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
The purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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