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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Drug: Brinzolamide 1% ophthalmic solution (Azopt); Drug: Latanoprost 0.005% ophthalmic solution (Xalatan); Drug: Placebo eye drops

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: September 24, 2008
• First Submitted That Met QC Criteria: September 24, 2008
• First Posted (Estimate): September 25, 2008

Study Record Updates

• Last Update Posted (Estimate): January 13, 2014
• Last Update Submitted That Met QC Criteria: December 11, 2013
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Ophthalmic Solutions; Pharmaceutical Solutions; Brinzolamide; Latanoprost
• Other Study ID Numbers: SMA-07-08