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

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma

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

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research


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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months

Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months

Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months

Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months


Minimum age: 35 Years. Maximum age: N/A. Gender(s): Both.


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.


- 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


- 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.

Locations and Contacts

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

Starting date: October 2007
Last updated: December 11, 2013

Page last updated: August 23, 2015

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