Weinreb Robert N, Ong Tuyen, Scassellati Sforzolini Baldo, Vittitow Jason L, Singh Kuldev, Kaufman Paul L
Hamilton Glaucoma Center and Department of Ophthalmology, Shiley Eye Center University of California San Diego, La Jolla, California, USA.
Bausch + Lomb, Bridgewater, New Jersey, USA.
Br J Ophthalmol. 2015 Jun;99(6):738-45. doi: 10.1136/bjophthalmol-2014-305908. Epub 2014 Dec 8.
To assess the efficacy and safety of latanoprostene bunod (LBN) compared with latanoprost 0.005%, and to determine the optimum drug concentration(s) of LBN in reducing intraocular pressure (IOP) in subjects with open angle glaucoma or ocular hypertension.
Randomised, investigator-masked, parallel-group, dose-ranging study. Subjects instilled one drop of study medication in the study eye once daily each evening for 28 days and completed five study visits. The primary efficacy endpoint was the reduction in mean diurnal IOP at Day 28.
Of the 413 subjects randomised (LBN 0.006%, n=82; LBN 0.012%, n=85; LBN 0.024%, n=83; LBN 0.040%, n=81; latanoprost, n=82), 396 subjects completed the study. Efficacy for LBN was dose-dependent reaching a plateau at 0.024%-0.040%. LBN 0.024% led to significantly greater reductions in diurnal IOP compared with latanoprost at the primary endpoint, Day 28 (p=0.005), as well as Days 7 (p=0.033) and 14 (p=0.015). The incidence of adverse events, mostly mild and transient, was numerically higher in the LBN treatment groups compared with the latanoprost group. Hyperaemia was similar across treatments.
LBN 0.024% dosed once daily was the lower of the two most effective concentrations evaluated, with significantly greater IOP lowering and comparable side effects relative to latanoprost 0.005%. LBN dosed once daily for 28 days was well tolerated.
NCT01223378.
评估比马前列素苄酯（LBN）与0.005%拉坦前列素相比的疗效和安全性，并确定LBN降低开角型青光眼或高眼压症患者眼压（IOP）的最佳药物浓度。
随机、研究者设盲、平行组、剂量范围研究。受试者每晚在研究眼滴入一滴研究药物，每日一次，共28天，并完成五次研究访视。主要疗效终点是第28天平均日眼压的降低情况。
413名受试者被随机分组（LBN 0.006%，n = 82；LBN 0.012%，n = 85；LBN 0.024%，n = 83；LBN 0.040%，n = 81；拉坦前列素，n = 82），396名受试者完成了研究。LBN的疗效呈剂量依赖性，在0.024% - 0.040%时达到平台期。在主要终点第28天，以及第7天（p = 0.033）和第14天（p = 0.015），0.024%的LBN导致日眼压降低幅度显著大于拉坦前列素。与拉坦前列素组相比，LBN治疗组不良事件发生率在数值上更高，大多为轻度且短暂。各治疗组的充血情况相似。
每日给药一次的0.024% LBN是所评估的两种最有效浓度中较低的一种，与0.005%拉坦前列素相比，其降低眼压效果显著更好且副作用相当。每日给药一次，持续28天的LBN耐受性良好。
NCT01223378。
