Dry Eye Syndrome Clinical Trial
Official title:
Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops: Prospective Double-Blind Randomized Study
Aqueous deficiency dry eye is mainly caused by Sjogren syndrome (SS), an autoimmune, chronic, inflammatory and systemic disease which affects most commonly the lacrimal and salivary glands.The ocular treatment is focused in increasing lubrification and decreasing inflammation with topical autologous serum, topical immunosuppressive agents and corticotherapy. Use of topical immunosuppressants has increased in recent years because the topical corticotherapy leads to ocular complications. The most used immunosuppressant is cyclosporine. Tacrolimus , another immunosuppressant, has been used in treatment of immune and inflammatory ocular diseases.This study describes a prospective controlled double-blinded randomized study of the clinical outcome of SS dry eyes patients treated with 0.03% tacrolimus eye drops. As secondary purposes, outcome of dry eye symptoms and any ocular symptoms of the eye drops were also questioned to the patients.
Aqueous deficiency dry eye is mainly caused by Sjogren syndrome (SS), an autoimmune,
chronic, inflammatory and systemic disease which affects most commonly the lacrimal and
salivary glands. The hyperreactivity of B lymphocytes causes lymphoplasmacytic infiltration,
which induces production of antibodies against antigens of the acinar epithelium and ducts
of the lacrimal exocrine gland . The ocular treatment is focused in increasing lubrification
and decreasing inflammation with topical autologous serum, topical immunosuppressive agents
and corticotherapy. Use of topical immunosuppressants has increased in recent years because
the topical corticotherapy leads to ocular complications.
Among topical immunosuppressants the most used ones are tacrolimus, also known as FK506 and
cyclosporine A (CsA). Their mechanism of action is similar, but FK 506 is described to be 10
to 100 times more potent than CsA. Tacrolimus is a macrolide with immunomodulatory action
and becomes biologically active only when it binds to immunophilin and acts by inhibiting
calcineurin, limiting transduction of the signal that carries information from the cell
membrane to the nucleus, with the aim of stimulating interleukin (IL) - 2 synthesis, and
inhibiting T and B lymphocyte activation . Generally, tacrolimus suppresses the immune
response by inhibiting the release of other inflammatory cytokines (eg, IL-3, IL-4, IL-5,
IL-8, interferon- ϒ, and tumor necrosis factor - α) .
The systemic and topical use of tacrolimus is already well established in ophthalmologic
treatments of immune-mediated diseases , uveitis, graft-versus-host disease , corneal
transplants and ocular pemphigoid . In veterinary medicine, topical tacrolimus aqueous
suspension is well established to treat dry eye in dogs . In humans, tacrolimus eye drops
were reported to be effective in treating severe allergic conjunctivitis . In a previous
report, our group has showed the clinical outcomes of a case series of eight patients with
dry eye using 0.03% tacrolimus eye drops 5 based on evidence in treating animals with KCS.
This study describes a prospective controlled double-blinded randomized study of the
clinical outcome of SS dry eyes patients treated with 0.03% tacrolimus eye drops. As
secondary purposes, outcome of dry eye symptoms and any ocular symptoms of the eye drops
were also questioned to the patients.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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