Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis
Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
Summary
Atopic keratoconjunctivitis (AKC) is a rare type of ocular allergy that is often associated
with eczema. Over time, the complications from this disease process lead to loss of vision
due to continual scarring of the corneal surface. The pathophysiology of AKC has not been
fully elucidated, and the triggers are still unknown.
Corticosteroids are very effective in controlling the acute symptoms of AKC. However, two
thirds of patients managed with a combination of oral antihistamine, topical mast cell
stabilizer, and intermittent topical steroid regimen eventually developed significant
keratopathy and vision loss. Additionally, there are many side effects of corticosteroids,
including local immunosuppression, cataract formation, and increased risk of glaucoma.
Cyclosporin A is an immunomodulator that specifically inhibits T lymphocytes by blocking the
expression of the interleukin-2 receptor. It also blocks the release of inflammatory
mediators from mast cells and eosinophils. Cyclosporin has no known side effects except for
burning upon instillation, and safe to use over long-term . The investigators have
demonstrated that a 0.05% ophthalmic emulsion of cyclosporine has been shown to be effective
at improving the ocular signs and symptoms of AKC over short-term. However, the long-term
efficacy of cyclosporine A in slowing the natural history of AKC and possible steroid sparing
effects have not been assessed. The investigators hypothesize that cyclosporine A can be used
as a mainstay treatment of AKC to control signs and symptoms over a long period of time and
also prevent the progression of this disease.