White Eric M, Macy Jonathan I, Bateman Kirk M, Comstock Timothy L
Complete Family Vision Care, San Diego, CA, USA.
Curr Med Res Opin. 2008 Jan;24(1):287-96. doi: 10.1185/030079908x253898.
This study compared the safety and efficacy of loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T; Zylet) with dexamethasone 0.1%/tobramycin 0.3% (DM/T; Tobradex) in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis.
This was a multicenter, randomized, investigator-masked, parallel-group study. Subjects with clinically diagnosed blepharokeratocon-junctivitis in at least one eye were randomized to LE/T (n = 138) or DM/T (n = 138) administered four times per day, for 14 days. The primary efficacy endpoint was the change from baseline to Day 15 (+/- 1 day) in the signs and symptoms composite score using a non-inferiority metric to compare LE/T to DM/T. Safety endpoints included visual acuity (VA), biomicroscopy, intraocular pressure (IOP) assessments, and adverse events.
At Day 15, the mean (SD) change from baseline in the signs and symptoms composite score was -15.2 (7.3) for LE/T-treated subjects and -15.6 (7.7) for DM/T-treated subjects. The upper bound of the 90% confidence interval for the difference in change from baseline was less than the non-inferiority margin not only at Day 15 but also at Day 7 and Day 3 for both the intent-to-treat and per protocol populations. Subjects treated with DM/T experienced a significant increase in IOP versus those treated with LE/T at Day 7, Day 15, and overall (mean [SD] of 0.6 [2.3] vs, -0.1 [2.2], p = 0.03, 1.0 [3.0] vs. -0.1 [2.4], p = 0.01, and 2.3 [2.3] vs. 1.6 [1.7], p = 0.02, respectively).
LE/T satisfied the condition of non-inferiority to DM/T in decreasing the signs and symptoms of ocular inflammation associated with blepharokeratoconjunctivitis. Subjects treated with DM/T experienced more of an increase in IOP.
Although the single-masked design of this study could be considered a limitation, care was taken to ensure that the investigator was masked.
本研究比较了0.5%氯替泼诺/0.3%妥布霉素（LE/T；Zylet）与0.1%地塞米松/0.3%妥布霉素（DM/T；Tobradex）治疗睑缘角膜结膜炎相关眼部炎症的安全性和有效性。
这是一项多中心、随机、研究者设盲、平行组研究。至少一只眼临床诊断为睑缘角膜结膜炎的受试者被随机分为LE/T组（n = 138）或DM/T组（n = 138），每天给药4次，共14天。主要疗效终点是使用非劣效性指标比较LE/T与DM/T，从基线到第15天（±1天）体征和症状综合评分的变化。安全性终点包括视力（VA）、生物显微镜检查、眼压（IOP）评估和不良事件。
在第15天，LE/T治疗组受试者体征和症状综合评分相对于基线的平均（标准差）变化为-15.2（7.3），DM/T治疗组为-15.6（7.7）。不仅在第15天，而且在第7天和第3天，意向性分析人群和符合方案人群中，从基线变化差异的90%置信区间上限均小于非劣效界值。在第7天、第15天以及总体上，DM/T治疗组受试者的眼压相对于LE/T治疗组受试者显著升高（平均[标准差]分别为0.6[2.3]对-0.1[2.2]，p = 0.03；1.0[3.0]对-0.1[2.4]，p = 0.01；2.3[2.3]对1.6[1.7]，p = 0.02）。
在减轻睑缘角膜结膜炎相关眼部炎症的体征和症状方面，LE/T满足非劣效于DM/T的条件。DM/T治疗组受试者的眼压升高更多。
尽管本研究的单盲设计可被视为一个局限性，但已采取措施确保研究者设盲。
