Elsevier

Ophthalmology

Volume 105, Issue 10, 1 October 1998, Pages 1960-1967
Ophthalmology

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

Presented in part at Association for Research in Vision and Ophthalmology annual meeting, Fort Lauderdale, Florida, April 1996.
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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 ≤ 0.007) were observed in patients treated with brimonidine as compared to timolol, whereas the mean decrease 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.

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

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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.

    Members of the Brimonidine Study Group 2 are listed in the Appendix at the end of this article.

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