Viewing Study NCT00121147



Ignite Creation Date: 2024-05-05 @ 11:45 AM
Last Modification Date: 2024-10-26 @ 9:12 AM
Study NCT ID: NCT00121147
Status: COMPLETED
Last Update Posted: 2006-02-24
First Post: 2005-07-13

Brief Title: Additivity Study Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan
Sponsor: Hermann Eye Center
Organization: Hermann Eye Center

Study Overview

Official Title: A Comparison of the Additivity of Brinzolamide Ophthalmic Suspension 1 Azopt and Brimonidine Tartrate Ophthalmic Solution 015 Alphagan P to Travoprost Ophthalmic Solution 0004 Travatan in Patients With Elevated IOP on Travoprost A Three Month Double-Masked Multi-Center Trial in the United States
Status: COMPLETED
Status Verified Date: 2005-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 015 Alphagan-P an alpha 2 agonist are added to Travoprost Ophthalmic Solution 0004 Travatan a prostaglandin in patients with primary open angle glaucoma ocular hypertension and pseudoexfoliation syndrome Brinzolamide Ophthalmic Suspension 1 Azopt Brimonidine Tartrate Ophthalmic Solution 015 Alphagan-P and Travoprost Ophthalmic Solution 0004 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None