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

• Sponsor: Aristotle University Of Thessaloniki (Other)
• Overall Status: Completed
• CT.gov ID: NCT00486486
• Collaborator: (none)
• Enrollment: 60
• Locations: 2
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 30
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: Drug: bimatoprost/timolol fixed combination AM; Drug: Bimatoprost/timolol fixed combination dosed PM	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bimatoprost/Timolol AM therapy	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
Active Comparator: Bimatoprost/Timolol PM therapy	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

Outcome Measures

Primary Outcome Measures

1. Mean 24-hour IOP [3 months of therapy]

Secondary Outcome Measures

1. Side effects with medications [3 months of therapy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 39 Years to 81 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glaucoma Unit, 1st University Department of Ophthalmology	Thessaloniki		Greece	546 36
2	Glaucoma Unit, 1st University Dept of Ophthalmology	Thessaloniki		Greece

Sponsors and Collaborators

• Aristotle University Of Thessaloniki

Investigators

• Principal Investigator: Anastasios Konstas, MD, PhD, Head of the Glaucoma Unit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki
• ClinicalTrials.gov Identifier: NCT00486486
• Other Study ID Numbers: A3241
• First Posted: Jun 14, 2007
• Last Update Posted: May 12, 2014
• Last Verified: May 1, 2014

• Keywords provided by AGP Konstas, Professor in Ophthalmology, Aristotle University Of Thessaloniki: 24-hour IOP control
• Additional relevant MeSH terms: Glaucoma; Timolol; Bimatoprost

Study Results

No Results Posted as of May 12, 2014