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A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329

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ClinicalTrials.gov Identifier: NCT00934089
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : May 3, 2021
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 6, 2009
First Posted Date  ICMJE July 8, 2009
Results First Submitted Date  ICMJE April 6, 2021
Results First Posted Date  ICMJE May 3, 2021
Last Update Posted Date May 3, 2021
Study Start Date  ICMJE January 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2021)
  • Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour) [ Time Frame: 8 AM on Baseline (Day -8), 8 AM on Day 14 (0 Hour) ]
    IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 14.
  • Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours) [ Time Frame: 10 AM on Baseline (Day -8), 10 AM on Day 14 (2 Hours) ]
    IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury, 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 10 AM on Day -8 as baseline for 10 AM value on Day 14.
  • Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (4 Hours) [ Time Frame: 12 PM on Baseline (Day -8), 12 PM on Day 14 (4 Hours) ]
    IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 12 PM on Day -8 as baseline for 12 PM value on Day 14.
  • Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 2 PM (6 Hours) [ Time Frame: 2 PM on Baseline (Day -8), 2 PM on Day 14 (6 Hours) ]
    IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 2 PM on Day -8 as baseline for 2 PM value on Day 14.
  • Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 4 PM (8 Hours) [ Time Frame: 4 PM on Baseline (Day -8), 4 PM on Day 14 (8 Hours) ]
    IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 4 PM on Day -8 as baseline for 4 PM value on Day 14.
  • Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 6 PM (10 Hours) [ Time Frame: 6 PM on Baseline (Day -8), 6 PM on Day 14 (10 Hours) ]
    IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 6 PM on Day -8 as baseline for 6 PM value on Day 14.
  • Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 PM (12 Hours) [ Time Frame: 8 PM on Baseline (Day -8), 8 PM on Day 14 (12 Hours) ]
    IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both the eyes, and eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 PM on Day -8 as baseline for 8 PM value on Day 14.
  • Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 PM (14 Hours) [ Time Frame: 10 PM on Day -8 (Baseline), 10 PM on Day 14 (14 Hours) ]
    IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 10 PM on Day -8 as baseline for 10 PM value on Day 14.
  • Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 12 AM (16 Hours) [ Time Frame: 12 AM on Baseline (Day -7), 12 AM on Day 15 (16 Hours) ]
    IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 12 AM on Day -7 as baseline for 12 AM value on Day 15.
  • Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 4 AM (20 Hours) [ Time Frame: 4 AM on Baseline (Day -7), 4 AM on Day 15 (20 Hours) ]
    IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 4 AM on Day -7 as baseline for 4 AM value on Day 15.
  • Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 6 AM (22 Hours) [ Time Frame: 6 AM on Baseline (Day -7), 6 AM on Day 15 (22 Hours) ]
    IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as the IOP at that time point. If 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 6 AM on Day -7 as baseline for 6 AM value on Day 15.
  • Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 8 AM (24 Hours) [ Time Frame: 8 AM on Baseline (Day -7), 8 AM on Day 15 (24 Hours) ]
    IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -7 as baseline for 8 AM value on Day 15.
  • Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 16: 8 AM (48 Hours) [ Time Frame: 8 AM on Baseline (Day -8), 8 AM on Day 16 (48 Hours) ]
    IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit and Day 16. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 16.
  • Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 17: 8 AM (72 Hours) [ Time Frame: 8 AM on Baseline (Day -8), 8 AM on Day 17 (72 Hours) ]
    IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit and Day 17. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 17.
  • Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 21: 8 AM (168 Hours) [ Time Frame: 8 AM on Day -8 (Baseline), 8 AM on Day 21 (168 Hours) ]
    IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit and Day 21. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 21.
  • Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 5 Minutes on Day 14 [ Time Frame: 5 minutes post-dose on Day 14 ]
  • Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.25 Hours on Day 14 [ Time Frame: 0.25 hours post-dose on Day 14 ]
  • Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.5 Hours on Day 14 [ Time Frame: 0.5 hours post-dose on Day 14 ]
  • Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.75 Hours on Day 14 [ Time Frame: 0.75 hours post-dose on Day 14 ]
  • Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 1 Hour on Day 14 [ Time Frame: 1 hour post-dose on Day 14 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2009)
  • Intraocular pressure (IOP) change from baseline [ Time Frame: 14 days ]
  • Plasma concentrations of the active metabolite of PF-04217329 [ Time Frame: 7 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2021)
  • Diastolic Ocular Perfusion Pressure (DOPP) [ Time Frame: 8 AM, 10 AM, 12 PM, 2 PM, 4 PM, 6 PM, 8 PM, 10 PM on Day 14; 12 AM, 4 AM, 6 AM, 8 AM on Day 15 ]
    DOPP = diastolic blood pressure minus IOP of the study eye. IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit and Day 15. IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye.
  • Change From Baseline in Diastolic Ocular Perfusion Pressure (DOPP) at Day 14 (8 AM, 10 AM, 12 PM, 2 PM, 4 PM, 6 PM, 8 PM, 10 PM) and Day 15 (12 AM, 2 AM, 4 AM, 6 AM and 8 AM) [ Time Frame: 8 AM, 10 AM, 12 PM, 2 PM, 4 PM, 6 PM, 8 PM, and 10 PM on Day -8 (Baseline), Day 14; 12 AM, 4 AM, 6 AM, 8 AM on Day -7 (Baseline), Day 15 ]
    DOPP=diastolic blood pressure minus IOP of the study eye. IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. Change at various post-dose time points on Day 14 and Day 15 was calculated from the values at same time points on Day -8 and Day -7 respectively (for example, value at 8 AM on Day -8 was used as baseline value for 8 AM value on Day 14 and value at 8 AM on Day -7 was used as baseline value for 8 AM value on Day 15).
  • Number of Participants With Ocular and Systemic Adverse Events (AEs) [ Time Frame: Baseline up to 28 days after last dose of study medication (up to 58 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. Number of participants with ocular (AE related to eye) and systemic (all AEs including eye) AEs were reported.
  • Percentage of Participants With Photophobia and Iritis [ Time Frame: Baseline up to 28 days after last dose of study medication (up to 58 Days) ]
    Percentage of participants with treatment emergent photophobia (abnormal sensitivity or intolerance of eye towards light) and iritis (inflammation of the iris of eye) were reported. 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.
  • Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 [ Time Frame: 8 AM on Day 1 (Baseline), Days 7, 13, 16, 21, 28, 35 ]
    Corneal thickness was measured using an ultrasonic pachymeter. Corneal thickness in both study eye and fellow eye were reported. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.
  • Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35 [ Time Frame: 8 AM on Day 1 (Baseline), Day 13, 35 ]
    Endothelial cell count was defined as the number of cells per millimeter square (cells/mm^2) of endothelium and was calculated using confocal microscopy for both study eye and fellow eye. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2009)
  • Diastolic ocular perfusion pressure and mean change from baseline [ Time Frame: 14 days ]
  • Ocular (visual acuity, conjunctival hyperemia, and biomicroscopy) and systemic (blood pressure, clinical labs) safety assessments. [ Time Frame: 14 days ]
Current Other Pre-specified Outcome Measures
 (submitted: April 6, 2021)
  • Maximum Conjunctival Hyperemia Score [ Time Frame: Day -8 (Baseline), Day 1 to 35 ]
    Conjunctival hyperemia score was assessed using slit-lamp examination on a photographic reference scale ranging from 0 (normal) to 3 (severe). Higher score indicated severe condition. Conjunctival hyperemia was recorded to the nearest whole number using standard rounding rules (for example, a score of 1.5 was rounded up to 2 and a score of 1.4 was rounded down to 1). Highest conjunctival hyperemia score observed at Day -8 (baseline) and through Day 1 to 35 were reported. Maximum conjunctival hyperemia score for both study eye and fellow eye was reported. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.
  • Change From Baseline in Maximum Conjunctival Hyperemia Score Observed [ Time Frame: Day -8 (Baseline), Day 1 to 35 ]
    Conjunctival hyperemia score was assessed using slit-lamp examination on a photographic reference scale ranging from 0 (normal) to 3 (severe). Conjunctival hyperemia was recorded to the nearest whole number using standard rounding rules (for example, a score of 1.5 was rounded up to 2 and a score of 1.4 was rounded down to 1). Change between highest conjunctival hyperemia score observed through Day 1 to 35 and highest conjunctival hyperemia score at baseline (Day -8) was reported. Maximum conjunctival hyperemia score for both study eye and fellow eye was reported. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.
  • Total Corneal Staining Score [ Time Frame: 8 AM on Day 1 (Baseline) ]
    Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0= no staining, 1= scattered micropunctate staining (dots were discrete and countable), 2= areas of clustered micropunctate or one macropunctate stain, 3= areas of confluent micropunctate stain or two or more macropunctate stain or filaments. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Total corneal score from both study eye and fellow eye were reported. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and baseline visit was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.
  • Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 [ Time Frame: 8 AM Day 1 (Baseline), Day 7, 13, 16, 21, 28, 35 ]
    Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0= no staining, 1= scattered micropunctate staining (dots were discrete and countable), 2= areas of clustered micropunctate or one macropunctate stain, 3= areas of confluent micropunctate stain or two or more macropunctate stain or filaments. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Total corneal score from both study eye and fellow eye were reported. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and baseline visit was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329
Official Title  ICMJE A Phase 2, Single-masked, Randomized, Crossover Study Of The 24-hour Intraocular Pressure Lowering And Systemic Exposure of Pf-04217329 Alone And In Combination With Latanoprost
Brief Summary This study will characterize the effect of PF-04217329, alone and in combination with latanoprost, on circadian intraocular pressure and blood pressure in glaucoma patients. Blood samples will be collected to measure the amount of active metabolite of PF-04217329 in the plasma following dosing.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Glaucoma, Open-Angle
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: PF-04217329
    Topical ocular solution, once-daily for 14 days
  • Drug: latanoprost vehicle
    Topical ocular solution, once-daily for 14 days
  • Drug: latanoprost
    Topical ocular solution, once-daily for 14 days
    Other Name: Xalatan
Study Arms  ICMJE
  • Experimental: PF-04217329 + placebo
    Active study drug + latanoprost vehicle
    Interventions:
    • Drug: PF-04217329
    • Drug: latanoprost vehicle
  • Experimental: PF-04217329 + latanoprost
    Active study drug + latanoprost
    Interventions:
    • Drug: PF-04217329
    • Drug: latanoprost
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 11, 2010)
31
Original Estimated Enrollment  ICMJE
 (submitted: July 6, 2009)
32
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes
  • Intraocular Pressure (IOP) of at least 22 mmHg and not more than 30 mmHg in either eye at 8 AM after discontinuing previous glaucoma treatment
  • Visual acuity correctable to 20/100 or better in each eye.

Exclusion Criteria:

  • Closed/barely open anterior chamber angle or a history of acute angle closure in either eye.
  • Diagnosis of a clinically significant or progressive retinal disease (eg, diabetic retinopathy, macular degeneration) in either eye.
  • Advanced glaucoma or a history of severe central visual field loss in either eye.
  • History of ocular surgery or trauma in either eye within 6 months of the screening visit.
  • History of ocular infection, ocular inflammation, or laser surgery in either eye within 3 months of the screening visit.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00934089
Other Study ID Numbers  ICMJE A0191002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP