A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 0.24% Ophthalmic Solution Used Twice Daily in Healthy Adult Subjects and in Pediatric Subjects With a History or Family History of Atopic Disease (Including Allergic Conjunctivitis)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 512
- 试验地点
- 1
- 主要终点
- Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1)
研究概览
简要总结
The purpose of this study is to evaluate the safety of AC-170 0.24% used twice daily in Healthy Adult Subjects and in Pediatric subjects with a history or family history of atopic disease (including allergic conjunctivitis).
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 2 years of age
- •be able to self-administer eye drops or have a parent/legal guardian available for this purpose
- •if less than 18 years old have a history or family history of atopic disease (including allergic conjunctivitis)
- •have ocular health within normal limits
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 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%
干预措施: AC-170 0% (Drug)
结局指标
主要结局
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1)
时间窗: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8)
时间窗: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22)
时间窗: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.
次要结局
- Safety of AC 170 0.024% Compared to Its Vehicle(Up to 12 Weeks)