NCT00357539已完成1 期
Comparison of the Ocular Tolerance, the Safety and the Ocular Pharmacokinetics After One Drop of Three Different Concentrations of T1225 (0.5% - 1.0% - 1.5%) in 48 Healthy Volunteers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
- 主要终点
- Objective ocular symptoms
研究概览
简要总结
To compare the ocular tolerance, safety and ocular pharmacokinetics of 3 concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225.
详细描述
The present phase I clinical trial was performed in order to investigate the ocular tolerance, safety and the ocular pharmacokinetics of a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in healthy volunteers.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged from 18 to 45 years old;
- •Written informed consent;
- •Healthy volunteers (without any ocular symptom);
- •Normal ocular examination in both eyes (corrected visual acuity (VA) >= 6/10 - slit lamp examination without clinical relevant abnormalities - tear break-up time (BUT) >= 10 seconds - lachrymal secretion in the Schirmer test >= 10 mm in 5 minutes - lissamine green test total score < 4).
排除标准
- •Ocular trauma, infection or inflammation within the last 3 months;
- •Conjunctival hyperaemia score >= 2, watering score >= 2, folliculo-papillary conjunctivitis score >= 2, number of fluorescein-stained punctuations >= 10;
- •Blepharitis, conjunctivitis, uveitis;
- •Ocular laser treatment within the last 3 months;
- •Ocular surgery, including LASIK and PRK, within the last 12 months;
- •Topical ocular treatment during the last month;
- •Ocular antibiotics within the last 7 days;
- •Medication during the study (except paracetamol and contraceptives).
结局指标
主要结局
Objective ocular symptoms
Subjective ocular symptoms
次要结局
- Systemic adverse events
- Ocular adverse events
- Ocular pharmacokinetic
研究者
研究点 (2)
Loading locations...
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