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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Brinzolamide; Latanoprost; Ophthalmic Solutions; Pharmaceutical Solutions

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.