Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00595101 | A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension. | PHASE2 | COMPLETED | 117 | — | — | Dec 1, 2007 | Jun 1, 2008 | Sep 14, 2020 | 13 | Japan |
| NCT00441883 | Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma | PHASE2 | COMPLETED | 176 | — | — | Mar 1, 2007 | Jul 1, 2008 | Sep 14, 2020 | 19 | United States |
Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Diurnal IOP, defined as the mean IOP over the day based on values obtained at 8 AM, 10 AM, 1 PM, and 4 PM, was calculated for each visit. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point.
| Arm | Type | Description |
|---|---|---|
| PF-03187207 High Dose and Latanoprost Vehicle | EXPERIMENTAL | A single drop of each, once daily in study eye for 28 days |
| Latanoprost 0.005% and PF-03187207 Vehicle | EXPERIMENTAL | A single drop of each, once daily in study eye for 28 days |
| PF-03187207 Medium Dose and Latanoprost Vehicle | EXPERIMENTAL | A single drop of each, once daily in study eye for 28 days |
| PF-03187207 Low Dose and Latanoprost Vehicle | EXPERIMENTAL | A single drop of each, once daily in study eye for 28 days |
| PF-03187207 and Latanoprost Vehicle | EXPERIMENTAL | One drop of each, once daily in study eye for 28 days |
| Name | Type | Description |
|---|---|---|
| PF-03187207 | DRUG | - |
| Latanoprost 0.005% | DRUG | - |
| PF-03187207 Vehicle | DRUG | One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207. |
| Latanoprost Vehicle | DRUG | - |
| PF-03187207 and Latanoprost Vehicle | DRUG | - |
| Latanoprost 0.005% and PF-03187207 Vehicle | DRUG | - |
Inclusion Criteria: * Man or woman at least 20 years of age * Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes. Exclusion Criteria: * Closed/barely open anterior chamber angle or a history of acute angle closure in either eye * Contraindications to latanoprost a...