The purpose of this study is to compare the efficacy and safety of the preservative-free fixed-dose combination of tafluprost and timolol (FDC) to concomitant administration of tafluprost and timolol. This study will enroll patients who have ocular hypertension or glaucoma. The study schedule includes seven visits to the study site and three stages: * washout of 5 days to 4 weeks depending on current glaucoma medication (if any) * 6-month study treatment period * 1-3 weeks post-study period
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
401
Preservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily Treatment period 6 months
Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops administered once daily. For masking purposes also: vehicle for timolol administered twice daily Treatment period 6 months
Unnamed facility
Debrecen, Hungary
Change from baseline in the average diurnal intra-ocular pressure (IOP) at 6 months
Time frame: 6 months
Change from baseline in average diurnal IOP at 2 weeks, 6 weeks and 3 months
Time frame: 2 weeks, 6 weeks and 3 months
Change from baseline in timewise IOPs
Change from baseline in timewise IOPs (at 8:00, 10:00, 16:00) at 2 weeks, 6 weeks, 3 months and 6 months
Time frame: 2 weeks, 6 weeks, 3 months and 6 months
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