An Evaluation of the Safety and Tolerability of Ocular Lubricants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 8
- 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 and tolerability of two new artificial tear formulations in subjects with moderate dry eye disease.
详细描述
Each subject will receive 2 investigational products (one drop per eye of each investigational product) in a cross-over study design according to a randomization schedule. Individual duration of participation will be approximately 21 days.
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
- Double (Participant, Investigator)
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
- •Subject must be willing and able to understand and sign an ethics committee approved informed consent form.
- •Subject must be willing and able to attend all study visits as required by the protocol.
- •Subject must exhibit symptoms of dry eye at the Screening Visit.
- •Subject must currently use artificial tears.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Has any known active ocular disease and/or infection.
- •Has any known infection or inflammation that requires treatment or has a systemic condition that, in the opinion of the investigator, may affect a study outcome variable.
- •Any ocular injury to either eye in the 12 weeks prior to screening.
- •Current wearer of contact lenses or has a history of contact lens wear within the previous 1 month.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Sequence 1: FID123440, then FID123437
One drop of FID123440 test formulation in each eye in Period 1, followed by 1 drop of FID123437 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods.
干预措施: FID123437 test formulation (Other)
Sequence 2: FID123437, then FID123440
One drop of FID123437 test formulation in each eye in Period 1, followed by 1 drop of FID123440 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods.
干预措施: FID123437 test formulation (Other)
Sequence 2: FID123437, then FID123440
One drop of FID123437 test formulation in each eye in Period 1, followed by 1 drop of FID123440 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods.
干预措施: FID123440 test formulation (Other)
Sequence 1: FID123440, then FID123437
One drop of FID123440 test formulation in each eye in Period 1, followed by 1 drop of FID123437 test formulation in each eye in Period 2 as randomized. Each period is 1 day long with at least 2 calendar days separating the periods.
干预措施: FID123440 test formulation (Other)
结局指标
主要结局
Number of Treatment-Emergent Adverse Events (AEs)
时间窗: Visit 2 [1 to 7 days after Visit 1/Screening (Day 1)] through Exit Visit. Exit Visit will occur 3 to 13 days after Visit 2 depending on observed visit windows.]
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.
Number of Subjects with Biomicroscopy Findings Outside of Normal Limit
时间窗: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.
The investigator will observe the corneal and other ocular structures under white light of the slit lamp. The number of subjects with biomicroscopy findings outside of normal limits will be recorded.
Best Corrected Visual Acuity (BCVA)
时间窗: Visit 1/Screening (Day 1) through Exit Visit. Exit Visit will occur 4 to 20 days after Visit 1 depending on observed visit windows.
BCVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts and recorded in logarithm Minimum angle of resolution (logMar).
次要结局
未报告次要终点