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 is an investigational small molecule being studied for the treatment of Primary Open-Angle Glaucoma and Ocular Hypertension. It is administered to lower elevated eye pressure in patients with these conditions. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
PF-04217329 is being developed by Pfizer, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for ophthalmic use.
PF-04217329 is in Phase 2 clinical development. It has completed one Phase 2 trial, which was a randomized, double-blind, controlled study. The drug remains investigational and has not received FDA approval for any indication.
PF-04217329 has been studied in one completed clinical trial, identified as NCT00572455. This Phase 2 study evaluated the safety and efficacy of the drug in patients with glaucoma or elevated eye pressure. The trial enrolled 318 participants in the United States and included adults aged 18 years and older.
PF-04217329 is a distinct investigational compound developed by Pfizer. It is not known to be the same as any other marketed glaucoma medication. Its mechanism of action and chemical structure are specific to this drug candidate, which is being evaluated for its ability to reduce intraocular pressure.