Dry Eye Evaluation and Management (DREAM) Study

描述（由申请人提供）：干眼病（DED）是一种常见的、与年龄相关的眼部疾病，其最轻微的形式会导致眼部不适、疲劳和视觉障碍等干扰生活质量的令人烦恼的症状，而其更严重的形式会导致慢性疼痛和视力波动。目前对DED的治疗是不充分和昂贵的。临床和临床前研究均表明，无论DED的病因如何，眼表炎症均与DED相关。医生和患者都越来越多地转向“天然”治疗来缓解，特别是ω3多不饱和脂肪酸（PUFA）。ω3 PUFA具有抗炎作用，这使得临床医生和患者认为这种膳食补充剂有助于干眼症患者。ω3补充剂经常被临床医生推荐，并在新闻界广泛推广，尽管ω3治疗DED的疗效数据非常有限。 干眼评估和管理（DREAM）解决了干眼治疗知识的科学差距，特别是ω3，并扩展了对DED体征，症状和炎症生物标志物随时间推移的行为的了解。完成一系列连续的双盲随机临床试验将提供关于ω3对DED疗效的最高水平证据，以及关于补充的长期影响的信息。此外，计划的纵向评估将首次全面描述未经治疗的眼睛（仅人工泪液）1年内DED特征的变化。来自临床试验和纵向评估的数据将允许评估可用于跟踪和预测疾病状态变化的炎症生物标志物和体征，并可能提高我们对DED发病机制的理解。这些活动的结果将为DED和眼表异常领域的未来研究提供证据基础。如果ω3被证明是有效的，它将提供其他治疗方法的替代方案，包括药物，从而减少药物和专业护理的健康支出，并提高DED患者的生产力和生活质量。DREAM的结果将具有直接的临床意义。

DESCRIPTION (provided by applicant): Dry eye disease (DED) is a common, age-related ocular condition that in its mildest forms causes bothersome symptoms of ocular discomfort, fatigue, and visual disturbance that interfere with quality of life and in its more severe forms causes chronic pain and fluctuating vision. Current treatments for DED are inadequate and expensive. Both clinical and pre-clinical research has demonstrated that inflammation of the ocular surface is associated with DED, regardless of the cause of DED. Both physicians and patients are increasingly turning to "natural" treatments for relief, specifically ω3 polyunsaturated fatty acids (PUFAs). ω3 PUFAs have anti-inflammatory actions, which have led clinicians and patients to assume that this dietary supplementation helps dry eye sufferers. ω3 supplements are often recommended by clinicians and widely promoted in the lay press despite only very limited data on the efficacy of ω3 for the treatment of DED. The Dry Eye Evaluation and Management (DREAM) addresses the scientific gap in knowledge of dry eye treatment, specifically ω3, and expands knowledge of the behavior over time of DED signs, symptoms, and inflammatory biomarkers. Completion of a sequential set of two double-masked randomized clinical trials will provide the highest level of evidence on the efficacy of ω3 for DED and information on the long-term effects of supplementation. In addition, the planned longitudinal assessment will provide the first comprehensive description of the changes in characteristics of DED over 1 year in untreated eyes (only artificial tears). Data from the clinical trials and the longitudinal assessment will allow evaluation of inflammatory biomarkers and signs that may be used in tracking and predicting change in disease status, and may improve our understanding of the pathogenesis of DED. The results of these activities will form an evidence base for future research in the area of DED and ocular surface abnormalities. If ω3 proves to be efficacious it would provide an alternative to other treatments, including pharmaceuticals, thereby decreasing health expenditures for medications and professional care, and improving productivity and quality of life in those with DED. Results of DREAM will have immediate clinical implications.