Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-04217329- Lowest Dose · 1 trial · 2 indications
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 14.
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 28.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
| Arm | Type | Description |
|---|---|---|
| Stage 1: PF-04217329 - Lowest Dose | EXPERIMENTAL | - |
| Stage 1: PF-04217329 - Low Dose | EXPERIMENTAL | - |
| Stage 1: PF-04217329 - Middle Dose | EXPERIMENTAL | - |
| Stage 1: PF-04217329 - High Middle Dose | EXPERIMENTAL | - |
| Stage 1: PF-04217329 - High Dose | EXPERIMENTAL | - |
| Stage 1: PF-02417329 - Highest Dose | EXPERIMENTAL | - |
| Stage 1: PF-04217329 - Vehicle | EXPERIMENTAL | - |
| Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle | EXPERIMENTAL | - |
| Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle | EXPERIMENTAL | - |
| Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle | EXPERIMENTAL | - |
| Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005% | EXPERIMENTAL | - |
| Stage 2: PF-04217329 - Middle Dose + Latanoprost 0.005% | EXPERIMENTAL | - |
| Stage 2: PF-04217329 - High Dose + Latanoprost 0.005% | EXPERIMENTAL | - |
| Stage 2: PF-04217329 - Vehicle + Latanoprost 0.005% | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-04217329 - Lowest Dose | DRUG | 1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study. |
| PF-04217329 - Low Dose | DRUG | 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study. |
| PF-04217329 - Middle Dose | DRUG | 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study. |
| PF-04217329 - High Middle Dose | DRUG | 1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study. |
| PF-04217329 - High Dose | DRUG | 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study. |
| PF-4217329 - Highest Dose | DRUG | 1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study. |
| PF-04217329 - Vehicle | DRUG | 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study. |
| Latanoprost Vehicle | DRUG | 1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study. |
| Latanoprost 0.005% | DRUG | 1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study. |
Inclusion Criteria: * Diagnosis of primary open-angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in 1 or both eyes. * Qualifying intraocular pressure (IOP) in the same eye at the Eligibility 1 and 2 measurements. Exclusion Criteria: * Closed/barely open anterior c...
PF-04217329- Lowest Dose is an investigational small molecule developed by Pfizer, Inc. (PFE) for ophthalmology. It was studied in a Phase 2 clinical trial for Primary Open-Angle Glaucoma and ocular hypertension. It is not an approved product and remains in clinical development.
PF-04217329- Lowest Dose was studied for Primary Open-Angle Glaucoma, a form of glaucoma, and for ocular hypertension, which is elevated eye pressure. The Phase 2 trial enrolled patients with these conditions. It is investigational and has not been approved for any use.
PF-04217329- Lowest Dose is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored the Phase 2 study of the drug in patients with glaucoma or elevated eye pressure in the United States.
PF-04217329- Lowest Dose is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved by the FDA for Primary Open-Angle Glaucoma or any other indication.
PF-04217329- Lowest Dose was evaluated in the Phase 2 trial NCT00572455, titled Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure. The trial enrolled 318 patients, was randomized, double-blind, and controlled, and has been completed.
Yes, PF-04217329- Lowest Dose and PF-04217329 - Lowest Dose refer to the same investigational Pfizer compound. The two spellings differ only in punctuation around the dose designation. Both names describe the lowest-dose arm of the PF-04217329 program studied in the Phase 2 glaucoma trial.