Original article : Clinical science
Phase III Clinical Trial of Brimonidine in Patients with Primary Open-angle Glaucoma and Ocular Hypertension -Comparison of the Effects of Brimonidine Monotherapy versus Timolol Monotherapy, or Combination Brimonidine/Prostaglandins Therapy versus Combination Placebo/Prostaglandins Therapy
Makoto Araie1, Yoshio Yamazaki2, Kazuhisa Sugiyama3, Yasuaki Kuwayama4, Hidenobu Tanihara5
1 Kanto Central Hospital, The Mutual Aid Association of Public School Teachers
2 Division of Ophthalmology, Department of Visual Sciences, Nihon University School of Medicine
3 Department of Ophthalmology and Visual Science, Kanazawa University Graduate School of Medical Science
4 Fukushima Eye Clinic
5 Department of Ophthalmology and Visual Science, Kumamoto University Graduate School of Medical Sciences
Objective: To compare the intraocular pressure (IOP) -lowering effect and safety of topical brimonidine to that of timolol, and to study the additive effect of topical brimonidine to topical prostaglandin (PG) analogues in 475 patients with either ocular hypertension or primary open angle glaucoma.
Methods: The primary endpoint was the mean IOP change from the baseline at 0 and 2 hours at week 4.
Results: The mean changes were -4.7±2.1 (S.D.) in the timolol and -4.0±2.0 mmHg in the brimonidine group (p=0.0138) . The 95% confidence interval of the inter-group difference was greater than the pre-determined criterion of non-inferiority of brimonidine to timolol. When added to PG analogues, the IOP-lowering effect of brimonidine (-2.9±1.8 mmHg) was greater than that of the placebo (-2.1±1.8 mmHg) (p=0.0010). No appreciable adverse side effects were encountered.
Conclusion: Topical brimonidine showed an additive IOP-lowering effect to topical PG analogues, although its IOP-lowering effect was inferior to topical timolol as monotherapy.
Nippon Ganka Gakkai Zasshi (J Jpn Ophthalmol Soc) 116: 955-966, 2012.
Key words
Brimonidine, Timolol, Prostaglandin, Glaucoma, Concomitant use
Reprint requests to
Makoto Araie, M.D., Ph. D. Kanto Central Hospital, The Mutual Aid Association of Public School Teachers. 6-25-1 Kamiyoga, Setagaya-ku, Tokyo 158-8531, Japan
Received: 6 January 2012. Accepted in revised form: 1 May 2012.
Nihon Ganka Gakkai Zasshi
116: 955-966,2012
