Who is sponsoring NCT01448837?

NCT01448837 is sponsored by Aristotle University Of Thessaloniki.

What drugs are being tested in NCT01448837?

Interventions: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring, Latanoprost, 24-hour intraocular pressure monitoring.

What is the status of NCT01448837?

NCT01448837 is currently COMPLETED.

Last reviewed 2014-05-09 · How we verify

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

NCT01448837 Phase 4 COMPLETED

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.

Details

Lead sponsor	Aristotle University Of Thessaloniki
Phase	Phase 4
Status	COMPLETED
Enrolment	37
Start date	2010-04
Completion	2011-03

Conditions

Glaucoma

Interventions

Bimatoprost/Timolol, 24-hour intraocular pressure monitoring
Latanoprost, 24-hour intraocular pressure monitoring

Primary outcomes

24-hour IOP reduction between the two medications — 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).

Countries

Greece