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
NCT ID: NCT00847483
Last Updated: 2021-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
375 participants
INTERVENTIONAL
2002-01-31
2002-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Latanoprost
latanoprost 0.005% ophthalmic solution
One drop in the evening in the affected eye(s) at 8:00pm
Travoprost
Travoprost 004% sterile ophthalmic solution
One drop in the evening in the affected eye(s) at 8:00pm
Bimatoprost
Bimatoprost .03% sterile ophthalmic solution
One drop in the evening in the affected eye(s) at 8:00pm
Interventions
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latanoprost 0.005% ophthalmic solution
One drop in the evening in the affected eye(s) at 8:00pm
Travoprost 004% sterile ophthalmic solution
One drop in the evening in the affected eye(s) at 8:00pm
Bimatoprost .03% sterile ophthalmic solution
One drop in the evening in the affected eye(s) at 8:00pm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Bellflower, California, United States
Pfizer Investigational Site
Inglewood, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Gainesville, Florida, United States
Pfizer Investigational Site
Lakeland, Florida, United States
Pfizer Investigational Site
Ormond Beach, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Bloomingdale, Illinois, United States
Pfizer Investigational Site
Evansville, Indiana, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
Pfizer Investigational Site
Shreveport, Louisiana, United States
Pfizer Investigational Site
Bangor, Maine, United States
Pfizer Investigational Site
Kansas City, Missouri, United States
Pfizer Investigational Site
Kansas City, Missouri, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
Las Vegas, Nevada, United States
Pfizer Investigational Site
Bloomfield, New Jersey, United States
Pfizer Investigational Site
Willingboro, New Jersey, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, United States
Pfizer Investigational Site
Streetsboro, Ohio, United States
Pfizer Investigational Site
Oklahoma City, Oklahoma, United States
Pfizer Investigational Site
Tulsa, Oklahoma, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
Pfizer Investigational Site
Maryville, Tennessee, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
El Paso, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Layton, Utah, United States
Pfizer Investigational Site
Norfolk, Virginia, United States
Pfizer Investigational Site
Norfolk, Virginia, United States
Pfizer Investigational Site
Virginia Beach, Virginia, United States
Pfizer Investigational Site
Wenatchee, Washington, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6111081
Identifier Type: -
Identifier Source: secondary_id
XALA-0091-157
Identifier Type: -
Identifier Source: org_study_id
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