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PhXA41 is not inferior to timolol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Timolol | Active Comparator |
| |
| PhXA41 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PhXA41 | Drug | One drop in the affected eye once daily for six months. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment. | 6 mos |
| Measure | Description | Time Frame |
|---|---|---|
| to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups. | 6 mos |
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Inclusion Criteria:
Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
IOP of 22mmHg or higher obtained during the pre-study period.
Patients currently not treated or on single-drug treatment for the elevated IOP are eligible after a medication free period (wash-out) of:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | La Jolla | California | 92093-0946 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19427617 | Derived | Varma R, Hwang LJ, Grunden JW, Bean GW, Sultan MB. Assessing the efficacy of latanoprost vs timolol using an alternate efficacy parameter: the intervisit intraocular pressure range. Am J Ophthalmol. 2009 Aug;148(2):221-6. doi: 10.1016/j.ajo.2009.02.035. Epub 2009 May 9. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| timolol |
| Drug |
One drop in the affected eye twice daily for six months. |
|
| Los Angeles |
| California |
| 90033 |
| United States |
| Pfizer Investigational Site | Gainesville | Florida | 32610 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60611 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60612 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40292 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21209 | United States |
| Pfizer Investigational Site | Ann Arbor | Michigan | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110 | United States |
| Pfizer Investigational Site | Omaha | Nebraska | 68105 | United States |
| Pfizer Investigational Site | River Edge | New Jersey | 07661-1931 | United States |
| Pfizer Investigational Site | New York | New York | 10003 | United States |
| Pfizer Investigational Site | New York | New York | 10029 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97210-3049 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19107-5599 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29425-0001 | United States |
| Pfizer Investigational Site | Madison | Wisconsin | 53705-3611 | United States |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| D013999 | Timolol |
| ID | Term |
|---|---|
| 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 |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
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