EUCTR2016-003903-79-IT进行中（未招募）1 期
A double-masked study ofSYL1001 in patients with moderate to severe dry eye disease (DED). - HELIX
SYLENTIS S.A.0 个研究点目标入组 289 人开始时间: 2018年1月31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
- 289
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
- •1)Patient is a male or a female aged = 18 years at screening visit. 2) Have given their written consent to participate in the study,
- •after having received all information relating to the design, aims and possible
- •risks resulting therefrom. 3)Common symptoms of persistent, daily, moderate to severe dry eye
- •lasting more than six months. 4)Use of artificial tears during the last 30 days prior to the selection phase
- •5)VAS scale for eye discomfort/pain between 30 - 80 in one of the eyes and = 20 in the fellow eye.
- •6)CFS = 2 and = 4 on the Oxford scale (0-5) in at least 1 eye region in the eye with the highest VAS scoring for eye
- •discomfort/pain. 7)TBUT < 10 seconds in the eye with the highest VAS scoring for eye discomfort/pain. TBUT =1 in both eyes.
- •8)Hyperemia score =1 (McMonnies scale) in the eye with the highest VAS scoring for eye discomfort/pain. 9)Schirmer's test
- •without anesthesia = 2 and < 10 mm/5min in the eye with the highest VAS scoring for eye discomfort/pain. Value = 2 in the fellow
- •eye. 10)Corrected visual acuity = 0.7 logMAR (20/100 Snellen or 50 ETDRS) in both eyes.11)If the subject is selected in a French
- •site, he/she must be covered by a National Social Security System at screening visit.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1)Pregnant or breastfeeding females or females with a positive pregnancy test at the screening visits. 2)Females of childbearing
- •potential not willing to use
- •a medically acceptable contraceptive method (definition in section 6.3) from enrolment until after the final visit. 3)Current,
- •previous chronic or recurrent medical condition which, according to the investigator, might impact the interpretation of the study
- •results or put the subject at risk.4)Current concomitant use of any medications with analgesic activity (such as regular pain killer
- •users) by any route of administration at the time of entry into the study and during the study. 5)Change in concomitant systemic
- •medication one month before the study and during the study that might impact the interpretation of the results according to the
- •investigator. 6)Concomitant treatment with cyclosporine, tacrolimus, sirolimus (systemic or ophthalmic) for the previous 2 months
- •before entering the study. 7)Any eye concomitant treatment at the time of entry into the study. Unpreserved artificial tears will be
- •provided by the Sponsor to use throughout the study. A maximum of 4 daily drops is allowed. 8)History of hypersensitivity to
- •SYL1001, to any component of the formulation or to ophthalmic diagnostic agents. 9)Use of contact lenses or punctual plugs
- •during the treatment and the previous 7 days (prior to treatment initiation). 10)Clinically significant laboratory abnormalities
- •according to investigator's opinion. 11)Previous refractive surgery, cornea transplant. Meibomian gland dysfunction or history of lid
- •malposition (ectropion, entropion, ptosis) that may affect acurate assessment of the disease and/or mask the effects of the drug.
- •12)Any other ocular surgery in the past 1 year. 13)Any other eye disease that is significant in the investigator's opinion.
- •14)Currently participating or having participated in another clinical trial within the 2 months prior to inclusion. Patient that already
- •participatedin SYL1001_IV trial.15) Non-compliance after the run-in period.
研究者
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