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首页> 外文期刊>Clinical ophthalmology >Efficacy and safety of olopatadine hydrochloride 0.77% in patients with allergic conjunctivitis using a conjunctival allergen-challenge model
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Efficacy and safety of olopatadine hydrochloride 0.77% in patients with allergic conjunctivitis using a conjunctival allergen-challenge model

机译：结膜变应原挑战模型对盐酸奥洛他定0.77％过敏性结膜炎的疗效和安全性

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Background: Symptom relief for the duration of 24 hours after treatment would benefit patients with allergic conjunctivitis. Objective: To compare the safety and efficacy of olopatadine 0.77% with vehicle or olopatadine 0.2% in patients with allergic conjunctivitis in a conjunctival allergen-challenge clinical study. Patients and methods: In this Phase III, multicenter, double-masked, parallel-group, randomized trial, patients with allergic conjunctivitis received olopatadine 0.77%, its vehicle, or olopatadine 0.2%, administered once at visits 3A (day 0), 4A (day 14 ±2), and 5 (day 21 +3). Allergic conjunctivitis-associated sign and symptom assessments included ocular itching, conjunctival redness, total redness, chemosis, and tearing scores. Adverse events and ocular safety parameters were also assessed. Results: A total of 202 qualifying patients were randomized. Olopatadine 0.77% was superior (P<0.001) to vehicle for treatment of ocular itching at 3, 5, and 7 minutes postchallenge at onset of action and 16- and 24-hour duration of action. Conjunctival redness mean scores were significantly lower for olopatadine 0.77% versus vehicle at all three post-conjunctival allergen-challenge time points: onset (-1.52 to -1.48; P<0.001), 16 hours (-1.50 to -1.38; P<0.01), and 24 hours (-1.58 to?-1.38; P<0.05). At 24 hours, olopatadine 0.77% was superior to olopatadine 0.2% at all three postchallenge time points for ocular itching (P<0.05), conjunctival redness (P<0.05), and total redness (P<0.05). No clinically relevant differences in safety parameters or adverse events were observed between the treatment groups. Conclusion: Olopatadine 0.77% is superior to both its vehicle and olopatadine 0.2% for the treatment of allergen-mediated ocular itching and conjunctival redness. Ocular itching symptom relief is maintained over 24 hours, supporting once-daily dosing and demonstrating a comparable safety profile to olopatadine 0.2%.
机译：背景：治疗后24小时内症状缓解将使过敏性结膜炎患者受益。目的：比较结膜过敏原挑战性结膜炎患者中0.77％奥洛他定与媒介物或0.2％奥洛他定的安全性和有效性。患者和方法：在此III期，多中心，双掩蔽，平行组，随机试验中，过敏性结膜炎患者接受olopatadine 0.77％，其媒介物或olopatadine 0.2％，在第3A次访问（第0天），4A时一次（第14天±2天）和5（第21天+3天）。过敏性结膜炎相关的体征和症状评估包括眼瘙痒，结膜发红，总发红，化学反应和流泪评分。还评估了不良事件和眼睛安全性参数。结果：总共202名合格患者被随机分组​​。发作后第3、5和7分钟，作用时间为16和24小时，奥洛他定0.77％优于（P <0.001）媒介物治疗眼瘙痒。在所有三个结膜后变应原攻击时间点上，奥洛他定的结膜充血平均得分显着低于媒介物，为0.77％：发作（-1.52至-1.48; P <0.001），16小时（-1.50至-1.38; P <0.01） ）和24小时（-1.58至？-1.38; P <0.05）。在攻击后三个时间点，眼瘙痒（P <0.05），结膜发红（P <0.05）和总发红（P <0.05）在所有三个挑战时间点，奥洛他汀0.77％优于奥洛他汀0.2％。在治疗组之间未观察到安全性参数或不良事件的临床相关差异。结论：在过敏原介导的眼瘙痒和结膜发红方面，奥洛他汀0.77％优于其载体和奥洛他汀0.2％。眼睛瘙痒症状缓解持续24小时，支持每天一次给药，显示出与0.2％的奥洛他定相当的安全性。

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