Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
The purpose of this study is to compare the additive effect on eye pressure of Azopt and Alphagan P to Travatan.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Travatan | Drug | |||
| Azopt | Drug | |||
| Alphagan P | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Mean decrease in diurnal intraocular pressure (IOP) (mean of the three daily intraocular pressures) at month 3 visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Women
General:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert M Feldman, M.D. | Hermann Eye Fund / University of Texas | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doheny Eye Institute | Los Angeles | California | 90033-4666 | United States | ||
| The Eye Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Percent of patients reaching specific target pressures after three months of treatment. |
| 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 |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D017889 | Exfoliation Syndrome |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D007499 | Iris Diseases |
| D014603 | Uveal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069557 | Travoprost |
| C111827 | brinzolamide |
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided