EUCTR2014-004857-15-EE进行中（未招募）1 期
DOSE-FINDING STUDY TO ASSESS THE SAFETY AND EFFECT OF SYL1001 IN PATIENTS WITH OCULAR PAIN - NA
Sylentis0 个研究点目标入组 60 人开始时间: 2015年4月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients aged ? 18 years
- •- Men or women (individuals of either sex can participate in the study)
- •- Have submitted their written 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.
- •oOSDI scale between 13-70
- •oVAS scale between 2 ? 7
- •- Eye tests in both eyes until 15 days before inclusion:
- •oCorneal fluorescein staining. Oxford scale > 0
- •oTear break-up time (TBUT) < 10 seconds
- •oSchirmer?s test with anaesthesia < 10 mm/5min
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- 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.
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