A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin
Completed · Phase 4 · Has a placebo group
Conditions studied: Glaucoma
In brief
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.
Key facts
- Study ID
- NCT00759941
- Run by
- Alcon Research
- People needed
- 86
- Starts
- 2007-10-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2014-01-13
Who can join
Age: 35 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
Where it is running
- Contact Alcon Call Center for Trial Locations — Fort Worth, Texas, United States
Full record on ClinicalTrials.gov
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