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

Primary Purpose

Ocular Hypertension, Glaucoma, Open-Angle

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
latanoprost 0.005% (Xalatan)
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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.

Full Information

First Posted
August 29, 2005
Last Updated
April 4, 2008
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00140062
Brief Title
Efficacy And Safety Of Xalatan Compared To Usual Care In Patients With Open Angle Glaucoma Or Ocular Hypertension.
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 Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Glaucoma, Open-Angle

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
329 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
latanoprost 0.005% (Xalatan)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Safety and the health care utilization in the two treatment groups over 36 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Helsinki
ZIP/Postal Code
00700
Country
Finland
Facility Name
Pfizer Investigational Site
City
Kuopio
ZIP/Postal Code
70100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Lahti
ZIP/Postal Code
15110
Country
Finland
Facility Name
Pfizer Investigational Site
City
Rovaniemi
ZIP/Postal Code
96200
Country
Finland
Facility Name
Pfizer Investigational Site
City
Seinajoki
ZIP/Postal Code
60100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Tammisaari
Country
Finland
Facility Name
Pfizer Investigational Site
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Jönköping
ZIP/Postal Code
551 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Karlstad
ZIP/Postal Code
652 20
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Kristianstad
ZIP/Postal Code
291 31
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Linkoping
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Ludvika
ZIP/Postal Code
771 81
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Molndal
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Nacka
ZIP/Postal Code
131 83
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Norrkoping
ZIP/Postal Code
601 82
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Norrkoping
ZIP/Postal Code
602 36
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Nyköping
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Orebro
ZIP/Postal Code
70361
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Seinajoki
ZIP/Postal Code
151 72
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
113 22
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Sundsvall
ZIP/Postal Code
851 86
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Täby
ZIP/Postal Code
183 34
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=912-OPT-0091-156&StudyName=Efficacy+And+Safety+Of+Xalatan+Compared+To+Usual+Care+In+Patients+With+Open+Angle+Glaucoma+Or+Ocular+Hypertension%2E
Description
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Learn more about this trial

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

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