Clinical trial NCT00159653: A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma
Official title: A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Xalacom Given In The Evening, Xalatan Given In The Evening, And Timolol Given In The Morning In Patients With Open Angle Glaucoma Or Ocular Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 500
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 demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.


Eligibility criteria: Inclusion Criteria:

* Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening

Exclusion Criteria:

* Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
* History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening

Primary outcomes:
measure: The mean IOP measurements obtained in the study eye at each time point
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Poway
country: United States
facility: Pfizer Investigational Site
state: California
city: Redding
country: United States
facility: Pfizer Investigational Site
state: California
city: Redding
country: United States
facility: Pfizer Investigational Site
state: California
city: Danbury
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Cape Coral
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Lakeland
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Morrow
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Homewood
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: North Dartmouth
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Saint Joseph
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Newark
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Bethpage
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: High Point
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Matthews
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Cranberry Township
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: North Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Amarillo
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Nanaimo
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Moncton
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: Saint John
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: Saint John
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: Bridgewater
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Oakville
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: