Purpose: Fixed-combination medication to treat glaucoma can reduce intraocular\npressure (IOP) without negative effects of concomitant medication.\nTafluprost/timolol fixed-combination ophthalmic solution (TTFC) has been\nreported to show similar effectiveness in lowering IOP, compared with concomitant\nuse of its component drugs, tafluprost and timolol. However, the\ndifference in IOP-lowering effects between TTFC and concomitant use of tafluprost\nand gel-forming timolol is unknown. Hence, we conducted this switching\nstudy from tafluprost and gel-forming timolol to TTFC in glaucoma patients\nundergoing multi-drug therapy. Design: Multi-center, open-label, interventional\nclinical study. Methods: Twenty-eight patients (28 eyes; safety\nanalysis set) with primary open-angle glaucoma and ocular hypertension,\nwho had completed the 4-week-concomitant phase of tafluprost and\ngel-forming timolol, were treated for 8 weeks with TTFC. IOP, adherence,\nocular surface safety, and the usability of ophthalmic solution were compared\nbefore and after switching. This study was approved by the ethics committees\nof Kitasato University Hospital and all other study sites. All patients provided\nwritten informed consent to participate. Results: IOP at 8 weeks after switching\nwas significantly lower than before switching (P = 0.0001) in the efficacy\nanalysis set (n = 24). The self-reported adherence rate remained high after\nswitching; moreover, there was no meaningful change in ocular surface safety.\nPatient questionnaires regarding usability of medication revealed that\n85.7% of patients preferred their instillation prescription after switching, including\nTTFC. Among the safety analysis set (n = 28), no adverse events were\nreported in relation to the study drug. Conclusion: TTFC showed greater\nIOP reduction than concomitant therapy. Thus, TTFC may be a better option\nin glaucoma patients than concomitant therapy.
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