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

Glaucoma Clinical Trial

— BTFC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00486486
• Other study ID #: A3241
• Status: Completed
• Phase: Phase 4
• First received: June 13, 2007
• Last updated: May 9, 2014
• Start date: March 2007
• Est. completion date: July 2008

Study information

• Verified date: May 2014
• Source: Aristotle University Of Thessaloniki
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 39 Years to 81 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
Greece	Glaucoma Unit, 1st University Department of Ophthalmology	Thessaloniki
Greece	Glaucoma Unit, 1st University Dept of Ophthalmology	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean 24-hour IOP		3 months of therapy	No
Secondary	Side effects with medications		3 months of therapy	Yes