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

NCT00934089 | Completed Phase 2 Results

• 1 other identifier: A0191002
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 8

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.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (20)

• Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (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.

  8 AM on Baseline (Day -8), 8 AM on Day 14 (0 Hour)

• Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (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.

  10 AM on Baseline (Day -8), 10 AM on Day 14 (2 Hours)

• Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (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.

  12 PM on Baseline (Day -8), 12 PM on Day 14 (4 Hours)

• Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 2 PM (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.

  2 PM on Baseline (Day -8), 2 PM on Day 14 (6 Hours)

• Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 4 PM (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.

  4 PM on Baseline (Day -8), 4 PM on Day 14 (8 Hours)

• Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 6 PM (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.

  6 PM on Baseline (Day -8), 6 PM on Day 14 (10 Hours)

• Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 PM (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.

  8 PM on Baseline (Day -8), 8 PM on Day 14 (12 Hours)

• Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 PM (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.

  10 PM on Day -8 (Baseline), 10 PM on Day 14 (14 Hours)

• Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 12 AM (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.

  12 AM on Baseline (Day -7), 12 AM on Day 15 (16 Hours)

• Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 4 AM (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.

  4 AM on Baseline (Day -7), 4 AM on Day 15 (20 Hours)

• Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 6 AM (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.

  6 AM on Baseline (Day -7), 6 AM on Day 15 (22 Hours)

• Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 8 AM (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.

  8 AM on Baseline (Day -7), 8 AM on Day 15 (24 Hours)

• Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 16: 8 AM (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.

  8 AM on Baseline (Day -8), 8 AM on Day 16 (48 Hours)

• Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 17: 8 AM (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.

  8 AM on Baseline (Day -8), 8 AM on Day 17 (72 Hours)

• Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 21: 8 AM (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.

  8 AM on Day -8 (Baseline), 8 AM on Day 21 (168 Hours)

• Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 5 Minutes on Day 14

  5 minutes post-dose on Day 14

• Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.25 Hours on Day 14

  0.25 hours post-dose on Day 14

• Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.5 Hours on Day 14

  0.5 hours post-dose on Day 14

• Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.75 Hours on Day 14

  0.75 hours post-dose on Day 14

• Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 1 Hour on Day 14

  1 hour post-dose on Day 14

Secondary Outcomes (6)

• Diastolic Ocular Perfusion Pressure (DOPP)

  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

• 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)

  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

• Number of Participants With Ocular and Systemic Adverse Events (AEs)

  Baseline up to 28 days after last dose of study medication (up to 58 Days)

• Percentage of Participants With Photophobia and Iritis

  Baseline up to 28 days after last dose of study medication (up to 58 Days)

• Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35

  8 AM on Day 1 (Baseline), Days 7, 13, 16, 21, 28, 35

Other Outcomes (4)

• Maximum Conjunctival Hyperemia Score

  Day -8 (Baseline), Day 1 to 35

• Change From Baseline in Maximum Conjunctival Hyperemia Score Observed

  Day -8 (Baseline), Day 1 to 35

• Total Corneal Staining Score

  8 AM on Day 1 (Baseline)

Study Arms (2)

PF-04217329 + placebo

EXPERIMENTAL

Active study drug + latanoprost vehicle

Drug: PF-04217329; Drug: latanoprost vehicle

PF-04217329 + latanoprost

EXPERIMENTAL

Active study drug + latanoprost

Drug: PF-04217329; Drug: latanoprost

Interventions

PF-04217329 DRUG

Topical ocular solution, once-daily for 14 days

PF-04217329 + placebo

latanoprost vehicle DRUG

Topical ocular solution, once-daily for 14 days

PF-04217329 + placebo

latanoprost DRUG

Topical ocular solution, once-daily for 14 days

Also known as: Xalatan

PF-04217329 + latanoprost

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (8)

West Coast Clinical Trials, LLC

Cypress, California, 90630, United States

Location

Glory Medical Group

Garden Grove, California, 92844, United States

Location

East-West Eye Institute

Gardena, California, 90247, United States

Location

Ophthalmology Corporation

Long Beach, California, 90806, United States

Location

East-West Eye Institute

Los Angeles, California, 90013, United States

Location

Los Angeles Eye Medical Group

Los Angeles, California, 90057, United States

Location

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Southern California Glaucoma Consultants

Pasadena, California, 91105, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

PF 04217329; Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 3, 2021
• Results First Posted: May 3, 2021

Record last verified: 2021-04

Locations

US (8)