Efficacy And Safety Of Xalatan Compared To Usual Care In Patients With Open Angle Glaucoma Or Ocular Hypertension.
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
1 other identifier
interventional
329
2 countries
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2002
Longer than P75 for phase_4
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 29, 2005
CompletedFirst Posted
Study publicly available on registry
August 31, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedApril 7, 2008
April 1, 2008
August 29, 2005
April 4, 2008
Conditions
Outcome Measures
Primary Outcomes (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 Outcomes (1)
Safety and the health care utilization in the two treatment groups over 36 months.
Interventions
Eligibility Criteria
You may qualify if:
- Unilateral or bilateral open-angle glaucoma, exfoliative glaucoma, pigmentary glaucoma or ocular hypertension
- IOP of \> 21 mm Hg on current treatment
You may not qualify if:
- Any previous or current treatment with latanoprost or other prostaglandin analogues
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (27)
Pfizer Investigational Site
Ekenäs, Finland
Pfizer Investigational Site
Helsinki, 00100, Finland
Pfizer Investigational Site
Helsinki, 00700, Finland
Pfizer Investigational Site
Kuopio, 70100, Finland
Pfizer Investigational Site
Lahti, 15110, Finland
Pfizer Investigational Site
Rovaniemi, 96200, Finland
Pfizer Investigational Site
Seinäjoki, 60100, Finland
Pfizer Investigational Site
Tampere, 33100, Finland
Pfizer Investigational Site
Turku, 20100, Finland
Pfizer Investigational Site
Jönköping, 551 85, Sweden
Pfizer Investigational Site
Karlstad, 652 20, Sweden
Pfizer Investigational Site
Kristianstad, 291 31, Sweden
Pfizer Investigational Site
Linköping, Sweden
Pfizer Investigational Site
Ludvika, 771 81, Sweden
Pfizer Investigational Site
Mölndal, Sweden
Pfizer Investigational Site
Nacka, 131 83, Sweden
Pfizer Investigational Site
Norrköping, 601 82, Sweden
Pfizer Investigational Site
Norrköping, 602 36, Sweden
Pfizer Investigational Site
Nyköping, Sweden
Pfizer Investigational Site
Örebro, 70361, Sweden
Pfizer Investigational Site
Seinajoki, 151 72, Sweden
Pfizer Investigational Site
Stockholm, 113 22, Sweden
Pfizer Investigational Site
Stockholm, Sweden
Pfizer Investigational Site
Sundsvall, 851 86, Sweden
Pfizer Investigational Site
Täby, 183 34, Sweden
Pfizer Investigational Site
Uppsala, 751 85, Sweden
Pfizer Investigational Site
Uppsala, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 29, 2005
First Posted
August 31, 2005
Study Start
February 1, 2002
Study Completion
April 1, 2006
Last Updated
April 7, 2008
Record last verified: 2008-04