Back to resultsA Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Brinzolamide 1% ophthalmic solution (Azopt)
Placebo eye drops
Latanoprost 0.005% ophthalmic solution (Xalatan)
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma
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.
Sites / Locations
- Contact Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Xalatan + Azopt
Xalatan + Placebo
Arm Description
Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months
Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM & 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00759941
Brief Title
A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin
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 Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xalatan + Azopt
Arm Type
Experimental
Arm Description
Xalatan dosed once a day at 10 pm, with Azopt dosed three times a day at 8 AM, 2 PM, and 10:05 PM as an adjunctive therapy for 3 months.
Arm Title
Xalatan + Placebo
Arm Type
Active Comparator
Arm Description
Xalatan dosed once a day at 10 pm, with placebo dosed three times a day at 8 AM, 2 PM, and 10:05 PM concomitantly for 3 months.
Intervention Type
Drug
Intervention Name(s)
Brinzolamide 1% ophthalmic solution (Azopt)
Other Intervention Name(s)
AZOPT
Intervention Description
One drop three times a day in both eyes for 3 months
Intervention Type
Drug
Intervention Name(s)
Placebo eye drops
Intervention Description
One drop three times a day in both eyes for 3 months
Intervention Type
Drug
Intervention Name(s)
Latanoprost 0.005% ophthalmic solution (Xalatan)
Other Intervention Name(s)
Xalatan
Intervention Description
One drop once a day in both eyes for 3 months
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months
Description
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Time Frame
Day 0, 3 months
Title
Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months
Description
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Time Frame
Day 0, 3 months
Title
Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months
Description
Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.
Time Frame
Day 0, 3 months
Title
Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months
Description
Diurnal intraocular pressure is the mean of the three timepoints measured (8AM, 12PM & 4PM). Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in mean intraocular pressure.
Time Frame
Day 0, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin
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