Cargando…

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

PURPOSE: 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 O...

Descripción completa

Detalles Bibliográficos
Autores principales: Garcia-Medina, Jose J., Benitez-del-Castillo, Javier, Rodríguez-Agirretxe, Iñaki, Lopez-Lopez, Fernando, Moreno-Valladares, Antonio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Mary Ann Liebert, Inc., publishers 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9048172/
https://www.ncbi.nlm.nih.gov/pubmed/35230148
http://dx.doi.org/10.1089/jop.2021.0099
_version_ 1784695879327809536
author Garcia-Medina, Jose J.
Benitez-del-Castillo, Javier
Rodríguez-Agirretxe, Iñaki
Lopez-Lopez, Fernando
Moreno-Valladares, Antonio
author_facet Garcia-Medina, Jose J.
Benitez-del-Castillo, Javier
Rodríguez-Agirretxe, Iñaki
Lopez-Lopez, Fernando
Moreno-Valladares, Antonio
author_sort Garcia-Medina, Jose J.
collection PubMed
description PURPOSE: 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. METHODS: 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. RESULTS: 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 mmHg at baseline to 16.7 mmHg at month 6 (22.3% decrease; P < 0.0001). Significant IOP reductions were observed at weeks 4 and 12 (P < 0.0001). Baseline PGA and beta-blocker users demonstrated mean month 6 IOP reductions of 5.5 mmHg (23.5%; P < 0.001) and 3.5 mmHg (14.6%; P = 0.029), 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. CONCLUSION: 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.
format Online
Article
Text
id pubmed-9048172
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Mary Ann Liebert, Inc., publishers
record_format MEDLINE/PubMed
spelling pubmed-90481722022-04-28 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 Garcia-Medina, Jose J. Benitez-del-Castillo, Javier Rodríguez-Agirretxe, Iñaki Lopez-Lopez, Fernando Moreno-Valladares, Antonio J Ocul Pharmacol Ther Original Articles PURPOSE: 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. METHODS: 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. RESULTS: 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 mmHg at baseline to 16.7 mmHg at month 6 (22.3% decrease; P < 0.0001). Significant IOP reductions were observed at weeks 4 and 12 (P < 0.0001). Baseline PGA and beta-blocker users demonstrated mean month 6 IOP reductions of 5.5 mmHg (23.5%; P < 0.001) and 3.5 mmHg (14.6%; P = 0.029), 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. CONCLUSION: 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. Mary Ann Liebert, Inc., publishers 2022-04-01 2022-04-06 /pmc/articles/PMC9048172/ /pubmed/35230148 http://dx.doi.org/10.1089/jop.2021.0099 Text en © Jose J. Garcia-Medina et al. 2022; Published by Mary Ann Liebert, Inc. https://creativecommons.org/licenses/by/4.0/This Open Access article is distributed under the terms of the Creative Commons License [CC-BY] (http://creativecommons.org/licenses/by/4.0 (https://creativecommons.org/licenses/by/4.0/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Articles
Garcia-Medina, Jose J.
Benitez-del-Castillo, Javier
Rodríguez-Agirretxe, Iñaki
Lopez-Lopez, Fernando
Moreno-Valladares, Antonio
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9048172/
https://www.ncbi.nlm.nih.gov/pubmed/35230148
http://dx.doi.org/10.1089/jop.2021.0099
work_keys_str_mv AT garciamedinajosej treatmentofopenangleglaucomaandocularhypertensionwithpreservativefreetafluprosttimololfixeddosecombinationtherapyresultsfromthevisionarystudypopulationinspain
AT benitezdelcastillojavier treatmentofopenangleglaucomaandocularhypertensionwithpreservativefreetafluprosttimololfixeddosecombinationtherapyresultsfromthevisionarystudypopulationinspain
AT rodriguezagirretxeinaki treatmentofopenangleglaucomaandocularhypertensionwithpreservativefreetafluprosttimololfixeddosecombinationtherapyresultsfromthevisionarystudypopulationinspain
AT lopezlopezfernando treatmentofopenangleglaucomaandocularhypertensionwithpreservativefreetafluprosttimololfixeddosecombinationtherapyresultsfromthevisionarystudypopulationinspain
AT morenovalladaresantonio treatmentofopenangleglaucomaandocularhypertensionwithpreservativefreetafluprosttimololfixeddosecombinationtherapyresultsfromthevisionarystudypopulationinspain