The proposed Dry Eye Evaluation and Management (DREAM) study is a set of two multicenter randomized Clinical trials designed to evaluate effectiveness and safety of ? 3 fatty acid supplementation for treatment of patients with mild to moderate dry eye disease. Dry eye disease is a highly prevalent, age-related condition that in its mildest forms causes bothersome symptoms of ocular discomfort, fatigue, and visual disturbance, and in its severe forms causes chronic pain and fluctuating vision. The goal of the Coordinating Center (CC) is to contribute to the success of DREAM by providing study leadership, data management, data analysis, and communication, and by facilitating the execution of the study protocol. The CC provides expertise on design of multicenter studies and on implementation and maintenance of high quality data management systems, statistical analysis, and quality assurance programs.
The specific aims of the Coordinating Center to fulfill this role are to: - Collaborate with the other members of the study group to further refine the study design; - Create and maintain the study database through design of data collection forms, data capture, data editing, and data management; - Provide timely, regular reports concerning study progress and performance to the clinical sites, the Central Laboratory for Fatty Acids and laboratories for HLA-DR and cytokine determination, the Executive Committee and its subcommittees, and the Data and Safety Monitoring Committee; - Design and implement a full program of quality assurance activities, with the Operations Committee; - Provide interim and final statistical analysis of the study data on primary and secondary outcomes; - Contribute to and prepare support materials for all DREAM meetings, including the Data and Safety Monitoring Committee, the Investigative Group, the Executive Committee, and the Operations Committee; - Participate and lead in the preparation of scientific presentations and reports; - Administer subcontracts with DREAM clinical centers.
Findings from the DREAM will inform patients and their eye care providers with information on the effectiveness of omega 3 fatty acid (fish oil) supplementation in relieving symptoms of dry eye disease and if the supplements are initially effective, on how long they need to be taken.