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

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ClinicalTrials.gov Identifier: NCT00759941
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : August 16, 2012
Last Update Posted : January 13, 2014
Sponsor:
Information provided by (Responsible Party):

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.

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2007
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months [ Time Frame: Day 0, 3 months ]
    Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.

  2. Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months [ Time Frame: Day 0, 3 months ]
    Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.

  3. Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months [ Time Frame: Day 0, 3 months ]
    Intraocular pressure was measured by Goldmann applanation tonometry. A negative number indicated a reduction in intraocular pressure.

  4. Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months [ Time Frame: Day 0, 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.


Eligibility Criteria

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00759941     History of Changes
Other Study ID Numbers: SMA-07-08
First Posted: September 25, 2008    Key Record Dates
Results First Posted: August 16, 2012
Last Update Posted: January 13, 2014
Last Verified: July 2012

Keywords provided by Alcon Research:
Glaucoma

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