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| ID | Type | Description | Link |
|---|---|---|---|
| A6641006 |
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Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed combination of latanoprost 0.005% and timolol 0.5% | Experimental |
| |
| latanoprost 0.005% | Active Comparator |
| |
| Timolol - 0.5% | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| latanoprost 0.005% | Drug | placebo in the morning and latanoprost .005% in the evening |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups. | 6 months | |
| Primary objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all effect from baseline between the monotherapies latanoprost and timolol | 6 months | |
| To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26 |
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Inclusion Criteria:
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 | Anaheim | California | 92801 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| fixed combination latanoprost-timolol |
| Drug |
one drop in the morning and placebo in the evening |
|
| timolol 0.5% | Drug | one drop in the morning and evening |
|
| 6 months |
| To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups | 6 months |
| To describe the IOP development from baseline to Week 26 for all treatment groups | 6 months |
| To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination | 6 months |
| To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52 | 6 months |
| To follow the safety variables throughout the study periods. | 6 months |
| Anaheim |
| California |
| 92807 |
| United States |
| Pfizer Investigational Site | Sacramento | California | 95819 | United States |
| Pfizer Investigational Site | Sacramento | California | 95823 | United States |
| Pfizer Investigational Site | San Francisco | California | 94115 | United States |
| Pfizer Investigational Site | Boulder | Colorado | 80304-3573 | United States |
| Pfizer Investigational Site | Denver | Colorado | 80210 | United States |
| Pfizer Investigational Site | Largo | Florida | 34640 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33613 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30322 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30342 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30349 | United States |
| Pfizer Investigational Site | East Point | Georgia | 30223 | United States |
| Pfizer Investigational Site | Griffin | Georgia | 30223 | United States |
| Pfizer Investigational Site | Morrow | Georgia | 30260 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60612 | United States |
| Pfizer Investigational Site | Wheaton | Illinois | 60187 | United States |
| Pfizer Investigational Site | Elkhart | Indiana | 46515 | United States |
| Pfizer Investigational Site | Mishawaka | Indiana | 46545 | United States |
| Pfizer Investigational Site | South Bend | Indiana | 46601 | United States |
| Pfizer Investigational Site | South Bend | Indiana | 46617 | United States |
| Pfizer Investigational Site | Iowa City | Iowa | 52245 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40207 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21201 | United States |
| Pfizer Investigational Site | Owings Mills | Maryland | 21117 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02111 | United States |
| Pfizer Investigational Site | Golden Valley | Minnesota | 55422 | United States |
| Pfizer Investigational Site | Minneapolis | Minnesota | 55421 | United States |
| Pfizer Investigational Site | Kansas City | Missouri | 64111 | United States |
| Pfizer Investigational Site | Kansas City | Missouri | 64114 | United States |
| Pfizer Investigational Site | Warrensburg | Missouri | 64093 | United States |
| Pfizer Investigational Site | Concord | New Hampshire | 03301 | United States |
| Pfizer Investigational Site | South Plainfield | New Jersey | 07080 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28204 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28210 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28260 | United States |
| Pfizer Investigational Site | Matthews | North Carolina | 28105 | United States |
| Pfizer Investigational Site | Monroe | North Carolina | 28112 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97201 | United States |
| Pfizer Investigational Site | Portland | Oregon | 97210 | United States |
| Pfizer Investigational Site | Wyomissing | Pennsylvania | 19610 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29412 | United States |
| Pfizer Investigational Site | Mt. Pleasant | South Carolina | 29464-3245 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38119 | United States |
| Pfizer Investigational Site | Austin | Texas | 78731-4941 | United States |
| Pfizer Investigational Site | Galveston | Texas | 77555-1141 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | Charlottesville | Virginia | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23219 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23235 | United States |
| Pfizer Investigational Site | Tacoma | Washington | 98431 | United States |
| Pfizer Investigational Site | Madison | Wisconsin | 53705 | United States |
| Pfizer Investigational Site | Madison | Wisconsin | 53715 | United States |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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