24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol

Study Overview
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Brief Summary
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The proposed crossover study will compare for the first time the quality of 24-hour intraocular pressure control with the combination of travoprost and brinzolamide/timolol compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently controlled with travoprost. This comparison may determine the real efficacy of the two fixed combinations when added to the prostaglandin. The design of the proposed study should facilitate a better understanding of the role of these medications in glaucoma management.

Official Title
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Quality of 24-hour Intraocular Pressure Control Obtained With the Brinzolamide/Timolol Fixed Combination Compared With the Brimonidine/Timolol Fixed Combination When Added to Travoprost Monotherapy in Subjects With Open-angle Glaucoma

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Brimonidine/timolol fixed combination drops added to travoprost
* Drug: Brinzolamide/timolol fixed combination drops added to travoprost


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has open-angle glaucoma and is older than 29 years Patients should exhibit typical disc, or field changes and an untreated morning IOP greater than 25 mm Hg Patients are treated for at least 3 months with travoprost and should have demonstrated at least a 20% morning IOP reduction Patient deemed by PI to require adjunctive therapy to obtain desired target IOP Patient should exhibit IOP greater than 18 mm Hg on travoprost monotherapy (2 separate IOP readings at 10:00) Patient has mild to moderate glaucoma (field loss more than 16 dB; cupping 0.8 or less) Distance best corrected Snellen visual acuity at least 0.1 No contraindications to travoprost, brimonidine, brinzolamide and β-blockers No history of lack of response (<10% morning IOP reduction) to any medication Patient can understand the instructions and adhere to medications Exclusion Criteria: Female patient of childbearing potential or lactating mother History of trauma, inflammation, surgery History of past use of steroids (within 2 months), severe dry eyes and use of contact lenses Signs of ocular infection, except blepharitis Evidence of corneal abnormality that may affect IOP measurements etc Closed angle History of non-compliance

Ages Eligible for Study
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Minimum Age: 29 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: Brinzolamide/Timolol therapy<br>Chronic therapy for 3 months with brinzolamide/timolol drops given twice daily added to travoprost drops | Drug: Brimonidine/timolol fixed combination drops added to travoprost<br>* twice daily administration<br>* Other names: Combigan;Drug: Brinzolamide/timolol fixed combination drops added to travoprost<br>* twice daily dosing<br>* Other names: Azarga;|
| Active Comparator: Brimonidine/Timolol therapy<br>Chronic therapy for 3 months with brimonidine/timolol drops given twice daily added to travoprost drops | Drug: Brimonidine/timolol fixed combination drops added to travoprost<br>* twice daily administration<br>* Other names: Combigan;Drug: Brinzolamide/timolol fixed combination drops added to travoprost<br>* twice daily dosing<br>* Other names: Azarga;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean 24-hour intraocular pressure |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluctuation of 24-hour intraocular pressure |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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24-hour IOP control, brinzolamide/timolol, brimonidine/timolol, travoprost