Status: Finalised First registered on: 16/12/2014
Last updated on: 19/09/2016
1. Study identification
EU PAS Register NumberEUPAS8241
Official titleA population-based cohort study using an existing database to evaluate the association between latanoprost use and primary malignant ocular melanoma and facial cutaneous melanoma
Study title acronym
Study typeObservational study
Brief description of the studyThe primary research aim of this study is to examine the potential association between latanoprost and primary malignant ocular melanoma (OM) and facial cutaneous melanoma (CM), respectively. The secondary research aim is to examine the potential association between prostaglandin analogues (PGAs) and primary malignant OM and facial CM, respectively. A population-based cohort study will be conducted based on secondary use of existing data. The study population will include patients with recorded glaucoma or ocular hypertension (OH) in the Swedish national health care registers from July 1st, 2005 to December 31st, 2011 and with no previous malignant melanoma. Exposure groups (latanoprost, other topical PGAs and topical non-PGAs) will be categorized based on drug exposure data collected from the Swedish Prescription Drug Register (SPDR). Primary malignant OM and facial CM of each patient will be identified from the Swedish Cancer Register (SCR). Cox regression models will be developed to evaluate independent effects of having OM and facial CM, respectively, in association with use of latanoprost and topical PGAs, adjusting for potential confounding variables.
Was this study requested by a regulator?Yes: United Kingdom
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCentre for Pharmacoepidemiology (CPE)
Department/Research groupDepartment of medicine/Clinical epidemiology unit
Organisation/affiliationKarolinska Institutet
Website/Homepagehttp://ki.se/meds/centrum-for-lakemedelsepidemiologi
Details of (Primary) lead investigator
Title Dr
Last name George
First name Prethibha
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed15/05/201310/06/2013
Start date of data collection15/02/201505/01/2015
Start date of data analysis15/04/201512/05/2015
Date of interim report, if expected
Date of final study report30/09/201609/09/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPfizer Inc.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name George
First name Prethibha
Address line 1235 East 42nd Street
Address line 2MS 219-9-1 
Address line 3 
CityNew York 
Postcode10017 
CountryUnited States
Phone number (incl. country code)1-212-7335422 
Alternative phone number 
Fax number (incl. country code) 
Email address prethibha.george@pfizer.com
Public Enquiries
Title Dr 
Last name George 
First name Prethibha 
Address line 1235 East 42nd Street 
Address line 2MS 219-9-1 
Address line 3 
CityNew York 
Postcode10017 
CountryUnited States 
Phone number (incl. country code)1-212-7335422 
Alternative phone number 
Fax number (incl. country code) 
Email address prethibha.george@pfizer.com 
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