Ocular Immunology and Uveitis Foundation, Harvard Medical School, Massachusetts Eye Research and Surgery Institution , Cambridge, MA 02142, USA.
J Ocul Pharmacol Ther. 2010 Oct;26(5):475-83. doi: 10.1089/jop.2010.0059.
The aim of this study was to evaluate the efficacy and safety of difluprednate ophthalmic solution 0.05% (Durezol; Alcon Laboratories, Fort Worth, TX) compared with prednisolone acetate ophthalmic suspension 1% (Pred Forte; Allergan, Inc., Irvine, CA) for endogenous anterior uveitis.
In this phase 3, multicenter, randomized, noninferiority trial, 90 patients with endogenous anterior uveitis [>10 anterior chamber (AC) cells and an AC flare score of ≥2 in at least 1 eye] received either difluprednate 4x /day (QID) (n=50) or prednisolone 8x/day (n=40) for 14 days, followed by a 2-week tapering regimen. The main outcome measure was change from baseline in AC cell grade on day 14.
At day 14, mean AC cell grade improvement for difluprednate-treated patients was similar to prednisolone-treated patients (2.1 vs. 1.9, respectively), proving noninferiority. At day 14, 68.8% of difluprednate patients had AC cell clearing (grade 0:≥ 1cell) compared with 61.5% of prednisolone patients. In the prednisolone-treated group, 12.5% of patients were withdrawn because of investigator-determined lack of efficacy; no difluprednate-treated patients were withdrawn for this reason (P=0.01). Clinically significant intraocular pressure elevation occurred in 3 difluprednate-treated patients (6.0%) and 2 prednisolone-treated patients (5.0%).
Difluprednate administered QID is at least as effective as prednisolone administered 8x/day in resolving the inflammation and pain associated with endogenous anterior uveitis. Difluprednate provides effective treatment for anterior uveitis and requires less frequent dosing than prednisolone acetate.
Trial NCT00501579 was registered at the National Institutes of Health Registry in July 2007 ( http://clinicaltrials.gov/ct2/show/NCT00501579?term=sirion&rank=4 ).
本研究旨在评估双氯非那胺滴眼液 0.05%(Durezol;爱尔康实验室,沃思堡,得克萨斯州)与醋酸泼尼松龙滴眼液 1%(Pred Forte;艾尔建公司,欧文,加利福尼亚州)治疗内源性前葡萄膜炎的疗效和安全性。
在这项 3 期、多中心、随机、非劣效性试验中,90 例内源性前葡萄膜炎[≥10 个前房(AC)细胞和至少 1 只眼的 AC 闪光评分≥2]患者接受双氯非那胺 4 次/天(QID)(n=50)或泼尼松龙 8 次/天(n=40)治疗 14 天,然后进行 2 周的减量方案。主要观察指标为第 14 天时 AC 细胞等级的基线变化。
第 14 天时,双氯非那胺治疗患者的 AC 细胞等级改善与泼尼松龙治疗患者相似(分别为 2.1 和 1.9),证明具有非劣效性。第 14 天时,68.8%的双氯非那胺患者的 AC 细胞得到清除(等级 0:≥1 个细胞),而泼尼松龙组为 61.5%。在泼尼松龙治疗组中,因研究者确定疗效不佳而退出的患者有 12.5%;没有因该原因退出的双氯非那胺治疗患者(P=0.01)。3 例(6.0%)双氯非那胺治疗患者和 2 例(5.0%)泼尼松龙治疗患者出现临床显著眼压升高。
QID 给予双氯非那胺治疗与 8 次/天给予泼尼松龙治疗一样有效,可缓解与内源性前葡萄膜炎相关的炎症和疼痛。双氯非那胺为前葡萄膜炎提供有效治疗,且给药频率低于醋酸泼尼松龙。
2007 年 7 月,试验 NCT00501579 在国立卫生研究院注册(http://clinicaltrials.gov/ct2/show/NCT00501579?term=sirion&rank=4)。