Clinical Investigation to Evaluate the Tolerance of T10070 on Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change from baseline in clinical examination on eyes and peri-ocular skin
研究概览
简要总结
The goal of this clinical trial investigation is to evaluate the tolerance of the T10070 on healthy volunteers by clinical examination under ophthalmological control.
Participants will attend 2 visits (inclusion at day 0 and follow-up/final at D7/D9. After inclusion, subjects will have to apply T10070 6 times a day during 7 to 9 days. The following tasks will be asked to participants:
- ophtalmological examination
- diary completion to record T10070 applications, potential discomfort/reactions observed and medication taken.
- complete subject questionnaire about usability of the product
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 是
入选标准
- •Informed consent signed and dated
- •Subject ≥ 18 years old
- •Healthy volunteer
- •Normal ocular examination in both eyes
- •Normal skin examination in both eyes
排除标准
- •Far best-corrected visual acuity (BCVA) ≥ +0.1 LogMar (e.g., ≤ 0.8 in decimal value or ≤ 80/100 Snellen equivalent)
- •Known or suspected hypersensitivity to one of the components of the T10070
- •History of trauma, infection, clinically significant inflammation within the 3 previous months
- •Ongoing or know history of ocular allergy and/or uveitis and/or viral infection
- •Diagnosed keratoconus
- •Any palpebral abnormality
结局指标
主要结局
Change from baseline in clinical examination on eyes and peri-ocular skin
时间窗: signs assessment at Day 0 and Day 7/Day 9
A clinical examination will be performed before and after product use on eyes and peri-ocular skin using 5-point structured scales (from "Absence (0)" to "Severe (4)") to evaluate the intensity of several signs.
Change from baseline in subjective evaluation of ocular and cutaneous signs by subjects
时间窗: Signs assessment at Day 0 and Day 7/Day 9
A subjective tolerance evaluation will be performed before and after product use using 5-point structured scales (from "No reaction (0)" to "Severe (4)").
Local tolerance assessed by Investigator
时间窗: Local tolerance assessed at Day 7/Day 9
Assessed using a 4-point scale (from "Bad tolerance" to "Very good tolerance").
次要结局
- Adverse Events(Day 7/Day 9)
- Subject questionnaire on product usability(Day 7/Day 9)