We continued investigating the natural history and treatment of the autoimmune exocrinopathy, Sjogren's Syndrome, which is associated with a particularly severe form of dry eye in which the pathogenesis may include sex hormone insufficiency and dysregulated immune regulation. Specifically, protocol 06-D-0181, A randomized placebo controlled, proof of concept study of Raptiva, a humanized anti-CD11a monoclonal antibody in patients with Sjogren's syndrome, is nearing completion. ? ? With continued interest with in improving the tools for diagnosis and evaluation of dry eye, we co-authored a publication describing the menisci and importance of blink magnitude in dry eye. Dry eye affects 5-30% of the population over the age of 50 years and risk factors include female sex, age, sex hormone alterations, refractive surgery, particular medications and infections and a variety of specific clinical diseases such as graft vs. host disease. Vision targeted health-related quality of life (QOL) instruments quantify an aspect of dry eye that is not measured in other ways. A wide variety of validated instruments that measure QOL and symptoms are available; however, clinically meaningful changes remain to be defined. We have begun a clinical protocol to evaluate the comparability of QOL instrument in dry eye and control subjects administered via the web or conventional completion with paper and pen. ? ? Data analysis of the ocular response from a placebo-controlled, randomized controlled trial of systemic testosterone treatment in women with premature ovarian insufficiency remains ongoing. As part of our interest in outcome measures for ocular surface disease, data analysis is near completion from a one of its kind study on validation of digital imaging of ocular surface vital dye staining as an outcome measure for clinical trials.
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