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PF-04217329 - Lowest Dose

Phase 2

Primary Open-Angle Glaucoma | Small molecule | Cardiovascular |Pfizer, Inc.|Last Updated: Apr 30, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment318
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00572455Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.PHASE2 COMPLETED 318Dec 11, 2007Jun 26, 2009Apr 30, 202123 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I
Stage I: Baseline, 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 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.

Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II
Stage II: Baseline, Day 28

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.

Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I
Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 days)

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.

Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II
Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days)

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.

Secondary Endpoints
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I
Stage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I
Stage I: 8 AM, 10 AM, 1 PM, 4 PM on Day 0 (Baseline), 8 AM on Day 1, 8 AM, 10 AM, 1 PM, 4 PM on Day 7, and 14
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II
Stage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Stage 1: PF-04217329 - Lowest DoseEXPERIMENTAL -
Stage 1: PF-04217329 - Low DoseEXPERIMENTAL -
Stage 1: PF-04217329 - Middle DoseEXPERIMENTAL -
Stage 1: PF-04217329 - High Middle DoseEXPERIMENTAL -
Stage 1: PF-04217329 - High DoseEXPERIMENTAL -
Stage 1: PF-02417329 - Highest DoseEXPERIMENTAL -
Stage 1: PF-04217329 - VehicleEXPERIMENTAL -
Stage 2: PF-04217329 - Low Dose + Latanoprost VehicleEXPERIMENTAL -
Stage 2: PF-04217329 - Middle Dose + Latanoprost VehicleEXPERIMENTAL -
Stage 2: PF-04217329 - High Dose + Latanoprost VehicleEXPERIMENTAL -
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 -
Interventions
NameTypeDescription
PF-04217329 - Lowest DoseDRUG1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.
PF-04217329 - Low DoseDRUG1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
PF-04217329 - Middle DoseDRUG1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
PF-04217329 - High Middle DoseDRUG1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.
PF-04217329 - High DoseDRUG1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
PF-4217329 - Highest DoseDRUG1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.
PF-04217329 - VehicleDRUG1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
Latanoprost VehicleDRUG1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
Latanoprost 0.005%DRUG1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites23

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...

Countries:United States
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