EUCTR2015-005405-36-HU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4月21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 system,
- •c. Ocular hypertension or glaucoma requiring an ophthalmic medicinal product,
- •d. Infectious conjunctivitis, severe blepharitis, and/or progressive pterygium.
- •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 LogMar.
- •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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