May 2003
Volume 44, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2003
A Randomized, Multi-Center Trial of Topical Cyclosporin 0.05% in Steriod-Resistant Atopic Keratoconjunctivitis
Author Affiliations & Notes
  • J.D. Gottsch
    Anterior Segment/Ex Diseases, Johns Hopkins Hospital, Baltimore, MD, United States
  • E.K. Akpek
    Anterior Segment/Ex Diseases, Johns Hopkins Hospital, Baltimore, MD, United States
  • J.K. Dart
    Moorfields Eye Hospital, London, United Kingdom
  • S. Watson
    Moorfields Eye Hospital, London, United Kingdom
  • W. Christen
    Medicine, Harvard Medical School, Boston, MA, United States
  • D. Dursun
    Cornea Service, Bascom Palmer Eye Institute, Miami, FL, United States
  • S. Yoo
    Cornea Service, Bascom Palmer Eye Institute, Miami, FL, United States
  • T.P. O'Brien
    Cornea Service, Bascom Palmer Eye Institute, Miami, FL, United States
  • O.D. Schein
    Cornea Service, Bascom Palmer Eye Institute, Miami, FL, United States
  • Footnotes
    Commercial Relationships  J.D. Gottsch, Allergan Inc F; E.K. Akpek, Allergan Inc. F; J.K. Dart, Allergan Inc. F; S. Watson, Allergan Inc. F; W. Christen, None; D. Dursun, None; S. Yoo, None; T.P. O'Brien, None; O.D. Schein, None.
Investigative Ophthalmology & Visual Science May 2003, Vol.44, 672. doi:
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      J.D. Gottsch, E.K. Akpek, J.K. Dart, S. Watson, W. Christen, D. Dursun, S. Yoo, T.P. O'Brien, O.D. Schein; A Randomized, Multi-Center Trial of Topical Cyclosporin 0.05% in Steriod-Resistant Atopic Keratoconjunctivitis . Invest. Ophthalmol. Vis. Sci. 2003;44(13):672.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Abstract: : Purpose: We wanted to evaluate the efficacy and safety of topical cyclosporin A (CsA) 0.05% in the treatment of patients with severe, steroid resistant atopic keratoconjunctivitis (AKC) in a multi-center, placebo-controlled, double-masked, randomized trial. Methods: Twenty-two patients with AKC refractory to topical steroid treatment were randomly assigned (1:1) to treatment with topical 0.05% CsA eyedrops (Restasis, Allergan Inc) or placebo (artificial tears) for a period of 28 days: six times daily during the first 2 weeks and 4 times daily during the last 2 weeks. Symptoms (itching, tearing, discomfort, mucous discharge and photophobia) and signs (bulbar conjunctival hyperemia, upper tarsal conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis and blepharitis) of AKC were recorded on the day of enrollment and at the end of the treatment period. Separate composite scores were computed by summing the severity grade over all five symptoms and six signs of AKC for each patient. Results: There was a greater improvement in CsA group compared to placebo at the end of the 4-week treatment period (p=0.048 and p=0.002, for symptoms and signs respectively). No adverse effects of the treatment with CsA 0.05% eyedrops were observed. Conclusion: Topical CsA 0.05% (Restasis) appears to be safe and has a beneficial effect in alleviating signs and symptoms of severe AKC refractory to topical steroid treatment.

Keywords: cyclosporine • immunomodulation/immunoregulation • cytokines/chemokines 
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