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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00759941
First received: September 24, 2008
Last updated: December 11, 2013
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Glaucoma
Drug: Brinzolamide 1% ophthalmic solution (Azopt)
Drug: Placebo eye drops
Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months [ Time Frame: Day 0, 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0, 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0, 3 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 0, 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 86
Study Start Date: October 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Xalatan + Azopt
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.
Drug: Brinzolamide 1% ophthalmic solution (Azopt)
One drop three times a day in both eyes for 3 months
Other Name: AZOPT
Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)
One drop once a day in both eyes for 3 months
Other Name: Xalatan
Active Comparator: Xalatan + Placebo
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.
Drug: Placebo eye drops
One drop three times a day in both eyes for 3 months
Drug: Latanoprost 0.005% ophthalmic solution (Xalatan)
One drop once a day in both eyes for 3 months
Other Name: Xalatan

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759941

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00759941     History of Changes
Other Study ID Numbers: SMA-07-08
Study First Received: September 24, 2008
Results First Received: July 12, 2012
Last Updated: December 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Latanoprost
Brinzolamide
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014