See Clearly Vision Group, McLean, Virginia 22102, USA.
J Cataract Refract Surg. 2013 Feb;39(2):158-67. doi: 10.1016/j.jcrs.2012.09.013. Epub 2012 Dec 3.
To examine the efficacy and safety of a new gel formulation loteprednol etabonate 0.5% in the treatment of inflammation and pain after cataract surgery.
Seventeen United States clinical sites.
Prospective double-masked parallel-group study.
Patients with anterior chamber cell (ACC) grade 2 or higher after cataract surgery were randomized to loteprednol etabonate 0.5% gel or vehicle 4 times a day for 14 days. Primary outcome measures included the proportion of patients with complete resolution of ACC and grade 0 (no) pain on postoperative day 8. Safety measures included adverse events, intraocular pressure (IOP), visual acuity, biomicroscopy and funduscopy findings, and tolerability (ocular symptoms and drop comfort).
The intent-to-treat population included 406 patients (203 per treatment). On day 8, 30.5% of patients in the loteprednol etabonate group and 16.3% of patients in the vehicle group had complete resolution of ACC, whereas 72.9% and 41.9%, respectively, had grade 0 pain (both P<.001). Significant treatment differences for complete resolution of ACC and grade 0 pain favoring loteprednol etabonate were also found on day 15 and day 18. One patient in each treatment group had a significant increase in IOP (≥ 10 mm Hg). Analyses of pain, photophobia, and tearing favored loteprednol etabonate at different time points beginning on day 3. More than 85% of patients in each treatment group reported no discomfort on drop instillation.
Loteprednol etabonate gel 0.5% was efficacious and safe in treating postoperative inflammation and pain.
Dr. Rajpal is a consultant to Bausch & Lomb, Inc., Allergan, Inc., and Alcon Laboratories, Inc. Dr. Siou-Mermet and Ms. Erb are employees of Bausch & Lomb, Inc. Dr. Roel has no financial or proprietary interest in any material or method mentioned.
研究新型洛度沙胺丁酯 0.5%凝胶制剂治疗白内障术后炎症和疼痛的疗效和安全性。
美国 17 个临床中心。
前瞻性、双盲、平行分组研究。
房水细胞（ACC）术后 2 级或更高级别的患者被随机分为洛度沙胺丁酯 0.5%凝胶组或赋形剂组，每天 4 次，共 14 天。主要观察指标包括术后第 8 天 ACC 完全消退和无疼痛（0 级）的患者比例。安全性措施包括不良事件、眼压（IOP）、视力、眼前节和眼底检查结果以及耐受性（眼部症状和滴眼舒适度）。
意向治疗人群包括 406 例患者（每组 203 例）。第 8 天，洛度沙胺丁酯组 30.5%的患者 ACC 完全消退，而赋形剂组为 16.3%，洛度沙胺丁酯组 72.9%的患者疼痛评分为 0 级，赋形剂组为 41.9%（均 P<.001）。第 15 天和第 18 天，洛度沙胺丁酯在 ACC 完全消退和疼痛评分为 0 级方面也具有显著的治疗优势。两组各有 1 例患者 IOP 升高（≥ 10mmHg）。从第 3 天开始，在不同时间点分析疼痛、畏光和流泪时，洛度沙胺丁酯更具优势。两组各有超过 85%的患者在滴注时报告无不适。
洛度沙胺丁酯凝胶 0.5%治疗白内障术后炎症和疼痛安全有效。
Rajpal 博士是 Bausch & Lomb，Inc.、Allergan，Inc. 和 Alcon Laboratories，Inc. 的顾问。Siou-Mermet 博士和 Erb 女士是 Bausch & Lomb，Inc. 的员工。Roel 博士没有任何与所提到的材料或方法有关的财务或所有权利益。
