Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan

February 22, 2006 updated by: Hermann Eye Center

A Comparison of the Additivity of Brinzolamide Ophthalmic Suspension, 1% (Azopt) and Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan P) to Travoprost Ophthalmic Solution, 0.004% (Travatan) in Patients With Elevated IOP on Travoprost. A Three Month Double-Masked, Multi-Center Trial in the United States

The purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research study is to compare the effect on the pressure inside the eye when Brinzolamide Ophthalmic Suspension, 1% (Azopt), a carbonic anhydrase inhibitor, and Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan-P), an alpha 2 agonist, are added to Travoprost Ophthalmic Solution, 0.004% (Travatan), a prostaglandin, in patients with primary open angle glaucoma, ocular hypertension and pseudoexfoliation syndrome. Brinzolamide Ophthalmic Suspension, 1% (Azopt), Brimonidine Tartrate Ophthalmic Solution, 0.15% (Alphagan-P), and Travoprost Ophthalmic Solution, 0.004% (Travatan) are all currently approved by the FDA and on the market, being used by patients. Even though all three medications are currently approved for the purpose of the study they will be considered study medicines.

Glaucoma, Ocular Hypertension and Pseudoexfoliation syndrome have been treated with IOP-lowering medications or surgery to lower the pressure inside the eye to reduce the risk of visual field loss. Today, common treatments for a patient often begins with the prescription of a prostaglandin (Travoprost). If the prostaglandin does not lower the pressure inside the eye enough, a second drug is usually added. Topical carbonic anhydrase inhibitors (Brinzolamide) and alpha 2 agonists (Brimonidine) are common choices as additive medicines.

Study Type

Interventional

Enrollment

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033-4666
        • Doheny Eye Institute
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • The Eye Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Healthcare Eye Center
      • Atlanta, Georgia, United States, 30342
        • Omni Eye Services
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • University of Illinois Eye and Ear Infirmary
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Glaucoma Consultation Service
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Kresge Eye Institute
    • Mississippi
      • Ocean Springs, Mississippi, United States, 39564
        • Mississippi Eye Associates
    • New York
      • Bethpage, New York, United States, 11714
        • Eyecare Ophthalmology PC
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Dean McGee Eye Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Wills Eye Institute
      • Philadelphia, Pennsylvania, United States, 19114
        • The Keystone Eye Associates
    • Texas
      • Dallas, Texas, United States, 75231
        • Glaucoma Associates of Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Hermann Eye Center
      • Sugarland, Texas, United States, 77479
        • Lone Star Eye Associates
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Minimum age: 35 years
  • Uni or bilateral primary open angle glaucoma, ocular hypertension or pseudoexfoliation syndrome (POAG is defined as having VF and optic nerve changes consistent with glaucomatous disease)
  • Insufficient response to monotherapy: defined as IOP > 18mm Hg (mean diurnal) and less than 32 mm Hg on Travatan at baseline
  • Informed consent and HIPPA consent obtained at screening visit prior to any study events
  • Ability to adhere to study treatment visit plan

Exclusion Criteria:

  • Closed, occluded, or potentially occludable angle
  • History of angle closure
  • 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, alpha agonists 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)
  • Use of systemic medications known to effect IOP (e.g. Alpha agonists, Beta blockers, Ace inhibitors and angiotensin II receptor blockers) which have not been stable for three months prior to baseline and the dosage is not expected to change during the course of the study

Women

  • Pregnancy (study medications have been determined to cause possible harm to the fetus)
  • Women of childbearing potential who are not using contraceptive methods. Childbearing potential is defined as any woman who is not postmenopausal (12 months without a menstrual period) or surgically sterile. Contraceptive methods are defined as abstinence, having a vasectomized partner, or ongoing use of approved oral, injectable, topical or implanted contraceptives, a barrier method or an IUD

General:

  • Use of any investigational medication within one month prior to baseline visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mean decrease in diurnal intraocular pressure (IOP) (mean of the three daily intraocular pressures) at month 3 visit

Secondary Outcome Measures

Outcome Measure
Change in IOP from baseline at each time point
IOP at 8AM (prior to dosing), 12 noon and 4 pm at month 3
Percent IOP lowering from pretreatment baseline to the three month visit. Both diurnal average and at each time point
Percent of patients reaching specific target pressures after three months of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hermann Eye Center

Collaborators

Alcon Research

Investigators

  • Study Chair: Robert M Feldman, M.D., Hermann Eye Fund / University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Completion

October 1, 2005

Study Registration Dates

First Submitted

July 13, 2005

First Submitted That Met QC Criteria

July 19, 2005

First Posted (Estimate)

July 21, 2005

Study Record Updates

Last Update Posted (Estimate)

February 24, 2006

Last Update Submitted That Met QC Criteria

February 22, 2006

Last Verified

July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEF-042

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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