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

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Drug: Bimatoprost/timolol fixed combination dosed PM

• Registration Number: NCT00486486
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief 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).

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-06-13
• Study First Submitted QC: 2007-06-13
• Study First Posted: 2007-06-14
• Primary Completion: 2008-05
• Study Completion: 2008-07
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bimatoprost/Timolol AM therapy	Bimatoprost/timolol fixed combination dosed PM	-
Bimatoprost/Timolol PM therapy	Bimatoprost/timolol fixed combination dosed PM	-

Primary Outcome Measures

Name	Time	Method
Mean 24-hour IOP	3 months of therapy

Secondary Outcome Measures

Name	Time	Method
Side effects with medications	3 months of therapy

Trial Locations

Locations (2)

Glaucoma Unit, 1st University Department of Ophthalmology; 🇬🇷 Thessaloniki, Greece

Glaucoma Unit, 1st University Dept of Ophthalmology; 🇬🇷 Thessaloniki, Greece