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

Alcon

Status and phase: Completed; Phase 4

Conditions: Glaucoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00759941

SMA-07-08

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

Xalatan + Azopt

Experimental group

Description:

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.

Treatment:

Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)

Drug: Brinzolamide 1% ophthalmic solution (Azopt)

Xalatan + Placebo

Active Comparator group

Description:

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.

Treatment:

Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)

Drug: Placebo eye drops