gms | German Medical Science

102. Jahrestagung der DOG

Deutsche Ophthalmologische Gesellschaft e. V.

23. bis 26.09.2004, Berlin

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Restasis® (Cyclosporin A) eyedrops in the therapy of atopic keratoconjunctivitis (ALLERGAN 192371-012)

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  • corresponding author C. M. E. Deuter - Dept. of Ophthalmology, University of Tuebingen, Tuebingen
  • M. Zierhut - Dept. of Ophthalmology, University of Tuebingen, Tuebingen

Evidenzbasierte Medizin - Anspruch und Wirklichkeit. 102. Jahrestagung der Deutschen Ophthalmologischen Gesellschaft. Berlin, 23.-26.09.2004. Düsseldorf, Köln: German Medical Science; 2004. Doc04dogSA.13.01

The electronic version of this article is the complete one and can be found online at: http://www.egms.de/en/meetings/dog2004/04dog382.shtml

Published: September 22, 2004

© 2004 Deuter et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.

Outline

Text

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.