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

Phase 4

Completed

Interventions: Drug: Placebo eye drops
Drug: Brinzolamide 1% ophthalmic solution (Azopt)
Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)

Brief Summary: 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.

Recruitment & Eligibility

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.

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Xalatan + Azopt	Latanoprost 0.005% ophthalmic solution (Xalatan)	Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
Xalatan + Placebo	Placebo eye drops	Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
Xalatan + Placebo	Latanoprost 0.005% ophthalmic solution (Xalatan)	Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
Xalatan + Azopt	Brinzolamide 1% ophthalmic solution (Azopt)	Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months	Day 0, 3 months	Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months	Day 0, 3 months	Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months	Day 0, 3 months	Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months	Day 0, 3 months	Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM \& 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure.