A Single-Center Evaluation of the Relative Efficacy of EM-100 Compared to Zaditor® (Ketotifen Fumarate Ophthalmic Solution 0.035%) and Vehicle in the Treatment of Ocular Itching Associated With Allergic Conjunctivitis as Induced by the Conjunctival Allergen Challenge Model (Ora-CAC®)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Ocular Itching
研究概览
简要总结
A Single-Center study to demonstrate the non-inferiority of EM-100 to Zaditor® in the treatment of ocular itching.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •be at least 18 years old
- •have a positive history of allergic conjunctivitis and positive skin test reaction to allergens
- •be willing to avoid disallowed medications for the appropriate washout period and throughout the trial
- •be willing to avoid contact lens use
- •be willing to have a pregnancy test
- •must be able to read an eye chart from 10 feet away
排除标准
- •must not have any allergies to the study medications
- •must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
- •must not have used an investigational drug or device in the past 30 days or currently be enrolled in another investigational trial
研究组 & 干预措施
EM-100
One drop of EM-100 in either the right or left eye once on Day 1.
干预措施: EM-100 (Drug)
Zaditor®
One drop of Zaditor® in either the right or left eye once on Day 1.
干预措施: Zaditor® (Drug)
Vehicle
One drop of Vehicle in either the right or left eye once on Day 1.
干预措施: Vehicle (Drug)
结局指标
主要结局
Ocular Itching
时间窗: 3, 5 and 7 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1
Ocular itching scores were self-assessed by the participant using a 5-point scale with 0.5 unit increments, wherein 0 = None (normal, no itching), 1.0 = Intermittent tickle sensation involving more than just the corner of the eye, 2.0 = Mild continuous itch without desire to rub, 3.0 = Severe itch with desire to rub, and 4.0 = Incapacitating itch with irresistible urge to rub.
次要结局
- Conjunctival Redness(7, 15 and 20 minutes post-Conjunctival Allergen Challenge (CAC) on Day 1)