Purpose

To assess the six-month therapeutic profiles of lipid and non-lipid-based artificial tear supplements in managing dry eye disease (DED).

Methods

Ninety-nine participants fulfilling the TFOS DEWS II diagnostic criteria for DED (64% females; mean ± SD age, 44 ± 16 years) were enrolled in a prospective, multicentre, double-masked, parallel group, randomised controlled trial. Participants instilled lipid-based nanoemulsion drops or non-lipid-based aqueous drops for six months, at least four times daily. Symptomology, tear film and ocular surface characteristics were assessed at Days 0, 30, 60, 90, 120, 150 and 180.

Results

Sustained reductions in OSDI, DEQ-5, and SANDE symptom scores from baseline were observed from Day 30 onwards in both groups (all p < 0.05) and decreased superior lid wiper epitheliopathy grades from Day 60 onwards (all p ≤ 0.01). Improvements in non-invasive tear film breakup time, and sodium fluorescein and lissamine green staining scores followed from Day 120 onwards in both groups (all p < 0.05). Tear lipid layer grades increased from Day 90 onwards only with the lipid-based drops, and with significantly greater improvement in those with suboptimal lipid layer thickness at baseline (grade ≤3; p = 0.02). By Day 180, 19% of participants no longer fulfilled the diagnostic criteria for DED.

Conclusions

Over a six-month treatment period, improvements in dry eye symptomology preceded tear film and ocular surface changes with regular use of both lipid and non-lipid-based artificial tear supplements. Both formulations addressed most mild-to-moderate forms of aqueous deficient and evaporative DED, while evaporative cases benefitted preferentially from lipid-based supplementation. This represents a first step towards mapping DED therapeutic strategies according to disease subtype and severity.

中文翻译：

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制定基于证据的人工泪液补充剂治疗干眼病的指南：一项为期六个月的多中心，双掩盖随机对照试验

目的

评估脂质和非脂质人工泪液补充剂治疗干眼病（DED）的六个月治疗方案。

方法

符合TFOS DEWS II诊断标准的99位参与者（64％为女性；平均±SD年龄，44±16岁）参加了一项前瞻性，多中心，双掩蔽，平行组，随机对照试验。参与者滴注基于脂质的纳米乳剂滴剂或基于非脂质的水性滴剂六个月，每天至少四次。在第0、30、60、90、120、150和180天评估症状，泪膜和眼表特征。

结果

两组均从第30天开始观察到OSDI，DEQ-5和SANDE症状评分均较基线水平持续降低（所有p <0.05），而从第60天开始则观察到上睑刮水上皮病等级降低（所有p≤0.01）。从第120天开始，两组的无创性泪膜破裂时间，荧光素钠和赖氨酰胺绿染色分数均有所改善（所有p <0.05）。从第90天开始，仅基于脂质的滴眼液才增加了泪液脂质等级，对基线处脂质层厚度欠佳的受试者，其泪液脂质等级有了显着提高（等级≤3； p = 0.02）。到第180天，已有19％的参与者不再满足DED的诊断标准。

结论

在六个月的治疗期内，经常使用脂质和非脂质类人工泪液补充剂可以改善泪液膜和眼表的变化，从而改善干眼症状。两种配方均解决了水性不足和蒸发性DED的大多数轻度至中度形式，而蒸发性病例则优先受益于基于脂质的补充。这代表了根据疾病亚型和严重程度绘制DED治疗策略的第一步。