Effectiveness of Olopatadine HCl Ophthalmic Solution, 0.1% Compared to Epinastine HCl Ophthalmic Solution, 0.05% in the Treatment of Allergic Conjunctivitis to Japanese Cedar Pollen
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Mean Ocular Itching at 7 Minutes Post-CAC, Day 1
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of Olopatadine Hydrochloride (HCl) ophthalmic solution 0.1% versus Epinastine HCl ophthalmic solution, 0.05% in a population of healthy, adult Japanese patients (20 years of age or older) with a history of allergic conjunctivitis to Japanese Cedar Pollen. Patients will be randomly assigned to receive Olopatadine HCl ophthalmic solution, 0.1% in one eye and Epinastine HCl ophthalmic solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge (CAC) with Japanese cedar pollen will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be Japanese and live in Japan;
- •History of allergic conjunctivitis;
- •Positive skin test reaction to Japanese cedar at Visit 1;
- •Positive bilateral CAC reaction to the allergen at Visit 1 and Visit 2;
- •Able and willing to avoid all disallowed medications during the specified period;
- •Able to discontinue wearing contact lenses during the specified period;
- •Sign Informed Consent;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •History of hypersensitivity to the study drug or compounds;
- •Any ocular condition that, in the opinion of the investigator, could affect the patient's safety;
- •Ocular surgical intervention within 3 months or refractive surgery within 6 months prior to the start of the study;
- •Presence of active ocular infection;
- •Use of disallowed medications as specified in the protocol;
- •Pregnant, nursing, or planning to become pregnant during the study;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Olopatadine (right or left, randomized)
Olopatadine HCl ophthalmic solution, 0.1%, 1 drop in the right or left eye as randomized
干预措施: Olopatadine HCl ophthalmic solution, 0.1% (Drug)
Epinastine (fellow eye)
Epinastine HCl ophthalmic solution, 0.05%, 1 drop in the in the fellow eye
干预措施: Epinastine HCl ophthalmic solution, 0.05% (Drug)
结局指标
主要结局
Mean Ocular Itching at 7 Minutes Post-CAC, Day 1
时间窗: Day 1, 7 minutes post-CAC
A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).
次要结局
- Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1(Day 1, 20 minutes post-CAC)