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Keep this study
Lead
Aristotle University Of Thessaloniki
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).
Age
39–81
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
Clareo Health | 24-hour Intraocular Pressure (IOP) Control With the Bimatoprost/Timolol Fixed Combination
