April 2010
Volume 51, Issue 13
ARVO Annual Meeting Abstract  |   April 2010
Topical Cyclosporine 0.05% as a Long-Term Monotherapy for Atopic Keratoconjunctivitis
Author Affiliations & Notes
  • J. Tzu
    Wilmer Eye Institute, Baltimore, Maryland
  • C. A. Utine
    Wilmer Eye Institute, Baltimore, Maryland
  • M. E. Stern
    Biological Sciences, Allergan, Inc, Irvine, California
  • E. K. Akpek
    Anterior Segment/Immunol, Johns Hopkins Wilmer Eye Inst, Baltimore, Maryland
  • Footnotes
    Commercial Relationships  J. Tzu, None; C.A. Utine, None; M.E. Stern, Allergan, E; E.K. Akpek, Allergan, F.
  • Footnotes
    Support  William and Mary Greve Scholarship for Research to Prevent Blindness
Investigative Ophthalmology & Visual Science April 2010, Vol.51, 3788. doi:
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      J. Tzu, C. A. Utine, M. E. Stern, E. K. Akpek; Topical Cyclosporine 0.05% as a Long-Term Monotherapy for Atopic Keratoconjunctivitis. Invest. Ophthalmol. Vis. Sci. 2010;51(13):3788.

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

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Purpose: : To evaluate the long-term effectiveness of topical cyclosporine as a monotherapy for atopic keratoconjunctivitis (AKC).

Methods: : Ten patients with moderate to severe AKC requiring corticosteroids were enrolled in a prospective, open-label trial. Topical cyclosporine A (CsA) 0.05% eyedrops (Restasis, Allergan Inc.) were used as a monotherapy, 6 times daily during day 1 to day 28, followed by 4 times daily during day 29 to day 56 of the study. The patients were then challenged by withdrawing the therapy for 1 week between day 57 to day 63. Patients were then treated with topical CsA at a dose ranging from 2 to 6 times daily depending on clinical severity. Artificial tears, tacrolimus ointment for lid disease, or systemic cylosporine for significant atopic dermatitis were also allowed as therapy. Follow-up examinations were performed at 3 month intervals. The study was terminated once the last patient completed a follow-up period of at least 12 months. Symptoms (itching, tearing, discomfort, discharge, and photophobia) and signs (conjunctival hyperemia, upper conjunctival papillae, punctate keratitis, corneal neovascularization, cicatrizing conjunctivitis, and blepharitis) of AKC were assessed on the day of enrollment, on days 28, 56, 63 and at the end of the study. Additionally, disease flare-up requiring topical steroid use and disease findings over the long-term follow-up were recorded.

Results: : All patients experienced significant improvement of their symptoms and signs during the first two months of the study. All patients had a clinically significant relapse when examined at the end of the 1 week "withdrawal" period. Two patients relocated and were lost to follow-up. One patient was non-compliant and continued the treatment only for 7 months. During the treatment period (median of 21.5 months, 17.5 cumulative patient-years), a total of only two flare-up episodes (two patients) were noted requiring topical steroids. Both were associated with either a decrease in the dose of CsA eyedrops or brief discontinuation of the therapy by the patient. The one non-compliant patient was treated with topical steroids by a local physician and had worsening of his disease with decrease of vision from corneal findings at 24 months of follow-up. No side effects or progression of the disease were noted in the 7 patients who were able to continue with the treatment.

Conclusions: : These results suggest that adequate topical immunomodulation using CsA 0.05% eyedrops may favorably alter the long-term prognosis of patients with AKC.

Clinical Trial: : www.clinicaltrials.gov NCT00987467

Keywords: cornea: clinical science • cyclosporine • inflammation 

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