Status:
COMPLETED
Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan
Lead Sponsor:
Hermann Eye Center
Collaborating Sponsors:
Alcon Research
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
35+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan.
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00121147
Start Date
September 1 2003
End Date
October 1 2005
Last Update
February 24 2006
Active Locations (21)
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1
Doheny Eye Institute
Los Angeles, California, United States, 90033-4666
2
The Eye Center
Hamden, Connecticut, United States, 06518
3
University of Florida
Gainesville, Florida, United States, 32610
4
Emory Healthcare Eye Center
Atlanta, Georgia, United States, 30322