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

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by:
Hermann Eye Center
ClinicalTrials.gov Identifier:
NCT00121147
First received: July 13, 2005
Last updated: February 22, 2006
Last verified: July 2005
  Purpose

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


Condition Intervention
Open Angle Glaucoma
Ocular Hypertension
Pseudoexfoliation Syndrome
Drug: Travatan
Drug: Azopt
Drug: Alphagan P

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hermann Eye Center:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 200
Study Start Date: September 2003
Estimated Study Completion Date: October 2005
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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00121147

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

No publications provided

ClinicalTrials.gov Identifier: NCT00121147     History of Changes
Other Study ID Numbers: HEF-042
Study First Received: July 13, 2005
Last Updated: February 22, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Hermann Eye Center:
glaucoma
pseudoexfoliation

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Exfoliation Syndrome
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Iris Diseases
Uveal Diseases
Ophthalmic Solutions
Brimonidine
Travoprost
Brinzolamide
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014