PMID- 33886093
OWN - NLM
STAT- MEDLINE
DCOM- 20210622
LR  - 20211130
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 38
IP  - 6
DP  - 2021 Jun
TI  - Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free 
      Tafluprost/Timolol Fixed-Dose Combination Therapy: UK and Ireland Results from 
      the VISIONARY Study.
PG  - 2990-3002
LID - 10.1007/s12325-021-01725-7 [doi]
AB  - INTRODUCTION: Reducing intraocular pressure (IOP), the only modifiable risk 
      factor for open-angle glaucoma (OAG), is important for the preservation of vision 
      and slowing of disease progression. Preservative-free tafluprost 
      (0.0015%)/timolol (0.5%) fixed combination (PF Taf-T FC) is an approved 
      combination therapy for OAG treatment. The VISIONARY study aimed to evaluate the 
      effectiveness and tolerability of PF Taf-T FC in real-world clinical settings. 
      Here, we present the results from the United Kingdom (UK) and Ireland. METHODS: 
      This observational, multicentre, European, prospective study recorded data during 
      routine clinic appointments on the use of PF Taf-T FC for the treatment of OAG 
      and ocular hypertension (OHT) in patients whose disease was insufficiently 
      controlled on a prostaglandin analogue (PGA) or beta blocker monotherapy or who 
      did not tolerate these medications. Mean change in IOP, symptom severity, changes 
      in clinical signs, and tolerability were investigated over 6 months. RESULTS: 
      Eighty-two patients were recruited in the UK and Ireland. After 6 months of PF 
      Taf-T FC treatment, mean IOP was significantly reduced from 22.0 to 16.2 mmHg in 
      the UK group and from 18.6 to 14.1 mmHg in the Ireland group. In the UK (65 
      patients), 49 adverse events (AEs) were reported, of which 3 were serious. No AEs 
      were reported in the Ireland group (17 patients). Overall, 91.9% of UK physicians 
      reported PF Taf-T FC treatment to be the same or better than prior medication for 
      improving clinical signs; 90.0% of UK patients reported PF Taf-T FC treatment to 
      have good or very good tolerability. CONCLUSIONS: Treatment with PF Taf-T FC 
      resulted in significant reductions in mean IOP over 6 months. Patients and 
      physicians reported that treatment was well tolerated. These data demonstrate 
      real-world efficacy of PF Taf-T FC for the treatment of OAG and OHT in routine 
      clinical practice in the UK and Ireland. TRIAL REGISTRATION: European Union 
      electronic Register of Post-Authorisation Studies (EU PAS) register number, 
      EUPAS22204.
FAU - Ansari, Ejaz
AU  - Ansari E
AUID- ORCID: 0000-0001-8943-8209
AD  - Maidstone and Tunbridge Wells NHS Trust, University of Kent at Canterbury, Kent, 
      UK. e.ansari@nhs.net.
FAU - Pavicic-Astalos, Jasna
AU  - Pavicic-Astalos J
AD  - Institute of Eye Surgery, UPMC Whitfield, Waterford, Ireland.
FAU - Ayan, Filis
AU  - Ayan F
AD  - Santen UK Ltd, St Albans, UK.
FAU - King, Anthony J
AU  - King AJ
AD  - Nottingham University Hospitals NHS Trust, Nottingham, UK.
FAU - Kinsella, Matthew
AU  - Kinsella M
AD  - Buckinghamshire Healthcare NHS Trust, Stoke Mandeville Hospital, Aylesbury, 
      Buckinghamshire, UK.
FAU - Ng, Eugene
AU  - Ng E
AD  - Institute of Eye Surgery, UPMC Whitfield, Waterford, Ireland.
FAU - Nita, Anca
AU  - Nita A
AD  - Royal Victoria Infirmary, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, 
      Newcastle upon Tyne, UK.
CN  - VISIONARY Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20210422
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Prostaglandins F)
RN  - 1O6WQ6T7G3 (tafluprost)
RN  - 817W3C6175 (Timolol)
EIN - Adv Ther. 2022 Jan;39(1):831. PMID: 34846712
MH  - Antihypertensive Agents/therapeutic use
MH  - Drug Combinations
MH  - *Glaucoma, Open-Angle/drug therapy
MH  - Humans
MH  - Intraocular Pressure
MH  - Ireland
MH  - *Ocular Hypertension/drug therapy
MH  - Prospective Studies
MH  - Prostaglandins F
MH  - Timolol
MH  - United Kingdom
PMC - PMC8190000
OTO - NOTNLM
OT  - Fixed-dose combination
OT  - Ocular hypertension
OT  - Open-angle glaucoma
OT  - Ophthalmology
OT  - Preservative-free topical medication
OT  - Tafluprost
OT  - Timolol
EDAT- 2021/04/23 06:00
MHDA- 2021/06/23 06:00
PMCR- 2021/04/22
CRDT- 2021/04/22 12:29
PHST- 2021/02/09 00:00 [received]
PHST- 2021/03/24 00:00 [accepted]
PHST- 2021/04/23 06:00 [pubmed]
PHST- 2021/06/23 06:00 [medline]
PHST- 2021/04/22 12:29 [entrez]
PHST- 2021/04/22 00:00 [pmc-release]
AID - 10.1007/s12325-021-01725-7 [pii]
AID - 1725 [pii]
AID - 10.1007/s12325-021-01725-7 [doi]
PST - ppublish
SO  - Adv Ther. 2021 Jun;38(6):2990-3002. doi: 10.1007/s12325-021-01725-7. Epub 2021 
      Apr 22.