Study identification

PURI

https://redirect.ema.europa.eu/resource/20038

EU PAS number

EUPAS5278

Study ID

20038

Official title and acronym

Evaluation of the Use of Nepafenac in Selected European Populations

DARWIN EU® study

No

Study countries

Denmark
Netherlands

Study description

This 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.

Study status

Finalised
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
InstitutionNot-for-profitENCePP partner
N/A
RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
InstitutionNot-for-profitENCePP partner

Contact details

Alejandro Arana Navarro

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Alcon Labs, Inc.
Study protocol
Initial protocol

Redacted Nevanac Protocol Summary

English (584.01 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)