{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T03:07:16Z","timestamp":1792292836838,"version":"4.4.0"},"reference-count":59,"publisher":"SAGE Publications","issue":"3","license":[{"start":{"date-parts":[[2022,4,1]],"date-time":"2022-04-01T00:00:00Z","timestamp":1648771200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2022,4,1]],"date-time":"2022-04-01T00:00:00Z","timestamp":1648771200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Ocular Pharmacology and Therapeutics"],"published-print":{"date-parts":[[2022,4,1]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose:<\/jats:title>\n                    <jats:p>Data are presented from ophthalmology clinics in Spain participating in the VISIONARY study, examining the effectiveness, tolerability, and safety of the preservative-free tafluprost (0.0015%) and timolol (0.5%) fixed-dose combination (PF tafluprost\/timolol FC) in the treatment of OAG and OHT.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>An observational, multicenter prospective study examined treatment outcomes following a switch to PF tafluprost\/timolol FC in adult OAG\/OHT patients demonstrating insufficient response to beta-blocker or prostaglandin analog (PGA) monotherapy. Primary end point was mean change in intraocular pressure (IOP) from baseline at month 6. Changes in the severity of ocular signs and symptoms were also assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Overall, 92 patients (51.1% female) were included. Mean (standard deviation) age was 68.3 (12.1) years. Mean IOP was reduced from 21.9\u2009mmHg at baseline to 16.7\u2009mmHg at month 6 (22.3% decrease;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u20090.0001). Significant IOP reductions were observed at weeks 4 and 12 (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u20090.0001). Baseline PGA and beta-blocker users demonstrated mean month 6 IOP reductions of 5.5\u2009mmHg (23.5%;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009&lt;\u20090.001) and 3.5\u2009mmHg (14.6%;\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009=\u20090.029), respectively. Severity of conjunctival hyperemia, dry eye, irritation, itching, foreign body sensation, and eye pain was significantly reduced. Three treatment-related adverse events were reported, all were nonserious and mild\/moderate in severity.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>In real-world clinical practice, PF tafluprost\/timolol FC treatment provided significant IOP reductions over 6 months and was well tolerated among OAG\/OHT patients showing poor response to PGA or beta-blocker monotherapy. IOP-lowering efficacy and improvements in ocular signs and symptoms were evident from week 4 and maintained over the 6-month study period. Trial Registration: European Union electronic Register of Post-Authorisation Studies (EU PAS) register number EUPAS22204.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/jop.2021.0099","type":"journal-article","created":{"date-parts":[[2022,3,1]],"date-time":"2022-03-01T11:47:22Z","timestamp":1646135242000},"page":"252-260","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":13,"title":["Treatment of Open-Angle Glaucoma and Ocular Hypertension with Preservative-Free Tafluprost\/Timolol Fixed-Dose Combination Therapy: Results from the VISIONARY Study Population in Spain"],"prefix":"10.1177","volume":"38","author":[{"given":"Jose J.","family":"Garcia-Medina","sequence":"first","affiliation":[{"name":"Department of Ophthalmology, Hospital General Universitario Morales Meseguer, Murcia, Spain."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"Benitez-del-Castillo","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Hospital Universitario de Jerez, Jerez de la Frontera Cadiz, Spain."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"I\u00f1aki","family":"Rodr\u00edguez-Agirretxe","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Hospital Universitario Donostia, San Sebastian Guipuzcoa, Spain."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"Lopez-Lopez","sequence":"additional","affiliation":[{"name":"Instituto Oftalmol\u00f3gico Gomez-Ulla, Santiago de Compostela Galicia, Spain."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Moreno-Valladares","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, Complejo Hospitalario Universitario de Albacete, Albacete, Spain."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the VISIONARY Study Group (Spain)","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rafael","family":"Gimenez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Parrilla Vallejo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alfonso","family":"Anton lopez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergio","family":"Torregrosa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"jorge","family":"loscos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2022,4,6]]},"reference":[{"key":"e_1_3_6_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2014.05.013"},{"key":"e_1_3_6_3_2","doi-asserted-by":"publisher","DOI":"10.1136\/bjophthalmol-2015-307223"},{"key":"e_1_3_6_4_2","doi-asserted-by":"publisher","DOI":"10.1097\/01.ijg.0000133385.74502.29"},{"key":"e_1_3_6_5_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1755-3768.2008.01452.x"},{"key":"e_1_3_6_6_2","unstructured":"International Council of Ophthalmology. Guidelines for glaucoma care. 2016. Available at: www.icoph.org\/downloads\/ICOGlaucomaGuidelines.pdf Accessed September23 2021."},{"key":"e_1_3_6_7_2","first-page":"498","article-title":"The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma","volume":"126","author":"Collaborative Normal-Tension Glaucoma Study Group","year":"1998","unstructured":"Collaborative Normal-Tension Glaucoma Study Group. The effectiveness of intraocular pressure reduction in the treatment of normal-tension glaucoma. Collaborative Normal-Tension Glaucoma Study Group. Am. J. Ophthalmol. 126:498\u2013505, 1998.","journal-title":"Collaborative Normal-Tension Glaucoma Study Group"},{"key":"e_1_3_6_8_2","first-page":"429","article-title":"The Advanced Glaucoma Intervention Study (AGIS): 7","volume":"130","author":"The AGIS Investigators","year":"2000","unstructured":"The AGIS Investigators. The Advanced Glaucoma Intervention Study (AGIS): 7. The relationship between control of intraocular pressure and visual field deterioration. The AGIS Investigators. Am. J. Ophthalmol. 130:429\u2013440, 2000.","journal-title":"The relationship between control of intraocular pressure and visual field deterioration. The AGIS Investigators"},{"key":"e_1_3_6_9_2","doi-asserted-by":"publisher","DOI":"10.1001\/archopht.120.10.1268"},{"key":"e_1_3_6_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0161-6420(01)00874-0"},{"key":"e_1_3_6_11_2","doi-asserted-by":"publisher","DOI":"10.1001\/archopht.120.6.714"},{"key":"e_1_3_6_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0161-6420(01)00873-9"},{"key":"e_1_3_6_13_2","unstructured":"European Glaucoma Society. Terminology and guidelines for glaucoma. 2020. Available at https:\/\/www.eugs.org\/eng\/egs_guidelines_download.asp Accessed September23 2021."},{"key":"e_1_3_6_14_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0149-2918(01)80109-0"},{"key":"e_1_3_6_15_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2004.12.026"},{"key":"e_1_3_6_16_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-017-0843-9"},{"key":"e_1_3_6_17_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.survophthal.2008.08.011"},{"key":"e_1_3_6_18_2","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.2014.936850"},{"key":"e_1_3_6_19_2","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2018.1534958"},{"key":"e_1_3_6_20_2","first-page":"1","article-title":"Prostaglandin-timolol fixed combinations efficacy: myth or reality?","volume":"22","author":"Konstas A.G.P.","year":"2012","unstructured":"Konstas A.G.P., , Haidich A.B., , Rossetti L., et al. Prostaglandin-timolol fixed combinations efficacy: myth or reality?. Editorial. Eur. J. Ophthalmol. 22:1\u20134, 2012.","journal-title":"Editorial"},{"key":"e_1_3_6_21_2","doi-asserted-by":"publisher","DOI":"10.5301\/ejo.5000009"},{"key":"e_1_3_6_22_2","doi-asserted-by":"publisher","DOI":"10.1089\/jop.2012.0186"},{"key":"e_1_3_6_23_2","doi-asserted-by":"publisher","DOI":"10.1177\/112067210701700311"},{"key":"e_1_3_6_24_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1755-3768.2008.01250.x"},{"key":"e_1_3_6_25_2","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.86.4.418"},{"key":"e_1_3_6_26_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.joco.2018.07.003"},{"key":"e_1_3_6_27_2","doi-asserted-by":"publisher","DOI":"10.1080\/17425255.2016.1209481"},{"key":"e_1_3_6_28_2","doi-asserted-by":"publisher","DOI":"10.1097\/IJG.0b013e31825af67d"},{"key":"e_1_3_6_29_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-014-0163-3"},{"key":"e_1_3_6_30_2","doi-asserted-by":"publisher","DOI":"10.1089\/jop.2013.0229"},{"key":"e_1_3_6_31_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-014-0151-7"},{"key":"e_1_3_6_32_2","doi-asserted-by":"publisher","DOI":"10.1517\/14740338.2015.1010507"},{"key":"e_1_3_6_33_2","first-page":"485","article-title":"Pharmacokinetics, efficacy, and safety of the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% in healthy volunteers: a phase I comparison vs","volume":"55","author":"Kaarniranta K.","year":"2016","unstructured":"Kaarniranta K., , Ikaheimo K., , Mannermaa E., et al. Pharmacokinetics, efficacy, and safety of the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% in healthy volunteers: a phase I comparison vs. the corresponding preservative-free monotherapies. Clin. Pharmacokinet. 55:485\u2013494, 2016.","journal-title":"the corresponding preservative-free monotherapies"},{"key":"e_1_3_6_34_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-015-0476-9"},{"key":"e_1_3_6_35_2","first-page":"1436","article-title":"VISIONARY Study Group","volume":"37","author":"Oddone F.","year":"2020","unstructured":"Oddone F., , Tanga L., , K\u00f3thy P., , and Holl\u00f3 G.; VISIONARY Study Group. Treatment of open-angle glaucoma and ocular hypertension with preservative-free tafluprost\/timolol fixed-dose combination therapy: the VISIONARY study. Adv. Ther. 37:1436\u20131451, 2020.","journal-title":"Treatment of open-angle glaucoma and ocular hypertension with preservative-free tafluprost\/timolol fixed-dose combination therapy: the VISIONARY study"},{"key":"e_1_3_6_36_2","doi-asserted-by":"publisher","DOI":"10.2147\/OPTH.S128453"},{"key":"e_1_3_6_37_2","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2018-024129"},{"key":"e_1_3_6_38_2","first-page":"1","article-title":"Should real-world evidence be incorporated into regulatory approvals?","volume":"9","author":"Spitzer E.","year":"2018","unstructured":"Spitzer E., , Cannon C.P., , and Serruys P.W. Should real-world evidence be incorporated into regulatory approvals?. Expert. Opin. Drug Saf. 9:1\u20135, 2018.","journal-title":"Expert. Opin. Drug Saf"},{"key":"e_1_3_6_39_2","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.1226"},{"key":"e_1_3_6_40_2","unstructured":"Food and Drug Administration. The FDA Real-World Evidence (RWE) Framework and Considerations for Use in Regulatory Decision-Making. May 12 2021. Available at: https:\/\/www.fda.gov\/media\/148543\/download Accessed September23 2021."},{"key":"e_1_3_6_41_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-021-01725-7"},{"key":"e_1_3_6_42_2","first-page":"196","article-title":"The Hungarian VISIONARY Study: hungarian results in the European multicenter preservative-free tafluprost\/timolol fixed combination investigation","volume":"157","author":"Holl\u00f3 G","year":"2020","unstructured":"Holl\u00f3 G, , K\u00f3thy P, , a magyarorsz\u00e1gi VISIONARY-vizsg\u00e1l\u00f3k. The Hungarian VISIONARY Study: hungarian results in the European multicenter preservative-free tafluprost\/timolol fixed combination investigation. Ophthalmol. Hung. 157:196\u2013201, 2020.","journal-title":"Ophthalmol. Hung"},{"key":"e_1_3_6_43_2","doi-asserted-by":"publisher","DOI":"10.17116\/oftalma202013604176"},{"key":"e_1_3_6_44_2","doi-asserted-by":"publisher","DOI":"10.1097\/00003226-200310000-00008"},{"key":"e_1_3_6_45_2","unstructured":"NIDEK Co. LTD. Conversion table for representation of visual acuity. Available at: https:\/\/www.nidek-intl.com\/visual_acuity.html Accessed September23 2021."},{"key":"e_1_3_6_46_2","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1966.10502021"},{"key":"e_1_3_6_47_2","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.9.1.137"},{"key":"e_1_3_6_48_2","doi-asserted-by":"publisher","DOI":"10.1038\/eye.2008.148"},{"key":"e_1_3_6_49_2","doi-asserted-by":"publisher","DOI":"10.2147\/OPTH.S8011"},{"key":"e_1_3_6_50_2","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2010.482017"},{"key":"e_1_3_6_51_2","first-page":"187","article-title":"Randomized trial comparing three fixed combinations of prostaglandins\/prostamide with timolol maleate","volume":"5","author":"Rigollet J.P.","year":"2011","unstructured":"Rigollet J.P., , Ondategui J.A., , Pasto A., , and Lop L. Randomized trial comparing three fixed combinations of prostaglandins\/prostamide with timolol maleate. Clin. Ophthalmol. 5:187\u2013191, 2011.","journal-title":"Clin. Ophthalmol"},{"key":"e_1_3_6_52_2","doi-asserted-by":"publisher","DOI":"10.2147\/OPTH.S56735"},{"key":"e_1_3_6_53_2","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.2004.043232"},{"key":"e_1_3_6_54_2","doi-asserted-by":"publisher","DOI":"10.1167\/iovs.11-8186"},{"key":"e_1_3_6_55_2","doi-asserted-by":"publisher","DOI":"10.1001\/archopht.121.1.48"},{"key":"e_1_3_6_56_2","doi-asserted-by":"publisher","DOI":"10.1097\/IJG.0000000000000748"},{"key":"e_1_3_6_57_2","doi-asserted-by":"publisher","DOI":"10.1097\/IJG.0000000000001041"},{"key":"e_1_3_6_58_2","first-page":"211","article-title":"In vivo analysis of prostaglandins-induced ocular surface and periocular adnexa modifications in patients with glaucoma","volume":"32","author":"Di Staso S.","year":"2018","unstructured":"Di Staso S., , Agnifili L., , Cecannecchia S., , DI Gregorio A., , and Ciancaglini M. In vivo analysis of prostaglandins-induced ocular surface and periocular adnexa modifications in patients with glaucoma. In Vivo. 32:211\u2013220, 2018.","journal-title":"In Vivo"},{"key":"e_1_3_6_59_2","doi-asserted-by":"publisher","DOI":"10.1097\/IJG.0b013e318264cd68"},{"key":"e_1_3_6_60_2","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-018-0812-z"}],"container-title":["Journal of Ocular Pharmacology and Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1089\/jop.2021.0099","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/jop.2021.0099","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/jop.2021.0099","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T14:44:50Z","timestamp":1777646690000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1089\/jop.2021.0099"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,4,1]]},"references-count":59,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2022,4,1]]}},"alternative-id":["10.1089\/jop.2021.0099"],"URL":"https:\/\/doi.org\/10.1089\/jop.2021.0099","relation":{},"ISSN":["1080-7683","1557-7732"],"issn-type":[{"value":"1080-7683","type":"print"},{"value":"1557-7732","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,4,1]]}}}