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.

Abstract

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.

• Authors: Masaru Inatani, Yusuke Orii, Kentaro Iwasaki, Shogo Arimura, Hiromi Sunagawa, Minako Shiokawa, Kenji Inoue, Takuto Sakono, Takato Sakono, Rika Kuwamura, Akiko Yoshida, Junko Oi, Yasuaki Kuwayama, Kiyoshi Kano, Noriaki Kido, Akiko Matsuyama, Mineo Ozaki, Hideki Abe, Chizuru Inoue, Satoko Nakagawa, Kunihiro Musashi, Akiyasu Kanamori, Jinhee Lee, Shinichiro Otani, Ryota Aoki, Hirotaka Tanabe, Shunsuke Nakakura, Katsuyoshi Suzuki, Takeshi Sagara, Yoshiaki Saito, Motoyasu Sameshima, Mai Urahashi, Fumika Watanabe-Kitamura, Toshihiro Inoue, Fumie Kagaya, Yusuke Murai, Sotaro Mori, Kaori Ueda, Takuji Kurimoto, Yuko Yamada-Nakanishi, Makoto Nakamura, Takehiro Yamashita, Sosuke Ishiyama, Shinichi Manabe, Keiko Takaki, Ken Hayashi, Akiko Ishida, Aika Tsutsui, Kaoru Manabe, Masaki Tanito
• Journal: Advances in therapy (Adv Ther) Vol. 40 Issue 9 Pg. 4074-4092 (09 2023) ISSN: 1865-8652 [Electronic] United States
• PMID: 37452961 (Publication Type: Randomized Controlled Trial, Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2023. The Author(s).

Chemical References

• Timolol
• dorzolamide
• Antihypertensive Agents
• Ophthalmic Solutions
• Brimonidine Tartrate
• Prostaglandins, Synthetic
• Drug Combinations

Topics

• Humans
• Timolol (adverse effects)
• Glaucoma, Open-Angle (drug therapy)
• Cross-Over Studies
• Antihypertensive Agents (adverse effects)
• Ophthalmic Solutions (therapeutic use)
• Brimonidine Tartrate (therapeutic use)
• Intraocular Pressure
• Prostaglandins, Synthetic (therapeutic use)
• Drug Combinations