A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin

A Comparison of Brinzolamide Ophthalmic Suspension, 1% (Azopt) TID vs. Placebo TID Added to Latanoprost Ophthalmic Solution, 0.005% (Xalatan) in Patients With Elevated IOP on a Prostaglandin

The purpose of this study was to assess the efficacy of adding Azopt dosed three times a day to Xalatan as compared to that of adding placebo to Xalatan in patients with elevated intraocular pressure.

Inclusion Criteria:

• Unilateral or bilateral primary open angle glaucoma, ocular hypertension or pseudoexfoliation syndrome.
• Intraocular pressure greater than 18 mmHg (mean diurnal) and less than 32 mmHg.
• Other protocol-defined inclusion criteria applied.

Exclusion:

• 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, 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).
• Other protocol-defined exclusion criteria applied.