NCT01742884已完成4 期
Evaluation of the Efficacy and Safety of a Treatment for Dry Eye Syndrome: Thealoz
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年12月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Proportion of patients with fluorescein corneal staining reduction of at least 1 point
研究概览
简要总结
The purpose of this study is to determine if Thealoz is effective in Dry Eye Syndrome exposed to controlled adverse environmental conditions.
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
- Double (Participant, Investigator)
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
- •Man/woman ≥ 18 years old, able to freely give consent to participate in the study
- •Fluorescein corneal staining ≥ 1 and ≤ 3 in Oxford Scales
- •At least 2 of the following tests altered:
- •Ocular Surface Disease Index (OSDI) Test symptoms between 12 and 40
- •BUT ≤10 seconds
- •Lissamine green conjunctival staining ≥ 1
- •Schirmer Test without anesthesia ≤ 5 mm
- •Informed consent signed
- •Data protection consent signed
排除标准
- •Sensitivity or known intolerance to any of the product used in the study
- •Story of ocular infections or severe ocular inflammation within the 6 previous months to study inclusion
- •Any active ocular pathology other than Dry Eye Syndrome
- •Any traumatize or ocular surgery that may affect corneal sensitivity and/or normal tear distribution (e.g. cataract surgery, refractive surgery) within the 6 previous months to study inclusion
- •Use of contact lenses in the 3 previous months to study inclusion
- •Use of any ocular topical medications other than the treatment for Dry Eye Syndrome
- •Ocular treatment for Dry Eye Syndrome with corticosteroids 1 month before inclusion visit or Cyclosporin A 3 months before inclusion
- •Diagnosis of Rosacea or Severe Blepharitis (associated to systemic or ocular pathologies) Any severe uncontrolled systemic disease that may affect the eye (except for primary or secondary Sjögren)
- •Start, discontinuation or change within the study of the dosage of antihistaminics, cholinergic agents, beta blockers, anti depressants or any other systemic drugs with potential effects in the tear film
- •No pregnant or breastfeeding women is allowed to participate in the study. Childbearing potential women must use contraceptive means during the whole study.
- •Participation in another clinical trial in the last 30 days before study inclusion
结局指标
主要结局
Proportion of patients with fluorescein corneal staining reduction of at least 1 point
时间窗: 1 Month
Proportion of subjects with staining reduction within the treatment group vs proportion of staining reduction in control group
次要结局
- Best Corrected Visual Acuity(1 month)
- Intraocular pressure(1 month)
- Eye fundus alterations(1 month)
- Corneal Pachymetry(1 month)
研究者
研究点 (2)
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