View Clinical Trial (Medical Research Study)
Long-term Topical Cyclosporine for Atopic Keratoconjunctivitis - NCT00987467-21287(Clinical Trial 353232)
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| City: |
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Baltimore |
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State:
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MD |
| Zip Code: |
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21287 |
| Conditions: |
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Atopic Keratoconjunctivitis |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- 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
Exclusion Criteria:
- Patient has any other diagnosis (i.c. vernal keratoconjuntivitis, giant papillary
conjunctivitis) that may alter the clinical appearance or behavior of their ocular
surface) |
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| Study is available at: |
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Johns Hopkins Hospital - Wilmer Eye Institute Baltimore, MD 21287 United States
Primary Contact: Esen K Akpek, MD Phone: 410-955-7927
Secondary Contact: Esen K Akpek, MD Email: esakpek@jhmi.edu Phone: (410) 955 7927 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
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