Twelve-month results of an ongoing randomized trial comparing brimonidine tartrate 0.2% and timolol 0.5% given twice daily in patients with glaucoma or ocular hypertension☆
Section snippets
Planned study population
Patients 21 years of age or older were eligible to participate in this double-masked, parallel-group, active-controlled, multicenter study. An uneven randomization schedule consisting of a ratio of 3:2, with greater enrollment in the brimonidine group, was used to collect additional data on brimonidine. Written informed consent was obtained from each patient before treatment, and institutional review board approval was obtained at each site before study initiation.
Eligible patients had a
Participant flow and follow-up
The study was conducted from July 1993 to August 1995. A total of 483 patients were enrolled. Of these, 292 were assigned to the brimonidine treatment group and 191 to the timolol treatment group. All 483 patients received study medication and were included in the safety analysis. The protocol was followed throughout the investigation with no deviations from the study as planned.
The per-protocol criteria were met by 96% (463 of 483) of patients (brimonidine 96%, 280 of 292; timolol 96%, 183 of
Discussion
This study shows that brimonidine tartrate 0.2%, administered twice daily, effectively and safely lowers IOP in patients with open-angle glaucoma or ocular hypertension. The IOP-lowering efficacy of brimonidine was found to be comparable with that of timolol. Treatment with brimonidine produced rapid decreases in IOP (within 2 hours) and sustained efficacy, with no tachyphylaxis or long-term drift over the 12-month period.
Treatment with either brimonidine or timolol was generally
References (23)
- et al.
Systemic drug interactions with topical glaucoma medications
Surv Ophthalmol
(1990) Clinical experience with brimonidine 0.2% and timolol 0.5% in glaucoma and ocular hypertension
Surv Ophthalmol
(1996)A comparison of the safety and efficacy of twice daily brimonidine 0.2% versus betaxolol 0.25% in subjects with elevated intraocular pressure
Surv Ophthalmol
(1996)- et al.
Preclinical evaluation of brimonidine
Surv Ophthalmol
(1996) - et al.
Comparison of apraclonidine and timolol in chronic open-angle glaucoma. A three-month study
Ophthalmology
(1993) - et al.
Mechanisms of adrenergic agonist induced allergy bioactivation and antigen formation
Exp Eye Res
(1997) - et al.
Systemic effects of medications used to treat glaucoma
Ann Intern Med
(1990) - et al.
Systemic adverse reactions to glaucoma medications
Int Ophthalmol Clin
(1989) - et al.
Topical β-blocker therapy and central nervous system side effects. A preliminary study comparing betaxolol and timolol
Arch Ophthalmol
(1988) - et al.
Therapeutic use of α2-adrenoceptor agonists in glaucoma
Effects of brimonidine on aqueous humor dynamics in human eyes
Arch Ophthalmol
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2021, Annales Pharmaceutiques FrancaisesCitation Excerpt :TIMO is chemically as 2-propanol, 1-(1,1- dimethyl ethyl)amino-3-[[4-(4-morpholiny l)-1,2,5-thiadiazole- 3-yl]-,(S)-, (Z)-2-butenedioate (1:1) (salt)) and acts as by inhibition of b-adrenergic receptors in the ciliary epithelium their by reduces aqueous humor secretion. The combined therapy of BRIM with TIMO is an effective treatment for glaucoma and ocular hypertension [4]. The structural formulas of the two-parent compounds BRIM/TIMO and its impurities were presented in Tables 1 and 2.
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2020, Drug-Induced Ocular Side Effects, Eigtht EditionLong-term intraocular pressure-lowering efficacy and safety of ripasudil-brimonidine fixed-dose combination for glaucoma and ocular hypertension: a multicentre, open-label, phase 3 study
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Supported by a grant from Allergan, Inc., Irvine, California.
The author has no financial or proprietary interest in Allergan, Inc, or brimonidine.