PMID- 35677639
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 1177-5467 (Print)
IS  - 1177-5483 (Electronic)
IS  - 1177-5467 (Linking)
VI  - 16
DP  - 2022
TI  - Treatment of Open-Angle Glaucoma and Ocular Hypertension with the Fixed-Dose 
      Combination of Preservative-Free Tafluprost/Timolol: Clinical Outcomes from 
      Ophthalmology Clinics in Italy.
PG  - 1707-1719
LID - 10.2147/OPTH.S364880 [doi]
AB  - INTRODUCTION: The VISIONARY study examined the intraocular pressure 
      (IOP)-lowering efficacy and tolerability of the preservative-free fixed-dose 
      combination of tafluprost (0.0015%) and timolol (0.5%) (PF tafluprost/timolol FC) 
      in a real-world setting. The country-level data reported herein comprise the 
      largest and first observational study of PF tafluprost/timolol FC therapy in 
      Italy. METHODS: An observational, multicenter, prospective study included adult 
      Italian patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) 
      demonstrating insufficient response or poor tolerability with topical 
      prostaglandin analogue (PGA) or beta-blocker monotherapy. Treatment was switched 
      to PF tafluprost/timolol FC therapy at baseline. Primary endpoint was the 
      absolute mean IOP change from baseline at Month 6. Exploratory and safety 
      endpoints included change in IOP at Weeks 4 and 12, ocular signs, symptom 
      severity and reporting of adverse events (AEs). RESULTS: Overall, 160 OAG/OHT 
      patients were included. Mean +/- standard deviation IOP was reduced from 19.6 +/- 3.6 
      mmHg at baseline to 14.5 +/- 2.6 mmHg at Month 6 (reduction of 5.1 +/- 3.7 mmHg; 
      24.1%; p < 0.0001). IOP reduction was also statistically significant at Week 4 
      (23.1%; p < 0.0001) and Week 12 (24.7%; p < 0.0001). Based on data cutoff values 
      for mean IOP change of >/=20%, >/=25%, >/=30% and >/=35%, respective Month 6 responder 
      rates were 68.1%, 48.7%, 36.2% and 26.9%. Most ocular signs and symptoms were 
      significantly reduced in severity from baseline at Month 6. Two non-serious and 
      mild AEs were reported during the study period, among which, one AE was 
      treatment-related (eyelash growth).  . CONCLUSION: Italian OAG and OHT patients 
      demonstrated a significant IOP reduction from baseline at Week 4 that was 
      maintained over a 6-month period following a switch from topical PGA or 
      beta-blocker monotherapy to PF tafluprost/timolol FC therapy. Severity of most 
      ocular signs and symptoms was significantly reduced during the study period, and 
      PF tafluprost/timolol FC was generally well tolerated.
CI  - (c) 2022 Oddone et al.
FAU - Oddone, Francesco
AU  - Oddone F
AD  - Glaucoma Unit, IRCSS-Fondazione Bietti, Roma, Italy.
FAU - Scorcia, Vincenzo
AU  - Scorcia V
AUID- ORCID: 0000-0001-6826-7957
AD  - Department of Ophthalmology, University Magna Graecia of Catanzaro, Catanzaro, 
      Italy.
FAU - Iester, Michele
AU  - Iester M
AD  - Eye Clinic of Genoa, Department of Neuroscience, Rehabilitation, Ophthalmology, 
      Genetics, Maternal and Child Health (DiNOGMI), University of Genova, Genova, 
      Italy.
FAU - Sisto, Dario
AU  - Sisto D
AD  - Ophthalmology Department, University of Bari, Bari, Italy.
FAU - De Cilla, Stefano
AU  - De Cilla S
AD  - Department of Health Sciences, Eye Clinic, University of Piemonte Orientale, 
      Novara, Italy.
FAU - Bettin, Paolo
AU  - Bettin P
AD  - Department of Ophthalmology, IRCCS San Raffaele Scientific Institute, Vita-Salute 
      San Raffaele University, Milano, Italy.
FAU - Cagini, Carlo
AU  - Cagini C
AUID- ORCID: 0000-0002-3812-9219
AD  - Department of Medicine and Surgery, Ophthalmology Section, University of Perugia, 
      Perugia, Italy.
FAU - Figus, Michele
AU  - Figus M
AUID- ORCID: 0000-0003-2243-9033
AD  - Ophthalmology, Department of Surgery, Medicine, Molecular and Emergency, 
      University of Pisa, Pisa, Italy.
FAU - Marchini, Giorgio
AU  - Marchini G
AUID- ORCID: 0000-0002-4657-3168
AD  - Ophthalmology Unit, Department of Neurosciences, Biomedicine and Movement, 
      University of Verona, Verona, Italy.
FAU - Rossetti, Luca
AU  - Rossetti L
AD  - Eye Clinic, San Paolo Hospital, University of Milan, Milano, Italy.
FAU - Rossi, Gemma
AU  - Rossi G
AD  - University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
FAU - Salgarello, Tommaso
AU  - Salgarello T
AD  - Ophthalmology Unit, Department of Ageing, Neurosciences, Head-Neck and 
      Orthopaedics Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, 
      Roma, Italy.
AD  - Institute of Ophthalmology, Universita Cattolica del Sacro Cuore, Roma, Italy.
FAU - Scuderi, Gian Luca
AU  - Scuderi GL
AD  - NESMOS Department, Ophthalmology Unit, St. Andrea Hospital, Universita di Roma La 
      Sapienza, Roma, Italy.
FAU - Staurenghi, Giovanni
AU  - Staurenghi G
AUID- ORCID: 0000-0002-2299-5251
AD  - Eye Clinic, Department of Biomedical and Clinical Sciences Luigi Sacco, 
      University of Milan, Milano, Italy.
CN  - VISIONARY Study Group (Italy)
LA  - eng
PT  - Journal Article
DEP - 20220601
PL  - New Zealand
TA  - Clin Ophthalmol
JT  - Clinical ophthalmology (Auckland, N.Z.)
JID - 101321512
PMC - PMC9167838
OTO - NOTNLM
OT  - PF tafluprost/timolol FC
OT  - fixed-dose combination therapy
OT  - intraocular pressure
OT  - ocular hypertension
OT  - preservative-free topical medication
OT  - primary open-angle glaucoma
COIS- Francesco Oddone has received consultancy fees from Santen, Allergan, Sooft, 
      Thea, Omikron Italia, Centervue and Novartis. Vincenzo Scorcia has no relevant 
      financial disclosures. Michele Iester has received consultancy fees from SIFI and 
      Thea, speaker grant from Santen, Omikron Italia and Thea. Dario Sisto has no 
      relevant financial disclosures. Stefano De Cilla has no relevant financial 
      disclosures. Paolo Bettin has not received any fee from any company in the last 
      two years. Carlo Cagini has no relevant financial disclosures. Michele Figus has 
      no relevant financial disclosures. Giorgio Marchini has no relevant financial 
      disclosures. Luca Rossetti received fees from Aerie, Alcon, Allergan, Centervue, 
      Novartis, NTC, Omikron. Gemma Rossi has no relevant financial disclosures. 
      Tommaso Salgarello received no specific funding for this work. Gian Luca Scuderi 
      has received consultancy fees from Santen, Allergan, Sooft, Omikron Italy. 
      Giovanni Staurenghi has received consultant/advisor fees from Heidelberg 
      Engineering, Centervue, Apellis, Allergan, Astellas, Bayer, Boehringer, 
      Genentech, Iveric, Novartis, Roche and Chengdu Kanghong Biotechnology Co, Kyoto 
      Drug Discovery & Development Co; grant support from Heidelberg Engineering, 
      Optos, Optovue, Quantel Medical, Centervue, Carl Zeiss Meditec, Nidek and Topcon; 
      lecture fees from Heidelberg Engineering, Nidek, Bayer, Novartis and Roche; 
      patents/royalty from Ocular Instruments. The authors report no other conflicts of 
      interest in this work.
EDAT- 2022/06/10 06:00
MHDA- 2022/06/10 06:01
PMCR- 2022/06/01
CRDT- 2022/06/09 02:18
PHST- 2022/03/17 00:00 [received]
PHST- 2022/05/11 00:00 [accepted]
PHST- 2022/06/09 02:18 [entrez]
PHST- 2022/06/10 06:00 [pubmed]
PHST- 2022/06/10 06:01 [medline]
PHST- 2022/06/01 00:00 [pmc-release]
AID - 364880 [pii]
AID - 10.2147/OPTH.S364880 [doi]
PST - epublish
SO  - Clin Ophthalmol. 2022 Jun 1;16:1707-1719. doi: 10.2147/OPTH.S364880. eCollection 
      2022.