Clinical trial NCT00847483: Comparison of Latanoprost With Travoprost and Bimatoprost in Patients With Elevated IOP. A 12-weeks, Masked Evaluator, Phase IV Multi-center Study in the US
Official title: A Comparison of Latanoprost (Xalatan) With Travoprost (Travatan) and Bimatoprost (Lumigan) in Patients With Elevated Intraocular Pressure. A Twelve-week, Masked Evaluator, Phase IV, Multicenter Study in the United States. (Xalatan vs Travatan vs Lumigan).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Keywords: glaucoma
ocular hypertension
latanoprost
travoprost
bimatoprost
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-02-19
Enrollment: 375
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: Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost


Eligibility criteria: Inclusion Criteria:

* Unilateral or bilateral primary open angle glaucoma (POAG), exfoliative glaucoma, pigmentary glaucoma or ocular hypertension (glaucoma is defined as either visual fields defect or glaucomatous changes of the optic nerve head in association with elevated intraocular pressure. Ocular hypertension is defined as IOP ≥ 21 mmHg at diagnosis).
* Is currently receiving (at the screen visit) or has received topical monotherapy or dual therapy (within the past 6 months) for POAG or ocular hypertension.
* Required washout periods are 4 weeks for -adrenergic antagonists, prostaglandin analogues (including latanoprost, unoprostone, travoprost and bimatoprost) and 2 weeks for adrenergic agonists, and 5 days for cholinergic agonists and carbonic anhydrase inhibitors, prior to the baseline visit.
* Mean 8 AM IOP ≥ 23 mmHg at the baseline visit for all patients. Patients should be assigned treatment only after the 8 PM IOP is obtained.
* Visual acuity (best corrected) equal to or better than 20/200 (Snellen). ETDRS charts may be used and converted to Snellen units.
* Informed Consent: Signed Informed Consent is obtained at the screen visit.
* Able to adhere to treatment/visit planUnilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
* Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
* IOP of 22mmHg or higher obtained during the pre-study period.

Exclusion Criteria:

Ocular conditions

* Closed/barely open anterior chamber angle or history of acute angle closure. (Patients who are diagnosed with POAG after a successful peripheral iridotomy may be enrolled).
* History of ALT (Argon Laser Trabeculoplasty) within 3 months prior to the screen visit (the unlasered eye may be enrolled as the study eye).
* History of any ocular filtering surgical intervention (the unfiltered eye may be enrolled as the study eye).
* Ocular surgery (on the globe of the eye only), or inflammation/infection within 3 months prior to screen visit. (Applies to both fellow and study eyes.)
* Hypersensitivity to benzalkonium chloride or to any other component in latanoprost (Xalatan), travoprost (Travatan) or bimatoprost (Lumigan).
* Other abnormal ocular conditions or symptoms preventing the patient from entering the study, in the investigator's clinical judgement.

Other conditions

* Use of systemic medication known to affect IOP (i.e., alpha-adrenergic agonists, beta-adrenergic antagonists, calcium channel blockers, ACE inhibitors and/or angiotensin II receptor blockers, or corticosteroids), unless the patient and the medication dosage have been stable for three months prior to the screen visit and the dosage is not expected to change during the study.

Women

* Women of childbearing potential (WOCBP) who are not using contraceptive methods. Women of childbearing potential are defined as women who are not surgically sterile or not postmenopausal (at least 12 months without a menstrual period). Contraception is defined as abstinence, having a vasectomized partner, or the ongoing use of approved oral, injectable or implanted contraceptives, a barrier method, or an IUD.
* Pregnancy. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at the screen visit and baseline visit.
* Nursing mothers General
* Use of any investigational medication within 30 days prior to screen visit.

Primary outcomes:
measure: To compare the IOP reducing effect of latanoprost (Xalatan) versus travoprost (Travatan) versus bimatoprost (Lumigan) over a twelve-week period.
timeFrame: 12 weeks
measure: The mean change since baseline of Week 12 IOP measured at the time of peak (8:00AM) drug effect.
timeFrame: 12 weeks
Secondary outcomes:
measure: To study the safety variables within and between all treatment groups over 12 weeks
timeFrame: 12 weeks
measure: The mean change since baseline of Week 12 IOP measured at the time of trough (8:00PM) drug effect. The mean percentage change since baseline of diurnal IOP at Week 12.
timeFrame: 12 weeks
measure: The mean change since baseline of Week 12 IOP measured at the times of peak (8:00AM) and trough (8:00PM) drug effects evaluated by race. The percentage of patient withdrawals from the study
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bellflower
country: United States
facility: Pfizer Investigational Site
state: California
city: Inglewood
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Gainesville
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: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Bloomingdale
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Evansville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Bangor
country: United States
facility: Pfizer Investigational Site
state: Maine
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: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Bloomfield
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Willingboro
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Streetsboro
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Maryville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: El Paso
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Layton
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Wenatchee
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: