Clinical trial NCT00150267: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 976
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of increase of iris pigmentation
measure: incidence of development in darkening/lengthening/thickening of eyelashes and/or pigmentation of periorbital skin
measure: occurrence of ocular/periorbital adverse events
measure: occurrence of serious adverse events.
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Sydney
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Antwerpen
country: Belgium
facility: Pfizer Investigational Site
city: Brussel
country: Belgium
facility: Pfizer Investigational Site
city: Edegem
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Kobenhavn O
country: Denmark
facility: Pfizer Investigational Site
city: Odense C
country: Denmark
facility: Pfizer Investigational Site
city: Aire Sur Adour
country: France
facility: Pfizer Investigational Site
city: Carcassonne
country: France
facility: Pfizer Investigational Site
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Figeac
country: France
facility: Pfizer Investigational Site
city: Haguenau
country: France
facility: Pfizer Investigational Site
city: Le Cannet
country: France
facility: Pfizer Investigational Site
city: Loos
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Versailles
country: France
facility: Pfizer Investigational Site
city: Erlangen
country: Germany
facility: Pfizer Investigational Site
city: Freising
country: Germany
facility: Pfizer Investigational Site
city: Gerolzhofen
country: Germany
facility: Pfizer Investigational Site
city: Hirschaid
country: Germany
facility: Pfizer Investigational Site
city: Hoesbach
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Wuerzburg
country: Germany
facility: Pfizer Investigational Site
city: Piraeus
country: Greece
facility: Pfizer Investigational Site
state: Nikea-Piraeus
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Kavala
country: Greece
facility: Pfizer Investigational Site
city: Patras
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Ennis
country: Ireland
facility: Pfizer Investigational Site
state: Co. Clare
city: Galway
country: Ireland
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Perugia
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Torino
country: Italy
facility: Pfizer Investigational Site
city: Alkmaar
country: Netherlands
facility: Pfizer Investigational Site
city: Gouda
country: Netherlands
facility: Pfizer Investigational Site
city: Rijswijk
country: Netherlands
facility: Pfizer Investigational Site
city: Badalona
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Terrassa
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Palma De Mallorca
country: Spain
facility: Pfizer Investigational Site
state: Islas Baleares
city: Getafe
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Bilbao
country: Spain
facility: Pfizer Investigational Site
state: Vizcaya
city: Almeria
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Lugo
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Malaga
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Valladolid
country: Spain
facility: Pfizer Investigational Site
city: Zaragoza
country: Spain
facility: Pfizer Investigational Site
city: Motala
country: Sweden
facility: Pfizer Investigational Site
city: Orebro
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
city: Vasteras
country: Sweden
facility: Pfizer Investigational Site
city: Bristol
country: United Kingdom
facility: Pfizer Investigational Site
state: Gloucestershire
city: Cheltenham
country: United Kingdom
facility: Pfizer Investigational Site
state: Gloucestershire
city: Bolton
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancs
city: Uxbridge
country: United Kingdom
facility: Pfizer Investigational Site
state: Middlesex
city: Norwich
country: United Kingdom
facility: Pfizer Investigational Site
state: Norfolk
city: Redhill
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Birmingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Lancaster
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: