Department of Ophthalmology, Tsurumi University School of Dental Medicine, Kanagawa, Japan.
Department of Research, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Ocul Immunol Inflamm. 2021 Nov 17;29(7-8):1621-1626. doi: 10.1080/09273948.2020.1760309. Epub 2020 Jun 5.
: This study evaluated the efficacy and safety of once-daily Alcaftadine 0.25% (AGN-229666) for prevention of signs and symptoms of Japanese cedar-pollen allergic conjunctivitis.: This was a single-center, placebo-, and comparator-controlled study using the Ora-CAC® model of allergic conjunctivitis. The primary endpoint was ocular itching 16 hours after Alcaftadine 0.25% instillation; efficacy at 16 hours was compared with 0.1% Olopatadine, 4 hours after instillation. Secondary endpoints included conjunctival hyperemia.: 263 Japanese subjects were enrolled; 224 completed the trial. Alcaftadine 0.25% was statistically superior to vehicle for relief of ocular itching at 16 hours ( < .0001). Alcaftadine 0.25% at 16 hours was non-inferior to Olopatadine at 4 hours. Alcaftadine 0.25% was significantly better than vehicle for relief of conjunctival hyperemia. All treatments showed a low frequency of ocular adverse events.: Once-daily Alcaftadine 0.25% is safe and effective in preventing signs and symptoms of Japanese cedar-pollen allergic conjunctivitis.
这项研究评估了每日一次使用 0.25% 盐酸阿伐斯汀（AGN-229666）预防日本杉树花粉过敏结膜炎症状和体征的疗效和安全性。这是一项单中心、安慰剂对照和阳性对照研究，使用 Ora-CAC® 过敏性结膜炎模型。主要终点是滴用 0.25% 盐酸阿伐斯汀后 16 小时的眼部瘙痒；16 小时的疗效与滴用 0.1% 奥洛他定 4 小时后进行比较。次要终点包括结膜充血。共有 263 名日本受试者入组，224 名完成了试验。0.25%盐酸阿伐斯汀在缓解眼部瘙痒方面明显优于安慰剂（<0.0001）。16 小时时，0.25%盐酸阿伐斯汀与 4 小时时的奥洛他定相比非劣效。0.25%盐酸阿伐斯汀在缓解结膜充血方面明显优于安慰剂。所有治疗均显示眼部不良反应发生率低。每日一次使用 0.25% 盐酸阿伐斯汀预防日本杉树花粉过敏结膜炎的症状和体征安全有效。
