The Effect of 3% Diquafosol Ophthalmic Solution on Visual Display Terminal-associated Dry Eye
试验速览
- 阶段
- 4 期
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- the changes of Ocular Surface Disease Index (OSDI) scores
研究概览
简要总结
This study aims to evaluate the efficacy and safety of 3% Diquafosol Ophthalmic Solution for visual display terminal (VDT)-associated dry eye and to investigate the mechanism of treatment.
详细描述
The treatment period is 12 weeks. The day after subjects who meet the inclusion criteria undergo baseline examination is the day starting the medication. The dosing frequency was six times daily for 3% Diquafosol Ophthalmic Solution. The follow-up time points are 2, 4, 8, 12 weeks, and the investigator will evaluate the symptoms and signs of Dry Eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female with a diagnosis dry eye based on Chinese Dry Eye Diagnosis Standard (2020)；
- •Working in the offices with VDTs more than 4h daily；
- •Working in the offices with VDTs at least five days per week；
- •Provision of written informed consent.
排除标准
- •Known allergy to any eye drops
- •Ocular therapies other than artificial tears
- •Presence of any of the following conditions: active ocular infection, ocular inflammation, active ocular allergy, contact lens wear, ocular surgical history, laser treatment in the last 3 months, Meibomian gland dysfunction (MGD) over grade 2 (the grade is according to the report of the International Workshop on MGD in 2011), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment of the investigator may interfere with the interpretation of the study results
- •Pregnant and lactating women, or those planning a pregnancy over the course of the study
- •Uncontrolled systemic disease
- •Hypersensitivity or intolerance to diquafosol(DQS)
- •Subjects with a history of anxiety and depression
研究组 & 干预措施
Diquafosol group
The treatment period is 12 weeks. The day after subjects who meet the inclusion criteria undergo baseline examination is the day starting the medication. Dosing frequency was six times daily for 3% Diquafosol Ophthalmic Solution. The follow-up time points are 2, 4, 8, 12 weeks, and no other medication is required on the follow-up day.
干预措施: Diquafosol (Drug)
结局指标
主要结局
the changes of Ocular Surface Disease Index (OSDI) scores
时间窗: 12 weeks after intervention
OSDI is one of the most frequently used questionnaires for evaluation of Dry eye disease(DED). This includes 12 questions which measure the frequency of symptoms over the recent week, and the scores range from 0 to 100. The higher the score, the worse the result.
the changes of Tear break-up time (TBUT)
时间窗: 12 weeks after intervention
TBUT is the time from normal blinking to the first appearance of a break in the tear film. The BUT was measured using fluorescein with a metronome, and the average of three consecutive BUTs was calculated. The shorter the TBUT, the worse the outcome.
次要结局
- the changes of scores of Lissamine green staining(12 weeks after intervention)
- the changes of Lipid layer thickness(LLT)(12 weeks after intervention)
- the changes of Partial blink rate(PBR)(12 weeks after intervention)
- the changes of scores of Corneal fluorescein staining (CFS)(12 weeks after intervention)
- the changes of value of Schirmer Ⅰ test (SⅠt)(12 weeks after intervention)