A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 516
- 试验地点
- 1
- 主要终点
- Number of Treatment Related Adverse Events
研究概览
简要总结
This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution
详细描述
Central Cornea Endothelial Cell Counts will be done on a subset of approximately 150 subjects to complete 100 subjects as part of the safety measures.
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
- •be pregnant, nursing, or planning a pregnancy
研究组 & 干预措施
AC-170 0.24%
1 drop in each eye 3 times daily for up to 6 weeks
干预措施: AC-170 0.24% (Drug)
AC-170 Vehicle
1 drop in each eye 3 times daily for up to 6 weeks
干预措施: AC-170 Vehicle (Drug)
结局指标
主要结局
Number of Treatment Related Adverse Events
时间窗: up to 12 weeks
Adverse events will be measured through study completion
Tolerability of AC 170 0.24% 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 1 minute and 2 minutes 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% 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 1 minute and 2 minutes 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% 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 1 minute and 2 minutes 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
未报告次要终点