NCT01227291已完成1 期
Study With SYL040012. Tolerance and Effect on Intraocular Pressure in Subjects With IOP >= 21 mm Hg.
Sylentis, S.A.2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年10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
- 2
- 主要终点
- Tolerance on ocular surface (ocular and conjunctiva)
研究概览
简要总结
The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP.
详细描述
The aim of this study is to evaluate the tolerance and effect on unmedicated subjects with elevated IOP. An unmedicated subject is considered a person without any IOP/glaucoma treatment at least one month before recruitment.
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
- 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
- 否
入选标准
- •Both genders.
- •>/= 18 years of age with elevated IOP with OAG diagnosis.
- •Subjects must provide signed informed consent prior to participation in any study-related procedures
- •IOP >/= 21 mmHg and < 30 mmHg in three different assessment days.
- •Normal Ocular test (in both eyes):
- •Visual field: 24-2 or equivalent
- •Normal OCT
- •BCVA: >/= 0,5 (20/40) Snellen scale, or </=0.3 LogMar.
- •Normal Schirmer Test .
- •Normal funduscopy.
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, hematological, renal, neoplastic, hepatopathy, gastrointestinal distress, hypertension or infectious acute processes.
- •Previous chronic processes or with rebound characteristics that could interfere with the study according to the investigator's judgment.
- •Having used betablockers and corticoids sporadically in the last 15 days whichever the route of administration.
- •Previous eye refractive surgery
- •Subjects with visual alteration with more than 3 dioptres for hypermetropy and/or astigmatism.
- •Use of contact lenses during the last 7 days before starting the treatment.
- •Subjects who has participated in a clinical trial during the past 2 months before study entry.
- •Analytic alterations medically relevant, at investigator judgment.
- •Positive results in test drug abuse during selection period.
- •Subjects with at least 2 visual fields or fiber layer measured in two different days abnormals
- •History of ocular infection or inflammation within the past 3 months
- •Pachymetry(in the middle of the cornea) >600 microm or < 500 microm.
- •Subjects with IOP associated to close angle glaucoma
- •History of chronic or severe acute ocular disease (i.e. scleritis, uveitis, blepharitis, conjunctivitis or herpes simplex virus)
- •History of intolerance to any of the components of the drug formulation
- •Subjects with previous iridotomy with IOP related with close angle glaucoma.
- •Previous ocular surgery in glaucoma
- •Corneal refractive surgery (e.g., keratotomy, PRK, LASIK, etc)
研究组 & 干预措施
SYL040012
Experimental
SYL040012 Ophthalmic drop administration
干预措施: SYL040012 (Drug)
结局指标
主要结局
Tolerance on ocular surface (ocular and conjunctiva)
时间窗: 7 days + 24 hours
Local Tolerance and ocular surface(cornea and conjunctival) on the area of administration 24 hours after last administration of multiple dose during 7 days of 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 (VAS) in cases where a subjects refers them.
次要结局
- Tolerance, Adverse events, Pharmacokinetics and effect(11 days)
研究者
研究点 (2)
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