Dell S J, Lowry G M, Northcutt J A, Howes J, Novack G D, Hart K
Texan Eye Care, Austin, USA.
J Allergy Clin Immunol. 1998 Aug;102(2):251-5. doi: 10.1016/s0091-6749(98)70094-6.
Loteprednol etabonate is a site-active corticosteroid with efficacy and safety in treating ocular inflammation at the 0.5% concentration. Evidence from dose-response studies suggested that the 0.2% concentration might be effective in treating ocular allergy.
The objective of this study was to evaluate the effects of 0.2% loteprednol etabonate in reducing the signs and symptoms of seasonal allergic conjunctivitis.
This was a randomized, double-masked, placebo-controlled, parallel-group multicenter study. Patients with signs and symptoms of environmental seasonal allergic conjunctivitis received either loteprednol etabonate or placebo bilaterally four times daily for 42 days.
Enrolled were 133 patients (66 receiving loteprednol etahonate; 67 receiving placebo). A reduction in severity was seen in both loteprednol etabonate and placebo groups for bulbar conjunctival injection (1.3 vs 0.9 units on a 0 to 3 scale) and itching (3.5 vs 3.1 units on a 0 to 4 scale) over the first 2 weeks. The treatment effect was -0.5 and -0.6 units in favor of loteprednol etabonate (P < .001). Resolution (the proportion of patients with the sign or symptom no longer present) at visit 4 (day 14) strongly favored loteprednol etabonate-treated patients over placebo-treated patients (31% and 9%, and 54% and 38%, for injection and itching, respectively). Both treatments were well tolerated. No patients in either treatment group (0 for loteprednol etabonate and 0 for vehicle) had an elevation of intraocular pressure of 10 mm Hg or greater during the 6 weeks of treatment.
Loteprenol etabonate (0.2%) was more effective than placebo in the treatment of seasonal allergic conjunctivitis. Loteprednol etabonate (0.2%) had a safety profile comparable to placebo during this 6-week trial.
氯替泼诺酯是一种局部作用的皮质类固醇，0.5%浓度时在治疗眼部炎症方面具有疗效和安全性。剂量反应研究的证据表明，0.2%浓度可能对治疗眼部过敏有效。
本研究的目的是评估0.2%氯替泼诺酯在减轻季节性过敏性结膜炎体征和症状方面的效果。
这是一项随机、双盲、安慰剂对照、平行组多中心研究。患有环境性季节性过敏性结膜炎体征和症状的患者，每天双侧使用氯替泼诺酯或安慰剂4次，共42天。
共纳入133例患者（66例接受氯替泼诺酯；67例接受安慰剂）。在最初2周内，氯替泼诺酯组和安慰剂组的球结膜充血（0至3级，分别为1.3和0.9个单位）和瘙痒（0至4级，分别为3.5和3.1个单位）严重程度均有所降低。治疗效果氯替泼诺酯组比安慰剂组高-0.5和-0.6个单位（P <.001）。在第4次就诊（第14天）时，症状缓解（体征或症状不再出现的患者比例）方面，氯替泼诺酯治疗的患者明显优于安慰剂治疗组（充血分别为31%和9%，瘙痒分别为54%和38%）。两种治疗耐受性均良好。在6周治疗期间，两个治疗组均无患者（氯替泼诺酯组0例，赋形剂组0例）眼压升高10 mmHg或更高。
0.2%氯替泼诺酯治疗季节性过敏性结膜炎比安慰剂更有效。在为期6周的试验中，0.2%氯替泼诺酯的安全性与安慰剂相当。
