Dry Eye Clinical Trial
Official title:
Assessment of Inflammatory and Functional Changes in the Ocular Surface Associated With Dry Eye Disease
This project will examine the similarities and differences of the ocular surface and tear film in patients with Sjogren's syndrome related to dry eye, severe dry eye and those who do not have dry eye. This knowledge will help clinicians understand the processes that create these dry eye conditions and will strengthen the treatment and management strategies that will be used. The subjects will participate in a series of dry eye tests that they have already experienced in clinic, along with the gathering of tear samples and surface cells. These tissues will then be analyzed at a distant site.
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.
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