摘要
Abstract
Objective:The aim of this study was to evaluate the safety and efficacy of preservative-free 0.4%oxybuprocaine hydrochloride eye drops in patients with corneal conditions undergoing examinations that necessitate ocular surface anesthesia.By observing its application effects in healthy individuals and patients with mild to moderate dry eye(DED),it provides a reference for clinical corneal examinations.Methods:This prospective,single-arm trial enrolled healthy adults and DED patients from the outpatient department of Leshan Aier Eye Hospital between January 2025 and March 2025.The study eye was selected based on the following criteria:First,the eye with a lower fluorescein sodium corneal fluorescein staining(CFS)score at baseline was chosen.If the CFS scores were equal,the eye with the lower conjunctival lissamine green staining(CLGS)score was then selected.In cases where both CFS and CLGS scores were the same,the eye with the higher fluorescein tear film break-up time(FBUT)was picked.If both eyes had identical values,the right eye was designated as the study eye.All participants received 1-2 drops of preservative-free 0.4%oxybuprocaine hydrochloride.Pain scores measured using the numerical rating scale(NRS),and ocular surface parameters(CFS,CLGS,FBUT)were recorded at baseline,5 minutes,and 20 minutes after instillation.The primary endpoint was safety,while the secondary endpoint was NRS scores at 5 and 20 minutes in study eyes with baseline NRS≥1.Results:A total of 53 participants(53 eyes)were included in the study,all of Han ethnicity.The median age of the paticipants was 39 years,with an interquartile range of 32.00-53.00 years,and 54.7%(29/53)were female.Among them,17%(9/53)had mild to moderate DED.No statistically significant differences were found in FBUT,CFS,or CLGS between baseline and post-instillation time points(all P>0.05).Twenty participants with a baseline NRS of≥1 demonstrated statistically significant reductions in NRS scores at 5 and 20 minutes compared to baseline(both P<0.001).Conclusions:Preservative-free 0.4%oxybuprocaine hydrochloride eye drops were well-tolerated and safe for the ocular surface of both healthy individuals and patients with mild to moderate DED.Analgesic efficacy was clearly demonstrated at 5 and 20 minutes after instillation in subjects experiencing ocular surface pain,with no significant adverse effects on corneal/conjunctival integrity or tear film stability.关键词
盐酸奥布卡因/无防腐剂/眼表/表面麻醉/干眼症/疼痛数字评定量表Key words
oxybuprocaine hydrochloride/preservative-free/ocular surface/surface anesthesia/dry eye/numerical rating scale for pain分类
医药卫生
