NCT00121147

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (planned)
• Sponsor: Hermann Eye Center · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Open Angle Glaucoma
• Ocular Hypertension
• Pseudoexfoliation Syndrome

Interventions

Type	Name	Description
DRUG	Travatan
DRUG	Azopt
DRUG	Alphagan P

Timeline

• Start date: 2003-09-01
• Completion: 2005-10-01
• First posted: 2005-07-21
• Last updated: 2006-02-24

Locations

21 sites across 1 country: United States