Glaucoma Unit, 1st University Department of Ophthalmology
Thessaloniki, Greece
NCT Number: NCT01448837
The primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan) administered once in the evening (20:00) in newly-diagnosed patients with exfoliation syndrome (XFS) and ocular hypertension, or exfoliative glaucoma (XFG) previously untreated and IOP greater than 29 mm Hg.
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Notify Me21 year–80 year
All sexes
Interventional
Phase 4
Thessaloniki, Greece
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered once in the evening
Other names: Ganfort, Xalatan
assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing
Other names: Ganfort, Xalatan
Time frame: 3 months
Bimatoprost/Timolol will obtain a statistically greater 24-hour IOP reduction than latanoprost and the mean 24-hour IOP difference between the two medications will be clinically meaningful (at least 2 mm Hg).
Aristotle University Of Thessaloniki
Other
24-Hour Intraocular Pressure Control Obtained With the Bimatoprost/Timolol Fixed Combination Compared With Latanoprost as First Choice Therapy in Subjects With Exfoliation Syndrome, or Exfoliative Glaucoma
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