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
XLT
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).
2 other identifiers
interventional
375
1 country
40
Brief Summary
Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2002
Shorter than P25 for phase_4
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 16, 2009
CompletedFirst Posted
Study publicly available on registry
February 19, 2009
CompletedFebruary 2, 2021
February 1, 2009
7 months
February 16, 2009
February 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To compare the IOP reducing effect of latanoprost (Xalatan) versus travoprost (Travatan) versus bimatoprost (Lumigan) over a twelve-week period.
12 weeks
The mean change since baseline of Week 12 IOP measured at the time of peak (8:00AM) drug effect.
12 weeks
Secondary Outcomes (3)
To study the safety variables within and between all treatment groups over 12 weeks
12 weeks
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.
12 weeks
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
12 weeks
Study Arms (3)
Latanoprost
ACTIVE COMPARATORTravoprost
ACTIVE COMPARATORBimatoprost
ACTIVE COMPARATORInterventions
One drop in the evening in the affected eye(s) at 8:00pm
One drop in the evening in the affected eye(s) at 8:00pm
One drop in the evening in the affected eye(s) at 8:00pm
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Pfizer Investigational Site
Bellflower, California, 90706, United States
Pfizer Investigational Site
Inglewood, California, 90301, United States
Pfizer Investigational Site
San Diego, California, 92103, United States
Pfizer Investigational Site
San Diego, California, 92116, United States
Pfizer Investigational Site
San Francisco, California, 94115, United States
Pfizer Investigational Site
Gainesville, Florida, 32610, United States
Pfizer Investigational Site
Lakeland, Florida, 33805, United States
Pfizer Investigational Site
Ormond Beach, Florida, 32174, United States
Pfizer Investigational Site
Atlanta, Georgia, 30339, United States
Pfizer Investigational Site
Bloomingdale, Illinois, 60108, United States
Pfizer Investigational Site
Evansville, Indiana, 47710, United States
Pfizer Investigational Site
Louisville, Kentucky, 40207, United States
Pfizer Investigational Site
Louisville, Kentucky, 40217, United States
Pfizer Investigational Site
Shreveport, Louisiana, 771104, United States
Pfizer Investigational Site
Bangor, Maine, 04401, United States
Pfizer Investigational Site
Kansas City, Missouri, 64111, United States
Pfizer Investigational Site
Kansas City, Missouri, 64114, United States
Pfizer Investigational Site
Omaha, Nebraska, 68198-5540, United States
Pfizer Investigational Site
Las Vegas, Nevada, 89104, United States
Pfizer Investigational Site
Bloomfield, New Jersey, 07003, United States
Pfizer Investigational Site
Willingboro, New Jersey, 08046, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28210, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103, United States
Pfizer Investigational Site
Streetsboro, Ohio, 44241, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73104, United States
Pfizer Investigational Site
Tulsa, Oklahoma, 74104, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15224, United States
Pfizer Investigational Site
Charleston, South Carolina, 29412, United States
Pfizer Investigational Site
Charleston, South Carolina, 29414, United States
Pfizer Investigational Site
Charleston, South Carolina, 29425, United States
Pfizer Investigational Site
Maryville, Tennessee, 37803, United States
Pfizer Investigational Site
Memphis, Tennessee, 38119, United States
Pfizer Investigational Site
Dallas, Texas, 75231, United States
Pfizer Investigational Site
El Paso, Texas, 79902, United States
Pfizer Investigational Site
Houston, Texas, 77025, United States
Pfizer Investigational Site
Layton, Utah, 84041, United States
Pfizer Investigational Site
Norfolk, Virginia, 23505, United States
Pfizer Investigational Site
Norfolk, Virginia, 23507, United States
Pfizer Investigational Site
Virginia Beach, Virginia, 23456, United States
Pfizer Investigational Site
Wenatchee, Washington, 98801, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2009
First Posted
February 19, 2009
Study Start
January 1, 2002
Primary Completion
August 1, 2002
Study Completion
August 1, 2002
Last Updated
February 2, 2021
Record last verified: 2009-02