Evaluation of the Safety and Tolerability of Ocular Lubricants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 73
- 试验地点
- 10
- 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 three new artificial tear formulations in subjects with moderate dry eye disease.
详细描述
This study will be conducted in 2 stages. In Stage 1, subjects will attend a total of 10 scheduled visits: one Screening visit, four Investigational Product visits, four 12-hour Follow Up visits (one for each Investigational Product visit), and an Exit visit. At each Investigational Product visit, subjects will receive one drop of the investigational product in each eye (2 drops total), as randomized. The first Investigational Product visit will occur 1 to 7 days after the Screening visit. A washout period of 2 to 7 days will separate each Investigational Product visit. Total individual duration of participation in Stage 1 will be 8 to 34 days. The planned enrollment for Stage 1 is 72 subjects.
At the conclusion of Stage 1, an interim analysis will be conducted to help determine potential adaptations to the study design for Stage 2.
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
- 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
- •Willing and able to understand and sign an Ethics Committee-approved informed consent form.
- •Willing and able to attend all study visits as required by the protocol.
- •Exhibits symptoms of dry eye at the Screening Visit.
- •Currently uses habitual artificial tears to alleviate dry eye symptoms.
- •Willing and able to maintain similar environmental conditions throughout the study (for example, avoid extreme changes in humidity/temperature, avoid windy conditions) and refrain from swimming on Investigational Product visit days.
- •Other protocol-specified 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.
- •Has had an ocular injury to either eye in the past 12 weeks prior to screening.
- •Currently wears contact lenses or has a history of contact lens wear within the previous 1 month.
- •Has undergone any ocular surgery (including intraocular surgery) within the past 12 months or has any ocular surgery planned during the study.
- •Is pregnant, intends to become pregnant, or is breastfeeding.
- •Other protocol-specified exclusion criteria may apply.
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 the Screening Visit) through Visit 6/Study Exit. Visit 6 will occur 7 to 27 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: Screening Visit through Visit 6/Study Exit. Visit 6 will occur 8 to 34 days after Screening Visit, based 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: Screening through Visit 6/Study Exit. Visit 6 will occur 8 to 34 days after Screening Visit, based 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