Randomized Multicenter Clinical Trial Comparing 0.1% Brimonidine/0.5% Timolol Versus 1% Dorzolamide/0.5% Timolol as Adjuncts to Prostaglandin Analogues: Aibeta Crossover Study.
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Ошибки и ограничения
История · было → стало
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Inatani Masaru, Orii Yusuke, Iwasaki Kentaro, Arimura Shogo, Sunagawa Hiromi, Shiokawa Minako, Inoue Kenji, Sakono Takuto, Sakono Takato, Kuwamura Rika, Yoshida Akiko, Oi Junko, Kuwayama Yasuaki, Kano Kiyoshi, Kido Noriaki, Matsuyama Akiko, Ozaki Mineo, Abe Hideki, Inoue Chizuru, Nakagawa Satoko, Musashi Kunihiro, Kanamori Akiyasu, Lee Jinhee, Otani Shinichiro, Aoki Ryota, Tanabe Hirotaka, Nakakura Shunsuke, Suzuki Katsuyoshi, Sagara Takeshi, Saito Yoshiaki, Sameshima Motoyasu, Urahashi Mai, Watanabe-Kitamura Fumika, Inoue Toshihiro, Kagaya Fumie, Murai Yusuke, Mori Sotaro, Ueda Kaori, Kurimoto Takuji, Yamada-Nakanishi Yuko, Nakamura Makoto, Yamashita Takehiro, Ishiyama Sosuke, Manabe Shinichi, Takaki Keiko, Hayashi Ken, Ishida Akiko, Tsutsui Aika, Manabe Kaoru, Tanito Masaki
Аннотация
METHODS: A total of 110 patients with open-angle glaucoma or ocular hypertension previously treated with prostaglandin analogue monotherapy were randomized to receive either BTFC or DTFC as adjunctive therapy for 8 weeks. These patients were then crossed over to the alternative treatment arm for another 8 weeks. The reduction in intraocular pressure (IOP) (primary outcome), occurrence of adverse events, ocular discomfort after instillation, and patient preference (secondary outcomes) were recorded through patient interviews.
RESULTS: BTFC instillation for 8 weeks reduced IOP by 3.55 mmHg, demonstrating non-inferiority to DTFC instillation (3.60 mmHg; P < 0.0001, mixed-effects model). Although adverse events were rare with both combinations, patients reported greater discomfort with DTFC than with BTFC (P < 0.0001). More patients preferred BTFC (P < 0.0001) over DTFC, as BTFC caused minimal or no eye irritation.
CONCLUSION: As BTFC offered better tolerability than DTFC with comparable reduction in IOP, we recommend it as an alternative for patients who experience ocular discomfort with DTFC-prostaglandin analogue combination therapy.
TRIAL REGISTRATION NUMBER: jRCTs051190125.