Evaluation of Safety and Tolerability of Ocular Lubricants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Number of Treatment-Emergent Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety profile of test formulations for an artificial tear product versus a comparator product.
详细描述
Subjects will be randomized to one of five different treatment sequences. Subjects will attend 6 scheduled visits with an expected individual duration of participation of 11 to 42 days. This study will be conducted in Australia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and sign an informed consent form.
- •Willing and able to attend all study visits as required by the protocol.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any known active ocular disease.
- •Any systemic condition that, in the opinion of the investigator, may affect a study outcome variable.
- •Any ocular injury to either eye in the past 12 weeks prior to screening.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Number of Treatment-Emergent Adverse Events (AEs)
时间窗: Up to Day 30 (Study Exit)
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). The number of adverse events as observed or reported will be recorded.
Mean Best Corrected Visual Acuity (BCVA)
时间窗: Screening, up to Day 30 (Study Exit)
Visual Acuity will be assessed with correction in place using letter charts. BCVA will be measured in logarithm Minimum Angle of Resolution (logMAR).
Number of Device Deficiencies
时间窗: Up to Day 30 (Study Exit)
A device deficiency is inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. The number of device deficiencies as observed or reported will be recorded.
Number of Subjects with Biomicroscopy Findings Outside of Normal Limits
时间窗: Screening, up to Day 30 (Study Exit)
The cornea, conjunctiva, and eyelid will be assessed using a slit lamp. The number of subjects with biomicroscopy findings outside of normal limits will be recorded.
Mean Total Ocular Surface Staining Score
时间窗: Screening, up to Day 30 (Study Exit)
Ocular surface staining will be assessed using a slit lamp and recorded on a 15-point scale.
次要结局
未报告次要终点