The signs of ocular-surface disorders after switching from latanoprost to tafluprost/timolol fixed combination: a prospective study

Abstract

PurposeTo evaluate the ocular-surface safety of a 0.001% benzalkonium chloride-containing tafluprost/timolol fixed combination (TTFC) in patients with primary open-angle glaucoma (POAG) or ocular hypertension who have inadequate intraocular pressure (IOP) control with latanoprost monotherapy.MethodsThis study is a multicenter, prospective, single-arm, open-label clinical study. Patients with POAG or ocular hypertension who have inadequate IOP control with latanoprost monotherapy were considered eligible. After providing informed consent, patients continued latanoprost monotherapy for 12 weeks, followed by a switch to TTFC. We evaluated the extent of ocular-surface damage using superficial punctate keratopathy (SPK) score, tear breakup time (TBUT), hyperemia score, IOP, systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate at 0, 4, and 12 weeks after switching.ResultsA total of 68 patients were enrolled, of whom, 64 patients were included in the final analysis. No significant changes in SPK score, TBUT, or hyperemia score were observed at 4 and 12 weeks compared with week 0. IOP decreased significantly at 4 (13.9±2.5 mmHg) and 12 (14.1±2.5 mmHg) weeks, relative to week 0 (15.3±2.7 mmHg). No significant changes in either SBP or DBP were observed during the study, although patients’ mean heart rate decreased significantly after switching to TTFC. Adverse drug reactions to TTFC occurred in seven patients including two incidences of asthma and one of arrhythmia, and no events were serious.ConclusionThe ocular-surface safety of TTFC is not significantly different to that of latanoprost. Furthermore, switching from latanoprost to TTFC in patients with insufficient IOP control has additive IOP-lowering effects. TTFC is an effective approach for patients receiving latanoprost monotherapy who require more intensive IOP reduction.

Efficacy and Safety of Switching Prostaglandin Analog Monotherapy to Tafluprost/Timolol Fixed-Combination Therapy

“…The clinical use of Taf/Tim was initiated worldwide in 2014, and evidence-based reports on the efficacy and safety of Taf/Tim have been limited. Okumichi et al reported that, compared with latanoprost monotherapy, Taf/Tim significantly reduced IOP by approximately 8% [ 11 ]. The aim of our prospective, open-label, multicenter study was to assess the effect and safety of Taf/Tim combination ophthalmic solution.…”

“…Fuwa et al reported that Taf/Tim solution showed a lower cytotoxic effect on cultured human epithelial cells than a latanoprost/timolol fixed-combination (Lat/Tim) solution containing 0.02% BAC [ 12 ]. Okumichi et al reported that the ocular surface safety of Taf/Tim solution was not significantly different from that of latanoprost [ 11 ].…”