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A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension

Primary Purpose

Glaucoma, Open-Angle, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Xalacom
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

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

Inclusion Criteria: Patients with open angle glaucoma and/or ocular hypertension requiring a reduction of IOP who were insufficiently responsive to topical betablockers Exclusion Criteria: Previous and current treatment with any topical ophthalmic drug containing prostaglandins; any condition in which treatment with the betablocking agent, timolol, was contraindicated.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
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Outcomes

Primary Outcome Measures

Incidence of increase of iris pigmentation
incidence of development in darkening/lengthening/thickening of eyelashes and/or pigmentation of periorbital skin
occurrence of ocular/periorbital adverse events
occurrence of serious adverse events.

Secondary Outcome Measures

Full Information

First Posted
September 6, 2005
Last Updated
November 4, 2008
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00150267
Brief Title
A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension
Official Title
A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension
Study Type
Interventional

2. Study Status

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

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
To estimate the frequency of patients with ocular/periorbital adverse events. To identify any possible long-term adverse consequences of increased iris pigmentation and to follow serious adverse events throughout the study period.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
976 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Xalacom
Primary Outcome Measure Information:
Title
Incidence of increase of iris pigmentation
Title
incidence of development in darkening/lengthening/thickening of eyelashes and/or pigmentation of periorbital skin
Title
occurrence of ocular/periorbital adverse events
Title
occurrence of serious adverse events.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with open angle glaucoma and/or ocular hypertension requiring a reduction of IOP who were insufficiently responsive to topical betablockers Exclusion Criteria: Previous and current treatment with any topical ophthalmic drug containing prostaglandins; any condition in which treatment with the betablocking agent, timolol, was contraindicated.
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
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Pfizer Investigational Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2067
Country
Australia
Facility Name
Pfizer Investigational Site
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Liege
ZIP/Postal Code
B-4000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Kobenhavn O
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Pfizer Investigational Site
City
Aire Sur Adour
ZIP/Postal Code
40800
Country
France
Facility Name
Pfizer Investigational Site
City
Carcassonne
ZIP/Postal Code
11000
Country
France
Facility Name
Pfizer Investigational Site
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Pfizer Investigational Site
City
Figeac
ZIP/Postal Code
46100
Country
France
Facility Name
Pfizer Investigational Site
City
Haguenau
ZIP/Postal Code
67500
Country
France
Facility Name
Pfizer Investigational Site
City
Le Cannet
ZIP/Postal Code
06110
Country
France
Facility Name
Pfizer Investigational Site
City
Loos
ZIP/Postal Code
59120
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille
ZIP/Postal Code
13012
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75011
Country
France
Facility Name
Pfizer Investigational Site
City
Versailles
ZIP/Postal Code
78000
Country
France
Facility Name
Pfizer Investigational Site
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Facility Name
Pfizer Investigational Site
City
Freising
ZIP/Postal Code
85354
Country
Germany
Facility Name
Pfizer Investigational Site
City
Gerolzhofen
ZIP/Postal Code
97447
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hirschaid
ZIP/Postal Code
96114
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hoesbach
ZIP/Postal Code
63768
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
Pfizer Investigational Site
City
Mainz
ZIP/Postal Code
55124
Country
Germany
Facility Name
Pfizer Investigational Site
City
Wuerzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Pfizer Investigational Site
City
Piraeus
State/Province
Nikea-Piraeus
ZIP/Postal Code
184 54
Country
Greece
Facility Name
Pfizer Investigational Site
City
Athens
ZIP/Postal Code
10 672
Country
Greece
Facility Name
Pfizer Investigational Site
City
Kavala
Country
Greece
Facility Name
Pfizer Investigational Site
City
Patras
Country
Greece
Facility Name
Pfizer Investigational Site
City
Thessaloniki
Country
Greece
Facility Name
Pfizer Investigational Site
City
Ennis
State/Province
Co. Clare
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Galway
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Pfizer Investigational Site
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Pfizer Investigational Site
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Pfizer Investigational Site
City
Padova
ZIP/Postal Code
35100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Perugia
ZIP/Postal Code
06122
Country
Italy
Facility Name
Pfizer Investigational Site
City
Pisa
ZIP/Postal Code
56127
Country
Italy
Facility Name
Pfizer Investigational Site
City
Siena
ZIP/Postal Code
23100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Torino
Country
Italy
Facility Name
Pfizer Investigational Site
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Gouda
ZIP/Postal Code
2805 AH
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Rijswijk
ZIP/Postal Code
2289 CA
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Pfizer Investigational Site
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Pfizer Investigational Site
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07500
Country
Spain
Facility Name
Pfizer Investigational Site
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Pfizer Investigational Site
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Pfizer Investigational Site
City
Almeria
ZIP/Postal Code
04009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Pfizer Investigational Site
City
Lugo
ZIP/Postal Code
27004
Country
Spain
Facility Name
Pfizer Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Pfizer Investigational Site
City
Malaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valladolid
ZIP/Postal Code
47005
Country
Spain
Facility Name
Pfizer Investigational Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Pfizer Investigational Site
City
Motala
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Orebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Vasteras
ZIP/Postal Code
721 89
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Bristol
State/Province
Gloucestershire
ZIP/Postal Code
BS1 2LX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Cheltenham
State/Province
Gloucestershire
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bolton
State/Province
Lancs
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Uxbridge
State/Province
Middlesex
ZIP/Postal Code
UB8 3NN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UZ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Redhill
State/Province
Surrey
ZIP/Postal Code
RH1 5RH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Lancaster
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=912-OPT-0076-019&StudyName=A%205-Year%20Postmarketing%20Safety%20Study%20Of%20Xalcom%20In%20Patients%20With%20Open%20Angle%20Glaucoma%20Or%20Ocular%20Hypertension
Description
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Learn more about this trial

A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension

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