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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

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Belleflower, California, 90706 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Glaucoma, Ocular Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT00847483
Pfizer
Completed
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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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