Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan
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
1 other identifier
interventional
200
1 country
21
Brief Summary
The purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2003
Typical duration for not_applicable
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 13, 2005
CompletedFirst Posted
Study publicly available on registry
July 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedFebruary 24, 2006
July 1, 2005
July 13, 2005
February 22, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean decrease in diurnal intraocular pressure (IOP) (mean of the three daily intraocular pressures) at month 3 visit
Secondary Outcomes (4)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hermann Eye Centerlead
- Alcon Researchcollaborator
Study Sites (21)
Doheny Eye Institute
Los Angeles, California, 90033-4666, United States
The Eye Center
Hamden, Connecticut, 06518, United States
University of Florida
Gainesville, Florida, 32610, United States
Emory Healthcare Eye Center
Atlanta, Georgia, 30322, United States
Omni Eye Services
Atlanta, Georgia, 30342, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Illinois Eye and Ear Infirmary
Chicago, Illinois, 60612, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Glaucoma Consultation Service
Boston, Massachusetts, 02114, United States
Kresge Eye Institute
Detroit, Michigan, 48201, United States
Mississippi Eye Associates
Ocean Springs, Mississippi, 39564, United States
Eyecare Ophthalmology PC
Bethpage, New York, 11714, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
Wills Eye Institute
Philadelphia, Pennsylvania, 19107, United States
The Keystone Eye Associates
Philadelphia, Pennsylvania, 19114, United States
Glaucoma Associates of Texas
Dallas, Texas, 75231, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Hermann Eye Center
Houston, Texas, 77030, United States
Lone Star Eye Associates
Sugarland, Texas, 77479, United States
West Virginia University Eye Institute
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert M Feldman, M.D.
Hermann Eye Fund / University of Texas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 13, 2005
First Posted
July 21, 2005
Study Start
September 1, 2003
Study Completion
October 1, 2005
Last Updated
February 24, 2006
Record last verified: 2005-07