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| Sponsor: | Hermann Eye Center |
|---|---|
| Collaborator: |
Alcon Research |
| Information provided by: | Hermann Eye Center |
| ClinicalTrials.gov Identifier: | NCT00121147 |
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: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | October 2005 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Women
General:
Contacts and 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 | |
| Hermann Eye Center | |
| Houston, Texas, United States, 77030 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Glaucoma Associates of Texas | |
| Dallas, Texas, United States, 75231 | |
| Lone Star Eye Associates | |
| Sugarland, Texas, United States, 77479 | |
| United States, West Virginia | |
| West Virginia University Eye Institute | |
| Morgantown, West Virginia, United States, 26506 | |
| Study Chair: | Robert M Feldman, M.D. | Hermann Eye Fund / University of Texas |
More Information
| Study ID Numbers: | HEF-042 |
| Study First Received: | July 13, 2005 |
| Last Updated: | February 22, 2006 |
| ClinicalTrials.gov Identifier: | NCT00121147 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
glaucoma pseudoexfoliation |
|
Neurotransmitter Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic Agonists Pathologic Processes Glaucoma Therapeutic Uses Syndrome Glaucoma, Open-Angle Cardiovascular Diseases Uveal Diseases Disease Adrenergic alpha-Agonists |
Brinzolamide Eye Diseases Vascular Diseases Exfoliation Syndrome Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Travoprost Carbonic Anhydrase Inhibitors Iris Diseases Ocular Hypertension Hypertension Brimonidine |