Chen Di, Zhang Shunhua, Bian Ailing, Hong Jing, Deng Yingping, Zhang Mingchang, Chen Wei, Shao Yan, Zhao Jialiang
Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College.
Department of Ophthalmology, Peking University Third Hospital, Beijing.
Medicine (Baltimore). 2019 Aug;98(31):e16710. doi: 10.1097/MD.0000000000016710.
Dry eye disease (DED) is a chronic ocular surface disease that affects hundreds of millions of people worldwide. Although 0.05% cyclosporine ophthalmic emulsion (CsA OE) has long been prescribed in the U.S. for the treatment of DED, it is not commercially available in China. Our study aims to compare the efficacy and safety profile of 0.05% CsA OE versus vehicle in Chinese patients with moderate to severe DED.
This was a multicenter, randomized, double-masked, 2-parallel-arm, 3-month phase III study. Patients with moderate to severe DED were randomized to receive twice-daily 0.05% CsA OE or its vehicle, along with unpreserved hypromellose eye drops 3 times per day. Patients were followed up at day 7, 28, 56, and 84, as well as 2 weeks after the medications were discontinued for safety assessment.
A total of 240 patients were randomized. The overall effective rate (OER) and efficacy index were significantly better in the CsA OE than vehicle group at all follow up times (all P < .05), and the OER of CsA OE and vehicle group at month 3 was 70.6% and 27.8%, respectively (P < .001) (primary endpoint). The patients in CsA OE group displayed a significant improvement in dry eye symptoms from day 28 and ocular surface test results from day 7 (all P < .05). The ocular surface disease index scores of 0.05% CsA OE treated patients were significantly better than those treated with vehicle control at day 56 and 84 (P = .0061 and <.001, respectively). Drug related adverse events (AEs) were recorded in 6(5%) and 3(2.5%) patients in the CsA OE and vehicle groups respectively (P = .4061) with ocular pain as the most frequently reported AEs, and it was mostly mild to moderate. There were no detrimental effects on visual acuity, intraocular pressure, or vital signs.
Twice-daily instillation of 0.05% CsA OE was effective and well tolerated for the treatment of moderate to severe DED in Chinese population during the 3 months of the study.
干眼症（DED）是一种慢性眼表疾病，全球数亿人受其影响。尽管0.05%环孢素眼用乳剂（CsA OE）在美国长期被用于治疗干眼症，但在中国尚无商业供应。我们的研究旨在比较0.05% CsA OE与赋形剂在中国中重度干眼症患者中的疗效和安全性。
这是一项多中心、随机、双盲、双平行组、为期3个月的III期研究。中重度干眼症患者被随机分为两组，分别接受每日两次的0.05% CsA OE或其赋形剂治疗，同时每天使用3次不含防腐剂的羟丙甲纤维素滴眼液。在第7天、28天、56天和84天以及停药2周后对患者进行随访，以进行安全性评估。
共有240名患者被随机分组。在所有随访时间点，CsA OE组的总有效率（OER）和疗效指数均显著优于赋形剂组（所有P<0.05），CsA OE组和赋形剂组在第3个月时的OER分别为70.6%和27.8%（P<0.001）（主要终点）。CsA OE组患者从第28天起干眼症状有显著改善，从第7天起眼表测试结果有显著改善（所有P<0.05）。在第56天和84天，0.05% CsA OE治疗患者的眼表疾病指数评分显著优于赋形剂对照组（分别为P = 0.0061和<0.001）。CsA OE组和赋形剂组分别有6名（5%）和3名（2.5%）患者记录到与药物相关的不良事件（P = 0.4061），最常报告的不良事件为眼痛，大多为轻至中度。对视力、眼压或生命体征无不良影响。
在本研究的3个月期间，每日两次滴注0.05% CsA OE对中国人群中重度干眼症的治疗有效且耐受性良好。
