The purpose of this study was to evaluate the safety and efficacy of adding AZARGA® as a single agent to prostaglandin monotherapy in patients with either ocular hypertension or primary open-angle glaucoma.
This study consisted of 3 study visits (Screening/Baseline, Week 4, and Week 12). Eligible patients self-administered the study medication (AZARGA® Eye Drops), adjunct to their current prostaglandin monotherapy for 3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Topical ocular therapy used daily as prescribed
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.
Time frame: Baseline, Week 12
Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only prostaglandin subgroups with ≥ 15 patients were analyzed. Only one eye (study eye) contributed to the mean.
Time frame: Baseline, Week 12
Mean Change From Baseline in IOP at Week 4
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.
Time frame: Baseline, Week 4
Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was assessed.
Time frame: Week 12
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