School of Optometry and Vision Science, UNSW Sydney, Sydney, NSW, Australia.
Stats Central, UNSW Sydney, Sydney, NSW, Australia.
Cont Lens Anterior Eye. 2022 Dec;45(6):101736. doi: 10.1016/j.clae.2022.101736. Epub 2022 Jul 12.
To examine the effect of hydroxypropyl-guar nanoemulsion (HP-Guar nanoemulsion, Alcon Laboratories Ltd, Fort Worth, TX, USA) versus saline (0.9% sodium chloride; Pfizer Inc., Bentley WA Australia) on the comfort and tear film properties of people with dry eye disease both in the short-term (up to 2 h post-drop instillation) and longer-term (after 4 weeks of 4-times daily use), and to examine the effect on tear inflammatory markers after 4 weeks.
This was a prospective, investigator-masked, randomised, cross-over dispensing study. Twenty participants with dry eye disease (5 males: 15 females) with average age 46.9 ± 14.4 (range 26 to 70) years were randomized to either HP-Guar nanoemulsion, or saline eye drops. Ocular symptoms, lipid layer thickness, tear evaporation, tear osmolarity and non-invasive break-up time were measured pre-drop instillation, 1 h and 2 h post-eye drop instillation, and after 4-weeks of 4-times daily drop use. Tear inflammatory mediators were measured pre-drop instillation and after 4-weeks. After 4-weeks, patients had a 4-week washout period and then crossed over to the alternate drop.
With HP-Guar nanoemulsion, participants reported less grittiness/burning/stinging 1 h post eye drop instillation compared to baseline (79.5 ± 23.3 vs. 66.8 ± 27.7, p = 0.02); less dryness 1 h and 2 h post eye drop instillation compared to baseline (77.8 ± 23.0 and 76.2 ± 23.7 vs. 61.0 ± 27.1 respectively, p < 0.01 for both); and greater overall satisfaction 1 h post drop instillation and after 4 weeks of daily use compared to baseline (80.4 ± 21.6 and 83.4 ± 16.6 vs. 68.6 ± 26.0 respectively, p ≤ 0.011 for both). With saline, participants reported less dryness after 4 weeks of daily use compared to baseline (74.2 ± 23.8 vs. 60.2 ± 24.0, p < 0.01). For HP-Guar nanoemulsion, average lipid layer thickness was significantly thicker 2 h post drop-instillation (79.5 ± 21.7 nm) compared to baseline (63.7 ± 18.9 nm) and the 4-week assessment (62.4 ± 23.1 nm, p < 0.01 for both). For saline, average lipid layer thickness was significantly thicker at 1 h and 2 h post eye drop instillation (76.0 ± 23.8 nm and 80.4 ± 24.8 nm) compared to baseline (61.0 ± 15.6 nm, p < 0.01 for both). There was no difference in inflammatory mediators or other tear variables between drops or visits.
HP-Guar nanoemulsion was more effective for improving a range of subjective dry eye symptoms both in the short and long-term compared to saline. Both HP-Guar nanoemulsion and saline transiently increased lipid layer thickness.
研究羟丙基瓜尔胶纳米乳液（Alcon Laboratories Ltd，得克萨斯州沃思堡，美国）与生理盐水（0.9%氯化钠；辉瑞公司，澳大利亚 Bentley WA）对短期（滴注后 2 小时内）和长期（4 倍每日使用 4 周后）干眼患者舒适度和泪膜特性的影响，以及 4 周后对泪液炎症标志物的影响。
这是一项前瞻性、研究者盲法、随机交叉分配研究。20 名患有干眼疾病的参与者（5 名男性：15 名女性），平均年龄 46.9±14.4 岁（范围 26 至 70 岁），随机分为羟丙基瓜尔胶纳米乳液或生理盐水滴眼剂组。在滴注前、滴注后 1 小时和 2 小时以及 4 倍每日滴眼 4 周后测量眼部症状、脂质层厚度、泪液蒸发、泪液渗透压和非侵入性泪膜破裂时间。在滴注前和 4 周后测量泪液炎症介质。4 周后，患者进行 4 周洗脱期，然后交叉使用另一种滴眼剂。
与生理盐水相比，使用羟丙基瓜尔胶纳米乳液的患者在滴注后 1 小时报告的眼痛/烧灼感/刺痛感明显减少（79.5±23.3 与 66.8±27.7，p=0.02）；在滴注后 1 小时和 2 小时时的干燥感明显减少（77.8±23.0 和 76.2±23.7 与 61.0±27.1，p<0.01 均）；在滴注后 1 小时和 4 周每日使用后，总体满意度明显增加（80.4±21.6 和 83.4±16.6 与 68.6±26.0，p≤0.011 均）。使用生理盐水的患者在 4 周每日使用后干燥感明显减少（74.2±23.8 与 60.2±24.0，p<0.01）。对于羟丙基瓜尔胶纳米乳液，在滴注后 2 小时时平均脂质层厚度明显更厚（79.5±21.7nm）与基线（63.7±18.9nm）和 4 周评估（62.4±23.1nm，p<0.01 均）。对于生理盐水，在滴注后 1 小时和 2 小时时平均脂质层厚度明显更厚（76.0±23.8nm 和 80.4±24.8nm）与基线（61.0±15.6nm，p<0.01 均）。在滴注前后，两种滴眼剂之间或访问之间的炎症介质或其他泪液变量没有差异。
与生理盐水相比，羟丙基瓜尔胶纳米乳液在短期和长期内更有效地改善了一系列主观干眼症状。羟丙基瓜尔胶纳米乳液和生理盐水都可短暂增加脂质层厚度。
