Rosenwasser Lanny J, Mahr Todd, Abelson Mark B, Gomes Paul J, Kennedy Kathryn
Children's Mercy Hospital & Clinics, Kansas City, MO 64108, USA.
Allergy Asthma Proc. 2008 Nov-Dec;29(6):644-53. doi: 10.2500/aap.2008.29.3176. Epub 2008 Dec 6.
Allergic conjunctivitis is an inflammatory condition of the ocular surface characterized by ocular itching, redness, tearing, chemosis, and eyelid swelling. The purpose of this study was to assess the comparative efficacy of an ophthalmic antihistamine/mast cell stabilizer solution and an intranasal steroid at reducing the signs and symptoms of allergic conjunctivitis induced by the conjunctival allergen challenge (CAC) model. Sixty subjects were enrolled in a single center, randomized, placebo-controlled, parallel-treatment, four-visit CAC study. After titration and confirmation of the allergic reaction at visits 1 and 2, subjects were randomized at visit 3 into one of 4 treatment groups (olopatadine 0.2% ophthalmic solution, fluticasone furoate nasal spray, a tear substitute, or saline nasal spray), dosed with study medication, and challenged 15 minutes later, after which ocular allergic signs and symptoms were assessed. Subjects continued treatment of the assigned medication for 6 days. At visit 4, subjects underwent similar procedures to those performed at visit 3. Fifty-nine subjects completed the study. Olopatadine 0.2% ophthalmic solution showed statistical and clinical superiority over fluticasone furoate nasal spray at all post-CAC time points after a single dose (p < 0.001) and after a 1-week loading period (p < 0.01) for ocular itching, the primary end point. Similarly, olopatadine 0.2% showed statistical and clinical superiority over fluticasone furoate for the majority of time points for ocular redness, tearing, chemosis, and eyelid swelling. Olopatadine 0.2% ophthalmic solution was statistically and clinically superior to fluticasone furoate nasal spray for the relief of signs and symptoms of allergic conjunctivitis.
过敏性结膜炎是一种眼表炎症性疾病,其特征为眼痒、眼红、流泪、结膜水肿和眼睑肿胀。本研究的目的是评估一种眼科抗组胺药/肥大细胞稳定剂溶液和一种鼻用类固醇在减轻结膜过敏原激发(CAC)模型诱发的过敏性结膜炎的体征和症状方面的相对疗效。60名受试者参加了一项单中心、随机、安慰剂对照、平行治疗、四次访视的CAC研究。在第1次和第2次访视时滴定并确认过敏反应后,受试者在第3次访视时被随机分为4个治疗组之一(0.2%奥洛他定眼药水、糠酸氟替卡松鼻喷雾剂、泪液替代品或生理盐水鼻喷雾剂),给予研究药物,并在15分钟后进行激发试验,之后评估眼部过敏体征和症状。受试者继续使用指定药物治疗6天。在第4次访视时,受试者接受与第3次访视类似的程序。59名受试者完成了研究。在单次给药后(p<0.001)以及1周负荷期后(p<0.01),对于主要终点眼痒,0.2%奥洛他定眼药水在所有CAC后时间点均显示出优于糠酸氟替卡松鼻喷雾剂的统计学和临床优势。同样,在大多数时间点,对于眼红、流泪、结膜水肿和眼睑肿胀,0.2%奥洛他定也显示出优于糠酸氟替卡松的统计学和临床优势。0.2%奥洛他定眼药水在缓解过敏性结膜炎的体征和症状方面在统计学和临床上均优于糠酸氟替卡松鼻喷雾剂。