Multicenter trial of therapeutic efficacy and safety of domestic latanoprost on primary open angle glaucoma and ocular hypertension / 中华实验眼科杂志

ABSTRACT

Background Prostaglandin eye drops is front-line medicines of lowing intraocular pressure for primary open angle glaucoma (POAG),but its price is higher for long-term application.Domestic latanoprost drops has been applied in clinic.However,its trial of lowing intraocular pressure effect and safety from sizable sample and multi-center is lack.Objective This study was to observe the efficacy and safety of domestic latanoprost for POAG and ocular hypertension.Methods This prospective,multicenter trial was conducted at 25 hospitals in 5 territories of China,and 837 eyes of 576 patients with POAG and ocular hypertension were recruited in the hospitals based on the uniform criteria.Domestic latanoprost drops was topically used once per day at night for 3 months.Intraocular pressure (IOP) was measured 1 month and 2 months,3 months to assess the efficacy of drug,and vision acuity,blood pressure,pulse,ocular symptoms and signs were observed to evaluate the safety of the drug.This study approved by the Ethics Committee of Wuhan General Hospital of Guangzhou Military Command,and all patients were informed consent and signed informed consent.Results IOP was (28.36±7.86),(19.66±5.46),(19.59±7.86) and (19.35 ± 5.03) mmHg in pretreatment and posttreatment 1 month,2 months and 3 months,respectively,showing a significant difference among various time points (F =748.325,P =0.000),and the IOPs were markedly lower in posttreatment than those in pretreatment (all at P＜0.001).The falling range of IOP was (30.43 ±7.18)％,(30.19 ± 8.72)％,(30.71±9.90) ％ in posttreatment 1 month,2 months and 3 months,respectively.The efficiency was 95.70％,91.76％ and 88.05％ in 1 month,2 months and 3 months.Conjunctival hyperemia was observed in 13％ eyes at the end of following-up.No drug-related systemic and other ocular adverse reactions were found.Conclusions Domestic latanoprost drops can low IOP effectively without serious adverse reaction in POAG and ocular hypertensive patients.