0.1%酒石酸溴莫尼定与0.15%酒石酸溴莫尼定每日两次治疗青光眼或高眼压症的12个月随机试验。

Brimonidine-purite 0.1% versus brimonidine-purite 0.15% twice daily in glaucoma or ocular hypertension: a 12-month randomized trial.

作者信息

Cantor Louis B, Safyan Eleonora, Liu Ching-Chi, Batoosingh Amy L

机构信息

Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN 46202, USA.

出版信息

Curr Med Res Opin. 2008 Jul;24(7):2035-43. doi: 10.1185/03007990802199287. Epub 2008 Jun 4.

DOI:10.1185/03007990802199287

PMID:18534052

Abstract

OBJECTIVE

To compare the safety and intraocular pressure (IOP)-lowering effects of brimonidine-purite 0.1% with the marketed formulation of brimonidine-purite 0.15% (Alphagan P 0.15%) when used twice daily (BID) by patients with glaucoma or ocular hypertension previously treated with brimonidine-purite 0.15% for at least 6 weeks.

METHODS

In a 12-month, randomized, double-masked, multicenter, parallel group, non-inferiority study, patients with glaucoma or ocular hypertension who were treated with brimonidine-purite 0.15% BID were randomly assigned to continue brimonidine-purite 0.15% (n=102) or to administer brimonidine-purite 0.1% (n=105) BID for 12 months. IOP was measured at approximately 8 a.m. (hour 0) and 10 a.m. (hour 2).

MAIN OUTCOME MEASURES

Mean change from baseline IOP and adverse events.

RESULTS

Demographics and baseline characteristics were similar between treatment groups. Treated-baseline mean IOPs at both timepoints were similar between groups (p > or = 0.606). Brimonidine-purite 0.1% provided IOP-lowering that was non-inferior to brimonidine-purite 0.15% at each of the 12 follow-up timepoints, and there were no statistically significant between-group differences at any timepoint. The most commonly reported adverse event was conjunctival hyperemia (13.5% for brimonidine-purite 0.1%; 10.8% for brimonidine-purite 0.15%). No significant differences in the incidence of adverse events were noted between the two formulations.

CONCLUSIONS

Brimonidine-purite 0.1% BID is as effective as brimonidine-purite 0.15% BID in lowering IOP in patients with glaucoma or ocular hypertension who were previously treated with brimonidine-purite 0.15%, and both formulations are well tolerated. Limitations of the study include enrollment of only patients who were already on treatment with brimonidine-purite 0.15%. The 0.1% formulation of brimonidine-purite allows for decreased exposure to brimonidine while providing an IOP-lowering effect comparable to that of the 0.15% formulation. Clinical trial registered at clinicaltrials.gov; identifier: NCT00168363.

摘要

目的

比较0.1%的溴莫尼定纯品与市售的0.15%溴莫尼定纯品制剂（阿法根P 0.15%）对曾使用0.15%溴莫尼定纯品治疗至少6周的青光眼或高眼压症患者每日两次用药时的安全性和降眼压效果。

方法

在一项为期12个月的随机、双盲、多中心、平行组、非劣效性研究中，将每日两次使用0.15%溴莫尼定纯品治疗的青光眼或高眼压症患者随机分配，继续使用0.15%溴莫尼定纯品（n = 102）或每日两次使用0.1%溴莫尼定纯品（n = 105），为期12个月。分别于上午8点左右（第0小时）和上午10点左右（第2小时）测量眼压。

主要观察指标

眼压较基线的平均变化及不良事件。

结果

各治疗组的人口统计学和基线特征相似。两组在两个时间点的治疗后基线平均眼压相似（p≥0.606）。在12个随访时间点中的每一个时间点，0.1%的溴莫尼定纯品降低眼压的效果均不劣于0.15%的溴莫尼定纯品，且在任何时间点两组之间均无统计学显著差异。最常报告的不良事件为结膜充血（0.1%的溴莫尼定纯品为13.5%；0.15%的溴莫尼定纯品为10.8%）。两种制剂的不良事件发生率无显著差异。

结论

对于曾使用0.15%溴莫尼定纯品治疗的青光眼或高眼压症患者，每日两次使用0.1%的溴莫尼定纯品降低眼压的效果与每日两次使用0.15%的溴莫尼定纯品相同，且两种制剂耐受性均良好。本研究的局限性包括仅纳入了已使用0.15%溴莫尼定纯品治疗的患者。0.1%的溴莫尼定纯品制剂可减少对溴莫尼定的暴露，同时提供与0.15%制剂相当的降眼压效果。临床试验已在clinicaltrials.gov注册；标识符：NCT00168363。