Grant Abstract: Dry Eye Evaluation and Management (DREAM) Study

Grant Number: 5U01EY022881-03
PI Name: Asbell
Project Title: Dry Eye Evaluation and Management (DREAM) Study

Abstract: This supplemental funding from the Office of Dietary Supplements (ODS) will support expanded biomarker analysis (identifying inflammatory cells) of samples collected in the DREAM U10 grant to elucidate the role of omega-3, a dietary supplement in treatment of Dry Eye Disease (DED). DED is a chronic inflammatory disease characterized by sustained eye pain/irritation associated with variable vision that diminishes the quality of life. Although omega-3 is known to have anti-inflammatory effects that are beneficial for heart disease and rheumatoid arthritis, there is only limited evidence on its efficacy for DED. DREAM (The Dry Eye Assessment and Management Trial) is a NEI-funded U10 Grant (U10EY022881, FDA IND 106,387) to evaluate the safety and efficacy of omega-3 for DED in a multi-center, double-blind, randomized clinical trial of approximately 600 subjects followed for 1-2 years. Dr. Asbell is the Study Cahir for DREAM. The Coordinating Center at the University of Pennsylvania is funded by a companion NEI funded U10 grant (U10EY022879-01) and is chaired by Maureen Maguire, PhD. The Specific Aims for the DREAM Expanded Biomarker Analysis are: 1. Omega-3 supplementation in DED alters the inflammatory environment of the ocular surface as determined by flow cytometry of cells collected from impression cytology (IC) samples of the anesthetized conjunctiva. 2. Biomarkers of ocular inflammation predict response to supplementation with omega-3, allowing for a personalized approach to provide best patient care. Accomplishing the specific aims of this proposal will fill a recognized gap in our understanding of the mechanism of action of ometa-3 dietary supplement as an anti-inflammatory agent in DED. We will be going far beyond our original proposal in DREAM to now provide a comprehensive view of inflammation on the ocular surface and identify mechanisms by which omega-3 may influence it. Using 12 antibodies to identify specific effector cells combined with analysis of tears, all done under masked analysis, correlated with signs and symptoms in a well-characterized cohort of DED patients will allow us to better classify DED and determine which subjects would most benefit from nutritional supplementation with omega-3. Results will provide a mechanistic understanding of omega-3 and DED and be the basis for future research in omega-3 for the treatment of DED and other inflammatory processes.

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