Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis

Completed · Not applicable

Conditions studied: Atopic Keratoconjunctivitis

In brief

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.

Key facts

Study ID

NCT00987467

Run by

Johns Hopkins University

People needed

12

Starts

2007-08-01

Expected to finish

2009-09-01

Last updated by the study team

2018-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has known diagnosis of atopic keratoconjunctivitis
• Patient has been on cyclosporine 0.05% eye drops for control of atopic keratoconjunctivitis
• Patient has been followed up for at least for 1 year
• Patient is able to give informed consent
• Patient is able to tolerate a full ophthalmic exam

You may not qualify if…

• Patient has any other diagnosis (i.c. vernal keratoconjunctivitis, giant papillary conjunctivitis) that may alter the clinical appearance or behavior of their ocular surface)

Where it is running

• Johns Hopkins Hospital - Wilmer Eye Institute — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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