A Study to Assess Alcon's Ocular Image Quantification Using Conjunctival Allergan Provocation Testing (CAPT) and Natural Allergen Exposure in an Environmental Exposure Chamber (EEC)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours
研究概览
简要总结
The purpose of this study was to evaluate ocular responses with different allergen provocation methods.
详细描述
Subjects demonstrating a successful allergen response to a common allergen received the first study treatment and used as instructed for 5 days, after which they entered the Environmental Exposure Chamber (EEC) for a 3-hour exposure to a known concentration of the allergen. After waiting at least 7 days, subjects received the second study treatment and used as instructed for 5 days, after which a 3-hour Conjunctival Allergen Provocation Test (CAPT) was performed with an escalating concentration of the allergen. Subjects dosed with study treatment approximately 15 minutes prior to each allergen provocation test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of allergic conjunctivitis;
- •Active signs and symptoms of ocular allergies;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •History of dry eye;
- •Presence of ocular infection;
- •Presence of severe or serious ocular conditions;
- •Symptoms of allergic conjunctivitis;
- •Use of topical or systemic ocular medications as specified in protocol;
- •Ocular surgery or laser surgery within 6 months of study start;
- •Unwilling to discontinue contact lens wear 72 hours prior to Visit 1 and during study period;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Tears Naturale II
One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
干预措施: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II) (Other)
Patanol
One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
干预措施: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol) (Drug)
结局指标
主要结局
Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours
时间窗: Baseline, 3 hours
As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.
Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours
时间窗: Baseline, 3 hours
As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.
次要结局
未报告次要终点