NCT01739244已完成2 期
Dose Finding Clinical Trial With SYL040012 to Evaluate the Tolerability and Effect on Intraocular Pressure in Subjects With Ocular Hypertension or Open Angle Glaucoma
Sylentis, S.A.11 个研究点 分布在 3 个国家目标入组 80 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 11
- 主要终点
- Difference in AUC between IOP Curve Obtained at the Established Time Points and the Same Curve Performed at Baseline Period
研究概览
简要总结
The aim of this dose-finding clinical trial is to evaluate the systemic tolerability, local tolerability and intraocular pressure lowering effect of three different doses of SYL040012 in subjects with ocular hypertension or open-angle glaucoma.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Subjects must provide signed informed consent prior to participation in any study-related procedures.
- •Male and female subjects in good or fair general health as assessed by the investigator.
- •≥18 years of age.
- •Previous history or newly diagnosed elevated IOP (≥21 mmHg) with or without open-angle glaucoma in both eyes.
- •Normal result, or result typical for open-angle glaucoma of the following assessments in both eyes or available results in writing within the last 3 months prior to baseline period i.e. up to 4 months before Day 1, on condition that no new ocular signs or symptoms (e.g. marked deterioration of vision, eye pain) has occurred since then which would justify a repeat examination:
- •Visual field 24-2 or equivalent
- •Optical coherence tomography (OCT)
- •Best corrected visual acuity ≥0.5 (20/40) on the Snellen chart, or ≤ 0.3 logMAR
- •Schirmer test (lacrimation)
- •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.
- •Females of childbearing potential not willing to use a medically acceptable contraceptive method from enrolment until after the follow-up visit.
- •Any current disease or condition that might compromise the respiratory, cardiovascular, endocrine, neurological, haematological, renal, or gastrointestinal function.
- •Previous chronic processes or with rebound characteristics that could interfere with the study according to the investigator's judgment.
- •Body temperature.
- •Intolerability of any components of SYL040012 or placebo.
- •Unable to comply with the clinical trial requirements as judged by the investigator.
- •Beta blockers or corticosteroids use (other than cutaneous or intra-articular) for the treatment of concurrent diseases, even if sporadically, or any ocular or nasal vasoconstrictor treatment in the last 15 days prior to the first investigational product administration
- •Previous refractive surgery; cataract extraction in the last 6 months
- •Previous surgery for glaucoma.
- •Participation in a clinical trial within 2 months before the enrolment visit
- •Use of any other investigational product within 60 days before the enrolment visit.
- •Other drugs for the treatment of concurrent diseases are allowed. However, their dosages should be kept constant throughout the study.
- •Use of contact lenses in the last 7 days prior to the first investigational product administration and wearing contact lenses throughout the trial
- •History of ocular infection or inflammation within the last 3 months before the enrolment visit
- •Angle-closure or pigmentary glaucoma.
- •Chronic or current acute eye diseases such as scleritis, uveitis, blepharitis, conjunctivitis, or ocular Herpes simplex virus infection
研究组 & 干预措施
Placebo
Placebo Comparator
Ocular topical administration of placebo eye drops
干预措施: Placebo (Drug)
SYL040012 eye drops dose A
Experimental
Ocular topical administration of SYL040012 eye drops dose A
干预措施: SYL040012 (Drug)
SYL040012 eye drops dose B
Experimental
Ocular topical administration of SYL040012 eye drops dose B
干预措施: SYL040012 (Drug)
SYL040012 eye drops dose C
Experimental
Ocular topical administration of SYL040012 eye drops dose C
干预措施: SYL040012 (Drug)
结局指标
主要结局
Difference in AUC between IOP Curve Obtained at the Established Time Points and the Same Curve Performed at Baseline Period
时间窗: 14 days + (4-7 days)
Simple Corneal and Conjunctival Evaluation
时间窗: 15 days + (3-6 days)
次要结局
- Visual acuity, anterior segment and ocular fundus examination as measures of local tolerability.(14 days + (4-7 days))
- Physical exploration and laboratory tests as measurements of general tolerability(14 days + (4-7 days))
- Assessment of Adverse Events Appearance(14 days + (4-7 days))
研究者
研究点 (11)
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