NCT01438281已完成1 期
Phase I Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers
Sylentis, S.A.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Local tolerance assessment of cornea and conjunctival sac after administration of one dose of SYL1001 for period 1 and after 7 days of administration of SYL1001 with one dose per day for period 2.
研究概览
简要总结
The purpose of this study is to determine whether SYL1001 is safe for the prevention and treatment of ocular pain and dry eye syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Subjects must provide signed inform consent prior to participation.
- •BMI between 19,5 y 29 kg/m
- •Normal ocular test in both eyes: IOP </=21 mmHg. BCVAof >/=0,8 (20/25)Snellen scale, or </=0.1 LogMar.
- •Normal fluorescein Clearance Test in both eyes.
- •Normal funduscopy in both eyes.
排除标准
- •Pregnant or breastfeeding females or those with a positive pregnancy test or who will not use a medically acceptable contraceptive method from selection and during the study.
- •Current relevant disease.
- •Previous chronic processes or with rebound characteristics that could interfere with study according investigator's judgment.
- •Volunteers who have received pharmacological treatment, including medicinal plants, during the four weeks previous to beginning the study.
- •Having used corticoids sporadically in the last 30 days whichever the route aof administration, or any med by ocular or nasal administration route.
- •Case history of hypersensitivity to meds or any other allergic process.
- •Visual alterations: previous eye surgery, glaucoma, use of lenses, uveitis or ocular surface pathology (dry eye, blepharitis).
- •Volunteers with visual alteration with more than 3 dioptres in either eye.
- •Volunteers who has participated in a clinical trial during the past fout months before study entry.
- •Blood or derivate transfusion during the six previous months to study entry.
- •Case history of drug or alcohol abuse or dependence.
- •Positive result in test drug abuse during selection period.
- •positive serology results to hepatitis B virus(HbsAg), virus C o VIH.
- •Analytic alterations medically relevant, at investigator's judgement.
研究组 & 干预措施
SYL1001
Experimental
干预措施: SYL1001 (Drug)
结局指标
主要结局
Local tolerance assessment of cornea and conjunctival sac after administration of one dose of SYL1001 for period 1 and after 7 days of administration of SYL1001 with one dose per day for period 2.
时间窗: Period I: 3 days, Period II: 11 days
Local tolerance and ocular surface (cornea and conjunctival) on the area of administration 24 hours after last administration. It will be performed using a slit lamp which will be performed before, during and after the administration at established times. Adverse events will be registered and the determination of subjective tolerance will use the visual analogical scale in cases where asubjects refers them
次要结局
- General tolerance assessment after administration of one dose of SYL1001 (period 1) and after 7 days administration (period 2)(Period I: 3 days; Period II: 11 days)
研究者
研究点 (1)
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