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

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.

Inclusion Criteria:

• Minimum age: 35 years
• Uni or bilateral primary open angle glaucoma, ocular hypertension or pseudoexfoliation syndrome (POAG is defined as having VF and optic nerve changes consistent with glaucomatous disease)
• Insufficient response to monotherapy: defined as IOP > 18mm Hg (mean diurnal) and less than 32 mm Hg on Travatan at baseline
• Informed consent and HIPPA consent obtained at screening visit prior to any study events
• Ability to adhere to study treatment visit plan

Exclusion Criteria:

• Closed, occluded, or potentially occludable angle
• History of angle closure
• Previous intraocular surgery, except uncomplicated clear cornea phacoemulsification or argon laser trabeculoplasty
• Argon laser trabeculoplasty or phacoemulsification within the last 3 months
• Central corneal thickness outside the 500 - 600 (inclusive) micron range as measured by ultrasonic pachymetry
• Ocular or periocular inflammation within 3 months prior to study (except blepharitis related or seasonal allergic conjunctivitis)
• History of uveitis or previous intraocular inflammation (other than post-operatively)
• Hypersensitivity to sulfa, alpha agonists or benzalkonium chloride
• History of use of any steroids for over 1 week within 3 months of screening or likely need for any corticosteroids during the study (except inhaled, nasal or topical non-ocular)
• Use of systemic medications known to effect IOP (e.g. Alpha agonists, Beta blockers, Ace inhibitors and angiotensin II receptor blockers) which have not been stable for three months prior to baseline and the dosage is not expected to change during the course of the study

Women

• Pregnancy (study medications have been determined to cause possible harm to the fetus)
• Women of childbearing potential who are not using contraceptive methods. Childbearing potential is defined as any woman who is not postmenopausal (12 months without a menstrual period) or surgically sterile. Contraceptive methods are defined as abstinence, having a vasectomized partner, or ongoing use of approved oral, injectable, topical or implanted contraceptives, a barrier method or an IUD

General:

• Use of any investigational medication within one month prior to baseline visit