Comstock Timothy L, Paterno Michael R, Singh Angele, Erb Tara, Davis Elizabeth
Bausch and Lomb Inc., Rochester, NY, USA;
Clin Ophthalmol. 2011;5:177-86. doi: 10.2147/OPTH.S16832. Epub 2011 Feb 10.
To compare the safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% (LE ointment), a new topical ointment formulation, with vehicle for the treatment of inflammation and pain following cataract surgery.
Two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies were conducted. Patients aged ≥18 years with a combined postoperative anterior chamber cells and flare (ACI) ≥ Grade 3 following uncomplicated cataract surgery participated in seven study visits. Patients self-administered either topical LE ointment or vehicle four times daily for 14 days. Efficacy outcomes included the proportion of patients with complete resolution of ACI and the proportion of patients with no (Grade 0) pain at postoperative day 8. Safety outcomes included the incidence of adverse events, ocular symptoms, changes in intraocular pressure and visual acuity, and biomicroscopy and funduscopy findings.
Data from the two studies were combined. The integrated intent-to-treat population consisted of 805 patients (mean [standard deviation] age 69.0 [9.2] years; 58.0% female and 89.7% white). Significantly more LE ointment-treated patients than vehicle-treated patients had complete resolution of ACI (27.7% versus 12.5%) and no pain (75.5% versus 43.1%) at day 8 (P < 0.0001 for both). Fewer LE ointment-treated patients required rescue medication (27.7% versus 63.8%), and fewer had an ocular adverse event (47.2% versus 78.0%, P < 0.0001) while on study treatment. The most common ocular adverse events with LE ointment were anterior chamber inflammation, photophobia, corneal edema, conjunctival hyperemia, eye pain, and iritis. Mean intraocular pressure decreased in both treatment groups. Four patients had increased intraocular pressure ≥10 mmHg (three LE ointment and one vehicle) prior to rescue medication. Visual acuity and dilated funduscopy results were similar between the treatment groups, with the exception of visual acuity at visits 5 and 6, which favored LE ointment.
LE ointment was efficacious and well tolerated in the treatment of ocular inflammation and pain following cataract surgery.
比较0.5%氯替泼诺妥布霉素眼膏（LE眼膏）这一新型局部眼膏制剂与赋形剂治疗白内障手术后炎症和疼痛的安全性及有效性。
开展了两项随机、多中心、双盲、平行组、赋形剂对照研究。年龄≥18岁、白内障手术无并发症且术后前房细胞和闪辉（ACI）合并≥3级的患者参与了七次研究访视。患者每日自行局部使用LE眼膏或赋形剂4次，共14天。疗效指标包括术后第8天ACI完全消退的患者比例以及无痛（0级）患者比例。安全性指标包括不良事件发生率、眼部症状、眼压和视力变化以及生物显微镜检查和眼底检查结果。
两项研究的数据合并。意向性分析总人群包括805例患者（平均[标准差]年龄69.0[9.2]岁；女性占58.0%，白人占89.7%）。在第8天，接受LE眼膏治疗的患者ACI完全消退（27.7%对12.5%）和无痛（75.5%对43.1%）的比例显著高于接受赋形剂治疗的患者（两者P均<0.0001）。接受LE眼膏治疗的患者需要急救药物的较少（27.7%对63.8%），且在研究治疗期间发生眼部不良事件的较少（47.2%对78.0%，P<0.0001）。使用LE眼膏最常见的眼部不良事件是前房炎症、畏光、角膜水肿、结膜充血、眼痛和虹膜炎。两个治疗组的平均眼压均降低。4例患者在急救药物治疗前眼压升高≥10mmHg（3例使用LE眼膏，1例使用赋形剂）。除第5次和第6次访视时的视力有利于LE眼膏外，两组间视力和散瞳眼底检查结果相似。
LE眼膏治疗白内障手术后眼部炎症和疼痛有效且耐受性良好。
