A prospective contralateral eye comparison of the tolerability of two artificial tears with different physical properties in patients with dry eye disease

Fatin Amalina Che Arif, Mohd Radzi Hilmi, K. M. Kamal
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引用次数: 3

Abstract

Background: Artificial tears (ATs) are widely used in ophthalmic practice with various formulations, mainly as a treatment for dry eye, owing to their rapid ability to alleviate the signs and symptoms of this condition. We aimed to investigate drop comfort and subjective ocular symptoms after instillation of the following ATs with different physical properties: Optive® non-preservative (OUD) and Systane® Hydration non-preservative (SHUD). Methods: This was a prospective, double-blind, randomized, contralateral eye comparison study. A rheometer and a digital pH meter were used to evaluate the viscosity and pH of both ATs prior to instillation. We recruited 36 patients with dry eye disease. Single standardized AT volumes were set using a micropipette for all patients. Ocular discomfort was assessed using the Ora Calibra™ Ocular Discomfort and 4-Symptom Questionnaire (OOD4SQ; 0 – 5 scale) before and 60 min after instillation. Drop comfort was assessed using the Ora Calibra™ Drop Comfort Scale (0 – 10 scale) immediately after AT instillation. The difference in the drop comfort score (DCS) between the two ATs and ocular discomfort scores using OOD4SQ before and 60 min after instillation of each AT were recorded and compared. Results: The viscosities and pH of SHUD and OUD were 32.73 centipoise (cP) and 7.74 and 14.42 cP and 7.19, respectively. The mean (standard deviation) DCS was higher in the SHUD group than in the OUD group (1.83 [1.21] versus 1.67 [1.12]); however, the difference was not statistically significant (P > 0.05). There was a significant reduction in all parameters of OOD4SQ including overall discomfort, burning, dryness, grittiness, and stinging 60 min after OUD instillation (all P < 0.05), while a significant difference was only noted in dryness (P < 0.05) in the SHUD group. Conclusions: OUD, which has a lower viscosity and pH compared to SHUD, provides less subjective sensation and better ocular comfort 60 min after instillation. Further randomized clinical trials including patients with dry eye disease of different severities, larger sample sizes, and longer follow-up periods are required to verify our findings.
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干眼病患者对两种不同物理性质人工泪液耐受性的前瞻性对侧眼比较
背景:人工泪液(ATs)在眼科实践中被广泛应用于各种配方,主要用于治疗干眼症,因为它们能够迅速缓解干眼症的体征和症状。我们的目的是研究滴入以下具有不同物理性质的ATs后的舒适度和主观眼部症状:Optive®无防腐剂(OUD)和Systane®水合无防腐剂(SHUD)。方法:这是一项前瞻性、双盲、随机、对侧眼比较研究。在注射前使用流变仪和数字pH计评估两种ATs的粘度和pH值。我们招募了36名干眼症患者。所有患者使用微量移液管设置单一标准化AT体积。眼部不适采用Ora Calibra™眼部不适和4症状问卷(OOD4SQ;0 - 5刻度)注射前和注射后60分钟。滴注AT后立即使用Ora Calibra™滴注舒适度量表(0 - 10级)评估滴注舒适度。记录两种AT滴注前和滴注后60 min滴注后滴注舒适评分(DCS)和OOD4SQ眼不适评分的差异并进行比较。结果:SHUD和OUD的黏度和pH分别为32.73厘泊(cP)和7.74厘泊(cP), 14.42厘泊(cP)和7.19厘泊(cP)。SHUD组DCS均值(标准差)高于OUD组(1.83[1.21]对1.67 [1.12]);但差异无统计学意义(P > 0.05)。OUD灌胃60min后,OOD4SQ的整体不适、灼烧感、干燥感、沙砾感、刺痛感等各项指标均显著降低(P < 0.05),而SHUD组仅在干燥感方面有显著差异(P < 0.05)。结论:与SHUD相比,OUD具有更低的粘度和pH值,在注入60 min后主观感觉更少,眼部舒适度更好。需要进一步的随机临床试验,包括不同严重程度的干眼病患者,更大的样本量和更长的随访期来验证我们的发现。
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