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 actively recruiting participants. We recently reported a sex based comparison of disease manifestations of Sjogren's syndrome. Despite similar objective evidence of extent of oral, ocular and immunologic manifestations of disease, women reported more severe pain and negative impact on vision targeted quality of life than men. ? ? In line with our interest in improving the tools for clinical trials in dry eye, we are part of a team that recently published 2 landmark reports on the epidemiology of and diagnostic methodologies for dry eye. Standardized templates for a comprehensive battery of diagnostic modalities for dry eye evaluation were developed and are available at www.tearfilm.org. 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. Further study of the epidemiology of dry eye in a wider variety of populations and geographic regions is warranted.? ? 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 underway 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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