Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(S01BC10) nepafenac
nepafenac

Medical condition to be studied

Off label use
Population studied

Short description of the study population

New users of nepafenac and new users of other selected ophthalmic NSAIDs with at least 6 months of previous enrolment in the database.

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

4000
Study design details

Main study objective

The main objective of the study is to characterize off-label use of nepafenac.

Data analysis plan

The analysis will be descriptive. In the baseline analysis, characteristics of users of nepafenac and users of other selected ophthalmic NSAIDs will be assessed at the cohort entry date. The medical condition associated with use of nepafenac and other ophthalmic NSAIDs will be also assessed.In the treatment period analysis, a) patterns of duration of prescriptions for nepafenac or other ophthalmic NSAIDS will be evaluated, especially those of off-label duration b) patterns of duration of prescriptions for nepafenac or other ophthalmic NSAIDs without prior cataract surgery will be evaluated c) the proportion of patients using specific medications during treatment with nepafenac or other ophthalmic NSAIDs will be evaluated.
Documents
Study publications
Margulis AV, Houben E, Hallas J, Overbeek JA, PottegAard A, Torp‐Pedersen T, Pe…