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July 1997

A 1-Year Study of Brimonidine Twice Daily in Glaucoma and Ocular Hypertension: A Controlled, Randomized, Multicenter Clinical Trial

Author Affiliations

From the New England Eye Center, Tufts University School of Medicine, Boston, Mass (Dr Schuman); the Naval Medical Center, San Diego, Calif (Dr Choplin); Allergan Inc, Irvine, Calif (Dr David and Ms Chen); Dr Horwitz is in private practice in Houston, Tex, and Dr Albracht is in private parctice in Castro Valley, Calif. Drs Schuman, Horwitz, Choplin, and Albracht have no proprietary interest in Allergan Inc or brimonidine.; Dr David and Ms Chen are employees of Allergan Inc.

Arch Ophthalmol. 1997;115(7):847-852. doi:10.1001/archopht.1997.01100160017002

Objective:  Brimonidine tartrate is a highly selective α2-agonist. This study investigates the safety and efficacy of 0.2% brimonidine administered twice daily for 1 year in patients with glaucoma or ocular hypertension.

Methods:  The study design was a multicenter, double-masked, randomized, parallel-group, active-controlled comparison clinical trial. Subjects instilled 0.2% brimonidine or 0.5% timolol maleate twice daily for 12 months. Subjects were examined at baseline, week 1, and months 1, 2,3,6, 9, and 12. A subset of subjects was examined at week 2.

Results:  Of 443 subjects enrolled in this study, 374 met the entry criteria; 186 received brimonidine and 188 received timolol. Brimonidine-treated subjects showed an overall mean peak reduction in intraocular pressure (IOP) of 6.5 mm Hg; timolol-treated subjects had a mean peak reduction in IOP of 6.1 mm Hg. Brimonidine lowered mean peak IOP significantly more than timolol at week 2 and month 3 (P<.03); no significant difference was observed between the groups for this variable at other visits throughout the 1-year course of the study. No evidence of tachyphylaxis was seen in either group. Allergy was seen in 9% of subjects treated with brimonidine. Dry mouth was more common in the brimonidine-treated group than in the timolol-treated group (33.0% vs 19.4%), but complaints of burning and stinging were more common in the timolol-treated group (41.9%) than in the brimonidine-treated patients (28.1%). Headache, fatigue, and drowsiness were similar in the 2 groups. In general, the tolerance to medication was acceptable.

Conclusions:  Brimonidine is safe and effective in lowering IOP in glaucomatous eyes. Brimonidine provides a sustained long-term ocular hypotensive effect, is well tolerated, and has a low rate of allergic response.