Dubiner Harvey B, Noecker Robert
Clayton Eye Center, Morrow, GA.
Clin Ophthalmol. 2012;6:525-31. doi: 10.2147/OPTH.S30690. Epub 2012 Mar 29.
The purpose of this study was to characterize intraocular pressure (IOP) reduction throughout the day with travoprost ophthalmic solution 0.004% dosed once daily in the evening.
The results of seven published, randomized clinical trials including at least one arm in which travoprost 0.004% was dosed once daily in the evening were integrated. Means (and standard deviations) of mean baseline and on-treatment IOP, as well as mean IOP reduction and mean percent IOP reduction at 0800, 1000, and 1600 hours at weeks 2 and 12 were calculated.
From a mean baseline IOP ranging from 25.0 to 27.2 mmHg, mean IOP on treatment ranged from 17.4 to 18.8 mmHg across all visits and time points. Mean IOP reductions from baseline ranged from 7.6 to 8.4 mmHg across visits and time points, representing a mean IOP reduction of 30%. Results of the safety analysis were consistent with the results from the individual studies for travoprost ophthalmic solution 0.004%, with ocular hyperemia being the most common side effect.
Travoprost 0.004% dosed once daily in the evening provides sustained IOP reduction throughout the 24-hour dosing interval in subjects with ocular hypertension or open-angle glaucoma. No reduction of IOP-lowering efficacy was observed at the 1600-hour time point which approached the end of the dosing interval.
本研究的目的是描述0.004%的曲伏前列素滴眼液每晚一次给药后全天眼压(IOP)的降低情况。
整合了七项已发表的随机临床试验结果,这些试验至少有一个治疗组采用每晚一次给予0.004%曲伏前列素的给药方案。计算了平均基线眼压和治疗期间眼压的平均值(及标准差),以及在第2周和第12周的08:00、10:00和16:00时眼压的平均降低值和平均降低百分比。
平均基线眼压范围为25.0至27.2 mmHg,在所有访视和时间点,治疗期间的平均眼压范围为17.4至18.8 mmHg。各访视和时间点的眼压平均降低值范围为7.6至8.4 mmHg,平均眼压降低了30%。安全性分析结果与0.004%曲伏前列素滴眼液的各单项研究结果一致,眼部充血是最常见的副作用。
对于高眼压症或开角型青光眼患者,每晚一次给予0.004%曲伏前列素可在24小时给药间隔内持续降低眼压。在接近给药间隔结束的16:00时间点未观察到降眼压疗效降低。