Status: Finalised First registered on: 28/11/2013
Last updated on: 20/06/2017
1. Study identification
EU PAS Register NumberEUPAS5312
Official titleObservational study of the persistence antiglaucoma eyedrops to
Study title acronym
Study typeObservational study
Brief description of the studyGlaucoma is an eye disease leading, if not treated, to progressive, irreversible vision loss. Prevalence of glaucoma in France is around 2% of the population older than 40. Treatment of glaucoma is usually topical ocular hypotensive medication (eye drops), that should be administered at long term. Adherence, and especially persistence, are essential for the success of the treatment. Non- or poor adherence may induce public health and economic consequences. Persistence under hypotensive eye drops medications in glaucoma management is expected to be rather poor (induced by chronical condition and mode of administration) but is not well documented. This study aims to assess in the french population the persistence under different topical ocular hypotensive medications, based on the French national health insurance database (EGB) which contains healthcare reimbursement data of 1/97 of the French population. The objective of the study is to compare the 12-month persistence under different topical ocular hypotensive medications in glaucoma management. It will include the description and the comparison of persistence in glaucoma management between different topical ocular hypotensive treatments 12 months after treatment initiation, the identification of predictive factors for persistent and non persistent patients and the assessment of the prevalence and incidence of topical ocular hypotensive medications in France from 2005 to 2009.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 belongsPELyon
Department/Research groupUnité de Pharmacoépidémiologie
Organisation/affiliationUniversité Claude Bernard Lyon 1
Website/Homepagehttp://eia.univ-lyon1.fr
Details of (Primary) lead investigator
Title Dr
Last name VAN GANSE
First name Eric
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

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/06/2010
Start date of data collection31/08/2010
Start date of data analysis
Date of interim report, if expected
Date of final study report31/03/2011
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPfizer100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name VAN GANSE
First name Eric
Address line 1Unité de Pharmacoépidémiologie
Address line 2Faculte d'Odontologie Universite Lyon 1 
Address line 311 rue Guillaume Paradin 
CityLyon cedex 08 
PostcodeF-69372 
CountryFrance
Phone number (incl. country code)33-478778610 
Alternative phone number 
Fax number (incl. country code)33-478778660 
Email address eric.van-ganse@univ-lyon1.fr
Public Enquiries
Title Dr 
Last name VAN GANSE 
First name Eric 
Address line 1Unité de Pharmacoépidémiologie 
Address line 2Faculte d'Odontologie Universite Lyon 1 
Address line 311 rue Guillaume Paradin 
CityLyon cedex 08 
PostcodeF-69372 
CountryFrance 
Phone number (incl. country code)33-478778610 
Alternative phone number 
Fax number (incl. country code)33-478778660 
Email address eric.van-ganse@univ-lyon1.fr 
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