Silverstein Eye Centers, Kansas City, MO, USA.
Curr Med Res Opin. 2011 Sep;27(9):1693-703. doi: 10.1185/03007995.2011.597663. Epub 2011 Jul 14.
To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution 0.09% dosed once daily for the treatment of ocular inflammation and pain following cataract extraction with posterior chamber intraocular lens implantation.
A total of 455 subjects (455 study eyes: 230 bromfenac, 225 placebo) were enrolled in two randomized double-masked, placebo-controlled, clinical trials at 64 ophthalmology clinics in the United States. Subjects were randomized to receive either bromfenac 0.09% or placebo dosed once daily. Dosing began 1 day before cataract surgery (Day -1), continued on day of surgery (Day 0), and for 14 days following surgery. Evaluations were completed on Days 1, 3, 8, 15 and 22. The primary efficacy endpoint was cleared summed ocular inflammation score (SOIS) by Day 15. The secondary efficacy endpoint was the number of subjects who were pain-free at Day 1.
The bromfenac 0.09% group was significantly higher compared to the placebo group in the primary endpoint of the proportion of subjects who had cleared ocular inflammation by Day 15 (P < 0.0001). The mean SOIS for the bromfenac 0.09% group was lower than the placebo group at Days 3, 8, 15, and 22 (P < 0.0001). More bromfenac 0.09% subjects were pain free at Days 1, 3, 8, and 15 (P < 0.0001). Fewer subjects in the bromfenac 0.09% group withdrew from the clinical trials due to lack of efficacy at Day 15 (P < 0.0001). Fewer adverse events were reported in the bromfenac 0.09% group than the placebo group. Limitations included advanced age, female predominance, and surgical nuances among cataract surgeons, making cross-trial comparisons difficult.
Bromfenac ophthalmic solution 0.09% dosed once daily is clinically safe and effective for the treatment of ocular inflammation and the reduction of ocular pain associated with cataract surgery.
评估溴芬酸钠滴眼液 0.09%，每日一次给药，用于治疗白内障超声乳化吸除联合后房型人工晶状体植入术后眼部炎症和疼痛的疗效和眼部安全性。
共纳入 455 例受试者（455 只眼：230 例溴芬酸钠，225 例安慰剂），他们在美国 64 家眼科诊所参与了两项随机、双盲、安慰剂对照的临床试验。受试者随机接受溴芬酸钠 0.09%或安慰剂，每日一次。给药于白内障手术前 1 天（第-1 天）开始，手术当天（第 0 天）继续，术后 14 天结束。在第 1、3、8、15 和 22 天进行评估。主要疗效终点为第 15 天的总和眼部炎症评分（SOIS）清除率。次要疗效终点为第 1 天无疼痛的受试者人数。
与安慰剂组相比，溴芬酸钠 0.09%组第 15 天清除眼部炎症的受试者比例显著更高（P<0.0001）。在第 3、8、15 和 22 天，溴芬酸钠 0.09%组的平均 SOIS 低于安慰剂组（P<0.0001）。在第 1、3、8 和 15 天，更多的溴芬酸钠 0.09%组受试者无疼痛（P<0.0001）。在第 15 天，由于疗效不佳而退出临床试验的受试者中，溴芬酸钠 0.09%组比例显著低于安慰剂组（P<0.0001）。溴芬酸钠 0.09%组报告的不良事件少于安慰剂组。限制因素包括白内障手术医生年龄较大、女性居多以及手术技巧差异，使得临床试验之间的比较变得困难。
溴芬酸钠滴眼液 0.09%，每日一次给药，用于治疗白内障超声乳化吸除联合后房型人工晶状体植入术后眼部炎症和疼痛是安全且有效的。
