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
NCT00847483
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
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.
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Descriptive Information | ||||
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Brief Title ICMJE | 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 ICMJE | 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). | |||
Brief Summary | Compare the IOP lowering properties of latanoprost, travoprost and bimatoprost | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 375 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | August 2002 | |||
Actual Primary Completion Date | August 2002 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Ocular conditions
Other conditions
Women
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00847483 | |||
Other Study ID Numbers ICMJE | XALA-0091-157 A6111081 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | February 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |