24-hr Intraocular Pressure Control With Dorzolamide/Timolol vs the Brimonidine/Timolol Fixed Combination

Study Overview
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Brief Summary
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The proposed study will compare for the first time the quality of 24-hour IOP control with Brimonidine/Timolol fixed combination (BTFC) versus Dorzolamide/Timolol fixed combination (DTFC) after a run-in period of 2 months with timolol. This crossover comparison may determine the real efficacy of the two fixed combinations and the design of the proposed study may explain for the first time why the 24-hour IOP reduction provided by BTFC is less than might be anticipated.

Official Title
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Quality of 24-hour Intraocular Pressure Control Obtained With Dorzolamide/Timolol Fixed Combination (DTFC) Compared With the Brimonidine/Timolol Fixed Combination (BTFC) in Subjects With Primary Open-angle Glaucoma

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: treatment with dorzolamide/timolol
* Drug: treatment with brimonidine/timolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive, newly diagnosed or previously untreated POAG patients Patients with typical glaucomatous disc, or visual field damage Patient must have IOP (at 10:00 ± 1 hour)greater than 25 mm Hg Exclusion Criteria: Uncontrolled glaucoma Distance best corrected Snellen visual acuity worse than 1/10 Contraindications to brimonidine or dorzolamide and β-blockers History of lack of response (<10% morning IOP reduction) to any medication Patient can not understand the instructions and adhere to medications Patient is a female of childbearing potential or lactating mother Prior surgery, past use of steroids (within 2 months) Severe dry eyes and use of contact lenses History of non-adherence Patients with closed angles

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: Drug: Dorzolamide/Timolol<br> | Drug: treatment with dorzolamide/timolol<br>* 24-hour IOP control with the two fixed combinations<br>|
| Active Comparator: Treatment with Brimonidine/Timolol<br> | Drug: treatment with brimonidine/timolol<br>* 24-hour pressure control with brimonidine/timolol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the quality of 24-hour IOP control after 2 months of chronic therapy with the Dorzolamide/Timolol fixed combination versus the Brimonidine/Timolol fixed combination in primary open-angle glaucoma. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess fluctuation of 24-hour 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, primary open-angle glaucoma, brimonidine/timolol, dorzolamide/timolol