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