NCT00133627已完成4 期
Safety and Efficacy Comparison Ketotifen Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 229
- 试验地点
- 1
研究概览
简要总结
Medications available for the treatment of seasonal allergic conjunctivitis include antihistamines. These medicines block the release of histamine, a substance in the body that is released when an allergic reaction occurs. Novartis (NVS) has developed an eye drop formulation of a well tried antihistamine called ketotifen. This study will compare the efficacy and the tolerability of ketotifen eye drops with emedastine, which is a popular treatment for seasonal allergic conjunctivitis in China.
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
- Double
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3 years or older.
- •History of seasonal allergic conjunctivitis
- •Presence of bilateral ocular itching/conjunctival hyperaemia (redness) at baseline:
- •at least intensity degree 2 for itching, and
- •at least intensity degree 4 for composite score of itching and conjunctival hyperaemia
排除标准
- •Other systemic/ophthalmic conditions
- •Presence of any form of allergic conjunctivitis other than seasonal allergic conjunctivitis (e.g. perennial allergic conjunctivitis, vernal keratoconjunctivitis, atopic keratoconjunctivitis, giant papillary conjunctivitis).
- •Active bacterial or viral conjunctivitis or history of ocular herpes.
- •Presence or history of severe dry eye.
- •Previous treatments
- •Any systemic or ocular corticosteroids within two (2) weeks prior to randomization.
- •Any systemic or ocular mast cell stabilizers within two (2) weeks prior to randomization.
- •Any other ophthalmic medication within three (3) days prior to randomization.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究者
研究点 (1)
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