Status:
COMPLETED
A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin
Lead Sponsor:
Alcon Research
Conditions:
Glaucoma
Eligibility:
All Genders
35+ years
Phase:
PHASE4
Brief 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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00759941
Start Date
October 1 2007
End Date
July 1 2009
Last Update
January 13 2014
Active Locations (1)
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1
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134