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M. Tanaka, D. Murat, K. Fukagawa, N. Okada, N. Asano–Kato, Y. Takano, A. Igarashi, A. Kujira, K. Tsubota, H. Fujishima; The Efficacy of FK506 Eye–Drop in the Treatment of Ocular Surface Complications in Patients With Severe Allergic Patients With Corneal Complications . Invest. Ophthalmol. Vis. Sci. 2005;46(13):938.
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Purpose: It is well–known that FK506 strongly inhibits cytokine production by T cells. ECP is a tissue damage protein which is secreted from activated eosinophils. Tear ECP levels in allergic patients are known to be related to the severity of clinical findings. To examine the clinical efficacy and anti–inflammatory effects of FK506 eye drops, we studied the changes in clinical ocular findings and measured tear ECP levels of allergic patients before and after the treatment. Methods: Six eyes of 4 patients diagnosed AKC or VKC were enrolled in this study (all males: mean 12.5±2.6 years old) and treated with FK506. The study was placebo controlled where 8 eyes of 4 patients received saline drops in a masked fashion. Tear samples were collected from each patient using a capillary micropipette before and after the treatment. All patients received 0.1% FK506 or placebo eye drops 4 times a day for 1 month. A clinical score of corneal findings (0–4: 0=absent; 4=severe) was determined by slitlamp examination. Tear ECP measurement and corneal findings were evaluated before and after the treatment. Results: Clinical corneal scores improved significantly in patients treated with FK506 eye–drops compare to the placebo drop. Post–treatment tear ECP levels were also significantly reduced compared to the pretreatment level. Conclusions: FK506 eye drops were found to be safe and effective in the treatment of ocular complications in severe ocular allergy. Tear ECP level was observed to be a useful marker in assessing the severity of ocular allergy and efficacy of treatment with FK506.
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