The aim of this study was to investigate the possible effect of lodoxamide 0.1% ophthalmic solution (LOS) on tear T lymphocytes, especially Th2 (T helper 2 subgroup of helper T lymphocytes), in the tear specimens of patients with vernal keratoconjunctivitis (VKC) and to explore the mechanism of the anti-allergic effect of this drug. Twenty-eight active VKC patients were randomly divided into two groups each containing 14 patients. We obtained tear samples from all patients at the beginning of the study. LOS was prescribed to the study group (group A), but the controls (group B) received placebo over the course of 6 weeks. Tear samples were also collected from all patients following a 6-week course of treatment with either LOS or placebo. The percentages of Th1, Th2 and Th cells in the tear samples were measured by using a flow-cytometric technique and the results were compared to each other by using Wilcoxon matched-pairs signed-rank and Mann-Whitney U tests. We found that LOS treatment decreased the percentages of Th2 and Th cells in the tears of group A patients, while placebo had no effect on these values, Th1 cell count in the tears of both groups of patients did not show any significant change between the pre-and posttreatment stages, Our data suggest that LOS exerts, at least, some part of its anti-allergic effect via decreasing the Th2 cell number in the tears of VKC patients.