NCT00990743已完成1 期
Phase I Study With SYL040012. Tolerance and Effect on Intraocular Pressure
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: 2009年9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
- Part I: Local tolerance after administration of one dose of SYL040012.
研究概览
简要总结
The purpose of this study is to determine whether SYL040012 is safe for the treatment of ocular hypertension and glaucoma.
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
- •Healthy volunteers, any gender
- •18 to 45 years of age,
- •Subjects must provide signed informed consent prior to participation in any study-related procedures
- •Body Mass Index between 19,5 and 29 kg/m2
- •IOP </= 21 mmHg in both eyes
- •Have a BCVA (Best corrected visual acuity) of >/= 0.8 (20/25) (Snellen scale), or </= 0.1 (LogMar units)in both eyes
- •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. Females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the hole study.
- •Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplastic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes
- •Previous chronic processes or with rebound characteristics that could interfere with study according to the investigator's judgment.
- •Volunteers who have received pharmacological treatment, including medicinal plants, during the four weeks previous to beginning the study.
- •Having used anti-cholinergics, betablockers and corticoids sporadically in the last 30 days whichever the route of 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, uveitis or ocular surface pathology (dry eye, blepharitis).
- •Volunteers with visual alteration with more than 3 dioptres in either eye
- •Use of contact lenses
- •Volunteer who has participated in a clinical trial during the past four 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 or HIV
- •Analytic alterations medically relevant, at investigator's judgement.
研究组 & 干预措施
SYL040012
Experimental
干预措施: SYL040012 (Drug)
结局指标
主要结局
Part I: Local tolerance after administration of one dose of SYL040012.
时间窗: Part I: 3 days
Part II: Local tolerance after 7 days administration of SYL040012 with one dose per day.
时间窗: Part II: 11 days
次要结局
- Period I: Local Tolerance Assessment, Effect Assessment & Pharmacokinetic description after administration of one dose of SYL040012.Side effects. Analytics.(Part I: 1 hour, 1, 2, 3, days)
- Period II:Tolerance assessment, Pharmacokinetic description, Effect assessment on the IOP after 7 days administration. Side effects. Analytics(Part II: After each administration, at time 1 and 96 hours)
研究者
研究点 (1)
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