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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. Brimonidine Study Group 2.

Abstract：

OBJECTIVE:To compare the long-term safety and ocular-hypotensive efficacy of brimonidine tartrate 0.2% with timolol maleate 0.5% administered twice daily in patients with glaucoma or ocular hypertension. DESIGN:A double-masked, parallel-group, active-controlled, multicenter clinical trial of 12 months' duration. PARTICIPANTS:Four hundred eighty-three patients with glaucoma or ocular hypertension were enrolled. Of these, 463 were evaluated according to the protocol criteria (280 in the brimonidine tartrate group and 183 in the timolol group). INTERVENTIONS:Brimonidine tartrate 0.2% or timolol maleate 0.5% was administered twice daily. MAIN OUTCOME MEASURES:The primary efficacy variable was intraocular pressure (IOP). RESULTS:Brimonidine and timolol produced significant (P < 0.001) and sustained mean reductions in IOP throughout the 1-year follow-up when measured at hour 0 (trough) and at hour 2 (peak). At weeks 1 and 2 and month 12, significantly greater mean decreases in IOP measured at peak (P < or = 0.007) were observed in patients treated with brimonidine as compared to timolol, whereas the mean decreases in IOP measured at trough was significantly greater in patients treated with timolol as compared to brimonidine (P < 0.001) at all follow-up visits. Both drugs were well-tolerated. The incidence of adverse events was similar in both treatment groups, except for ocular allergy, oral dryness, and conjunctival follicles, which occurred more frequently in the brimonidine group, and burning-stinging, which occurred more frequently in the timolol group. Patients receiving timolol experienced significant decreases in heart rate at all follow-up visits. CONCLUSIONS:Topically applied twice daily for 12 months, brimonidine tartrate 0.2% was safe and effective in lowering IOP in patients with glaucoma or ocular hypertension.

journal_name

Ophthalmology

journal_title

Ophthalmology

authors

LeBlanc RP

doi

10.1016/s0161-6420(98)91048-x

subject

Has Abstract

pub_date

1998-10-01 00:00:00

pages

1960-7

issue

eissn

0161-6420

issn

1549-4713

pii

S0161-6420(98)91048-X

journal_volume

105

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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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. Brimonidine Study Group 2.