2016
DOI: 10.1016/j.ophtha.2016.02.044
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A Clinical Trial Comparing the Safety and Efficacy of Topical Tacrolimus versus Methylprednisolone in Ocular Graft-versus-Host Disease

Abstract: Purpose To evaluate the safety and efficacy of topical tacrolimus 0.05% vs. topical methylprednisolone 0.5% in patients with ocular graft-versus-host disease (GVHD). Design Phase I/II, prospective, randomized, double-masked clinical trial. Subjects Eighty eyes from 40 patients diagnosed with chronic ocular GVHD were enrolled. Methods Forty patients with ocular GVHD were randomized; 24 patients were treated with topical tacrolimus 0.05% and 16 patients with topical methylprednisolone 0.5% twice a day for … Show more

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Cited by 61 publications
(46 citation statements)
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“…A Phase I/II prospective, randomized, double-blind study showed that topical tacrolimus .05% was safe, well tolerated, and effective for ocular GVHD without the hypertensive effects of topical corticosteroids [91]. Topical .02% tacrolimus ointment also has exhibited rapid anti-inflammatory effects in patients with ocular GVHD, which allows a reduction of steroid use in the long term [92].…”
Section: Decrease In Ocular Surface Inflammationmentioning
confidence: 99%
“…A Phase I/II prospective, randomized, double-blind study showed that topical tacrolimus .05% was safe, well tolerated, and effective for ocular GVHD without the hypertensive effects of topical corticosteroids [91]. Topical .02% tacrolimus ointment also has exhibited rapid anti-inflammatory effects in patients with ocular GVHD, which allows a reduction of steroid use in the long term [92].…”
Section: Decrease In Ocular Surface Inflammationmentioning
confidence: 99%
“…In general, ancillary therapies should be maximized to reduce the need for systemic immunosuppression. While systemic absorption from topical therapies is rare, all patients, and in particular very young children, must be monitored for evidence of toxicity (Abud et al, ; Albuquerque et al, ; Brown, Edwards, Walsh‐Chocolaad, & Childs, ; Carpenter et al, ).…”
Section: Management Of Cgvhdmentioning
confidence: 99%
“…[9899] Furthermore, because of its potent immunosuppressive effects, tacrolimus has been used in various studies to prevent graft rejection in HR hosts as detailed below.…”
Section: Systemic Therapymentioning
confidence: 99%