Clinical Trial of Essential Fatty Acids for Dry Eye Disease: Planning Grant

描述（由申请人提供）：拟议的研究将以科学、受控的方式检查必需脂肪酸（EFA）在治疗干眼症（DED）中的作用。中度至重度DED是一种炎性疾病，其特征在于眼部刺激、眼痛、异物感、慢性红眼、恐惧症、视力波动和/或视力丧失。DED是一个广泛的，日益严重的问题，后果严重。DED是眼科医生办公室最常见的主诉，在美国有10-20%的成年人患有DED。女性比男性更常见，尤其是绝经后的女性。目前，中度至重度DED治疗不足。EFA是多不饱和脂肪酸，是人类饮食中必不可少的，因为它们不能由身体合成。EFA已在实验室研究，动物模型和一些人类临床试验中显示出改善炎症反应，并且它们在非处方药（OTC）中广泛使用，旨在对抗或预防与炎症相关的疾病，包括DED，尽管事实上还没有大型，良好对照和计划的随机双盲临床试验来测试EFA治疗DED的疗效和安全性。拟议的研究将填补这一信息空白。该计划补助金的具体目标是解决关键问题，以制定详细的操作手册，记录招募合适受试者的能力，并进行小型可行性研究，以完善程序并最终确定多中心，随机，安慰剂对照的EFA中度至重度DED研究的操作手册。这符合NIH的目标，即增加对眼表疾病和炎症的了解，以及解决女性更常见的人类疾病，并将扩大预防和治疗慢性疾病的有效证据。

DESCRIPTION (provided by applicant): The proposed study will examine in a scientific, controlled way the role of essential fatty acids (EFA) in the treatment of dry-eye disease (DED). Moderate to severe DED is an inflammatory disease, characterized by complaints of eye irritation, eye pain, foreign-body sensation, chronic red eyes, photophobia, fluctuation in vision, and/or loss of vision. DED is a widespread, growing problem with serious consequences. DED is the most common complaint to present in the ophthalmologist's office, with 10-20% of adults in the United States suffering from it. It appears to be more common in women than in men, particularly postmenopausal women. At present, moderate to severe DED is inadequately treated. EFA are polyunsaturated fatty acids which are essential in the human diet since they cannot be synthesized by the body. EFA have been shown in laboratory studies, animal models and some human clinical trials to ameliorate inflammatory reactions and they are widely available over the counter (OTC), purporting to combat or prevent diseases associated with inflammation, including DED, despite the fact that there have been no large, well-controlled and planned, randomized double-blind clinical trials to test the efficacy and safety of EFA for treatment of DED. The proposed study will address this gap in information. The specific aims of this Planning Grant are to resolve key issues in order to develop a detailed Manual of Operations, to document the ability to recruit suitable subjects, and to perform a small feasibility study to refine procedures and finalize the Manual of Operations for a multi-centered, randomized, placebo-controlled study of EFAs in moderate to severe DED. This is in line with NIH goals of increasing knowledge of ocular surface disease and inflammation, and of addressing human diseases more common in women, and will expand the evidence available on supplement-use to prevent and treat chronic disease.