Efficacy and safety of newly developed preservative-free latanoprost 0.005% eye drops versus preserved latanoprost 0.005% in open angle glaucoma and ocular hypertension: 12-week results of a randomized,multicenter, controlled phase Ⅲ trial  

作　　者：Joon Mo Kim Kyung Rim Sung Ji Woong Lee Haksu Kyung Seungsoo Rho Chan Yun Kim 

机构地区：[1]Department of Ophthalmology,Kangbuk Samsung Hospital,Sungkyunkwan University School of Medicine,Seoul 03181,Republic of Korea [2]Department of Ophthalmology,Seoul Asan Medical Center,Ulsan University College of Medicine,Seoul 05505,Republic of Korea [3]Department of Ophthalmology,Pusan National University Hospital,Pusan National University Medical School,Busan 49241,Republic of Korea [4]Department of Ophthalmology,National Medical Center,Seoul 04564,Republic of Korea [5]Department of Ophthalmology,CHA Bundang Medical Center,CHA University,Seongnam 13496,Republic of Korea [6]Department of Ophthalmology,Severance Hospital,Yonsei University College of Medicine,Seoul 03722,Republic of Korea

出　　处：《International Journal of Ophthalmology(English edition)》2021年第10期1539-1547,共9页国际眼科杂志（英文版）

基　　金：Taejoon Pharmaceutical。

摘　　要：AIM: To evaluate the therapeutic efficacy, safety and tolerability of newly developed preservative-free(PF) latanoprost generic [TJO-002] and compare it with benzalkonium chloride(BAK)-preserved latanoprost [Xalatan?] in patients with primary open angle glaucoma(POAG) and ocular hypertension(OHT).METHODS: Included patients were aged ≥19 y with POAG/OHT. After a washout period, patients with IOP 21-35 mm Hg at 9 a.m. were enrolled. After a full ophthalmic and glaucoma examination, 144 patients with POAG and OHT participated in this study. Subjects were randomly assigned either PF latanoprost(74 eyes) or BAK-preserved latanoprost(70 eyes). All subjects were examined at 4, 8, and 12 wk after first administration. At each follow-up visit,IOP was measured at 9 a.m. and 5 p.m. and compliance was assessed. Throughout the study, all adverse events were recorded and monitored by the masked investigators who measured IOP.RESULTS: Both groups showed a statistically significant decrease of average diurnal IOP at 12 wk compared to baseline(-7.21±3.10 mm Hg in the PF latanoprost group and-7.02±3.17 mm Hg in the BAK latanoprost group, both P<0.0001). There was no statistically significant diurnal IOP variation between the groups. In terms of tolerability, pruritus, burning/stinging, and sticky eye sensation, severity was significantly lower in the PF latanoprost group than in the BAK latanoprost group(P<0.05). CONCLUSION: PF latanoprost has at least similar efficacy in terms of IOP reduction and better tolerability compared with BAK latanoprost.

关 键 词：LATANOPROST benzalkonium chloride intraocular pressure preservative-free 

分 类 号：R775[医药卫生—眼科]