Dry Eye Clinical Trial
Official title:
Evaluation of the Effect of Topical Application of Tacrolimus 0.03% (FK506) Eye Drops Versus Cyclosporine 0.05% Eye Drops in Treatment of Dry Eye in Secondary Sjogren Syndrome
Evaluation of the effect of topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye drops in treatment of dry eye in Secondary Sjogren Syndrome.
Sjogren syndrome is a chronic autoimmune disorder characterized by immune cell infiltration
of exocrine glands (exocrinopathy or epitheliitis) and systemic complications due to
autoantibody production, immune complex deposition and lymphocytic infiltration of many
organs .The loss of aqueous tear flow in Sjogren syndrome is a result of inflammatory cell
infiltration of the lacrimal glands.The principal ocular manifestation of which is decreased
tear production leading to chronic irritation and damage to the corneal and conjunctival
epithelium. Dry eye associated with Sjogren syndrome (SS dry eye) is often more severe than
non-Sjogren dry eye (non-SS dry eye). Rose bengal staining, fluorescein staining, impression
cytology, and brush cytology show greater changes in SS dry eye owing to a lack of both basic
tearing and reflex tearing resulting from lacrimal gland destruction, which is the hallmark
of deteriorating clinical conditions.
The initial tear film ocular surface society dry eye workshop report noted the importance of
ocular surface inflammation not only in the development of, but as a downstream effect and
propagator of dry eye disease , and reviewed a range of therapies that function, at least in
part, by anti-inflammatory mechanisms of action. Thus understanding the link between
inflammation and dry eye validates the utilization of anti-inflammatory therapy in everyday
practice.
Cyclosporine is understood to be an immunomodulatory drug with anti-inflammatory properties,
as well as having other actions relevant to managing dry eye disease . Topical cyclosporine
was approved by the FDA for the treatment of moderate-to-severe dry eye disease in 2003,
based on an improvement in tear production.
Tacrolimus, a macrolide produced by Streptomyces tsukubaensis,was discovered in 1984 in Japan
while searching for new immunosuppressive and cancer chemotherapeutic agents. The use of
tacrolimus is of special interest in ophthalmology because it is indicated to be effective in
the treatment of immune-mediated diseases Thus, the investigators performed this study to
evaluate the effect of two different immunomodulatory eye drops on the ocular surface which
are topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye
drops in treatment of dry eye in Secondary Sjogren Syndrome.
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