To identify the relationship between epidermal growth factor (EGF) concentrations in human tears and clinical tear-flow parameters and how these vary with age and gender. Tear samples were collected with minimal stimulation from 68 healthy and asymptomatic adults (33 men, 35 women), aged 21-88 years. EGF concentrations were determined by sandwich enzyme-linked immunosorbent assay (ELISA) in 65 cases. Schirmer tests were performed without anesthesia, and the clearance of fluorescein from the tear film assessed. The Tear Function Index (TFI) was calculated from these values. There were approximately equal numbers of male and female subjects with a similar age distribution for each gender (48+/-3 and 51+/-3 years, mean+/-SEM, respectively). Ninety percent of tear EGF concentrations were between 0.75 and 7.1 ng/ml. Tear EGF level correlated significantly with Schirmer I value, but not with age. Schirmer I value correlated with tear clearance [LN (TCR)] but not with age. Tear EGF concentrations were significantly higher for men (3.4+/-0.3 ng/ml) than for women (2.4+/-0.3 ng/ml; p= 0.043). EGF concentrations in tear samples from normal humans were found to correlate with gender and Schirmer I value but not with tear clearance