Keratoconjunctivitus sicca (KCS), or dry eye, is a prevalent disease affecting an estimated one in five adults to varying degrees. Of Americans over the age of 65, some 4.3 million persons report tear film deficiencies, and certain diseases put patients at increased risk for the disease, including diabetes, lupus, arthritis, leukemia, fibromyalgia, acne rosacea, and Sjogren's syndrome. Significant research has focused on alleviating the effects and discomfort of dry eye, and new drugs and topical preparations are available. Results reported in the literature suggest that an external non-pharmacological treatment may be possible, based instead upon electrophysics. Dr. A. P. Krueger reports that tracheal tissues are stimulated to secrete mucus by exposure to negatively charged gaseous air ions. Dr. A. P. Wehner reports similar results for patients inhaling electro-aerosols. Finally, Dr. J. V. Forrester et al. have shown that electric fields play a significant role in ocular surface wound healing. Based upon these data, ADA believes that conjunctival goblet cells can be actively stimulated to secrete mucins and proliferate by subjecting them to an electric charge flux and electric field simultaneously. In Phase I, two experimental systems will be devised-one using coronal discharge and the other an electrospray technique-to supply calibrated levels of electric charge flux and electric field gradient to bovine conjunctival goblet cell cultures. Mucin secretion and proliferation will be evaluated to confirm or refute ADA's stimulation hypothesis. If confirmed, Phase II will incorporate in vivo testing to assess wound healing effects, anticipated stimulation of lacrimal and meibomian glands, and equipment development with the intent of commercializing a practical treatment system in Phase III.
