Department of Ophthalmology, Tsurumi University School of Dental Medicine, 2-1-3 Tsurumi, Tsurumi-ku, Yokohama-shi, Kanagawa, 230-8501, Japan.
Division of Ophthalmology, Department of Visual Sciences, Nihon University School of Medicine, Tokyo, Japan.
Jpn J Ophthalmol. 2024 Nov;68(6):651-659. doi: 10.1007/s10384-024-01108-9. Epub 2024 Sep 11.
The high prevalence of allergic conjunctivitis in Japan necessitates novel, easy-to-use treatment options for prophylactic use. We evaluated the safety and efficacy of a newly-developed 0.5% epinastine topical eyelid cream to prevent the development of allergic conjunctivitis.
This was a phase 3, single-centre, double-masked, intra-patient randomised trial in asymptomatic adults (aged 20-65 years) with seasonal allergic conjunctivitis in Japan.
The left and right eyes of eligible patients were randomised to receive a topical application of either 0.5% epinastine cream (~ 30 mg per dose) to one eye or placebo cream to the other (on the outer skin of the upper and lower eyelids) after a conjunctival antigen challenge (CAC) test. Symptom severity was assessed up to 24 h post-treatment. Primary efficacy endpoints were mean ocular itching and conjunctival hyperaemia severity scores in each eye; safety endpoints included adverse events (AEs) and adverse drug reaction (ADRs).
In total, 30 patients (60 eyes) were included in the study. The 0.5% epinastine topical eyelid cream reduced mean ocular itching scores (difference in least squares means ± standard error, - 1.12 ± 0.214; p < 0.0001) and mean conjunctival hyperaemia scores (- 0.54 ± 0.197; p = 0.0097) 24 h after treatment versus placebo. The 0.5% epinastine topical eyelid cream was well tolerated, with no AEs or ADRs reported.
With its novel route of administration, 0.5% epinastine topical eyelid cream may be considered a unique, easy-to-use, once-daily treatment option to prevent the onset of seasonal allergic conjunctivitis.
过敏性结膜炎在日本的高患病率需要新型、易于使用的预防治疗选择。我们评估了一种新开发的 0.5%埃皮纳斯汀眼用眼睑乳膏预防过敏性结膜炎发展的安全性和有效性。
这是一项在日本无症状成人（年龄 20-65 岁）季节性过敏性结膜炎患者中进行的 3 期、单中心、双盲、患者内随机试验。
符合条件的患者的左眼和右眼随机接受一种 0.5%埃皮纳斯汀乳膏（每剂量约 30mg）或另一只眼的安慰剂乳膏（在上、下眼睑的外皮肤）局部应用，然后进行结膜抗原挑战（CAC）试验。治疗后 24 小时内评估症状严重程度。主要疗效终点是每只眼的平均眼部瘙痒和结膜充血严重程度评分；安全性终点包括不良事件（AE）和药物不良反应（ADR）。
共有 30 名患者（60 只眼）纳入研究。0.5%埃皮纳斯汀眼用眼睑乳膏治疗后 24 小时可降低平均眼部瘙痒评分（最小二乘均数差异±标准误差，-1.12±0.214；p<0.0001）和平均结膜充血评分（-0.54±0.197；p=0.0097）。0.5%埃皮纳斯汀眼用眼睑乳膏耐受性良好，未报告任何 AE 或 ADR。
0.5%埃皮纳斯汀眼用眼睑乳膏的新型给药途径可能被视为一种独特、易于使用的每日一次治疗选择，可预防季节性过敏性结膜炎的发作。
