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

Completed · Not applicable

Conditions studied: Open Angle Glaucoma, Ocular Hypertension, Pseudoexfoliation Syndrome

In brief

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

Key facts

Study ID

NCT00121147

Run by

Hermann Eye Center

People needed

200

Starts

2003-09-01

Expected to finish

2005-10-01

Last updated by the study team

2006-02-24

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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