PMID- 32072493
OWN - NLM
STAT- MEDLINE
DCOM- 20201204
LR  - 20220408
IS  - 1865-8652 (Electronic)
IS  - 0741-238X (Print)
IS  - 0741-238X (Linking)
VI  - 37
IP  - 4
DP  - 2020 Apr
TI  - Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free 
      Tafluprost/Timolol Fixed-Dose Combination Therapy: The VISIONARY Study.
PG  - 1436-1451
LID - 10.1007/s12325-020-01239-8 [doi]
AB  - INTRODUCTION: A non-interventional, multicenter, European, prospective evaluation 
      of the effectiveness, tolerability, and safety of a topical preservative-free 
      tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (PF 
      tafluprost/timolol FC) in adults with open-angle glaucoma (OAG) and ocular 
      hypertension (OHT) demonstrating insufficient response to topical beta-receptor 
      blockers or prostaglandin analogue (PGA) monotherapy. METHODS: Mean intraocular 
      pressure (IOP) change from baseline was measured at study visits following a 
      switch to PF tafluprost/timolol FC. Primary endpoint was absolute mean IOP change 
      at month 6. Change from baseline concerning ocular signs and symptoms was also 
      explored. RESULTS: Analyses included 577 patients (59.6% female). Mean age (SD) 
      was 67.8 (11.67) years. Mean (SD) IOP reduction from baseline was significant at 
      all study visits; 5.4 (3.76) mmHg (23.7%) at week 4, 5.9 (3.90) mmHg (25.6%) at 
      week 12, and 5.7 (4.11) mmHg (24.9%) at month 6 (p < 0.0001 for all visits). At 
      month 6, 69.2%, 53.6%, 40.0%, and 25.8% were responders based on >/= 20%, >/= 25%, 
      >/= 30%, and >/= 35% cutoff values for mean IOP, respectively. Significant reductions 
      were observed concerning corneal fluorescein staining (p < 0.0001), dry eye 
      symptoms, irritation, itching, and foreign body sensation (p < 0.001 for each 
      parameter). Conjunctival hyperemia was significantly reduced at all study visits 
      (p < 0.0001 at each visit). Overall, 69 treatment-related adverse events (AEs) 
      were reported, one of which was serious (status asthmaticus). Most AEs were mild 
      to moderate in severity, and the majority had resolved or were resolving at the 
      end of the study period. CONCLUSION: In clinical practice, PF tafluprost/timolol 
      FC provided statistically and clinically significant IOP reductions in patients 
      with OAG and OHT insufficiently controlled on or intolerant to PGA or 
      beta-receptor blocker monotherapy. The full IOP reduction appeared at week 4 and 
      was maintained over the 6-month study period. Key symptoms of ocular surface 
      health improved. TRIAL REGISTRATION: European Union electronic Register of 
      Post-Authorisation Studies (EU PAS) register number, EUPAS22204.
FAU - Oddone, Francesco
AU  - Oddone F
AD  - IRCSS-Fondazione Bietti, Rome, Italy. oddone-bietti@gmail.com.
FAU - Tanga, Lucia
AU  - Tanga L
AD  - IRCSS-Fondazione Bietti, Rome, Italy.
FAU - Kothy, Peter
AU  - Kothy P
AD  - Department of Ophthalmology, Semmelweis University, Budapest, Hungary.
FAU - Hollo, Gabor
AU  - Hollo G
AD  - Department of Ophthalmology, Semmelweis University, Budapest, Hungary.
CN  - VISIONARY Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20200218
PL  - United States
TA  - Adv Ther
JT  - Advances in therapy
JID - 8611864
RN  - 0 (Antihypertensive Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Preservatives, Pharmaceutical)
RN  - 0 (Prostaglandins F)
RN  - 0 (Prostaglandins, Synthetic)
RN  - 1O6WQ6T7G3 (tafluprost)
RN  - 817W3C6175 (Timolol)
EIN - Adv Ther. 2020 Jun 21;:. PMID: 32567020
MH  - Aged
MH  - Aged, 80 and over
MH  - Antihypertensive Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Drug Combinations
MH  - Female
MH  - Glaucoma, Open-Angle/*drug therapy
MH  - Humans
MH  - Intraocular Pressure
MH  - Male
MH  - Middle Aged
MH  - Ocular Hypertension/*drug therapy
MH  - Preservatives, Pharmaceutical
MH  - Prospective Studies
MH  - Prostaglandins F/administration & dosage/adverse effects/*therapeutic use
MH  - Prostaglandins, Synthetic/administration & dosage/adverse effects/*therapeutic 
      use
MH  - Timolol/administration & dosage/adverse effects/*therapeutic use
MH  - Tonometry, Ocular
PMC - PMC7140739
OTO - NOTNLM
OT  - Fixed-dose combination
OT  - Ocular hypertension
OT  - Open-angle glaucoma
OT  - Ophthalmology
OT  - Preservative-free topical medication
OT  - Tafluprost
OT  - Timolol
FIR - Faschinger, Christoph
IR  - Faschinger C
FIR - Chen, Enping
IR  - Chen E
FIR - Hollo, Gabor
IR  - Hollo G
FIR - Nemeth, Gabor
IR  - Nemeth G
FIR - Bator, Gyorgy
IR  - Bator G
FIR - Tsorbatzoglou, Alexis
IR  - Tsorbatzoglou A
FIR - Acs, Tamas
IR  - Acs T
FIR - Ferencz, Maria
IR  - Ferencz M
FIR - Sohajda, Zoltan
IR  - Sohajda Z
FIR - Toth, Jeno
IR  - Toth J
FIR - Volner, Veronika
IR  - Volner V
FIR - Vogt, Gabor
IR  - Vogt G
FIR - Biro, Zsolt
IR  - Biro Z
FIR - Facsko, Andrea
IR  - Facsko A
FIR - Nemes, Janos
IR  - Nemes J
FIR - Berta, Andras
IR  - Berta A
FIR - Elek, Ilona
IR  - Elek I
FIR - Ng, Eugene
IR  - Ng E
FIR - Oddone, Francesco
IR  - Oddone F
FIR - Rossi, Gemma
IR  - Rossi G
FIR - Rossetti, Luca
IR  - Rossetti L
FIR - Vetrugno, Michele
IR  - Vetrugno M
FIR - Iester, Michele
IR  - Iester M
FIR - Marchini, Giorgio
IR  - Marchini G
FIR - Scorcia, Vincenzo
IR  - Scorcia V
FIR - Staurenghi, Giovanni
IR  - Staurenghi G
FIR - Cagini, Carlo
IR  - Cagini C
FIR - Salgarello, Tommaso
IR  - Salgarello T
FIR - Bettin, Paolo
IR  - Bettin P
FIR - Figus, Michele
IR  - Figus M
FIR - Scuderi, Gian Luca
IR  - Scuderi GL
FIR - De Cilla, Stefano
IR  - De Cilla S
FIR - Grundmane, Iveta
IR  - Grundmane I
FIR - Linavska, Nora
IR  - Linavska N
FIR - Volksone, Lasma
IR  - Volksone L
FIR - Laganovska, Guna
IR  - Laganovska G
FIR - Baumane, Kristine
IR  - Baumane K
FIR - Lemij, Hans
IR  - Lemij H
FIR - Gundersen, Kjell Gunnar
IR  - Gundersen KG
FIR - Zimina, Marina
IR  - Zimina M
FIR - Erichev, Valery
IR  - Erichev V
FIR - Karlova, Elena
IR  - Karlova E
FIR - Zakharova, Ekaterina
IR  - Zakharova E
FIR - Panova, Irina
IR  - Panova I
FIR - Malyugin, Boris
IR  - Malyugin B
FIR - Aguirrec, Inaki Rodriguez
IR  - Aguirrec IR
FIR - Lopez-Lopez, Fernando
IR  - Lopez-Lopez F
FIR - Valladares, Antonio Moreno
IR  - Valladares AM
FIR - Del Castillo, Javier Benitez
IR  - Del Castillo JB
FIR - Gimenez, Rafael
IR  - Gimenez R
FIR - Vallejo, Maria Parrilla
IR  - Vallejo MP
FIR - Medina, Jose Garcia
IR  - Medina JG
FIR - Lopez, Alfonso Anton
IR  - Lopez AA
FIR - Torregrosa, Sergio
IR  - Torregrosa S
FIR - Loscos, Jorge
IR  - Loscos J
FIR - Kolko, Miriam
IR  - Kolko M
FIR - Ansari, Ejaz
IR  - Ansari E
FIR - Broadway, David
IR  - Broadway D
FIR - Claridge, Katharine
IR  - Claridge K
FIR - Ruben, Simon
IR  - Ruben S
FIR - Kirwan, James
IR  - Kirwan J
FIR - Nita, Anca
IR  - Nita A
FIR - Smith, Micheal
IR  - Smith M
FIR - Moosavi, Areeb
IR  - Moosavi A
FIR - King, Anthony J W
IR  - King AJW
FIR - Kinsella, Matthew
IR  - Kinsella M
EDAT- 2020/02/20 06:00
MHDA- 2020/12/15 06:00
PMCR- 2020/02/18
CRDT- 2020/02/20 06:00
PHST- 2019/12/23 00:00 [received]
PHST- 2020/02/20 06:00 [pubmed]
PHST- 2020/12/15 06:00 [medline]
PHST- 2020/02/20 06:00 [entrez]
PHST- 2020/02/18 00:00 [pmc-release]
AID - 10.1007/s12325-020-01239-8 [pii]
AID - 1239 [pii]
AID - 10.1007/s12325-020-01239-8 [doi]
PST - ppublish
SO  - Adv Ther. 2020 Apr;37(4):1436-1451. doi: 10.1007/s12325-020-01239-8. Epub 2020 
      Feb 18.