Incidence, prevalence and burden of Dry Eye diseAse in France (IDEA)

Study identification

• EU PAS number:
  EUPAS29618
• Study ID:
  49825
• Official title and acronym:
  Incidence, prevalence and burden of Dry Eye diseAse in France (IDEA)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  Dry 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
• Study status:
  Finalised

Research institutions and networks

Institutions

Bordeaux PharmacoEpi, University of Bordeaux

France

Study timelines

Date when funding contract was signed

Actual:14/05/2018

Study start date

Planned:30/05/2019

Actual:21/10/2019

Data analysis start date

Planned:30/05/2019

Date of final study report

Planned:30/09/2019

Actual:21/10/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Shire

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable