在DuraSite中使用0.075%溴芬酸进行每日两次与每日一次给药：一项14天2期研究的结果
Twice-Daily vs. Once-Daily Dosing with 0.075% Bromfenac in DuraSite: Outcomes from a 14-Day Phase 2 Study.
作者信息
Trattler William, Hosseini Kamran
机构信息
Center for Excellence in Eye Care, Miami, FL, USA.
InSite Vision, Alameda, CA, USA.
出版信息
Ophthalmol Ther. 2017 Dec;6(2):277-284. doi: 10.1007/s40123-017-0102-x. Epub 2017 Aug 17.
INTRODUCTION
Bromfenac is a well-known topical ophthalmic nonsteroidal anti-inflammatory drug (NSAID) that is commercialized in the USA and other regions of the world. A new formulation, 0.075% bromfenac in DuraSite®, was developed to treat postoperative inflammation and reduce pain in patients who have undergone cataract surgery. We hypothesized that efficacy and safety would be enhanced with twice-daily (BID) dosing compared to once-daily (QD) dosing.
METHODS
This was a multicenter, double-masked, comparative study in which 40 and 45 subjects were randomized to groups receiving BID dosing and QD dosing, respectively. Subjects self-instilled the study drug for 14 days postoperative and were followed for an additional 2-week evaluation phase. The primary efficacy endpoint was the proportion of subjects with an anterior chamber cell (ACC) grade of 0 at day 15.
RESULTS
A total of 45 subjects had cleared ACC (grade "0") at day 15, of whom 21 were in the BID group (52.5%) and 24 were in the QD group (53.5%). A secondary analysis found 7/40 (17.5%) subjects in the BID group and 10/45 (22.2%) subjects in the QD group achieved an ACC grade of 0 at day 8. There were more adverse events in the QD group (n = 16) than in the BID group (n = 12).
CONCLUSION
Similar outcomes were observed for subjects using Bromfenac 0.075% in DuraSite® in the BID and QD dosing regimens for the treatment of post-cataract surgery inflammation.
TRIAL REGISTRATION
ClinicalTrials.gov identifier, NCT01190878.
FUNDING
InSite Vision (now a division of Sun Pharma).
引言
溴芬酸是一种知名的局部用眼科非甾体抗炎药（NSAID），已在美国和世界其他地区上市。一种新的制剂，即含0.075%溴芬酸的DuraSite®，被开发用于治疗白内障手术后患者的炎症并减轻疼痛。我们假设，与每日一次（QD）给药相比，每日两次（BID）给药可提高疗效和安全性。
方法
这是一项多中心、双盲、对照研究，分别将40名和45名受试者随机分为接受BID给药和QD给药的组。受试者在术后14天自行滴入研究药物，并在另外2周的评估期内进行随访。主要疗效终点是第15天时前房细胞（ACC）分级为0的受试者比例。
结果
共有45名受试者在第15天时ACC清除（分级为“0”），其中21名在BID组（52.5%），24名在QD组（53.5%）。一项次要分析发现，BID组7/40（17.5%）的受试者和QD组10/45（22.2%）的受试者在第8天时ACC分级为0。QD组的不良事件（n = 16）比BID组（n = 12）更多。
结论
在治疗白内障手术后炎症方面，使用含0.075%溴芬酸的DuraSite®的受试者，BID和QD给药方案的观察结果相似。
试验注册
ClinicalTrials.gov标识符，NCT01190878。
资助
InSite Vision（现为太阳制药的一个部门）。
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