Comparison of the Efficacy of Two Types of Artificial Tears in the Treatment of Dry Eye Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Subjective dry eye symptoms
研究概览
简要总结
Hyaluronic acid (HA), a natural component of the tear film, is a well-established active ingredient in artificial tears and has been reported to improve corneal and conjunctival staining in patients with DED. Thealoz Duo (Laboratoires Thea, Clermont Ferrand, France) is a novel artificial tear preparation containing two active ingredients: trehalose, a naturally occurring disaccharide with anhydrobiotic functions in many organisms, and hyaluronate, a widely distributed anionic glycosaminoglycan polysaccharide with lubricative and water-retaining properties in biological systems. The purpose of the current study is to investigate the effect of the Hyabak and Thealoz Duo in treatment of DED.
详细描述
The patients will be treated with Thealoz Duo (at least 3 times daily) in one eye and with Hyabak (at least 3 times daily) in the other eye, based on randomization table. Both Hyabak and Thealoz Duo are preservative free. The doctors who examine the patients will not get any information about the choice of artificial tears in each eye. Besides the artificial tears, if necessary, the patients will receive other treatments, for instance, steroids, cyclosporine etc., according to their dry eye severity.
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
- Single (Investigator)
盲法说明
The doctors who examine the patients will not get any information about the choice of artificial tears in each eye.
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
- •Dry Eye Severity Level (DESL) 1-3
- •Equivalent between-eye DESL
排除标准
- •Ocular infection and/or non-linked inflammation
- •Corneal pathology (except KSP)
- •Corneal refractive surgery or cataract surgery within 6 months prior to the study
研究组 & 干预措施
Thealoz Duo
Thealoz Duo, a combination of trehalose and hyaluronate, will be used on one of the selected eyes of a patient, at least 3 times daily
干预措施: Thealoz Duo (combination of trehalose and hyaluronate) eye drop and Hyabak (hyaluronate) eye drop (Drug)
Hyabak
Hyabak, sodium hyaluronate, will be used on the other eye of the patient, at least 3 times daily
干预措施: Thealoz Duo (combination of trehalose and hyaluronate) eye drop and Hyabak (hyaluronate) eye drop (Drug)
结局指标
主要结局
Subjective dry eye symptoms
时间窗: 3 months after treatment is initiated
Ocular Surface Disease Index (OSDI) dry eye questionnaire
次要结局
- Fluorescein tear film break up time(3 months after treatment is initiated)
- Schirmer test(3 months after treatment is initiated)
- Ocular surface staining(3 months after treatment is initiated)
- Tear film osmolarity(3 month after treatment is initiated)
- Meibum expressibility(1 month after treatment is initiated)
- Meibomian gland functionality(3 months after treatment is initiated)
- Meibum quality(3 months after treatment is initiated)
- Patient´s subjective evaluation of preference(3 months after the treatment is initiated)
- Luminex(3 months after treatment is initiated)