Clinical trial NCT00934089: A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour)
timeFrame: 8 AM on Baseline (Day -8), 8 AM on Day 14 (0 Hour)
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours)
timeFrame: 10 AM on Baseline (Day -8), 10 AM on Day 14 (2 Hours)
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (4 Hours)
timeFrame: 12 PM on Baseline (Day -8), 12 PM on Day 14 (4 Hours)
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 2 PM (6 Hours)
timeFrame: 2 PM on Baseline (Day -8), 2 PM on Day 14 (6 Hours)
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 4 PM (8 Hours)
timeFrame: 4 PM on Baseline (Day -8), 4 PM on Day 14 (8 Hours)
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 6 PM (10 Hours)
timeFrame: 6 PM on Baseline (Day -8), 6 PM on Day 14 (10 Hours)
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 PM (12 Hours)
timeFrame: 8 PM on Baseline (Day -8), 8 PM on Day 14 (12 Hours)
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 PM (14 Hours)
timeFrame: 10 PM on Day -8 (Baseline), 10 PM on Day 14 (14 Hours)
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 12 AM (16 Hours)
timeFrame: 12 AM on Baseline (Day -7), 12 AM on Day 15 (16 Hours)
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 4 AM (20 Hours)
timeFrame: 4 AM on Baseline (Day -7), 4 AM on Day 15 (20 Hours)
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 6 AM (22 Hours)
timeFrame: 6 AM on Baseline (Day -7), 6 AM on Day 15 (22 Hours)
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 8 AM (24 Hours)
timeFrame: 8 AM on Baseline (Day -7), 8 AM on Day 15 (24 Hours)
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 16: 8 AM (48 Hours)
timeFrame: 8 AM on Baseline (Day -8), 8 AM on Day 16 (48 Hours)
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 17: 8 AM (72 Hours)
timeFrame: 8 AM on Baseline (Day -8), 8 AM on Day 17 (72 Hours)
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 21: 8 AM (168 Hours)
timeFrame: 8 AM on Day -8 (Baseline), 8 AM on Day 21 (168 Hours)
measure: Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 5 Minutes on Day 14
timeFrame: 5 minutes post-dose on Day 14
measure: Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.25 Hours on Day 14
timeFrame: 0.25 hours post-dose on Day 14
measure: Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.5 Hours on Day 14
timeFrame: 0.5 hours post-dose on Day 14
measure: Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.75 Hours on Day 14
timeFrame: 0.75 hours post-dose on Day 14
measure: Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 1 Hour on Day 14
timeFrame: 1 hour post-dose on Day 14
Secondary outcomes:
measure: Diastolic Ocular Perfusion Pressure (DOPP)
timeFrame: 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
measure: 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)
timeFrame: 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
measure: Number of Participants With Ocular and Systemic Adverse Events (AEs)
timeFrame: Baseline up to 28 days after last dose of study medication (up to 58 Days)
measure: Percentage of Participants With Photophobia and Iritis
timeFrame: Baseline up to 28 days after last dose of study medication (up to 58 Days)
measure: Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35
timeFrame: 8 AM on Day 1 (Baseline), Days 7, 13, 16, 21, 28, 35
measure: Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35
timeFrame: 8 AM on Day 1 (Baseline), Day 13, 35
Other outcomes:
measure: Maximum Conjunctival Hyperemia Score
timeFrame: Day -8 (Baseline), Day 1 to 35
measure: Change From Baseline in Maximum Conjunctival Hyperemia Score Observed
timeFrame: Day -8 (Baseline), Day 1 to 35
measure: Total Corneal Staining Score
timeFrame: 8 AM on Day 1 (Baseline)
measure: Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35
timeFrame: 8 AM Day 1 (Baseline), Day 7, 13, 16, 21, 28, 35
Locations:
city: Cypress
country: United States
facility: West Coast Clinical Trials, LLC
state: California
city: Garden Grove
country: United States
facility: Glory Medical Group
state: California
city: Gardena
country: United States
facility: East-West Eye Institute
state: California
city: Long Beach
country: United States
facility: Ophthalmology Corporation
state: California
city: Los Angeles
country: United States
facility: East-West Eye Institute
state: California
city: Los Angeles
country: United States
facility: Los Angeles Eye Medical Group
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Pasadena
country: United States
facility: Southern California Glaucoma Consultants
state: California
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: