Phase 4
Completed N=86
A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin
Source: ClinicalTrials.gov NCT00759941 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months — -3.13; -2.57 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months |
-3.13; -2.57 | — |
| PRIMARY Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months |
-3.30; -2.48 | — |
| PRIMARY Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months |
-3.00; -2.33 | — |
| PRIMARY Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months |
-3.20; -2.48 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00759941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.