From Clinical Affairs, Bausch + Lomb (Vittitow), Bridgewater, New Jersey, and Clinical Affairs, Bausch + Lomb (Williams), Irvine, California, USA.
J Cataract Refract Surg. 2020 Aug;46(8):1092-1101. doi: 10.1097/j.jcrs.0000000000000218.
To compare loteprednol etabonate (LE) gel 0.5% with prednisolone acetate suspension (PA) 1% for the treatment of inflammation after cataract surgery in children.
Eleven sites in the United States.
Randomized, double-masked, parallel-group, noninferiority study.
Eligible patients were aged 11 years or younger and candidates for routine, uncomplicated cataract surgery. Patients were randomized to a 4-week postsurgical regimen with LE gel 0.5% or PA 1%, twice on the day of surgery, 4 times daily for 2 weeks, twice daily for 1 week, and once daily for 1 week. Assessments included anterior chamber (AC) cells/flare, anterior chamber inflammation (ACI), synechiae, precipitates on the intraocular lens/cornea, visual acuity, and intraocular pressure.
The intent-to-treat population comprised 105 patients (LE gel, n = 53; PA 1%, n = 52) including 52 patients aged 3 years or younger. Patients achieved a similar mean ACI grade on postoperative day 14 (primary efficacy endpoint) whether treated with LE gel 0.5% or PA 1% (difference = 0.006, 2-sided 95% CI, -0.281 to 0.292). Similar ACI outcomes additionally were observed in patients aged 3 years or younger. LE gel 0.5% and PA 1% also appeared equally effective in resolving inflammation at all visits (days 7, 14, and 28 postsurgery), based on categorical distributions of ACI, AC cells, and AC flare scores/grades (P ≥ .06). Synechiae and corneal/IOL precipitates occurred infrequently with no significant differences between groups. No safety or tolerability concerns were identified, including no treatment-related IOP increases.
LE gel 0.5% was safe and effective in treating pediatric postcataract surgical inflammation, with similar outcomes as PA 1%.
比较 0.5%洛度沙胺丁酯（LE）凝胶和 1%醋酸泼尼松龙混悬液（PA）治疗儿童白内障术后炎症的效果。
在美国 11 个研究地点开展。
随机、双盲、平行分组、非劣效性研究。
入选患者为 11 岁或以下、拟行常规白内障手术的儿童。患者随机分组，术后 4 周内接受 LE 凝胶 0.5%或 PA 1%治疗，手术当天各 2 次，术后 2 周内每日 4 次，1 周内每日 2 次，1 周内每日 1 次。评估指标包括前房细胞/渗出、前房炎症（ACI）、虹膜粘连、眼内晶状体/角膜沉淀物、视力和眼压。
意向治疗人群包括 105 例患者（LE 凝胶组 53 例，PA 1%组 52 例），其中 52 例患者年龄 3 岁或以下。术后第 14 天（主要疗效终点），LE 凝胶 0.5%组和 PA 1%组的平均 ACI 分级相似（差值=0.006，双侧 95%CI：-0.281 至 0.292）。3 岁或以下患者也观察到类似的 ACI 结果。基于 ACI、前房细胞和前房炎症评分/等级的分类分布，LE 凝胶 0.5%和 PA 1%在所有访视点（术后第 7、14 和 28 天）治疗炎症方面同样有效（P≥0.06）。虹膜粘连和角膜/眼内晶状体沉淀物发生频率较低，组间无显著差异。未发现安全性或耐受性问题，包括无治疗相关眼压升高。
0.5%LE 凝胶治疗儿童白内障术后炎症安全有效，与 1%PA 疗效相当。
