Park Chang Hyun, Kim Mee Kum, Kim Eun Chul, Kim Jae Yong, Kim Tae Im, Kim Hong Kyun, Song Jong Suk, Yoon Kyung Chul, Lee Do Hyung, Lee Hyung Keun, Chung Tae Young, Choi Chul Young, Kim Hyun Seung
Department of Ophthalmology, Yeouido St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea.
Department of Ophthalmology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Korean J Ophthalmol. 2019 Aug;33(4):343-352. doi: 10.3341/kjo.2018.0116.
To evaluate the efficacy and safety of cyclosporine nanoemulsion 0.05% compared to cyclosporine emulsion 0.05% and diquafosol sodium 3%.
This was a multicenter, randomized, evaluator-masked, active control, parallel, phase IV study. A total of 227 patients were randomly allocated to instill cyclosporine nanoemulsion 0.05% (CN) twice daily, cyclosporine emulsion 0.05% (CE) twice daily, or diquafosol sodium 3% (DQ) six times daily. Non-inferiority of CN was analyzed by primary endpoint (cornea and conjunctival staining scores at week 12). The secondary endpoints were scores of corneal staining, conjunctival staining, tear break-up time, Schirmer test, and Ocular Surface Disease Index at weeks 4 and 12.
Primary endpoints showed statistically significant improvements in all groups. Primary endpoints were -6.60 for the CN group, -5.28 for the CE group, and -6.63 for the DQ group (National Eye Institute scale from 0 to 33), verifying the non-inferiority of CN compared to CE (95% confidence interval, -0.15 to 2.80, Δ>-2.88). In intergroup comparison between CN and CE groups, the CN group had significantly more decreased conjunctival staining score at week 12. Intergroup comparison between CN and DQ groups showed consistent statistically significant improvements in TBUT and Schirmer test in the CN group. In the DQ group, TBUT showed late statistically significant improvement at week 12 and Schirmer test showed relatively short-term statistically significant improvement at week 4.
Cyclosporine nanoemulsion 0.05% was equivalently efficient compared to cyclosporine emulsion 0.05% and diquafosol sodium 3%. In addition, CN showed significant improvements in several parameters for treatment of dry eyes.
评估0.05%环孢素纳米乳剂相较于0.05%环孢素乳剂和3%地夸磷索钠的疗效和安全性。
这是一项多中心、随机、评估者盲法、活性对照、平行的IV期研究。总共227例患者被随机分配为每日两次滴注0.05%环孢素纳米乳剂（CN）、每日两次滴注0.05%环孢素乳剂（CE）或每日六次滴注3%地夸磷索钠（DQ）。通过主要终点（第12周时角膜和结膜染色评分）分析CN的非劣效性。次要终点为第4周和第12周时的角膜染色评分、结膜染色评分、泪膜破裂时间、泪液分泌试验和眼表疾病指数。
主要终点显示所有组均有统计学上的显著改善。CN组的主要终点为-6.60，CE组为-5.28，DQ组为-6.63（美国国立眼科研究所评分范围为0至33），证实了CN相较于CE的非劣效性（95%置信区间，-0.15至2.80，Δ>-2.88）。在CN组和CE组的组间比较中，CN组在第12周时结膜染色评分显著降低。CN组和DQ组的组间比较显示，CN组在泪膜破裂时间和泪液分泌试验方面有一致的统计学显著改善。在DQ组中，泪膜破裂时间在第12周时显示出后期统计学显著改善，泪液分泌试验在第4周时显示出相对短期的统计学显著改善。
0.05%环孢素纳米乳剂与0.05%环孢素乳剂和3%地夸磷索钠疗效相当。此外，CN在治疗干眼的几个参数方面显示出显著改善。
