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

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

doi:10.3390/jcm9103093

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

J Clin Med. 2020 Sep 25;9(10):3093. doi: 10.3390/jcm9103093.

Authors

Hiroshi Fujishima¹, Naoko Okada^{1

2}, Kenji Matsumoto³, Eisuke Shimizu⁴, Shinji Fukuda^{5

6

7}, Masaru Tomita⁵

Affiliations

¹ Department of Ophthalmology, Tsurumi University School of Dental Medicine, Tsurumi, Yokohama 230-8501, Japan.
² Department of Pharmaceutical Sciences, Nihon Pharmaceutical University, Saitama 362-0806, Japan.
³ Department of Allergy and Clinical Immunology, National Research Institute for Child Health and Development, Tokyo 157-8535, Japan.
⁴ Department of Ophthalmology, Keio University School of Medicine, Tokyo 160-8582, Japan.
⁵ Institute for Advanced Biosciences, Keio University, Tsuruoka, Yamagata 997-0052, Japan.
⁶ Intestinal Microbiota Project, Kanagawa Institute of Industrial Science and Technology, Kawasaki 210-0821, Kanagawa, Japan.
⁷ Transborder Medical Research Center, University of Tsukuba, Tsukuba 305-8575, Ibaraki, Japan.

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.

Keywords: atopic keratoconjunctivitis; conjunctival injection; lactoferrin; tacrolimus ophthalmic suspension.