Conjunctival Injection Reduction in Patients with Atopic Keratoconjunctivitis Due to Synergic Effect of Bovine Enteric-Coated Lactoferrin in 0.1% Tacrolimus Ophthalmic Suspension.

Kenji Matsumoto,Shinji Fukuda,Eisuke Shimizu,Naoko Okada,Hiroshi Fujishima,Masaru Tomita

doi:10.3390/jcm9103093

Abstract

Lactoferrin (LF), a multifunctional glycoprotein found in mammalian milk, is reported to have immunoregulatory effects. The present study aimed to evaluate whether enteric-coated LF (eLF) could improve symptoms in patients with atopic keratoconjunctivitis (AKC). This randomized double-blind placebo-controlled single-center trial comprised Japanese patients (n = 20; aged 22–60 years) with AKC. Patients treated with 0.1% tacrolimus ophthalmic suspension (TALYMUS®) were administered eLF (400 mg/d of bovine LF) or placebo tablets for 12 weeks. Conjunctival injection was examined, papillae formation in the palpebral conjunctiva was evaluated, and corneal fluorescein score, itchy sensation in end-point itching scale, and serum allergic parameters were assessed. Conjunctival injection was significantly reduced in the LF group than in the placebo group (p = 0.0017, Mann–Whitney U-test). Papillae formation in the palpebral conjunctiva showed a statistical decrease in the LF group than in the placebo group (p = 0.010, unpaired T-test). LF combined with TALYMUS® could be a promising treatment strategy to mitigate AKC.

Highlights

IntroductionLF, which is present at high concentration in mucosal secretions, plays a critical role during non-specific defense against infections and inflammation [4]
Lactoferrin (LF) is a multifunctional iron-binding glycoprotein found at the highest concentrations in breast milk and has anti-bacterial, antiviral, immunostimulatory, antioxidant, and cancer-preventive potentials [1,2,3].LF, which is present at high concentration in mucosal secretions, plays a critical role during non-specific defense against infections and inflammation [4]
The serum concentrations of Lactate dehydrogenase (LDH), immunoglobulin E (IgE), thymus and activation-regulated chemokine (TARC), and eosinophilic cationic protein (ECP) were determined by SRL Inc., before and after treatment, using a commercially available enzyme-linked immunosorbent assay

Summary

Introduction

LF, which is present at high concentration in mucosal secretions, plays a critical role during non-specific defense against infections and inflammation [4]. Serum LF is produced by acinar cells in the lacrimal gland and possibly by tear neutrophils during infection and inflammation. LF has been identified in tears and vitreous humor, while its genes have been detected in human cornea and retinal pigment epithelium (RPE) cell cultures. Positive antibody reactions for human LF in the cornea, iris, and RPE tissues have been previously reported [7]. Oxidative stress induces ocular surface inflammation; LF present in tear film exhibits anti-microbial and anti-oxidative properties [7,8], making it a potential biomarker for mucosal immune competence [6]

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Conclusion