Effect of Olopatadine Hydrochloride 0.2% Ophthalmic Solution on Epicutaneous Skin Prick Testing With Histamine and Saline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
研究概览
简要总结
Use of olopatadine ophthalmic solution (eye drops) will decrease allergy skin test reactivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 75 years
- •Healthy volunteers (no major illnesses or active symptoms)
排除标准
- •Known allergy or hypersensitivity to the drugs or components
- •Pregnant or nursing women
- •Women wishing to become pregnant during the study's duration
- •Use of topical or oral medications with antihistaminic activity for 14 days proceeding randomization
- •Dermatographism as evidenced on skin testing on visit 1
- •Chronic urticaria active within the past 6 months
- •Severe hypertension
- •Psychiatric diagnoses which could potentially affect medication compliance, such as schizophrenia or delusional disorders, as determined by the investigator obtaining informed consent and based on the subject's past medical history
- •Inability to provide informed consent
研究组 & 干预措施
olopatadine then placebo
participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
干预措施: olopatadine (Drug)
placebo then olopatadine
participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
干预措施: olopatadine (Drug)
olopatadine then placebo
participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
干预措施: placebo (Drug)
placebo then olopatadine
participants received olopatadine 0.2% opthalmic solution 1 drop into each eye at the same time each day for 7 to 10 days followed by 7-10 day washout period. They then received a placebo, normal saline opthalmic solution 1 drop into each eye at the same time each day for 7-10 days
干预措施: placebo (Drug)
结局指标
主要结局
The Difference in Area (cm2) of the Flare Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
时间窗: at baseline and at return visit (between study day 7-10)
The Difference in Area (cm2) of the Wheal Size in Histamine Skin Test Response During Treatment With Olopatadine Compared to Placebo.
时间窗: at baseline and at return visit (between study day 7-10)
次要结局
未报告次要终点
研究者
John Michael Fahrenholz
MD
Vanderbilt University Medical Center