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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00150267




Registration number
NCT00150267
Ethics application status
Date submitted
6/09/2005
Date registered
8/09/2005
Date last updated
5/11/2008

Titles & IDs
Public title
A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension
Scientific title
A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension
Secondary ID [1] 0 0
912-OPT-0076-019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glaucoma, Open-Angle 0 0
Ocular Hypertension 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Xalacom

Treatment: Drugs: Xalacom
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of increase of iris pigmentation
Timepoint [1] 0 0
Primary outcome [2] 0 0
incidence of development in darkening/lengthening/thickening of eyelashes and/or pigmentation of periorbital skin
Timepoint [2] 0 0
Primary outcome [3] 0 0
occurrence of ocular/periorbital adverse events
Timepoint [3] 0 0
Primary outcome [4] 0 0
occurrence of serious adverse events.
Timepoint [4] 0 0

Eligibility
Key inclusion criteria
- Patients with open angle glaucoma and/or ocular hypertension requiring a reduction of
IOP who were insufficiently responsive to topical betablockers
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
976
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Sydney
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2067 - Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Antwerpen
Country [2] 0 0
Belgium
State/province [2] 0 0
Brussel
Country [3] 0 0
Belgium
State/province [3] 0 0
Edegem
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Belgium
State/province [6] 0 0
Liege
Country [7] 0 0
Denmark
State/province [7] 0 0
Kobenhavn O
Country [8] 0 0
Denmark
State/province [8] 0 0
Odense C
Country [9] 0 0
France
State/province [9] 0 0
Aire Sur Adour
Country [10] 0 0
France
State/province [10] 0 0
Carcassonne
Country [11] 0 0
France
State/province [11] 0 0
Dijon
Country [12] 0 0
France
State/province [12] 0 0
Figeac
Country [13] 0 0
France
State/province [13] 0 0
Haguenau
Country [14] 0 0
France
State/province [14] 0 0
Le Cannet
Country [15] 0 0
France
State/province [15] 0 0
Loos
Country [16] 0 0
France
State/province [16] 0 0
Marseille
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
France
State/province [18] 0 0
Versailles
Country [19] 0 0
Germany
State/province [19] 0 0
Erlangen
Country [20] 0 0
Germany
State/province [20] 0 0
Freising
Country [21] 0 0
Germany
State/province [21] 0 0
Gerolzhofen
Country [22] 0 0
Germany
State/province [22] 0 0
Hirschaid
Country [23] 0 0
Germany
State/province [23] 0 0
Hoesbach
Country [24] 0 0
Germany
State/province [24] 0 0
Mainz
Country [25] 0 0
Germany
State/province [25] 0 0
Wuerzburg
Country [26] 0 0
Greece
State/province [26] 0 0
Nikea-Piraeus
Country [27] 0 0
Greece
State/province [27] 0 0
Athens
Country [28] 0 0
Greece
State/province [28] 0 0
Kavala
Country [29] 0 0
Greece
State/province [29] 0 0
Patras
Country [30] 0 0
Greece
State/province [30] 0 0
Thessaloniki
Country [31] 0 0
Ireland
State/province [31] 0 0
Co. Clare
Country [32] 0 0
Ireland
State/province [32] 0 0
Galway
Country [33] 0 0
Italy
State/province [33] 0 0
Bologna
Country [34] 0 0
Italy
State/province [34] 0 0
Firenze
Country [35] 0 0
Italy
State/province [35] 0 0
Milano
Country [36] 0 0
Italy
State/province [36] 0 0
Padova
Country [37] 0 0
Italy
State/province [37] 0 0
Perugia
Country [38] 0 0
Italy
State/province [38] 0 0
Pisa
Country [39] 0 0
Italy
State/province [39] 0 0
Siena
Country [40] 0 0
Italy
State/province [40] 0 0
Torino
Country [41] 0 0
Netherlands
State/province [41] 0 0
Alkmaar
Country [42] 0 0
Netherlands
State/province [42] 0 0
Gouda
Country [43] 0 0
Netherlands
State/province [43] 0 0
Rijswijk
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Islas Baleares
Country [46] 0 0
Spain
State/province [46] 0 0
Madrid
Country [47] 0 0
Spain
State/province [47] 0 0
Vizcaya
Country [48] 0 0
Spain
State/province [48] 0 0
Almeria
Country [49] 0 0
Spain
State/province [49] 0 0
Lugo
Country [50] 0 0
Spain
State/province [50] 0 0
Malaga
Country [51] 0 0
Spain
State/province [51] 0 0
Valencia
Country [52] 0 0
Spain
State/province [52] 0 0
Valladolid
Country [53] 0 0
Spain
State/province [53] 0 0
Zaragoza
Country [54] 0 0
Sweden
State/province [54] 0 0
Motala
Country [55] 0 0
Sweden
State/province [55] 0 0
Orebro
Country [56] 0 0
Sweden
State/province [56] 0 0
Stockholm
Country [57] 0 0
Sweden
State/province [57] 0 0
Uppsala
Country [58] 0 0
Sweden
State/province [58] 0 0
Vasteras
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Gloucestershire
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Lancs
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Middlesex
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Norfolk
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Surrey
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Birmingham
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Glasgow
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Lancaster
Country [67] 0 0
United Kingdom
State/province [67] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00150267
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00150267