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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00140062

Purpose

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	Intervention	Phase
Ocular Hypertension Glaucoma, Open-Angle	Drug: latanoprost 0.005% (Xalatan)	Phase IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

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:

Safety and the health care utilization in the two treatment groups over 36 months.

Estimated Enrollment:	329
Study Start Date:	February 2002
Estimated Study Completion Date:	April 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00140062

Locations

Finland
Pfizer Investigational Site
Helsinki, Finland, 00700
Pfizer Investigational Site
Tampere, Finland, 33100
Pfizer Investigational Site
Turku, Finland, 20100
Pfizer Investigational Site
Kuopio, Finland, 70100
Pfizer Investigational Site
Rovaniemi, Finland, 96200
Pfizer Investigational Site
Seinajoki, Finland, 60100
Pfizer Investigational Site
Lahti, Finland, 15110
Pfizer Investigational Site
Helsinki, Finland, 00100
Pfizer Investigational Site
Tammisaari, Finland
Sweden
Pfizer Investigational Site
Stockholm, Sweden
Pfizer Investigational Site
Molndal, Sweden
Pfizer Investigational Site
Uppsala, Sweden, 751 85
Pfizer Investigational Site
Linkoping, Sweden
Pfizer Investigational Site
Nacka, Sweden, 131 83
Pfizer Investigational Site
JÃ¶nkÃ¶ping, Sweden, 551 85
Pfizer Investigational Site
Karlstad, Sweden, 652 20
Pfizer Investigational Site
Kristianstad, Sweden, 291 31
Pfizer Investigational Site
Orebro, Sweden, 70361
Pfizer Investigational Site
Sundsvall, Sweden, 851 86
Pfizer Investigational Site
Norrkoping, Sweden, 601 82
Pfizer Investigational Site
Norrkoping, Sweden, 602 36
Pfizer Investigational Site
TÃ¤by, Sweden, 183 34
Pfizer Investigational Site
NykÃ¶ping, Sweden
Pfizer Investigational Site
Uppsala, Sweden
Pfizer Investigational Site
Ludvika, Sweden, 771 81
Pfizer Investigational Site
Seinajoki, Sweden, 151 72
Pfizer Investigational Site
Stockholm, Sweden, 113 22

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org posting This link exits the ClinicalTrials.gov site

Study ID Numbers:	912-OPT-0091-156
Study First Received:	August 29, 2005
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00140062
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Latanoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009