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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00140062
First received: August 29, 2005
Last updated: April 4, 2008
Last verified: April 2008
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Finland
Pfizer Investigational Site
Helsinki, Finland, 00700
Pfizer Investigational Site
Helsinki, Finland, 00100
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
Pfizer Investigational Site
Stockholm, Sweden, 113 22
Pfizer Investigational Site
Sundsvall, Sweden, 851 86
Pfizer Investigational Site
Täby, Sweden, 183 34
Pfizer Investigational Site
Uppsala, Sweden
Pfizer Investigational Site
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

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

ClinicalTrials.gov processed this record on August 25, 2014