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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Drug: bimatoprost/timolol fixed combination AM
* Drug: Bimatoprost/timolol fixed combination dosed PM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 39 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bimatoprost/Timolol AM therapy<br> | Drug: Drug: bimatoprost/timolol fixed combination AM<br>* 3-month chronic dosing in the morning<br>Drug: Bimatoprost/timolol fixed combination dosed PM<br>* Evening dosing of bimatoprost/timolol fixed combination for a period of 3 months<br>|
| Active Comparator: Bimatoprost/Timolol PM therapy<br> | Drug: Drug: bimatoprost/timolol fixed combination AM<br>* 3-month chronic dosing in the morning<br>Drug: Bimatoprost/timolol fixed combination dosed PM<br>* Evening dosing of bimatoprost/timolol fixed combination for a period of 3 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean 24-hour IOP |  | 3 months of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects with medications |  | 3 months of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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24-hour IOP control