Clinical trial NCT00800267: A Study of Glaucoma or Ocular Hypertension in Patients Within the United States
Official title: A 6-month, Randomized, Double-masked Comparison of Fixed Combination of Latanoprost and Timolol With the Individual Components, Continuing Into a 6-month Open Label Safety Study of Fixed Combination in Patients With Glaucoma or Ocular Hypertension. A Multicenter Study in the United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ocular Hypertension
Glaucoma
Keywords: glaucoma
ocular hypertension
Fixed combination latanoprost-timolol
latanoprost
timolol
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 418
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: Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.


Eligibility criteria: Inclusion Criteria:

* Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
* Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour).

Exclusion Criteria:

* History of acute angle closure or closed/barely open anterior chamber angle.
* Current use of contact lenses.
* Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
* Ocular inflammation/infection occurring within three months prior to pre-study visit.
* Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
* Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
* Patients with conditions in which treatment with B-blocking agents are contraindicated: cardiac failure, sinus bradycardia, second and third degree atrio-ventricular block.
* Patients with conditions in which treatment with B-blocking agents are contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
* Inability to adhere to treatment/visit plan.
* Have participated in any other clinical study within one month prior to pre-study visit.

Primary outcomes:
measure: The differences from baseline in diurnal IOP reduction after six months of treatment will be tested between the fixed combination and the monotherapy groups.
timeFrame: 6 months
measure: Primary objective: to demonstrate that the fixed combination of latanoprost and timolol has a better IOP-reducing effect than the individual monotherapies.
timeFrame: 6 months
Secondary outcomes:
measure: To examine, within treatment groups, the diurnal IOP reducing effect from baseline for all effect from baseline between the monotherapies latanoprost and timolol
timeFrame: 6 months
measure: To compare the diurnal IOP reducing effect from baseline between the monotherapies latanoprost and timolol at Week 26
timeFrame: 6 months
measure: To compared the number of treatment failures and patients withdrawn due to uncontrolled IOP from baseline to Week 26 between treatment groups
timeFrame: 6 months
measure: To describe the IOP development from baseline to Week 26 for all treatment groups
timeFrame: 6 months
measure: To compared the IOP reducing effect from baseline to Week 26 of the monotherapies with the IOP reducing effect from Week 26 to Week 52 of the fixed combination
timeFrame: 6 months
measure: To examine, within the fixed combination treatment group, the diurnal IOP reducing effect from baseline to Week 26 and Week 52
timeFrame: 6 months
measure: To follow the safety variables throughout the study periods.
timeFrame: 6 months
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: Sacramento
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Boulder
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Largo
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: East Point
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Griffin
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Morrow
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Wheaton
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Elkhart
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Mishawaka
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: South Bend
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: South Bend
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Owings Mills
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Golden Valley
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Warrensburg
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Concord
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: South Plainfield
country: United States
facility: Pfizer Investigational Site
state: New Jersey
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: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Matthews
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Monroe
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Wyomissing
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Galveston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Charlottesville
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Madison
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: