Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan
NCT ID: NCT00121147
Last Updated: 2006-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2003-09-30
2005-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Travatan
Azopt
Alphagan P
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
ALL
Yes
Sponsors
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Alcon Research
INDUSTRY
Hermann Eye Center
OTHER
Principal Investigators
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Robert M Feldman, M.D.
Role: STUDY_CHAIR
Hermann Eye Fund / University of Texas
Locations
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Doheny Eye Institute
Los Angeles, California, United States
The Eye Center
Hamden, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Emory Healthcare Eye Center
Atlanta, Georgia, United States
Omni Eye Services
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Illinois Eye and Ear Infirmary
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Glaucoma Consultation Service
Boston, Massachusetts, United States
Kresge Eye Institute
Detroit, Michigan, United States
Mississippi Eye Associates
Ocean Springs, Mississippi, United States
Eyecare Ophthalmology PC
Bethpage, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, United States
Wills Eye Institute
Philadelphia, Pennsylvania, United States
The Keystone Eye Associates
Philadelphia, Pennsylvania, United States
Glaucoma Associates of Texas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Hermann Eye Center
Houston, Texas, United States
Lone Star Eye Associates
Sugarland, Texas, United States
West Virginia University Eye Institute
Morgantown, West Virginia, United States
Countries
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Other Identifiers
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HEF-042
Identifier Type: -
Identifier Source: org_study_id