The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
436
one drop in the morning and placebo in the evening
one drop in the morning and evening
placebo in the morning and latanoprost .005% in the evening
To demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.
Time frame: 6 months
To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all treatments at Week 26
Time frame: 6 Months
To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26
Time frame: 6 Months
To compare the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups
Time frame: 6 Months
To compare the proportion of patients reaching pre-specified (15, 18, and 21 mmHg) target diurnal IOPs between the treatment groups at Week 26
Time frame: 6 Months
To describe the IOP development from baseline to Week 26 for all treatment groups
Time frame: 6 Months
To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination
Time frame: 6 Months
To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52
Time frame: 6 Months
To follow the safety variables throughout the study periods.
Time frame: 6 Months
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Pfizer Investigational Site
Aachen, Germany
Pfizer Investigational Site
Aalen, Germany
Pfizer Investigational Site
Ahaus, Germany
Pfizer Investigational Site
Alzey, Germany
Pfizer Investigational Site
Aschaffenburg, Germany
Pfizer Investigational Site
Bad Abbach, Germany
Pfizer Investigational Site
Berlin, Germany
Pfizer Investigational Site
Coesfeld, Germany
Pfizer Investigational Site
Dillingen, Germany
Pfizer Investigational Site
Eitorf, Germany
...and 27 more locations