A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759941
• Other study ID #: SMA-07-08
• Status: Completed
• Phase: Phase 4
• First received: September 24, 2008
• Last updated: December 11, 2013
• Start date: October 2007
• Est. completion date: July 2009

Study information

• Verified date: July 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• Brinzolamide 1% ophthalmic solution (Azopt)
One drop three times a day in both eyes for 3 months
• Placebo eye drops
One drop three times a day in both eyes for 3 months
• Latanoprost 0.005% ophthalmic solution (Xalatan)
One drop once a day in both eyes for 3 months

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0, 3 months	No
Primary	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.	Day 0, 3 months	No
Primary	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.	Day 0, 3 months	No
Primary	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.	Day 0, 3 months	No