Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Shanghai, China.
J Ocul Pharmacol Ther. 2010 Aug;26(4):361-6. doi: 10.1089/jop.2009.0145.
The goals of this study were to compare the efficacy and safety profile of topical cyclosporine 0.05% versus vehicle in Chinese patients with moderate to severe dry eye disease.
In this multicenter, randomized, double-blind, vehicle-controlled, parallel-group study, 233 dry eye patients were allocated to receive either cyclosporine 0.05% or vehicle twice daily for 8 weeks. Primary outcome was the difference between groups, in total score of 4 symptoms and 4 signs change from baseline at weeks 2, 4, and 8. Changes in symptoms (ocular dryness, foreign body sensation, photophobia and burning) and signs (conjunctival hyperemia, Schirmer test, tear Break-up time (BUT), and corneal punctate fluorescein staining) at weeks 2, 4, and 8 as well as frequency of administration of concomitant artificial tears, were considered as secondary outcomes. The safety profile was evaluated by examining adverse events, changes in visual acuity, and ocular tolerance.
Greater improvements of the total score were seen in cyclosporine 0.05% group than in the vehicle group at all follow-up times (P < 0.01). Improvements in ocular dryness at week 8 (P = 0.040) and foreign body sensation during weeks 4 and 8 (P < 0.020) were significantly greater with cyclosporine. In addition, compared with the vehicle, cyclosporine significantly improved 2 objective dry eye disease signs: corneal staining at weeks 4 (P = 0.025) and 8 (P = 0.050) and the Schirmer test at week 4 (P = 0.035). However, no between-group difference approached statistical significance in photophobia, burning, BUT value, conjunctival hyperemia and frequency of administration of concomitant artificial tears at any follow-up times (P > 0.05).The cumulative frequency of adverse events did not significantly differ between the groups (P = 0.519), which were 11.21% and 8.55%, respectively. There were no patients who experienced reduced visual acuity.
Cyclosporine 0.05% ophthalmic emulsion is an effective and safe treatment for Chinese patients with moderate to severe dry eye disease.
本研究旨在比较环孢素 0.05%与载体在中国中重度干眼患者中的疗效和安全性。
在这项多中心、随机、双盲、载体对照、平行组研究中，233 名干眼患者被分配接受环孢素 0.05%或载体，每日两次，持续 8 周。主要结局是从基线开始，在第 2、4 和 8 周时，两组之间的 4 项症状和 4 项体征总评分的差异。第 2、4 和 8 周时症状（眼干、异物感、畏光和烧灼感）和体征（结膜充血、泪液分泌试验、泪膜破裂时间（BUT）和角膜荧光素染色点）的变化以及伴随人工泪液的使用频率均被视为次要结局。通过检查不良事件、视力变化和眼耐受性来评估安全性。
在所有随访时间点，环孢素 0.05%组的总评分改善均大于载体组（P<0.01）。第 8 周时眼干改善（P=0.040）和第 4 周和第 8 周时异物感改善（P<0.020）明显大于载体组。此外，与载体相比，环孢素显著改善了 2 项干眼客观体征：第 4 周和第 8 周角膜染色（P=0.025 和 P=0.050）和第 4 周泪液分泌试验（P=0.035）。然而，在任何随访时间点，畏光、烧灼感、BUT 值、结膜充血和伴随人工泪液使用频率均无显著组间差异（P>0.05）。不良事件的累积频率在两组之间没有显著差异（P=0.519），分别为 11.21%和 8.55%。没有患者出现视力下降。
环孢素 0.05%眼用乳液是治疗中国中重度干眼患者的一种有效且安全的治疗方法。
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