A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension
1 other identifier
interventional
976
12 countries
74
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
74 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
September 6, 2005
CompletedFirst Posted
Study publicly available on registry
September 8, 2005
CompletedNovember 5, 2008
November 1, 2008
September 6, 2005
November 4, 2008
Conditions
Outcome Measures
Primary Outcomes (4)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with open angle glaucoma and/or ocular hypertension requiring a reduction of IOP who were insufficiently responsive to topical betablockers
You may not qualify if:
- Previous and current treatment with any topical ophthalmic drug containing prostaglandins; any condition in which treatment with the betablocking agent, timolol, was contraindicated.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (74)
Pfizer Investigational Site
Sydney, New South Wales, 2000, Australia
Pfizer Investigational Site
Sydney, New South Wales, 2067, Australia
Pfizer Investigational Site
Antwerp, 2020, Belgium
Pfizer Investigational Site
Brussels, 1090, Belgium
Pfizer Investigational Site
Edegem, 2650, Belgium
Pfizer Investigational Site
Ghent, 9000, Belgium
Pfizer Investigational Site
Leuven, 3000, Belgium
Pfizer Investigational Site
Liège, B-4000, Belgium
Pfizer Investigational Site
København Ø, 2100, Denmark
Pfizer Investigational Site
Odense C, 5000, Denmark
Pfizer Investigational Site
Aire Sur Adour, 40800, France
Pfizer Investigational Site
Carcassonne, 11000, France
Pfizer Investigational Site
Dijon, 21000, France
Pfizer Investigational Site
Figeac, 46100, France
Pfizer Investigational Site
Haguenau, 67500, France
Pfizer Investigational Site
Le Cannet, 06110, France
Pfizer Investigational Site
Loos, 59120, France
Pfizer Investigational Site
Marseille, 13012, France
Pfizer Investigational Site
Paris, 75011, France
Pfizer Investigational Site
Versailles, 78000, France
Pfizer Investigational Site
Erlangen, 91052, Germany
Pfizer Investigational Site
Freising, 85354, Germany
Pfizer Investigational Site
Gerolzhofen, 97447, Germany
Pfizer Investigational Site
Hirschaid, 96114, Germany
Pfizer Investigational Site
Hösbach, 63768, Germany
Pfizer Investigational Site
Mainz, 55116, Germany
Pfizer Investigational Site
Mainz, 55124, Germany
Pfizer Investigational Site
Würzburg, 97070, Germany
Pfizer Investigational Site
Piraeus, Nikea-Piraeus, 184 54, Greece
Pfizer Investigational Site
Athens, 10 672, Greece
Pfizer Investigational Site
Kavala, Greece
Pfizer Investigational Site
Pátrai, Greece
Pfizer Investigational Site
Thessaloniki, Greece
Pfizer Investigational Site
Ennis, Co. Clare, Ireland
Pfizer Investigational Site
Galway, Ireland
Pfizer Investigational Site
Siena, Siena, 23100, Italy
Pfizer Investigational Site
Bologna, 40138, Italy
Pfizer Investigational Site
Florence, 50139, Italy
Pfizer Investigational Site
Milan, 20142, Italy
Pfizer Investigational Site
Padua, 35100, Italy
Pfizer Investigational Site
Perugia, 06122, Italy
Pfizer Investigational Site
Pisa, 56127, Italy
Pfizer Investigational Site
Torino, Italy
Pfizer Investigational Site
Alkmaar, 1815 JD, Netherlands
Pfizer Investigational Site
Gouda, 2805 AH, Netherlands
Pfizer Investigational Site
Rijswijk, 2289 CA, Netherlands
Pfizer Investigational Site
Almería, Almeria, 04009, Spain
Pfizer Investigational Site
Palma de Mallorca, Balearic Islands, 07500, Spain
Pfizer Investigational Site
Badalona, Barcelona, 08916, Spain
Pfizer Investigational Site
Barcelona, Barcelona, 08025, Spain
Pfizer Investigational Site
Terrassa, Barcelona, 08221, Spain
Pfizer Investigational Site
Lugo, Lugo, 27004, Spain
Pfizer Investigational Site
Getafe, Madrid, 28905, Spain
Pfizer Investigational Site
Madrid, Madrid, 28034, Spain
Pfizer Investigational Site
Málaga, Malaga, 29009, Spain
Pfizer Investigational Site
Valencia, Valencia, 46014, Spain
Pfizer Investigational Site
Valladolid, Valladolid, 47005, Spain
Pfizer Investigational Site
Bilbao, Vizcaya, 48903, Spain
Pfizer Investigational Site
Zaragoza, Zaragoza, 50009, Spain
Pfizer Investigational Site
Motala, Sweden
Pfizer Investigational Site
Örebro, 701 85, Sweden
Pfizer Investigational Site
Stockholm, Sweden
Pfizer Investigational Site
Uppsala, 751 85, Sweden
Pfizer Investigational Site
Västerås, 721 89, Sweden
Pfizer Investigational Site
Bristol, Gloucestershire, BS1 2LX, United Kingdom
Pfizer Investigational Site
Cheltenham, Gloucestershire, GL53 7AN, United Kingdom
Pfizer Investigational Site
Bolton, Lancs, United Kingdom
Pfizer Investigational Site
Uxbridge, Middlesex, UB8 3NN, United Kingdom
Pfizer Investigational Site
Norwich, Norfolk, NR4 7UZ, United Kingdom
Pfizer Investigational Site
Redhill, Surrey, RH1 5RH, United Kingdom
Pfizer Investigational Site
Birmingham, B9 5SS, United Kingdom
Pfizer Investigational Site
Glasgow, G4 0SF, United Kingdom
Pfizer Investigational Site
Lancaster, LA1 4RP, United Kingdom
Pfizer Investigational Site
London, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
February 1, 2002
Last Updated
November 5, 2008
Record last verified: 2008-11