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

必需脂肪酸治疗干眼病的临床试验：规划补助金

基本信息

批准号：
7386987
负责人：
PENNY ASBELL
金额：
$ 25.35万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-04-01 至 2010-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7386987
关键词：
Address Adrenal Cortex Hormones Adult Adverse effects Animal Model Anti-Inflammatory Agents Artificial Tears Benefits and Risks Biological Markers Blindness Chronic Chronic Disease Clinical Clinical Research Clinical Trials Clinical Trials, Other Cyclosporine Cyclosporins Data Development Diet Disease Disease Outcome Dose Double-Blind Method Drug Industry Elderly Ensure Essential Fatty Acids Esthesia Eye Eye diseases Fatty Acids Feasibility Studies Foreign Bodies Goals Grant Health Professional Human Immune Immune response Impairment Incentives Inflammation Inflammatory Intake Knowledge Laboratory Study Lead Manuals Manufacturer Name Measures Mediating Methods Multi-Institutional Clinical Trial Operative Surgical Procedures Ophthalmologist Oral Outcome Outcome Measure Pain Pathogenesis Pathology Patient Selection Patients Photophobia Placebo Control Polyunsaturated Fatty Acids Postmenopause Procedures Quality Control Randomized Randomized Controlled Trials Reaction Recruitment Activity Research Design Role Safety Sample Size Severities Signs and Symptoms Site Standards of Weights and Measures Symptoms Testing Tissues United States United States Food and Drug Administration United States National Institutes of Health Vision Woman base chronic pain dietary supplements eye dryness human disease improved irritation men ocular surface placebo controlled study prevent randomized placebo controlled trial research clinical testing treatment duration

项目摘要

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.

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）在治疗干眼病（DED）中的作用。中度至重度 DED 是一种炎症性疾病，其特征是眼睛刺激、眼痛、异物感、慢性红眼、畏光、视力波动和/或视力丧失。 DED 是一个普遍存在、日益严重的问题，会带来严重后果。 DED 是眼科医生办公室最常见的病症，美国有 10-20% 的成年人患有 DED。女性似乎比男性更常见，尤其是绝经后女性。目前，中度至重度 DED 治疗不充分。 EFA 是多不饱和脂肪酸，是人类饮食中必需的脂肪酸，因为它们不能由人体合成。实验室研究、动物模型和一些人体临床试验表明，EFA 可以改善炎症反应，而且它们在非处方药 (OTC) 中广泛使用，旨在对抗或预防与炎症相关的疾病，包括 DED，尽管事实上目前还没有大型、控制良好、有计划的、随机双盲临床试验来测试 EFA 治疗 DED 的有效性和安全性。拟议的研究将解决这一信息差距。该规划拨款的具体目标是解决关键问题，以便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用途操作手册。 - 以 EFA 治疗中度至重度 DED 为中心、随机、安慰剂对照的研究。这符合 NIH 的目标，即增加对眼表疾病和炎症的了解，以及解决女性中更常见的人类疾病，并将扩大使用补充剂预防和治疗慢性疾病的现有证据。