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RESEARCH PRODUCT

Changes in ocular signs and symptoms in patients switching from bimatoprost-timolol to tafluprost-timolol eye drops: an open-label phase IV study.

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description

ObjectivesBimatoprost–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.DesignThis was a 12-week, open-label, phase IV study.SettingSixteen centres in Finland, Germany, Italy and the UK.ParticipantsPatients 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.InterventionsPatients were switched to PF tafluprost–timolol once daily in the treated eye(s).Primary and secondary outcome measuresThe 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.ResultsOf 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.ConclusionsSwitching 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 numberEudraCT2014-005273-37; Results.