Switching Study of Tafluprost/Timolol Fixed-Combination Ophthalmic Solution, Following Unfixed Combination of Tafluprost Ophthalmic Solution 0.0015% and Timolol Ophthalmic Gel-Forming Solution 0.5% ()
Author(s)
Kazuhiro Matsumura1,2,
Masayuki Kasahara1,2,3,
Yoshiaki Ichibe3,
Rie Amano4,
Hiroko Kasugai5,
Yayoi Yamakawa6,
Masayo Hashimoto7,
Nobuyuki Shoji1*
Affiliation(s)
1Department of Ophthalmology, School of Medicine, Kitasato University, Sagamihara, Kanagawa, Japan.
2Department of Ophthalmology, Tomei Atsugi Clinic, Atsugi, Kanagawa, Japan.
3Department of Ophthalmology, Kanagawa Dental University Yokohama Clinic, Yokohama, Kanagawa, Japan.
4Department of Ophthalmology, Toshiba Rinkan Hospital, Sagamihara, Kanagawa, Japan.
5Department of Ophthalmology, Sagamino Hospital, Sagamihara, Kanagawa, Japan.
6Department of Ophthalmology, Yamato Municipal Hospital, Yamato, Kanagawa, Japan.
7Japan Medical Affairs, Santen Pharmaceutical Co., Ltd., Osaka, Osaka, Japan.
ABSTRACT
Purpose: Fixed-combination medication to treat glaucoma can reduce intraocular pressure (IOP) without negative effects of concomitant medication. Tafluprost/timolol fixed-combination ophthalmic solution (TTFC) has been reported to show similar effectiveness in lowering IOP, compared with concomitant use of its component drugs, tafluprost and timolol. However, the difference in IOP-lowering effects between TTFC and concomitant use of tafluprost and gel-forming timolol is unknown. Hence, we conducted this switching study from tafluprost and gel-forming timolol to TTFC in glaucoma patients undergoing multi-drug therapy. Design: Multi-center, open-label, interventional clinical study. Methods: Twenty-eight patients (28 eyes; safety analysis set) with primary open-angle glaucoma and ocular hypertension, who had completed the 4-week-concomitant phase of tafluprost and gel-forming timolol, were treated for 8 weeks with TTFC. IOP, adherence, ocular surface safety, and the usability of ophthalmic solution were compared before and after switching. This study was approved by the ethics committees of Kitasato University Hospital and all other study sites. All patients provided written informed consent to participate. Results: IOP at 8 weeks after switching was significantly lower than before switching (P = 0.0001) in the efficacy analysis set (n = 24). The self-reported adherence rate remained high after switching; moreover, there was no meaningful change in ocular surface safety. Patient questionnaires regarding usability of medication revealed that 85.7% of patients preferred their instillation prescription after switching, including TTFC. Among the safety analysis set (n = 28), no adverse events were reported in relation to the study drug. Conclusion: TTFC showed greater IOP reduction than concomitant therapy. Thus, TTFC may be a better option in glaucoma patients than concomitant therapy.
Share and Cite:
Matsumura, K. , Kasahara, M. , Ichibe, Y. , Amano, R. , Kasugai, H. , Yamakawa, Y. , Hashimoto, M. and Shoji, N. (2019) Switching Study of Tafluprost/Timolol Fixed-Combination Ophthalmic Solution, Following Unfixed Combination of Tafluprost Ophthalmic Solution 0.0015% and Timolol Ophthalmic Gel-Forming Solution 0.5%.
Open Journal of Ophthalmology,
9, 168-182. doi:
10.4236/ojoph.2019.94019.
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