frame: Baseline (Day 0), Week 4, Week 8 at 11 AM
Least Squares Mean Change From Baseline in IOP at 9 AM
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). Data from 4 and 8 weeks at 9 AM were pooled, and a negative change indicates an improvement. One eye (target eye) was used for the analysis.
Time frame: Baseline (Day 0), Week 4, Week 8 at 9 AM
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