CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Cyclosporin 0.05% ophthalmicdrug
Likely dose
Not stated in record
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Search/NCT00987467
NCT00987467N/ACompleted

Long-term Results of Topical Cyclosporine 0.05% in the Treatment of Atopic Keratoconjunctivitis

Johns Hopkins University·interventional·Posted Oct 1, 2009·Updated Apr 2, 2018

In Brief

A clinical study evaluating Cyclosporin 0.05% ophthalmic for Atopic Keratoconjunctivitis. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 1, 2009
Enrollment StartAug 1, 2007
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 16.8 years ago

Interventions

Cyclosporin 0.05% ophthalmicdrug

Cyclosporine 0.05% ophthalmic solution, 1 drop 6 times in both eyes daily for first month, then 1 drop 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator.