NCT01776658已完成1 期
Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain
Sylentis, S.A.3 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年11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
- 60
- 试验地点
- 3
- 主要终点
- Changes from Baseline in the Ocular Pain Scores on the Visual Analog Scale (VAS) and in the Ocular Discomfort Scores on the Ocular Surface Disease Index (OSDI) as a Measure of SYL1001 Analgesic Effect versus Placebo.
研究概览
简要总结
The aim of this pilot study is to compare the analgesic effect of SYL1001 versus placebo in patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability are also evaluated.
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
- •Patients of both genders
- •Age ≥ 18 years old
- •Give written informed consent to participate in the study after having been informed of the study design, objectives and possible derived risks
- •Common mild to moderate dry eye symptoms. Persistent daily symptoms for more than three months:
- •OSDI scale: 13-30
- •VAS scale: 2-7
- •Ocular tests in both eyes:
- •Corneal staining with fluorescein. Oxford scale > 0
- •Tear Breakup Time Test: (BUT) < 10 seconds
- •Schirmer test with anaesthesia < 10 mm/5min
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 whole study.
- •Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes.
- •Past history of a chronic o recurring condition that could interfere with study according to the investigator's judgement.
- •Concomitant use of other drugs with analgesic activity by any route of administration at the enrolment period.
- •Changes in any ocular and/or systemic concomitant medication one month prior to the study commencement and during the study development.
- •Changes on the preestablished artificial tears dosage 15 days prior to the study commencement and during the study development.
- •Cyclosporine treatment initiation or changes in cyclosporine dosage or dosing regimen during the 6 months prior to enrolment.
- •Previous history of drug hypersensitivity.
- •Use of contact lenses
- •Case history of drug or alcohol abuse or dependence.
- •Relevant abnormal laboratory results as judged by the investigator
- •Previous refractive surgery
- •Participation in a clinical trial within 2 months before the enrolment visit
- •Relevant ocular pathology judged by the investigator.
研究组 & 干预措施
SYL1001 eye drops dose A
Experimental
Ocular topical administration of SYL1001 eye drops dose A
干预措施: SYL1001 (Drug)
Placebo
Placebo Comparator
Ocular topical administration of placebo eye drops
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from Baseline in the Ocular Pain Scores on the Visual Analog Scale (VAS) and in the Ocular Discomfort Scores on the Ocular Surface Disease Index (OSDI) as a Measure of SYL1001 Analgesic Effect versus Placebo.
时间窗: 10 days + (4-10 days)
Simple Corneal and Conjunctival Evaluation as a Measure of Safety and Tolerability using Ophthalmic Dyes and a Slit Lamp
时间窗: 10 days + (4-10 days)
次要结局
- Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability(10 days + (96-240 hours))
- Evaluation of Vital Signs, Blood, Urine and Ocular Parameters Alterations (IOP, Visual Acuity, Anterior Segment Exploration) Possibly Related to the Investigational Product(10 days + (96-240 hours))
研究者
研究点 (3)
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