NCT02455999已完成2 期
Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain
Sylentis, S.A.6 个研究点 分布在 2 个国家目标入组 66 人开始时间: 2015年6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
- 66
- 试验地点
- 6
- 主要终点
- Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS)
研究概览
简要总结
The aim of this pilot study is to compare the analgesic effect of two strengths of SYL1001 eye drops 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
- •Give written informed consent to participate in the study, after having received all information relating to the design, aims and possible risks resulting therefrom.
- •Common symptoms of persistent, daily, mild to moderate dry eye lasting more than three months: OSDI scale between 13-70 and VAS scale between 2 -
- •Eye tests in both eyes: Corneal fluorescein staining (Oxford scale > 0), Tear break-up time < 10 seconds and Schirmer's test with anaesthesia < 10 mm/5min.
- •Exclusion criteria:
- •Women who are pregnant or breastfeeding or who have a positive urine pregnancy test. Women who do not commit to use a medically acceptable method of contraception from the time of selection and throughout the study.
- •Any current, relevant disease, including respiratory disease, cardiovascular disease, endocrine disease, neurological disease, haematological disease, kidney disease, oncological disease, liver disease, gastrointestinal dysfunction, hypertension or active acute infectious processes.
- •Previous chronic or recurrent processes which, according to the investigator, could affect the development of the study.
- •Concomitant use of other medications with analgesic activity by any route of administration at the time of entry into the study.
- •Change in any concomitant eye and/or systemic medication of the patient one month before the study and during the study.
- •Changes in the pre-established administration schedule of artificial tears during the 15 days before the study and during the 10 days of the study.
- •Initiation of treatment with cyclosporine or changes in the dosage or administration schedule of cyclosporine within the 6 months before inclusion in the study.
- •History of hypersensitivity to drugs.
- •Use of contact lenses during the treatment and previous 15 days.
- •History of drug abuse or drug or alcohol dependence.
- •Laboratory abnormalities which, in the investigator's opinion, are clinically significant.
- •Previous refractive surgery.
- •Having participated in another clinical trial within the 2 months prior to inclusion.
- •Another eye disease that is significant in the investigator's opinion.
排除标准
- 未提供
研究组 & 干预措施
SYL1001 eye drops dose C
Experimental
SYL1001 eye drops dose C administration via the ophthalmic route
干预措施: SYL1001 (Drug)
SYL1001 eye drops dose D
Experimental
SYL1001 eye drops dose D administration via the ophthalmic route
干预措施: SYL1001 (Drug)
Placebo
Placebo Comparator
Placebo eye drops administration via the ophthalmic route
干预措施: Placebo (Drug)
结局指标
主要结局
Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS)
时间窗: 10 consecutive days
Change from the baseline scoring after fluorescein staining of the cornea
时间窗: 10 consecutive days
Frequency of occurrence of conjunctival hyperaemia
时间窗: 10 consecutive days
Change from the baseline scoring of ocular discomfort in the Ocular Surface Disease Index (OSDI)
时间窗: 10 consecutive days
次要结局
- Change from baseline in vital signs(10 consecutive days)
- Change from baseline in standard ocular parameters(10 consecutive days)
- Change from baseline in standard laboratory parameters(10 consecutive days)
- Assessment of Adverse Events (AEs) as a measure of SYL1001 safety(20 consecutive days)
研究者
研究点 (6)
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