Bartlett J D, Howes J F, Ghormley N R, Amos J F, Laibovitz R, Horwitz B
Department of Optometry, School of Optometry, University of Alabama, Birmingham.
Curr Eye Res. 1993 Apr;12(4):313-21. doi: 10.3109/02713689308999455.
Loteprednol etabonate (LE) is a new corticosteroid based on the "soft drug" concept. Contact lens-associated giant papillary conjunctivitis (GPC) was studied as a model for the anti-inflammatory effect of LE. Patients with bilateral GPC were enrolled in a multicenter, randomized, double-masked, placebo-controlled, parallel group comparison of loteprednol etabonate 0.5% ophthalmic suspension and the LE vehicle (placebo). Patients were instructed to instill 1 drop of the test medication into each eye 4 times daily for 4 weeks, and follow-up examinations occurred on Days 2 or 3, 7, 14, 21, and 28 of masked therapy. Of 113 patients enrolled, 110 patients (LE = 55; placebo = 55) completed the study as planned. Patients receiving LE demonstrated significant reduction in the primary ocular signs of GPC (papillae, p < 0.001) and were rated better in the Investigator's Global Assessment (p = 0.017). LE did not elevate intraocular pressure during the study, and ratings for bulbar conjunctival injection and the Patient Opinion Assessment demonstrated statistical trends that favored treatment with LE. LE was well tolerated and was clinically effective for the treatment of GPC.
氯替泼诺依碳酸酯（LE）是一种基于“软药”概念的新型皮质类固醇。以隐形眼镜相关性巨乳头性结膜炎（GPC）作为模型来研究LE的抗炎作用。双侧GPC患者参与了一项多中心、随机、双盲、安慰剂对照的平行组比较试验，比较0.5%氯替泼诺依碳酸酯眼用混悬液和LE赋形剂（安慰剂）。患者被指示每天4次向每只眼睛滴入1滴试验药物，持续4周，在遮蔽治疗的第2或3天、第7天、第14天、第21天和第28天进行随访检查。在纳入的113例患者中，110例患者（LE组 = 55例；安慰剂组 = 55例）按计划完成了研究。接受LE治疗的患者GPC的主要眼部体征（乳头，p < 0.001）显著减轻，在研究者整体评估中的评分更高（p = 0.017）。在研究期间，LE未升高眼压，球结膜充血评分和患者意见评估显示出有利于LE治疗的统计学趋势。LE耐受性良好，对GPC的治疗具有临床疗效。
