Assessment of Inflammatory and Functional Changes in the Ocular Surface Associated With Dry Eye Disease (JADE)
|ClinicalTrials.gov Identifier: NCT00809003|
Recruitment Status : Completed
First Posted : December 16, 2008
Last Update Posted : December 16, 2008
|Condition or disease|
|Sjogren's Syndrome Dry Eye|
Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. A number of factors have been implicated in triggering this disease, including age, hormone changes and autoimmune disease.
Sjogren's syndrome(SS) is a common autoimmune disorder, characterized by chronic inflammatory infiltration of exocrine glands (particularly salivary and lacrimal) and systemic immune reactivity, resulting in dry eye and dry mouth. The mechanism of inflammation of the lacrimal gland in these patients is well documented. It is believed that these pathological changes facilitate the secretion of inflammatory biochemicals on to the ocular surface. Additionally, in SS, there are also pathological changes to epithelial cells of the cornea and conjunctiva (such as upregulation of mRNAs coding for inflammatory cytokines) which subsequently contribute to the increased secretion of the cytokines themselves. Taken together, these changes result in an increased concentration of inflammatory mediators in the tear film, which then drive the propagation of the dry eye disease process. Severe dry eye (DE) patients present with a very similar clinical outcome to SS patients, however, inflammatory processes associated with either the initiation or propagation of their dry eye disease has not been well characterized.
This research project was established to quantify similarities and / or differences between SS and severe dry eye participants, with respect to ocular surface inflammation and function. Specifically, this study will examine dry eye symptoms, ocular surface integrity and tear film volume and flow. Additionally, the concentration of inflammatory cytokines present in the tear film will be quantified.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Assessment of Inflammatory and Functional Changes in the Ocular Surface Associated With Dry Eye Disease|
|Study Start Date :||September 2007|
|Study Completion Date :||December 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00809003
|Centre for Contact Lens Research, School of Optometry|
|Waterloo, Ontario, Canada, N2L3G1|
|Principal Investigator:||Desmond Fonn, MOptom||University of Waterloo|