School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia
School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia.
Br J Ophthalmol. 2020 Oct;104(10):1373-1377. doi: 10.1136/bjophthalmol-2019-315160. Epub 2020 Jan 16.
To evaluate the effects of a proprietary formulated eye drop with spp honey versus a conventional lubricant eye drop on tear film properties in subjects with symptoms related to dry eye disease after 28 days of treatment.
Forty-six subjects with symptoms related to dry eye (Ocular Surface Disease Index (OSDI) score >12) were enrolled and randomly assigned to receive either the test formulated eye drop (Optimel by Melcare Biomedical Pty Ltd) or control eye drops (Alcon, USA) in this double-masked study. Inferior lipid layer thickness (LLT), tear film evaporation rate (TER), fluorescein tear film break-up time (TBUT), corneal staining and subjective symptoms (OSDI and visual analogue scales (VAS)) were measured before and after 28 days of instilling the eye drops.
Forty-two subjects completed the study (21 subjects in each group). After 28 days of treatment, TER showed a significantly greater reduction with the formulated eye drop compared with the control (p=0.01). TBUT showed a slight but not statistically significant increase with the formulated eye drop compared with the control (p=0.06), and a significantly greater reduction (improvement) in OSDI scores was observed with the formulated eye drop compared with the control (p=0.01). No significant differences were found between the two groups for inferior LLT, corneal staining and any of the VAS scores.
The formulated eye drops were effective in reducing tear film evaporation rate and were more effective for improving symptoms of dry eye compared with the control eye drops after 28 days of treatment.
NCT03622619.
评估含有 spp 蜂蜜的专利配方滴眼液与常规润滑剂滴眼液对 28 天治疗后干眼症相关症状患者的泪膜特性的影响。
纳入 46 例干眼症相关症状患者（眼表面疾病指数（OSDI）评分>12），并将其随机分为接受试验配方滴眼液（Melcare Biomedical Pty Ltd 的 Optimel）或对照滴眼液（美国爱尔康）治疗的两组。本双盲研究在治疗前和治疗 28 天后分别测量下泪膜脂质层厚度（LLT）、泪膜蒸发率（TER）、荧光素泪膜破裂时间（TBUT）、角膜染色和主观症状（OSDI 和视觉模拟评分（VAS））。
42 例患者完成了研究（每组 21 例）。治疗 28 天后，与对照组相比，配方滴眼液可显著降低 TER（p=0.01）。与对照组相比，配方滴眼液可使 TBUT 略有增加（但无统计学意义，p=0.06），且配方滴眼液可显著降低（改善）OSDI 评分（p=0.01）。两组间下 LLT、角膜染色和任何 VAS 评分均无显著差异。
与对照滴眼液相比，治疗 28 天后，配方滴眼液可有效降低泪膜蒸发率，并更有效地改善干眼症的症状。
NCT03622619。
