This was a 6-month, observational, multicenter, European, prospective clinical study. In line with European Medicines Agency (EMA) requirements, the study was registered under the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®) European Union electronic Register of Post-Authorisation Studies (EU PAS Register) (EU PAS register number EUPAS22204). The study complied with the principles of the Declaration of Helsinki. All patients included were required to provide written informed consent prior to their enrollment. The study protocol was approved by the institutional review board (IRB) or independent ethics committee (IEC) at each center/institution. The study centers/institutions are listed in the Acknowledgments alongside the relevant principal investigator.
Data were prospectively collected during routine visits, between 10 April 2017 and 9 January 2019, at 66 ophthalmology clinics in Austria, Denmark, Hungary, Ireland, Italy, Latvia, Netherlands, Norway, Russia, Spain, Sweden, and the UK. For patients, attendance was mandatory only for the baseline and month 6 study visits. However, data were recorded during interim study visits at week 4 and week 12 for participants who chose to attend these visits.
Baseline measures were recorded under topical PGA or beta-receptor blocker medication within 7 days prior to therapy change to PF tafluprost/timolol FC. Variables were documented for each eye separately at baseline and at study visits following initiation of PF tafluprost/timolol FC treatment. Where data on both eyes were available, the eye with the higher baseline IOP value was selected for analysis (study eye).
Data were prospectively collected during routine visits, between 10 April 2017 and 9 January 2019, at 66 ophthalmology clinics in Austria, Denmark, Hungary, Ireland, Italy, Latvia, Netherlands, Norway, Russia, Spain, Sweden, and the UK. For patients, attendance was mandatory only for the baseline and month 6 study visits. However, data were recorded during interim study visits at week 4 and week 12 for participants who chose to attend these visits.
Baseline measures were recorded under topical PGA or beta-receptor blocker medication within 7 days prior to therapy change to PF tafluprost/timolol FC. Variables were documented for each eye separately at baseline and at study visits following initiation of PF tafluprost/timolol FC treatment. Where data on both eyes were available, the eye with the higher baseline IOP value was selected for analysis (study eye).