NCT00655109已完成4 期
A Comparison of Olopatadine Versus Fluticasone Nasal Spray in the Prevention of the Signs and Symptoms of Allergic Conjunctivitis
Greiner, Jack V., OD DO PhD1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ocular itching
研究概览
简要总结
To compare the clinical efficacy of olopatadine and fluticasone in a 3-week single center, double-masked, randomized, placebo controlled parallel treatment conjunctival allergen challenge (CAC) study in patients with allergic conjunctivitis
详细描述
Study will evaluate the efficacy of nasal anti-allergic therapy compared to ocular anti-allergic therapy in the prevention of ocular allergic symptoms.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age & either sex, any race
- •Willing and able to follow all instructions and attend all study visits
- •Positive history of ocular allergies
- •Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge
排除标准
- •Have planned surgery during trial period
- •Female currently pregnant, planning a pregnancy, or lactating
- •Use of disallowed medications
研究组 & 干预措施
1
Active Comparator
Olopatadine
干预措施: Olopatadine (Drug)
2
Active Comparator
Fluticasone
干预措施: Fluticasone (Drug)
3
Placebo Comparator
Placebo nasal spray
干预措施: Saline (Drug)
4
Placebo Comparator
Placebo Eyedrops
干预措施: Artificial tears (Drug)
结局指标
主要结局
Ocular itching
时间窗: Minutes following CAC
次要结局
- Ocular redness(Minutes following CAC)
研究者
研究点 (1)
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