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Efficacy And Safety Of Xalatan Compared To Usual Care In Patients With Open Angle Glaucoma Or Ocular Hypertension.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00140062
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : April 7, 2008
Sponsor:
Information provided by:
Pfizer

Brief Summary:
The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated.

Condition or disease Intervention/treatment Phase
Ocular Hypertension Glaucoma, Open-Angle Drug: latanoprost 0.005% (Xalatan) Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 329 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Post-Marketing Efficacy And Safety Study Of Xalatan Compared With "Usual Care" Over 36 Months In Patients With Primary Open-Angle Glaucoma, Exfoliative Glaucoma Or Ocular Hypertension
Study Start Date : February 2002
Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost
U.S. FDA Resources




Primary Outcome Measures :
  1. Time to treatment failure (change or addition of ocular hypertensive medical treatment, ocular surgery or laser trabeculoplasty) of latanoprost monotherapy or usual care over 36 months.

Secondary Outcome Measures :
  1. Safety and the health care utilization in the two treatment groups over 36 months.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral or bilateral open-angle glaucoma, exfoliative glaucoma, pigmentary glaucoma or ocular hypertension
  • IOP of > 21 mm Hg on current treatment

Exclusion Criteria:

  • Any previous or current treatment with latanoprost or other prostaglandin analogues

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140062


Locations
Finland
Pfizer Investigational Site
Helsinki, Finland, 00100
Pfizer Investigational Site
Helsinki, Finland, 00700
Pfizer Investigational Site
Kuopio, Finland, 70100
Pfizer Investigational Site
Lahti, Finland, 15110
Pfizer Investigational Site
Rovaniemi, Finland, 96200
Pfizer Investigational Site
Seinajoki, Finland, 60100
Pfizer Investigational Site
Tammisaari, Finland
Pfizer Investigational Site
Tampere, Finland, 33100
Pfizer Investigational Site
Turku, Finland, 20100
Sweden
Pfizer Investigational Site
Jönköping, Sweden, 551 85
Pfizer Investigational Site
Karlstad, Sweden, 652 20
Pfizer Investigational Site
Kristianstad, Sweden, 291 31
Pfizer Investigational Site
Linkoping, Sweden
Pfizer Investigational Site
Ludvika, Sweden, 771 81
Pfizer Investigational Site
Molndal, Sweden
Pfizer Investigational Site
Nacka, Sweden, 131 83
Pfizer Investigational Site
Norrkoping, Sweden, 601 82
Pfizer Investigational Site
Norrkoping, Sweden, 602 36
Pfizer Investigational Site
Nyköping, Sweden
Pfizer Investigational Site
Orebro, Sweden, 70361
Pfizer Investigational Site
Seinajoki, Sweden, 151 72
Pfizer Investigational Site
Stockholm, Sweden, 113 22
Pfizer Investigational Site
Stockholm, Sweden
Pfizer Investigational Site
Sundsvall, Sweden, 851 86
Pfizer Investigational Site
Täby, Sweden, 183 34
Pfizer Investigational Site
Uppsala, Sweden, 751 85
Pfizer Investigational Site
Uppsala, Sweden
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
ClinicalTrials.gov Identifier: NCT00140062     History of Changes
Other Study ID Numbers: 912-OPT-0091-156
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: April 7, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Antihypertensive Agents