Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan
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|ClinicalTrials.gov Identifier: NCT00121147|
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : February 24, 2006
|Condition or disease||Intervention/treatment||Phase|
|Open Angle Glaucoma Ocular Hypertension Pseudoexfoliation Syndrome||Drug: Travatan Drug: Azopt Drug: Alphagan P||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||September 2003|
|Study Completion Date :||October 2005|
- Mean decrease in diurnal intraocular pressure (IOP) (mean of the three daily intraocular pressures) at month 3 visit
- Change in IOP from baseline at each time point
- IOP at 8AM (prior to dosing), 12 noon and 4 pm at month 3
- Percent IOP lowering from pretreatment baseline to the three month visit. Both diurnal average and at each time point
- Percent of patients reaching specific target pressures after three months of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121147
|Study Chair:||Robert M Feldman, M.D.||Hermann Eye Fund / University of Texas|