Ophthalmic Consultants of Boston, Boston, Massachusetts, USA.
Ophthalmology. 2011 Nov;118(11):2120-7. doi: 10.1016/j.ophtha.2011.04.035. Epub 2011 Jul 16.
To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution (bromfenac) 0.09% dosed once daily for the treatment of ocular inflammation and pain after cataract surgery with posterior chamber intraocular lens implantation.
Randomized, double-masked, vehicle-controlled or active-controlled, multicenter, clinical trials.
A total of 872 subjects (872 study eyes: bromfenac in 584, placebo in 288).
Four randomized, double-masked, vehicle or active-controlled, clinical trials were conducted at 134 ophthalmology clinics in the United States. Subjects aged ≥ 18 years were randomized to receive either bromfenac 0.09% or placebo dosed once daily beginning 1 day before cataract surgery (day -1), continuing on the day of surgery (day 0), and continuing for an additional postoperative 14 days. Subjects were evaluated for efficacy and safety on days 1, 3, 8, 15, and 22. The primary efficacy end point was cleared ocular inflammation, measured by the summed ocular inflammation score (SOIS; anterior chamber cells and flare) by day 15. The secondary efficacy end point was the number of subjects who were pain-free at day 1. The data from the 4 trials were pooled for analyses.
The SOIS and ocular pain.
The proportion of subjects who had cleared ocular inflammation by day 15 was significantly higher in the bromfenac 0.09% group than in the placebo group (P < 0.0001). The mean SOIS in the bromfenac 0.09% group was significantly lower than in the placebo group at days 3, 8, 15, and 22 (P < 0.0001). The proportion of subjects who were pain-free at days 1, 3, 8, and 15 was significantly higher in the bromfenac 0.09% group than in the placebo group (P < 0.0001). The incidence of adverse events reported in the bromfenac 0.09% group was significantly lower than in the placebo group (P < 0.0001). On day 15, 84.0% of the bromfenac subjects had ≥ 1-line improvement in visual acuity compared with 66.1% of placebo subjects (P < 0.0001).
Bromfenac 0.09% dosed once daily was clinically safe and effective for reducing and treating ocular inflammation and pain associated with cataract surgery.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
评估溴芬酸钠（bromfenac）滴眼液 0.09%每日 1 次给药在白内障超声乳化术后治疗眼内炎症和疼痛的疗效和眼部安全性。
随机、双盲、安慰剂对照或阳性药物对照、多中心临床试验。
共 872 名受试者（872 只研究眼：溴芬酸组 584 只，安慰剂组 288 只）。
在美国 134 家眼科诊所进行了 4 项随机、双盲、安慰剂或阳性药物对照、多中心临床试验。年龄≥18 岁的受试者随机接受溴芬酸 0.09%或安慰剂，于白内障手术前 1 天（第-1 天）开始每日 1 次给药，持续至手术当天（第 0 天），并在术后额外 14 天继续给药。在第 1、3、8、15 和 22 天评估疗效和安全性。主要疗效终点是第 15 天通过总和眼内炎症评分（SOIS；前房细胞和闪辉）评估的眼内炎症清除率。次要疗效终点是第 1 天无疼痛的受试者比例。对 4 项试验的数据进行汇总分析。
SOIS 和眼部疼痛。
溴芬酸 0.09%组在第 15 天清除眼内炎症的受试者比例明显高于安慰剂组（P<0.0001）。溴芬酸 0.09%组在第 3、8、15 和 22 天的平均 SOIS 明显低于安慰剂组（P<0.0001）。溴芬酸 0.09%组在第 1、3、8 和 15 天无疼痛的受试者比例明显高于安慰剂组（P<0.0001）。与安慰剂组相比，溴芬酸 0.09%组报告的不良事件发生率明显较低（P<0.0001）。在第 15 天，84.0%的溴芬酸受试者的视力较基线至少提高 1 行，而安慰剂组为 66.1%（P<0.0001）。
溴芬酸 0.09%每日 1 次给药在减少和治疗白内障术后眼内炎症和疼痛方面具有临床安全性和有效性。
参考文献后可能会发现专有或商业披露信息。
