Clinical trial NCT00572455: Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.
Official title: A 2-STAGE, PHASE 2, DOUBLE-MASKED, RANDOMIZED, VEHICLE CONTROLLED, DOSE RESPONSE TRIAL OF PF-04217329 AND THE MARKETED FORMULATION OF LATANOPROST IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Open-Angle Glaucoma
Ocular Hypertension
Keywords: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-13
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of PF-04217329.


Eligibility criteria: 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 chamber angle or a history of acute angle closure in either eye.
* Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period.

Primary outcomes:
measure: Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I
timeFrame: Stage I: Baseline, Day 14
measure: Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II
timeFrame: Stage II: Baseline, Day 28
measure: Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I
timeFrame: Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 days)
measure: Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II
timeFrame: Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days)
Secondary outcomes:
measure: Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I
timeFrame: Stage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14
measure: 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
timeFrame: 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
measure: Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II
timeFrame: Stage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
measure: Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II
timeFrame: Stage II: 8 AM, 10 AM, 1 PM, and 4 PM on Day 0 (Baseline), 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
measure: Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I
timeFrame: Stage I: Day 1 up to Day 14
measure: Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II
timeFrame: Stage II: Day 1 up to Day 28
Other outcomes:
Locations:
city: Artesia
country: United States
facility: Sall Research Medical Center
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Petaluma
country: United States
facility: North Bay Eye Associates, Inc.
state: California
city: Poway
country: United States
facility: Centre For Health Care
state: California
city: Daytona Beach
country: United States
facility: Atlantic Institute of Clinical Research
state: Florida
city: Daytona Beach
country: United States
facility: Florida Health Care Plans
state: Florida
city: Fort Myers
country: United States
facility: Eye Associates of Fort Myers
state: Florida
city: Ormond Beach
country: United States
facility: International Eye Associates, PA
state: Florida
city: Atlanta
country: United States
facility: Coastal Research Associates,LLC
state: Georgia
city: Atlanta
country: United States
facility: Omni Eye Services of Atlanta
state: Georgia
city: Morrow
country: United States
facility: Eye Care Centers Management, Inc.
state: Georgia
city: Evansville
country: United States
facility: The Eye Group of Southern Indiana
state: Indiana
city: Louisville
country: United States
facility: Taustine Eye Center
state: Kentucky
city: Rochester
country: United States
facility: Rochester Ophthalmological Group, PC
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose and Throat Associates, PA
state: North Carolina
city: High Point
country: United States
facility: Cornerstone Eye Care
state: North Carolina
city: Tulsa
country: United States
facility: Mark J. Weiss, MD. Inc.
state: Oklahoma
city: Bristol
country: United States
facility: Glaucoma Care Center at Century Eye Care
state: Pennsylvania
city: Philadelphia
country: United States
facility: Wills Eye Institute
state: Pennsylvania
city: Charleston
country: United States
facility: Bluestein Custom Vision
state: South Carolina
city: Memphis
country: United States
facility: Total Eye Care, PA
state: Tennessee
city: Austin
country: United States
facility: Texan Eye Care, PA
state: Texas
city: Austin
country: United States
facility: Eye Physicians of Austin
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Schachar RA, Raber S, Courtney R, Zhang M. A phase 2, randomized, dose-response trial of taprenepag isopropyl (PF-04217329) versus latanoprost 0.005% in open-angle glaucoma and ocular hypertension. Curr Eye Res. 2011 Sep;36(9):809-17. doi: 10.3109/02713683.2011.593725.