NCT00486486

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

A 3-month, 4-centre, Crossover, Double-masked Study Investigating the 24-hour Intraocular Pressure Control With the Bimatoprost/Timolol Fixed Combination Dosed Morning, or Evening in Subjects With Exfoliative Glaucoma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 39 Years – 81 Years
• Healthy volunteers: Not accepted

Summary

The objective of this crossover, randomized, placebo controlled, double-masked study is to compare the short-term (12 weeks) mean 24-hour IOP control and safety of the new fixed combination (bimatoprost/timolol, BTFC) given PM with placebo once in the morning, versus BTFC given AM with placebo once in the evening versus bimatoprost given in the evening in patients with exfoliative glaucoma (XFG).

Detailed description

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).

Conditions

• Glaucoma

Interventions

Type	Name	Description
DRUG	Drug: bimatoprost/timolol fixed combination AM	3-month chronic dosing in the morning
DRUG	Bimatoprost/timolol fixed combination dosed PM	Evening dosing of bimatoprost/timolol fixed combination for a period of 3 months

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-05-01
• Completion: 2008-07-01
• First posted: 2007-06-14
• Last updated: 2014-05-12

Locations

2 sites across 1 country: Greece