NCT00331500已完成3 期
A Comparative Study of Olopatadine 0.2% Versus Vehicle in Patients With Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 287
- 主要终点
- Daily ocular itching and redness scores
研究概览
简要总结
The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass antigen challenge reaction (skin test), and a positive response to grass in the Conjunctival Allergen Challenge (CAC) model
排除标准
- •Under 10 years of age
研究组 & 干预措施
Olopatadine Hydrochloride 0.2%
Experimental
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop in each eye, once-daily in the morning for 6 weeks
干预措施: Olopatadine Hydrochloride Ophthalmic Solution, 0.2% (Drug)
Vehicle
Placebo Comparator
Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop in each eye, once-daily in the morning for 6 weeks
干预措施: Olopatadine Hydrochloride Ophthalmic Solution Vehicle (Drug)
结局指标
主要结局
Daily ocular itching and redness scores
时间窗: Up to Day 14
次要结局
- Percentage of patients with daily ocular itching and redness scores of 0(Up to Day 14)
研究者
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