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

Hideaki Okumichi,1 Yoshiaki Kiuchi,1 Tetsuya Baba,2 Takashi Kanamoto,3 Tomoko Naito,4,5 Shunsuke Nakakura,6 Hitoshi Tabuchi,6 Hiroki Nii,7 Chie Sueoka,7 Yosuke Sugimoto1,8 1Department of Ophthalmology and Visual Science, Graduate School of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan; 2Shirai Eye Hospital, Mitoyo, Japan; 3Department of Ophthalmology, Hiroshima Memorial Hospital, Hiroshima, Japan; 4Department of Ophthalmology, Okayama University Graduate School of Medicine, Okayama, Japan; 5Department of Ophthalmology, Konko Hospital, Asakuchi, Japan; 6Department of Ophthalmology, Saneikai Tsukazaki Hospital, Himeji, Japan; 7Department of Ophthalmology, Hiroshima General Hospital, Hiroshima, Japan; 8Department of Ophthalmology, Hiroshima Prefectural Hospital, Hiroshima, Japan Purpose: To 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.Methods: This 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.Results: A 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.Conclusion: The 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. Keywords: tafluprost/timolol fixed combination, latanoprost, glaucoma, ocular-surface safety, intraocular pressure