The purpose of this study is to compare the efficacy and safety of the preservative-free fixed tafluprost-timolol combination to those of tafluprost and timolol alone. This study will enroll patients who have ocular hypertension or glaucoma and who are using timolol or prostaglandin. The study medication period is 6 months, but the primary evaluation of efficacy is done at 3 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
600
Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00). Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00).
Eye clinic, University Hospital of Kuopio
Kuopio, Finland
Eye Clinic, University Hospital of Oulu
Oulu, Finland
Change from baseline in the average diurnal Intraocular Pressure (IOP) at 3 months
Time frame: At 3 months
Change from baseline in average diurnal IOP
Change from baseline in the average diurnal IOP at 2 weeks, 6 weeks and 6 months
Time frame: At 2 and 6 weeks and 6 months
Change from baseline in timewise IOPs
Change from baseline in timewise IOPs (at 8:00, 10:00, 16:00, 20:00)
Time frame: At 2 weeks, 6 weeks, 3 months and 6 months
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