Comparison of Immediate Therapeutic Effects of 3% Diquafosol and 2% Rebamipide in Dry Eye Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- visual analog scale (VAS) score
研究概览
简要总结
This study compares the immediate therapeutic and mucin-secreting effects 30 minutes after instillation of 3% diquafosol and 2% rebamipide in dry eye disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients 19 years or older
- •complaint of at least one dry eye symmptom and tear breakup time < 7 seconds
排除标准
- •Sjogren's syndrome
- •prescription history of systemic steroids or immunosuppressants
- •prior ocular surgery within six months of enrollment
- •treatment with diquafosol or rebamipide eye drops within 2 weeks of enrollment
- •treatment with punctal plug within 1 month of enrollment
- •intraocular pressure exceeding 25mmHg
- •usage of contact lens during the study
- •active ocular infection
- •pregnancy or breast-feeding
研究组 & 干预措施
R) DQS, L) REB
This is a paired-eye design study. Patients were randomly assigned to receive 3% diquafosol in the right eye and 2% rebamipide in the contralateral left eye, with the treatment assignment blinded to the examiner and patients.
干预措施: 3% diquafosol (right eye) and 2% rebamipide (left eye) (Drug)
R) REB, L) DQS
This is a paired-eye design study. Patients were randomly assigned to receive 3% diquafosol in the left eye and 2% rebamipide in the contralateral right eye, with the treatment assignment blinded to the examiner and patients.
干预措施: 2% rebamipide (right eye) and 3% diquafosol (left eye) (Drug)
结局指标
主要结局
visual analog scale (VAS) score
时间窗: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
Unit: points
tear breakup time (TBUT)
时间窗: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
Unit: Seconds
ocular staining score (OSS)
时间窗: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
National Eye Institute Scale, 0-15
tear meniscus height (TMH)
时间窗: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
Unit: mm
lipid layer thickenss (LLT)
时间窗: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
Unit: nm
corneal sensitivity (esthesiometer)
时间窗: Before instillation of eyedrops, and 30 minutes after instillation of eyedrops
Unit: mm
次要结局
- tear MUC1 concentration(Before instillation of eyedrops, and 30 minutes after instillation of eyedrops)
- tear MUC5AC concentration(Before instillation of eyedrops, and 30 minutes after instillation of eyedrops)
研究者
Dong Hyun Kim
Principal Investigator
Korea University Anam Hospital
