Kim Hyun Seung, Kim Tae-Im, Kim Jin Hyoung, Yoon Kyung Chul, Hyon Joon Young, Shin Ko Un, Choi Chul Young
1 Department of Ophthalmology and Visual Science, College of Medicine, St. Mary's Hospital, The Catholic University , Seoul, Korea.
2 Department of Ophthalmology, Vision Research Institute, Yonsei University College of Medicine , Seoul, Korea.
J Ocul Pharmacol Ther. 2017 Sep;33(7):530-538. doi: 10.1089/jop.2016.0164. Epub 2017 Jul 31.
Topical administration of the anti-inflammatory agent cyclosporin A (CsA) is recommended for long-term management of dry eye syndrome (DES), yet standard ophthalmic CsA preparations have been reported to be unstable. In this trial, the efficacy and safety of Clacier™ (based on a phase 3 study developed by Huons Co. Ltd.), a novel 0.05% CsA nanoemulsion formulation, are compared with those of the conventional Restasis emulsion.
Patients with moderate-to-severe DES were randomly assigned to receive topical 0.05% CsA in the form of Clacier or Restasis, to be administered twice daily for 12 weeks. The primary efficacy outcome was the change from baseline in corneal fluorescein staining scores at week 12; changes at weeks 4 and 8 were secondary endpoints. Additional endpoints included score changes from baseline in nonanesthetic Schirmer's test I, tear breakup time, ocular surface disease index, and conjunctival staining.
At week 12, corneal staining scores were improved in patients treated with Clacier and Restasis, with no significant difference between treatments (P = 0.41). Temporal conjunctival surface damage was significantly more ameliorated with Clacier treatment than with Restasis treatment (P = 0.034). Notably, tear film stability was improved more rapidly in Clacier patients at week 4 (P = 0.005) than in Restasis patients (P = 0.36). Improvements in tear production were comparable with both Clacier and Restasis treatments. Clacier did not increase the risk of adverse events as compared with Restasis.
Treatment with Clacier alleviated clinical signs and symptoms of DES comparably to the commercially available Restasis, resulting in improved quality of life for patients. Clacier is an effective and safe therapeutic agent for DES.
抗炎药物环孢素A（CsA）的局部给药被推荐用于干眼症（DES）的长期治疗，然而据报道标准的眼科用CsA制剂不稳定。在本试验中，将新型0.05% CsA纳米乳剂制剂Clacier™（基于Huons有限公司开展的一项3期研究）的疗效和安全性与传统的Restasis乳剂进行比较。
中重度DES患者被随机分配接受局部应用Clacier或Restasis形式的0.05% CsA，每天给药两次，持续12周。主要疗效指标是第12周时角膜荧光素染色评分相对于基线的变化；第4周和第8周的变化为次要终点。其他终点包括未麻醉状态下泪液分泌试验I、泪膜破裂时间、眼表疾病指数和结膜染色相对于基线的评分变化。
在第12周时，接受Clacier和Restasis治疗的患者角膜染色评分均有所改善，治疗组之间无显著差异（P = 0.41）。与Restasis治疗相比，Clacier治疗能更显著地改善颞侧结膜表面损伤（P = 0.034）。值得注意的是，在第4周时，Clacier治疗组患者的泪膜稳定性改善速度比Restasis治疗组更快（P = 0.005，P = 0.36）。泪液分泌的改善在Clacier和Restasis治疗中相当。与Restasis相比，Clacier没有增加不良事件的风险。
Clacier治疗缓解DES的临床体征和症状的效果与市售的Restasis相当，从而改善了患者的生活质量。Clacier是一种治疗DES的有效且安全的治疗药物。
