Changes in ocular signs and symptoms in patients switching from bimatoprost-timolol to tafluprost-timolol eye drops: an open-label phase IV study.
In: BMJ Open, Jg. 9 (2019-04-01), Heft 4, S. 1-8
Online
academicJournal
Zugriff:
Objectives Bimatoprost-timolol (bimatoprost 0.03%-timolol 0.5% fixed-dose combination [FDC]) and tafluprost-timolol (tafluprost 0.0015%-timolol 0.5% FDC) eye drops are currently the only topical intraocular pressure (IOP)-reducing therapies available as preservative-free (PF) prostaglandin and timolol FDC. The aim of this study was to investigate changes to ocular signs and symptoms when patients with ocular hypertension (OH) or open-angle glaucoma (OAG) switched from PF or benzalkonium chloride (BAK)-preserved bimatoprost-timolol to PF tafluprost-timolol eye drops. Design This was a 12-week, open-label, phase IV study. Setting Sixteen centres in Finland, Germany, Italy and the UK. Participants Patients with OH or OAG (IOP on medication ≤21 mm Hg), treated with PF or BAK-preserved bimatoprost-timolol for ≥4 weeks before screening, and presenting with conjunctival hyperaemia and ≥1 ocular symptom. Interventions Patients were switched to PF tafluprost-timolol once daily in the treated eye(s). Primary and secondary outcome measures The primary endpoints were change from screening to week 12 in conjunctival hyperaemia and worst ocular symptom. The secondary outcome measures were changes from screening in ocular signs (other than conjunctival hyperaemia) and symptoms at week 12. Results Of 123 enrolled patients, 121 were included in the intention-to-treat dataset, of which all were Caucasian and 54.5% were female; 76 patients used BAK-preserved bimatoprost-timolol and 45 used PF drops. Conjunctival hyperaemia and severity of worst ocular symptom following switch to PF tafluprost-timolol significantly reduced from screening to week 12 in all patients (p<0.001). The percentage of patients with ocular signs and symptoms was significantly reduced at week 12 compared with screening (p<0.001). IOP was not affected by the change of treatment. Conclusions Switching from BAK-preserved or PF bimatoprost-timolol to tafluprost-timolol reduced both signs and symptoms of ocular surface disease with no clinically relevant effect on IOP. Trial registration number EudraCT2014-005273-37; Results. [ABSTRACT FROM AUTHOR]
Copyright of BMJ Open is the property of BMJ Publishing Group and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Titel: |
Changes in ocular signs and symptoms in patients switching from bimatoprost-timolol to tafluprost-timolol eye drops: an open-label phase IV study.
|
---|---|
Autor/in / Beteiligte Person: | Alexander Bourne, Rupert Richard ; Kaarniranta, Kai ; Lorenz, Katrin ; Traverso, Carlo Enrico ; Vuorinen, Jouni ; Ropo, Auli |
Link: | |
Zeitschrift: | BMJ Open, Jg. 9 (2019-04-01), Heft 4, S. 1-8 |
Veröffentlichung: | 2019 |
Medientyp: | academicJournal |
ISSN: | 2044-6055 (print) |
DOI: | 10.1136/bmjopen-2018-024129 |
Sonstiges: |
|