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”

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).

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: May 2008

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).

Intervention(s) in this Clinical Trial

• Drug: Drug: bimatoprost/timolol fixed combination AM or PM
  • dosing AM or PM
• Drug: Drug: bimatoprost/timolol fixed combination PM
  • dosing at 08:00 or 20:00 of bimatoprost/timolol fixed combination for a period of 3 months

Primary Measures

• Mean 24-hour IOP
  • Time Frame: 3 months of therapy
    Safety Issue?: No

Secondary Measures

• Side effects with medications
  • Time Frame: 3 months of therapy
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 39 Years

Maximum Age for this Clinical Trial: 81 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Aristotle University Of Thessaloniki

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00486486

Study ID Number: A3241

ClinicalTrials.gov Identifier: NCT00486486

Health Authority: Greece: National Organization of Medicines