Artikel
Restasis® (Cyclosporin A) eyedrops in the therapy of atopic keratoconjunctivitis (ALLERGAN 192371-012)
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Veröffentlicht: | 22. September 2004 |
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Gliederung
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Problem
Atopic keratoconjunctivitis is the most severe form of ocluar allergy. Secondary complicationen like corneal ulceration may lead to irreversible reduction of visual acuity.
Goal of the planned study
Analysis of effectiveness and safety of Cyclosporin-A 0,05% emulsion (Restasis®, Allergan Ltd) in the treatment of atopic keratoconjunctivitis.
Material und method
In this industry sponsored (Allergan) international multicenter-doubleblind study (Phase-III-Study) 84 patients are planned to participate. The study consists of two parts: In the first phase (6 weeks) Cyclosporin-A emulsion will be compared to the carrier (placebo). In the second phase (additional 52 weeks) all the patients will be treated with Cyclosporin-A. Preexisting topical antiallergic treatment will be continued during the study period, but topical steroids will be tapered slowly.
Inclusion criteria
Patients with atopic keratoconjunctivitis associated with atopic dermatitis will be enclosed, when they areat least 18 years old.
Exclusion criteria
Systemic or topical treatment with Cyclosporin A in between the last 3 months before begin of the study. Contactlens wearers. Pregnancy or nursing period.
State of the art
a. Ethics commity: positiv decision.
b. Begin of the study: appr. June 2004
c. Participants: 30 centers worldwide, 10 of these in Europe, Tuebingen is the only center in Germany.