Status: Finalised First registered on: 03/05/2019
Last updated on: 31/10/2019
1. Study identification
EU PAS Register NumberEUPAS29618
Official titleIncidence, prevalence and burden of Dry Eye diseAse in France
Study title acronymIDEA
Study typeOther: Cohort study using the EGB (Echantillon Généraliste de Bénéficiaires), a permanent 1/97th random sample of the French healthcare claims database (SNDS)
Brief description of the studyDry Eye Disease (DED) is a multifactorial disorder due to excessive tear evaporation and/or insufficient tear production. The multiplicity of criteria (signs, symptoms, feelings) potentially used to define DED makes the assessment of DED prevalence complex (5 to 50% according to the Dry Eye Workshop II (DEWS II) of the Tear Film and Ocular Surface (TFOS) Society). Treatment of DED mainly relies on artificial tears and lifestyle advice for mild and medium stage. In some severe cases pharmacological therapy such as cyclosporine or lacrimal punctual plugs can be necessary. In France, most of the tears substitutes are reimbursed (11.3 millions of packs in 2015). All healthcare consumption regardless physician specialities would be very helpful to fully assess DED burden in France. In the context of the European Marketing Authorization Application for a new treatment for DED, Shire wants to better understand the burden of DED, through healthcare consumption regardless physician. This project is designed to estimate the prevalence and the incidence of the disease in France, as well as assess baseline characteristics of patients, treatment pattern, disease evolution, healthcare resource use and costs using EGB, a 1/97 permanent representative sample of the French nationwide claims database (SNDS). Patients with at least 3 dispensing of artificial tears over a 6-month period or one dispensing of ocular cyclosporine in 2014-2015 will be included and followed for 2 years. The French health technology assessment agency (Haute Autorité de Santé - HAS) estimates the population with DED between 3.5 and 4.7 millions of subjects in France, including 1 million with moderate or severe disease, that represents approximately 10 000 subjects expected in this EGB study. The study was cancelled at the request of the sponsor, SHIRE. The drug of interest was transferred to another pharmaceutical company which decided not to continue the associated study. Study final date: 2019/10/21
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 belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Dr
Last name Blin
First name Patrick
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 signed14/05/2018
Start date of data collection30/05/201921/10/2019
Start date of data analysis30/05/2019
Date of interim report, if expected
Date of final study report30/09/201921/10/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesShire100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Blin
First name Patrick
Address line 1University of Bordeaux
Address line 2Bordeaux PharmacoEpi CIC Bordeaux CIC1401 
Address line 3Bâtiment du Tondu, case 41, 146 rue Leo Saignat 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Blin 
First name Patrick 
Address line 1University of Bordeaux 
Address line 2Bordeaux PharmacoEpi CIC Bordeaux CIC1401 
Address line 3Bâtiment du Tondu, case 41, 146 rue Leo Saignat 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code) 
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