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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Glaucoma

Intervention / Treatment
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* Drug: Brinzolamide 1% ophthalmic solution (Azopt)
* Drug: Placebo eye drops
* Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xalatan + Azopt<br>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. | Drug: Brinzolamide 1% ophthalmic solution (Azopt)<br>* One drop three times a day in both eyes for 3 months<br>* Other names: AZOPT;Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)<br>* One drop once a day in both eyes for 3 months<br>* Other names: Xalatan;|
| Active Comparator: Xalatan + Placebo<br>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. | Drug: Placebo eye drops<br>* One drop three times a day in both eyes for 3 months<br>Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)<br>* One drop once a day in both eyes for 3 months<br>* Other names: Xalatan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months | Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure. | Day 0, 3 months | 
| Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months | Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure. | Day 0, 3 months | 
| Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months | Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure. | Day 0, 3 months | 
| Mean Change From Baseline in Intraocular Pressure, Diurnal, at 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. | Day 0, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma