EUCTR2015-005405-36-LT进行中（未招募）1 期
EFFICACY AND SAFETY ASSESSMENT OF T1580 VERSUS VEHICLE IN DRY EYE DISEASE TREATMENT
aboratoires Théa0 个研究点目标入组 450 人开始时间: 2016年5月17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
- 450
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
入选标准
- •Informed consent signed and dated
- •Menopausal woman.
- •Patient with BILATERAL persistent DED
- •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 270
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •Presence of an active condition :
- •a. Ocular rosacea, uveitis,
- •b. Abnormal eye lid anatomy, blinking, or naso-lachrymal drainage
- •c. Ocular hypertension or glaucoma requiring an ophthalmic medicinal
- •d. Infectious conjunctivitis, severe blepharitis, and/or progressive
- •Major corneal hypoaesthesia value = 20 mm as measured with a Cochet-
- •Bonnet aesthesiometer.
- •Far best corrected visual acuity (BCVA) worse than or equal to + 0.7
- •Any history of, or active, relevant ocular disorder condition other than
- •those listed above which is likely to interfere with the study results as
- •judged by the investigator at Screening or Baseline visits. Any
- •ophthalmic disease likely to change the assessment of fluctuating
- •blurred vision linked to dry eye disease or may result in a visual acuity
- •deterioration in the following year.
- •Other exclusion criteria are defined in the protocol (Exclusion criteria
- •regarding ocular history, Systemic/non Ophthalmic Exclusion Criteria,
- •Specific Exclusion Criteria Regarding Childbearing Potential Women,
- •Exclusion Criteria Related to General Conditions).
研究者
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