Nishiwaki-Dantas Maria Cristina, de Freitas Denise, Fornazari Denise, Dos Santos Myrna Serapião, Wakamatsu Tais Hitomi, Barquilha Caroline Nascimento, Ferrer Marília Trindade, Holzhausen Helga Caputo Nunes, Alves Monica
Department of Ophthalmology, Federal University of São Paulo, São Paulo, SP, Brazil.
Department of Ophthalmology and Otorhinolaryngology, University of Campinas, Campinas, SP, Brazil.
Ophthalmol Ther. 2024 Dec;13(12):3203-3213. doi: 10.1007/s40123-024-01058-y. Epub 2024 Nov 1.
Dry eye disease (DED) is a multifactorial condition of the ocular surface (OS) characterized by loss of tear film homeostasis, ocular discomfort, and vision disturbances. Most available ocular lubricants target the aqueous deficiency of the tear, restoring only this layer, leaving the tear lipid stratum deficient, as occurs in most patients with evaporative DED. An innovative propylene glycol-hydroxypropyl guar enriched with a phospholipid nanoemulsion (PG-HPG-PH-N) is indicated to restore deficiencies in both the lipid and aqueous layers of the tear film, and its composition was designed to increase lubricant retention on the OS. The purpose of this study was to evaluate, through the Ocular Surface Disease Index (OSDI) and clinical assessment, the treatment of patients who had DED due to aqueous deficiency arising from mixed or evaporative DED subtypes with a PG-HPG-PH-N ocular lubricant at a reduced frequency of twice a day, in a prospective, multicenter, and single-arm study.
Patients were screened from days - 7 to 0, and from day 1 (baseline and first day of treatment) to day 28 of treatment with this lubricant. After visit 1 (screening visit, days - 7 to 0), designed as pre-treatment OS assessment, patients returned to their research center on days 14 and 28 of treatment for a complete assessment, including anamnesis, the OSDI, corrected visual acuity, tear breakup time (TFBUT), OS staining evaluation, tolerability index, and environmental exposure questionnaire.
Seventy patients were enrolled in this study (60 women, 10 men), with a mean age of 45 (range 27-64) years. TFBUT results showed an improvement in tear film stability as vital dyes sodium fluorescein and lysamine green showed a decrease in corneal staining after 14 and 28 days of treatment. No significant adverse events were reported, demonstrating the good tolerability of the lubricant.
The PG-HPG-PH-N nanoemulsion can be considered to be a safe and effective ocular lubricant for treating DED due to aqueous deficiency, both mixed and evaporative subtypes.
Brazilian National Research Ethics Commission (ReBEC registration number 16055).
干眼疾病（DED）是一种眼表多因素病症，其特征为泪膜稳态丧失、眼部不适和视力障碍。大多数现有的眼部润滑剂针对泪液的水液缺乏，仅恢复这一层，而泪液脂质层仍缺乏，大多数蒸发型干眼患者就是这种情况。一种富含磷脂纳米乳剂的创新型丙二醇-羟丙基瓜尔胶（PG-HPG-PH-N）旨在恢复泪膜脂质层和水液层的缺乏，其成分设计用于增加润滑剂在眼表的滞留。本研究的目的是在前瞻性、多中心、单臂研究中，通过眼表疾病指数（OSDI）和临床评估，评估使用PG-HPG-PH-N眼部润滑剂以每天两次的减少频率治疗因混合性或蒸发型干眼亚型引起的水液缺乏型干眼患者的效果。
在第-7天至第0天以及从第1天（基线和治疗第一天）至使用该润滑剂治疗的第28天对患者进行筛选。在第1次就诊（筛选就诊，第-7天至第0天），即设计为治疗前眼表评估之后，患者在治疗的第14天和第28天返回其研究中心进行全面评估，包括问诊、OSDI、矫正视力、泪膜破裂时间（TFBUT）、眼表染色评估、耐受性指数和环境暴露问卷。
本研究共纳入70例患者（60例女性，10例男性），平均年龄45岁（范围27 - 64岁）。TFBUT结果显示泪膜稳定性有所改善，因为重要染料荧光素钠和丽丝胺绿显示在治疗14天和28天后角膜染色减少。未报告重大不良事件，表明该润滑剂具有良好的耐受性。
PG-HPG-PH-N纳米乳剂可被认为是一种安全有效的眼部润滑剂，用于治疗混合性和蒸发型亚型的水液缺乏型干眼。
巴西国家研究伦理委员会（ReBEC注册号16055）
