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CYTOTOXICITY POTENTIAL OF GANFORT EPITHELIAL CELLS J. Shen, W. Chang UD IN CULTURED HUMAN CORNEAL Pharmacokinetics and Drug Disposition, Allergan, USA Purpose: The assessment of ocular surface toxicity is crucial for the development of topical ophthalmic medications. We evaluated the cytotoxicity potential of the topical glaucoma medication Ganfort UD on corneal epithelial cells. Methods: Human corneal epithelial cells were grown on filters. Ganfort UD was applied to the apical side of the cell layers, while growth medium bathed the cells from the basolateral side. In similar fashion, phosphate buffered saline (PBS) was applied as a negative control, and PBS containing 0.01%, 0.02%, and 0.03% benzalkonium chloride (BAK) was applied to establish dose response under the same experimental condition. Following 16-hour incubation, cell viability was determined for all treatment arms (n=3 per arm) using the standard MTT assay. All samples were analyzed by spectrophotometry. Percent viability relative to saline treatment was calculated using the optical density values obtained for each treatment arm. Results: Dose-dependent increase in cytotoxicity was observed at BAK concentrations of 0.01%, 0.02%, and 0.03%, with 97.5% (p = 0.503), 77.1% (p0.05), and 29.5% (p0.05) cell viability relative to the saline control. Cells incubated with Ganfort UD had 119±7% (p0.05) cell viability relative to the PBS control. Conclusion: Ganfort UD showed no potential of cytotoxicity on culture human corneal epithelial cells, as expected for a formulation containing no preservative. This result is in contrast to prior, similar research showing cytotoxicity of formulations containing BAK, Polyquad (polyquauternium-1), and sofZia. Further research will be conducted using this model to compare Ganfort UD directly against formulations containing Polyquad and sofZia.