24-hour Intraocular Pressure (IOP) Control With the Bimatoprost/Timolol Fixed Combination

PRIMARY STUDY OBJECTIVES

• To show that the mean 24-hour IOP control obtained with BTFC (morning or evening) is statistically better to that with bimatoprost monotherapy given once on the evening.
• To demonstrate that the fixed combination will provide a significantly better IOP control in the morning when dosed in the evening.
• To test whether the mean 24-hour IOP control obtained with BTFC given once in the evening may be statistically better to that with BTFC given once in the morning.
• To show whether there will be less 24-hour fluctuation of IOP with the evening dosing of BTFC.

STUDY POPULATION

Consecutive newly-diagnosed, or suitably washed-out patients with exfoliative glaucoma (XFG) who exhibit a mean untreated IOP greater than 25 mm Hg at baseline (10:00).

Inclusion criteria

• The patient is suffering from XFG (if the patient has bilateral XFG, both eyes will be treated, but the worse eye will be selected for the statistical analysis)
• Patient is older than 39 years and younger than 85 years
• Patient is able and willing to participate in the study for the whole duration of the follow up. Will sign the consent form.
• At screening the untreated IOP at 10:00 (± 1 hr) is greater than 25 mm Hg and lower than 40 mm Hg
• After bimatoprost run-in therapy the treated IOP at 10:00 (± 1 hr) is greater than 19 mm Hg