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Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan

Ocular Hypertension Clinical Trial

Official title:
A Comparison of the Additivity of Brinzolamide Ophthalmic Suspension, 1% (Azopt) and Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan P) to Travoprost Ophthalmic Solution, 0.004% (Travatan) in Patients With Elevated IOP on Travoprost. A Three Month Double-Masked, Multi-Center Trial in the United States

Clinical Trial Summary

The purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan.

Clinical Trial Description

The purpose of this research study is to compare the effect on the pressure inside the eye when Brinzolamide Ophthalmic Suspension, 1% (Azopt), a carbonic anhydrase inhibitor, and Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan-P), an alpha 2 agonist, are added to Travoprost Ophthalmic Solution, 0.004% (Travatan), a prostaglandin, in patients with primary open angle glaucoma, ocular hypertension and pseudoexfoliation syndrome. Brinzolamide Ophthalmic Suspension, 1% (Azopt), Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan-P), and Travoprost Ophthalmic Solution, 0.004% (Travatan) are all currently approved by the FDA and on the market, being used by patients. Even though all three medications are currently approved for the purpose of the study they will be considered study medicines.

Glaucoma, Ocular Hypertension and Pseudoexfoliation syndrome have been treated with IOP-lowering medications or surgery to lower the pressure inside the eye to reduce the risk of visual field loss. Today, common treatments for a patient often begins with the prescription of a prostaglandin (Travoprost). If the prostaglandin does not lower the pressure inside the eye enough, a second drug is usually added. Topical carbonic anhydrase inhibitors (Brinzolamide) and alpha 2 agonists (Brimonidine) are common choices as additive medicines. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00121147
Study type Interventional
Source Hermann Eye Center
Contact
Status Completed
Phase N/A
Start date September 2003
Completion date October 2005
View Details
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