Status: Finalised First registered on: 27/11/2013
Last updated on: 25/07/2017
1. Study identification
EU PAS Register NumberEUPAS5278
Official titleEvaluation of the Use of Nepafenac in Selected European Populations
Study title acronym
Study typeObservational study
Brief description of the studyThis study is a drug utilization study to evaluate the use of nepafenac (Nevanac), an ophthalmic non-steroidal agent, in two selected European populations from Denmark and The Netherlands. In Europe, nepafenac has been approved for (1) prevention and treatment of postoperative pain and inflammation associated with cataract surgery in adults (approval in 2007) and (2) to reduce the risk of macular edema after cataract surgery in diabetic patients (approval in 2011). The aim of this study is describe the use of nepafenac. This will be a cohort study including new users of nepafenac and new users of other selected ophthalmic NSAIDs. The study will be conducted in the network of databases from the National Health Databases in Denmark and the PHARMO Record Linkage System database in the Netherlands. Patients will become eligible for cohort entry after 6 months of enrolment in the databases. The exposure will be based on dispensed prescriptions, medical condition concomitant to the exposure will be derived from diagnoses and procedures around the prescription dispensing date. Target conditions for this evaluation are cataract surgery, refractive procedures, other ophthalmic procedures, two or more ophthalmic surgeries or procedures, dry eye/Sjögren syndrome, uveitis/iritis, ophthalmic manifestations of allergy, ocular pain, macular edema, vitreous-related disorders. The study will report the frequency of the demographic characteristics of nepafenac users and users of other selected individual ophthalmic NSAIDs. The potential off-label use of nepafenac will be characterized as, a) use not preceded by cataract surgery b) use preceded by cataract but longer than 21 days in patients without diabetes or longer than 60 days in patients with diabetes c) use in individuals aged less than 19 years.
Was this study requested by a regulator?Yes: EMA
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 belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Website/Homepagewww.rtihs.org
Details of (Primary) lead investigator
Title Dr
Last name Arana Navarro
First name Alejandro
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3

PHARMO Institute
University of Southern Denmark Pharmacoepi center
RTI-HS
Countries in which this study is being conducted
International study

Denmark
Netherlands
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/02/201325/03/2013
Start date of data collection30/06/201522/09/2015
Start date of data analysis01/08/201522/09/2015
Date of interim report, if expected
Date of final study report31/03/201631/03/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesAlcon Labs, Inc.100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Arana Navarro
First name Alejandro
Address line 1Trav. Gracia, 56, Atico 1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain
Phone number (incl. country code)34933622805 
Alternative phone number 
Fax number (incl. country code)34934142610 
Email address aarana@rti.org
Public Enquiries
Title Dr 
Last name Arana Navarro 
First name Alejandro 
Address line 1Trav. Gracia, 56, Atico 1 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08006 
CountrySpain 
Phone number (incl. country code)34933622805 
Alternative phone number 
Fax number (incl. country code)34934142610 
Email address aarana@rti.org 
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