NCT00982163已完成不适用
A Single-Center Evaluation of the Pattern of Allergic Signs and Symptoms During 4 Weeks in Ragweed Season
ORA, Inc.1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2008年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Diary Data
研究概览
简要总结
The study was designed to evaluate the pattern of seasonal allergic signs and symptoms consistent with ongoing ocular allergic inflammation during ragweed season. It was hypothesized that a pattern of ongoing ocular allergic inflammation existed in certain subjects.
详细描述
Subjects who had a positive skin test to ragweed within 24 months of Visit 1 were instructed to complete a diary, which assessed their allergic signs and symptoms 3 times a day for 4 weeks. During the in-office visits, subjects were asked to completed a quality of life questionnaire, as well as a retrospective and/or prospective eye allergy questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects must:
- •be willing and able to read, sign, and date the informed consent and HIPAA documents prior to initiation of Visit 1 procedures or exams;
- •be at least 18 years of age;
- •be willing to avoid disallowed medication, such as anti-allergy therapies
- •have a positive history of ocular allergies and a positive skin test reaction to ragweed within the past 24 months;
- •have a calculated logMAR visual acuity score using the ETDRS Chart of 0.60 or better in each eye at Visit 1;
排除标准
- •Subjects may not:
- •have preauricular lymphadenopathy or any ocular condition that could affect study parameters (particularly, clinically significant blepharitis, follicular conjunctivitis and iritis);
- •have had any ocular infection within the last 30 days;
- •have a positive diagnosis of moderate to severe dry eye syndrome (i.e., requiring daily use of artificial tears);
- •wear contact lenses to each office visit; Note: Subjects will be allowed to use cold compresses.
结局指标
主要结局
Diary Data
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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