Purpose

To evaluate the prophylactic benefits of lipid-based and non-lipid-based artificial tear lubricants, in dry eye disease, after adverse environmental exposure.

Methods

Twenty-eight participants with dry eye disease were recruited in a prospective, double-masked, randomised crossover trial. On separate days, participants were randomised to receive a single application of a lipid-containing tear supplement (Systane Complete) to one eye, and a non-lipid containing eye drop (Systane Ultra) to the contralateral eye. Participants were then exposed to a previously validated simulated adverse environment. Symptoms, non-invasive tear film breakup time, lipid layer grade, and tear meniscus height were assessed at three time points; baseline, following eye drop instillation, and after exposure to the adverse environment.

Results

Both treatments effected improvements in symptoms and non-invasive tear film stability following instillation (all p < 0.05), although an improvement in lipid layer quality was limited to the lipid-containing nano-emulsion tear supplement (p = 0.003). Although protective effects were conferred by both treatments following exposure to the simulated adverse environment, more favourable symptomology scores, non-invasive tear film stability, and lipid layer quality were observed in the lipid-containing tear supplement group (all p < 0.05). No significant changes were observed in tear meniscus height in both treatment groups (all p > 0.05).

Conclusions

Both the lipid and non-lipid-based artificial tear supplement demonstrated prophylactic benefits in a simulated adverse environment. However, the ability to preserve tear film quality and reduce dry eye symptomology was greater with the lipid-containing eye drop.

Trial registration number

ACTRN12619000361101

中文翻译：

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比较在不利的环境条件下脂质和不含脂质的泪液补充剂的预防作用：一项随机交叉试验。

目的

评估在不利的环境暴露后，脂基和非脂基人工泪液润滑剂在干眼病中的预防作用。

方法

在一项前瞻性，双重掩盖，随机交叉试验中招募了28名患有干眼病的参与者。在不同的日子，将参与者随机分配给一只眼睛单次使用含脂质的眼泪补充剂（Systane Complete），对侧眼睛单次使用不含脂质的眼药水（Systane Ultra）。然后将参与者暴露于先前已验证的模拟不利环境中。在三个时间点评估症状，无创泪膜破裂时间，脂质层等级和泪液半月板高度。基线，滴眼液后以及暴露于不利环境后。

结果

尽管脂质层质量的改善仅限于含脂质的纳米乳剂眼泪补充剂（p = 0.003），但两种治疗均在滴注后改善了症状和无创性泪膜稳定性（所有p <0.05）。尽管在暴露于模拟不利环境后，两种治疗均具有保护作用，但在含脂质的泪液补充剂组中观察到了更佳的症状评分，无创泪膜稳定性和脂质层质量（所有p <0.05）。两个治疗组的泪液半月板高度均未观察到显着变化（所有p> 0.05）。

结论

脂质和非脂质人工泪液补充剂在模拟的不利环境中均显示出预防性益处。但是，含脂质的眼药水可保持泪膜质量和减轻干眼症状的能力更大。

试用注册号

ACTRN12619000361101