NCT01448837

24-Hour Intraocular Pressure Control With Bimatoprost/Timolol Versus Latanoprost as First Choice

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Glaucoma

Interventions

Type	Name	Description
DRUG	Bimatoprost/Timolol, 24-hour intraocular pressure monitoring	Administered once in the evening
DRUG	Latanoprost, 24-hour intraocular pressure monitoring	assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2011-10-07
• Last updated: 2014-05-12

Locations

1 site across 1 country: Greece