NCT01808768Unknown4 期
To Assess the Impact of Ocular Allergy Treatment on Patients Using an Opthalmic Agent (or no Treatment) Versus Alcaftadine(Lastacaft™)
Starx Research Center, LLC2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Quality of Life- Eye Allergy Patient Impact Questionnaire
研究概览
简要总结
To study the impact of alcaftadine in patients treated with other opthalmic ocular agents (or specific topical opthalmic treatment) in an allergy subspecialist outpatient setting.
详细描述
To assess the impact of ocular allergy treatment on patients using an ophthalmic agent (or no treatment) versus alcaftadine(Lastacaft™)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •patients age 18 and older with a history of seasonal or perennial forms of allergic conjunctivitis and skin test positive reactivity to seasonal aeroallergens
- •Total Ocular Symptom Score (TOSS) on the day of enrollment of 4 or more.
- •have allergic ocular symptoms for the past week for which they are either treating with ophthalmic agents or have had no treatment.
- •Are willing/able to follow instructions from the study investigator and his/her study staff.
- •Have signed infromed consent approved by Institutional Review Board or Independent Ethics Committee.
排除标准
- •Active ocular infection;
- •History of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
- •Ocular surgical intervention within three (3) months prior to visit 1 or scheduled during the study.
- •History of unstable, or uncontrolled disease of any nature.
- •Pregnancy or lactation;
- •Have a known hypersensitivity tp LASTACAFT™ (alcaftadine) -
研究组 & 干预措施
Alcaftadine
Experimental
subject on any ocular allergy ophthalmic treatment or no treatment will be started on Alcaftadine 0.25%(study drug)- 1 drop each eye daily for 1-2 weeks
干预措施: Alcaftadine (Drug)
结局指标
主要结局
Quality of Life- Eye Allergy Patient Impact Questionnaire
时间窗: 4 months
次要结局
- Ocular Surface Disease Index Pollen Count correlation of symptoms(6 months)
研究者
Jayesh G. Kanuga, M.D.
Medical Doctor
Starx Research Center, LLC
研究点 (2)
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