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NCT00150267 Clinical Trial

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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00150267
Other study ID # 912-OPT-0076-019
Secondary ID
Status Completed
Phase Phase 3
First received September 6, 2005
Last updated November 4, 2008
Start date February 2002

Study information
Verified date November 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 976
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Xalacom

Locations
Country Name City State
Australia Pfizer Investigational Site Sydney New South Wales
Australia Pfizer Investigational Site Sydney New South Wales
Belgium Pfizer Investigational Site Antwerpen
Belgium Pfizer Investigational Site Brussel
Belgium Pfizer Investigational Site Edegem
Belgium Pfizer Investigational Site Gent
Belgium Pfizer Investigational Site Leuven
Belgium Pfizer Investigational Site Liege
Denmark Pfizer Investigational Site Kobenhavn O
Denmark Pfizer Investigational Site Odense C
France Pfizer Investigational Site Aire Sur Adour
France Pfizer Investigational Site Carcassonne
France Pfizer Investigational Site Dijon
France Pfizer Investigational Site Figeac
France Pfizer Investigational Site Haguenau
France Pfizer Investigational Site Le Cannet
France Pfizer Investigational Site Loos
France Pfizer Investigational Site Marseille
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Versailles
Germany Pfizer Investigational Site Erlangen
Germany Pfizer Investigational Site Freising
Germany Pfizer Investigational Site Gerolzhofen
Germany Pfizer Investigational Site Hirschaid
Germany Pfizer Investigational Site Hoesbach
Germany Pfizer Investigational Site Mainz
Germany Pfizer Investigational Site Mainz
Germany Pfizer Investigational Site Wuerzburg
Greece Pfizer Investigational Site Athens
Greece Pfizer Investigational Site Kavala
Greece Pfizer Investigational Site Patras
Greece Pfizer Investigational Site Piraeus Nikea-Piraeus
Greece Pfizer Investigational Site Thessaloniki
Ireland Pfizer Investigational Site Ennis Co. Clare
Ireland Pfizer Investigational Site Galway
Italy Pfizer Investigational Site Bologna
Italy Pfizer Investigational Site Firenze
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Padova
Italy Pfizer Investigational Site Perugia
Italy Pfizer Investigational Site Pisa
Italy Pfizer Investigational Site Siena
Italy Pfizer Investigational Site Torino
Netherlands Pfizer Investigational Site Alkmaar
Netherlands Pfizer Investigational Site Gouda
Netherlands Pfizer Investigational Site Rijswijk
Spain Pfizer Investigational Site Almeria
Spain Pfizer Investigational Site Badalona Barcelona
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Bilbao Vizcaya
Spain Pfizer Investigational Site Getafe Madrid
Spain Pfizer Investigational Site Lugo
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Malaga
Spain Pfizer Investigational Site Palma De Mallorca Islas Baleares
Spain Pfizer Investigational Site Terrassa Barcelona
Spain Pfizer Investigational Site Valencia
Spain Pfizer Investigational Site Valladolid
Spain Pfizer Investigational Site Zaragoza
Sweden Pfizer Investigational Site Motala
Sweden Pfizer Investigational Site Orebro
Sweden Pfizer Investigational Site Stockholm
Sweden Pfizer Investigational Site Uppsala
Sweden Pfizer Investigational Site Vasteras
United Kingdom Pfizer Investigational Site Birmingham
United Kingdom Pfizer Investigational Site Bolton Lancs
United Kingdom Pfizer Investigational Site Bristol Gloucestershire
United Kingdom Pfizer Investigational Site Cheltenham Gloucestershire
United Kingdom Pfizer Investigational Site Glasgow
United Kingdom Pfizer Investigational Site Lancaster
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Norwich Norfolk
United Kingdom Pfizer Investigational Site Redhill Surrey
United Kingdom Pfizer Investigational Site Uxbridge Middlesex

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Australia,  Belgium,  Denmark,  France,  Germany,  Greece,  Ireland,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of increase of iris pigmentation
Primary incidence of development in darkening/lengthening/thickening of eyelashes and/or pigmentation of periorbital skin
Primary occurrence of ocular/periorbital adverse events
Primary occurrence of serious adverse events.
See also
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Completed NCT01664039 - An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN® Phase 4
Completed NCT01693315 - Multiple Dose-escalation Study of AMA0076 in Patients With Ocular Hypertension or Primary Open-angle Glaucoma Phase 2
Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
Completed NCT01410188 - Safety/Efficacy Study: OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension Phase 1/Phase 2
Completed NCT01489670 - Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension N/A

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