Table 2.

Study Outcomes for the DRy Eye Assessment and Management (DREAM©) Study.

Primary Mean change from baseline in OSDI score at 6 and 12 months

Secondary Compliance with the study treatment protocol as measured by changes in blood levels of fatty acids and pill counts ≥10 point change in OSDI-decrease for Primary Trial, increase for Extension Study Change in signs of DED (conjunctival and corneal staining, TBUT, Schirmer’s test) Use of artificial tears and other treatments for DED Quality of life as measured by the SF-36 Score on the Brief Ocular Discomfort Inventory (BODI) Cost and incremental cost-effectiveness Incidence of ocular and systemic adverse events, changes in visual acuity and intraocular pressure

Exploratory Contrast sensitivity Meibomian gland secretion evaluation Signs measured by keratography: Non-invasive tear break-up time, tear meniscus height, bulbar redness, meibography Tear osmolarity Biomarker levels: Mixed metalloproteinase 9 (MMP-9) in tears, tear cytokine levels (interferon-γ (INF-γ), interleukin-10 (IL-10), IL-17A, IL-1β, IL-6, IL-8, tumor necrosis factor-a (TNF-α)), expression of HLA-DR and other inflammatory markers (epithelial cells, white blood cells, dendritic cells, T regulatory cells, cytotoxic T cells, T helper (Th) cells, Th1, Th2, Th17, Th1/17) on conjunctival cells, and serum autoantibodies (SS-A/Ro, SS-B/La, antinuclear antibody (ANA), rheumatoid factor (RF), salivary gland protein-1 (SP-1), parotid secretory protein (PSP), carbonic anhydrase VI (CA6)) associated with Sjogren’s Syndrome and other autoimmune diseases