Fong Raymond, Cavet Megan E, DeCory Heleen H, Vittitow Jason L
Manhattan Eye, Ear and Throat Hospital and Lenox Hill Hospital, New York, NY, USA.
Medical Affairs, Bausch + Lomb, Rochester, NY, USA.
Clin Ophthalmol. 2019 Aug 1;13:1427-1438. doi: 10.2147/OPTH.S210597. eCollection 2019.
To evaluate the efficacy and safety of a submicron formulation of loteprednol etabonate (LE) gel 0.38% instilled three times daily (TID) compared with vehicle for the treatment of inflammation and pain following cataract surgery with intraocular lens implantation, integrated across two multicenter, double-masked, randomized, parallel-group, Phase III studies.
Subjects ≥18 years of age with anterior chamber (AC) cells ≥grade 2 (6-15 cells) on day 1 after cataract surgery were randomized to receive 1 drop of LE gel 0.38% TID, twice daily (not reported/analyzed herein), or vehicle instilled in the study eye for 14 days. Primary endpoints were the proportion of subjects with resolution of AC cells and grade 0 (no) pain at postoperative day 8. Safety outcomes included adverse events (AEs), ocular signs, fundoscopy results, visual acuity, intraocular pressure (IOP), and tolerability (drop comfort and ocular symptoms).
The integrated intent-to-treat population included 742 subjects (LE gel 0.38% TID, n=371; vehicle, n=371). Significantly more subjects in the LE gel 0.38% TID group compared with the vehicle group had complete resolution of AC cells (29.6% vs 15.1%) and grade 0 pain (74.4% vs 48.8%) at day 8 (<0.0001 for both). LE gel 0.38% TID was safe and well tolerated, with only 1 LE-treated subject experiencing an IOP elevation ≥10 mm Hg. Most treatment-related AEs were mild and occurred less frequently with LE gel 0.38% than with vehicle. The majority (>75%) of subjects in each treatment group reported no drop discomfort. There were no reports of blurred vision with LE gel.
The results of this integrated analysis indicate that LE (submicron) gel 0.38% administered TID is safe and effective for the treatment of ocular inflammation and pain following cataract surgery, with minimal risk of IOP elevation.
通过两项多中心、双盲、随机、平行组III期研究，评估每天三次（TID）滴注0.38%氯替泼诺乙酯（LE）亚微米制剂凝胶与赋形剂相比，在治疗白内障人工晶状体植入术后炎症和疼痛方面的疗效和安全性。
白内障手术后第1天前房（AC）细胞≥2级（6 - 15个细胞）的18岁及以上受试者被随机分配，接受1滴0.38% LE凝胶TID、每天两次（本文未报告/分析）或在研究眼中滴注赋形剂，持续14天。主要终点是术后第8天AC细胞消退且疼痛为0级（无）的受试者比例。安全性结果包括不良事件（AE）、眼部体征、眼底检查结果、视力、眼压（IOP）和耐受性（滴眼舒适度和眼部症状）。
综合意向性治疗人群包括742名受试者（0.38% LE凝胶TID组，n = 371；赋形剂组，n = 371）。与赋形剂组相比，0.38% LE凝胶TID组在第8天有更多受试者AC细胞完全消退（29.6%对15.）和疼痛为0级（74.4%对48.8%）（两者均<0.0001）。0.38% LE凝胶TID安全且耐受性良好，仅1名接受LE治疗的受试者眼压升高≥10 mmHg。大多数与治疗相关的AE为轻度，0.38% LE凝胶发生的频率低于赋形剂。每个治疗组中大多数（>75%）受试者报告无滴眼不适。没有关于LE凝胶导致视力模糊的报告。
这项综合分析的结果表明，每天三次给予0.38% LE（亚微米）凝胶治疗白内障术后眼部炎症和疼痛是安全有效的，眼压升高风险最小。
