24-Hour Intraocular Pressure Control With Bimatoprost/Timolol Versus Latanoprost as First Choice

Study Overview
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Brief Summary
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The primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan) administered once in the evening (20:00) in newly-diagnosed patients with exfoliation syndrome (XFS) and ocular hypertension, or exfoliative glaucoma (XFG) previously untreated and IOP greater than 29 mm Hg.

Official Title
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24-Hour Intraocular Pressure Control Obtained With the Bimatoprost/Timolol Fixed Combination Compared With Latanoprost as First Choice Therapy in Subjects With Exfoliation Syndrome, or Exfoliative Glaucoma

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring
* Drug: Latanoprost, 24-hour intraocular pressure monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has exfoliation syndrome with ocular hypertension, or exfoliative glaucoma and is older than 29 years Patient is newly diagnosed, or currently untreated and exhibits untreated morning IOP (2 separate IOP readings at 10:00)greater than 29 mm Hg in the study eye Study patients should have mild to moderate exfoliative glaucoma (VF loss <12 dB; cupping 0.8 or less) Patient with exfoliation syndrome should fulfill the IOP criterion (IOP > 29 mm Hg at 10:00) Patient deemed by investigator to require significant IOP reduction to obtain desired target IOP Patient agrees to be treated for at least 3 months with latanoprost and bimatoprost/timolol fixed combination drops dosed in the evening In study eye distance best corrected Snelen visual acuity greater than 1/10 Exclusion Criteria: Contraindications to therapy with latanoprost, bimatoprost, or β-blockers History of non-adherence or previously recorded evidence of lack of response (<10% morning IOP reduction) to any antiglaucoma medication Patient can not understand the instructions and adhere to medications Patient is a female of childbearing potential or lactating mother Past history of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses Signs of ocular infection, except blepharitis, or corneal abnormality that may affect IOP measurements The other eye can not receive the same therapy, or remain without medical therapy Closed angles

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 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 drops<br>The patients will be treated with bimatoprost/timolol fixed combination therapy | Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring<br>* Administered once in the evening<br>* Other names: Xalatan;Drug: Latanoprost, 24-hour intraocular pressure monitoring<br>* assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing<br>* Other names: Xalatan;|
| Active Comparator: Latanoprost drops<br>The patients will be crossed over to therapy with latanoprost | Drug: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring<br>* Administered once in the evening<br>* Other names: Xalatan;Drug: Latanoprost, 24-hour intraocular pressure monitoring<br>* assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing<br>* Other names: Xalatan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour IOP reduction between the two medications | Bimatoprost/Timolol will obtain a statistically greater 24-hour IOP reduction than latanoprost and the mean 24-hour IOP difference between the two medications will be clinically meaningful (at least 2 mm Hg). | 3 months |