Safety and Efficacy Study of a Eye Drop for Eye Allergy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 10 years of age
- •positive history of ocular allergies
- •positive skin test reaction to allergens.
排除标准
- •known allergy, contraindication, or sensitivities to the use of any of the study medication(s) or their components
- •ocular surgical intervention within three (3) months prior to visit 1 or during the study
- •known history of retinal detachment, diabetic retinopathy, or progressive retinal disease, or glaucoma
- •any other significant illness
研究组 & 干预措施
alcaftadine ophthalmic solution
active treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).
干预措施: alcaftadine (Drug)
inactive ophthalmic solution vehicle
Placebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).
干预措施: Placebo (Drug)
结局指标
主要结局
Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation
时间窗: Visit 4 (Day 14) up to 7 minutes following Allergen Challenge
0 to 4 scale, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"
Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.
时间窗: Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge
A 0 to 4 scale used, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation.
Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation
时间窗: Visit 4 (Day 14) At 20 minutes following Allergen Challenge
A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.
Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation
时间窗: Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment
A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.
次要结局
未报告次要终点