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Abstract #109855 Published in IGR 24-1
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
Inatani M; Orii Y; Iwasaki K; Arimura S; Sunagawa H; Shiokawa M; Inoue K; Sakono T; Sakono T; Kuwamura R; Yoshida A; Oi J; Kuwayama Y; Kano K; Kido N; Matsuyama A; Ozaki M; Abe H; Inoue C; Nakagawa S; Musashi K; Kanamori A; Lee J; Otani S; Aoki R; Tanabe H; Nakakura S; Suzuki K; Sagara T; Saito Y; Sameshima M; Urahashi M; Watanabe-Kitamura F; Inoue T; Kagaya F; Murai Y; Mori S; Ueda K; Kurimoto T; Yamada-Nakanishi Y; Yamada-Nakanishi Y; Nakamura M; Yamashita T; Ishiyama S; Manabe S; Takaki K; Hayashi K; Ishida A; Tsutsui A; Tsutsui A; Manabe K; Tanito MAdvances in Therapy 2023; 40: 4074-4092
INTRODUCTION: This multicenter, randomized, comparative, and investigator-masked crossover clinical trial sought to compare the efficacy and tolerability of fixed combinations of 0.1% brimonidine/0.5% timolol (BTFC) versus 1% dorzolamide/0.5% timolol (DTFC) as adjunctive therapies to prostaglandin analogues. 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.
Faculty of Medical Sciences, Department of Ophthalmology, University of Fukui, 23-3 Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui, 910-1193, Japan. inatani@u-fukui.ac.jp.
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