Safety and efficacy of bimatoprost/timolol fixed combination in Chinese patients with open-angle glaucoma or ocular hypertension  

作　　者：Ling Zhihong Zhang Mingchang Hu Yizhen Yin Zhengqin Xing Yiqiao Fang Aiwu Ye Jian Chen Xiaoming Liu Dachuan Wang Yusheng Sun Wei Dong Yangceng Sun Xinghuai 

机构地区：[1]Department of Ophthalmology, Eye and ENT Hospital, Fudan University, Shanghai 200031, China

出　　处：《Chinese Medical Journal》2014年第5期905-910,共6页中华医学杂志（英文版）

摘　　要：Background Lowering intraocular pressure （lOP） is currently the only therapeutic approach in primary open-angle glaucoma.and the fixed-combination medications are needed to achieve sufficiently low target lOP.A multicenter prospective study in the Chinese population was needed to confirm the safety and efficacy of Bimatoprost/Timolol Fixed Combination Eye Drop in China.In this study,we evaluated the safety and efficacy of Bimatoprost/Timolol Fixed Combination with concurrent administration of its components in Chinese patients with open-angle glaucoma or ocular hypertension.Methods In this multicenter,randomized,double-masked,parallel controlled study,patients with open-angle glaucoma or ocular hypertension who were insufficiently responsive to monotherapy with either topical β-blockers or prostaglandin analogues were randomized to one of two active treatment groups in a 1：1 ratio at 11 Chinese ophthalmic departments.Bimatoprost/timolol fixed combination treatment was a fixed combination of 0.03％ bimatoprost and 0.5％ timolol （followed by vehicle for masking） once daily at 19：00 P.M.and concurrent treatment was 0.03％ bimatoprost followed by 0.5％ timolol once daily at 19：00 P.M.The primary efficacy variable was change from baseline in mean diurnal intraocular pressure （IOP） at week 4 visit in the intent-to-treat （ITr） population.Primary analysis evaluated the non-inferiority of bimatoprost/timolol fixed combination to concurrent with respect to the primary variable using a confidence interval （CI） approach.Bimatoprost/timolol fixed combination was to be considered non-inferior to concurrent if the upper limit of the 95％ CI for the between-treatment （bimatoprost/timolol fixed combination minus concurrent） difference was-≤1.5 mmHg.Adverse events were collected and slit-lamp examinations were performed to assess safety.Between-group comparisons of the incidence of adverse events were performed using the Pearson chi-square test or Fisher＇s exact test.Results Of the enrolled Background Lowering intraocular pressure （lOP） is currently the only therapeutic approach in primary open-angle glaucoma.and the fixed-combination medications are needed to achieve sufficiently low target lOP.A multicenter prospective study in the Chinese population was needed to confirm the safety and efficacy of Bimatoprost/Timolol Fixed Combination Eye Drop in China.In this study,we evaluated the safety and efficacy of Bimatoprost/Timolol Fixed Combination with concurrent administration of its components in Chinese patients with open-angle glaucoma or ocular hypertension.Methods In this multicenter,randomized,double-masked,parallel controlled study,patients with open-angle glaucoma or ocular hypertension who were insufficiently responsive to monotherapy with either topical β-blockers or prostaglandin analogues were randomized to one of two active treatment groups in a 1：1 ratio at 11 Chinese ophthalmic departments.Bimatoprost/timolol fixed combination treatment was a fixed combination of 0.03％ bimatoprost and 0.5％ timolol （followed by vehicle for masking） once daily at 19：00 P.M.and concurrent treatment was 0.03％ bimatoprost followed by 0.5％ timolol once daily at 19：00 P.M.The primary efficacy variable was change from baseline in mean diurnal intraocular pressure （IOP） at week 4 visit in the intent-to-treat （ITr） population.Primary analysis evaluated the non-inferiority of bimatoprost/timolol fixed combination to concurrent with respect to the primary variable using a confidence interval （CI） approach.Bimatoprost/timolol fixed combination was to be considered non-inferior to concurrent if the upper limit of the 95％ CI for the between-treatment （bimatoprost/timolol fixed combination minus concurrent） difference was-≤1.5 mmHg.Adverse events were collected and slit-lamp examinations were performed to assess safety.Between-group comparisons of the incidence of adverse events were performed using the Pearson chi-square test or Fisher＇s exact test.Results Of the enrolled

关 键 词：GLAUCOMA OPEN-ANGLE bimatoprost/timolol fixed combination BIMATOPROST 

分 类 号：O212[理学—概率论与数理统计] Q987[理学—数学]