A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of Cetirizine 0.24% Ophthalmic Solution (Formula AFH-002) Compared to Vehicle (Formula AFH-001) in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose)
研究概览
简要总结
The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •positive bilateral conjunctival allergen challenge (CAC) reaction
排除标准
- •known contraindications or sensitivities to the study medication or its components
- •any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters
- •use of disallowed medication during the period indicated prior to the enrollment or during the study
研究组 & 干预措施
AC-170 0.24%
干预措施: AC-170 0.24% (Drug)
AC-170 0%
干预措施: AC-170 0% (Drug)
结局指标
主要结局
Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose)
时间窗: 3, 5, 7 minutes post-CAC
A treatment efficacy Conjunctival Allergen Challenge (CAC) was performed 16 hours + 1 hour after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose)
时间窗: 7, 15, 20 minutes post-CAC
A treatment efficacy CAC was performed 16 hours + 1 hour after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
时间窗: 7, 15, 20 minutes post-CAC
A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.
Ocular Itching at Onset of Action (15 Minutes Post-dose)
时间窗: 3, 5, 7 minutes post-CAC
A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
次要结局
- Nasal Congestion at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose)(7, 15, 20 minutes post-CAC)
- Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose)(7, 15, 20 minutes post-CAC)
- Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose)(7, 15, 20 minutes post-CAC)
- Eyelid Swelling at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose)(7, 15, 20 minutes post-CAC)
- Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose)(7, 15, 20 minutes post-CAC)
- Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose)(7, 15, 20 minutes post-CAC)
- Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Ciliary Redness at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Rhinorrhea at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Nasal Pruritis at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose)(7, 15, 20 minutes post-CAC)
- Tolerability of Study Medication at Visit 3A(upon instillation, 1 minute and 2 minutes post instillation)
- Episcleral Redness at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Chemosis at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Tearing at Duration of Action (16 Hours + 1 Hour Post-dose)(7, 15, 20 minutes post-CAC)
- Tearing at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)(7, 15, 20 minutes post-CAC)
- Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)(7, 15, 20 minutes post-CAC)