NCT03108664已完成3 期
HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye
Sylentis, S.A.40 个研究点 分布在 6 个国家目标入组 330 人开始时间: 2017年5月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 40
- 主要终点
- Change from baseline in Visual Analogue Scale (VAS) scores for eye discomfort/pain as a measurement of SYL1001 effect versus vehicle
研究概览
简要总结
The purpose of this study is to determine whether SYL1001 ophthalmic solution is safe and effective in the treatment of signs and symptoms of Dry Eye Disease.
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
- •Both genders
- •≥ 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 symptoms of persistent, daily, moderate to severe dry eye lasting more than six months.
- •Use of artificial tears
- •VAS scale for eye discomfort/pain between 30 - 80
- •CFS ≥ 2 and ≤ 4 on the Oxford scale
- •TBUT < 10 seconds
- •Hyperemia score ≥ 1 (McMonnies scale)
- •Schirmer's test without anesthesia ≥ 2 and < 10 mm/5min in the eye
- •Corrected visual acuity ≥ 0.7 logMAR
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
11.25 mg/mL SYL1001 ophthalmic solution
Experimental
1 drop of 11.25 mg/mL SYL1001 ophthalmic solution in the affected eye(s) q.d
干预措施: SYL1001 ophthalmic solution (Drug)
Vehicle ophthalmic solution
Experimental
1 drop of vehicle ophthalmic solution in the affected eye(s) q.d
干预措施: Vehicle opthalmic solution (Drug)
结局指标
主要结局
Change from baseline in Visual Analogue Scale (VAS) scores for eye discomfort/pain as a measurement of SYL1001 effect versus vehicle
时间窗: 28 days
Change from baseline in Corneal Fluorescein Staining (CFS) total scores obtained on the Oxford scale as a measurement of SYL1001 effect versus vehicle
时间窗: 28 days
Change from baseline in conjunctival hyperaemia scores based on the McMonnies scale as a measurement of SYL1001 effect versus vehicle
时间窗: 28 days
次要结局
- Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability(28 days)
研究者
研究点 (40)
Loading locations...
相似试验
已完成
1 期
Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy VolunteersOcular PainDry EyeNCT01438281Sylentis, S.A.30
已完成
1 期
Tolerance and Effect on Intraocular Pressure After Administration of SYL040012GlaucomaOcular HypertensionNCT00990743Sylentis, S.A.30
已完成
2 期
Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular PainOcular PainDry Eye SyndromeNCT02455999Sylentis, S.A.66
已完成
2 期
Evaluation of the Onset and Duration of Action of RX-10045 in Allergic ConjunctivitisAllergic ConjunctivitisNCT01639846C.T. Development America, Inc.60
已完成
2 期
Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye DiseaseDry Eye DiseaseNCT05486728Dreamhawk Vision Biotech, Inc.85