A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Cetirizine 0.1%/Fluticasone 0.005% Ophthalmic Solution Compared to Its Components and Vehicle in a Modified Conjunctival Allergen Challenge (CAC) Model During Pollen Season
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Ocular Itching at Onset of Action (15 Minutes Post-dose)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of AC-150 compared to vehicle and its components in the prevention of the signs and symptoms of allergic conjunctivitis in Enviro-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 medications during the period indicated prior to study enrollment or during the study.
研究组 & 干预措施
AC-150 Combo
干预措施: AC-150 Combo (Drug)
AC-150A 0.1%
干预措施: AC-150A 0.1% (Drug)
AC-150B 0.005%
干预措施: AC-150B 0.005% (Drug)
Vehicle
干预措施: Vehicle (Drug)
结局指标
主要结局
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.
Ocular Itching at Duration of Action (16 Hours Post-dose)
时间窗: 3, 5, 7 minutes post-CAC
A treatment efficacy CAC was performed 16 hours 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.
Ocular Itching at 8 Hours Post-dose at Visit 4A
时间窗: 3, 5, 7 minutes post-CAC
A treatment efficacy CAC was performed 8 hours 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 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.
Conjunctival Redness at Duration of Action (16 Hours Post-dose)
时间窗: 7, 15, 20 minutes post-CAC
A treatment efficacy CAC was performed 16 hours 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 8 Hours Post-dose at Visit 4A
时间窗: 7, 15, 20 minutes post-CAC
A treatment efficacy CAC was performed 8 hours 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.
次要结局
- Ciliary Redness at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Ciliary Redness at Duration of Action (16 Hours Post-dose)(7, 15, 20 minutes post-CAC)
- Ciliary Redness at 8 Hours Post-dose at Visit 4A(7, 15, 20 minutes post-CAC)
- Episcleral Redness at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Episcleral Redness at Duration of Action (16 Hours Post-dose)(7, 15, 20 minutes post-CAC)
- Episcleral Redness at 8 Hours Post-dose at Visit 4A(7, 15, 20 minutes post-CAC)
- Total Redness at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Total Redness at Duration of Action (16 Hours Post-dose)(7, 15, 20 minutes post-CAC)
- Total Redness at 8 Hours Post-Dose at Visit 4A(7, 15, 20 minutes post-CAC)
- Lid Swelling at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Lid Swelling Duration of Action (16 Hours Post-dose)(7, 15, 20 minutes post-CAC)
- Lid Swelling at 8 Hours Post-dose at Visit 4A(7, 15, 20 minutes post-CAC)
- Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)(7, 15, 20 minutes post-CAC)
- Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)(7, 15, 20 minutes post-CAC)
- Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A(7, 15, 20 minutes post-CAC)
- Tolerability of Study Medication at Visit 2B(upon instillation, 1 minute and 2 minutes post instillation)
- Tolerability of Study Medication at Visit 3(upon instillation, 1 minute and 2 minutes post instillation)