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临床试验/NCT07297316
NCT07297316已完成4 期

Comparison of Immediate Therapeutic Effects of 3% Diquafosol and 2% Rebamipide in Dry Eye Disease

Korea University Anam Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月3日最近更新:
干预措施

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

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

Other

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

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong Hyun Kim

Principal Investigator

Korea University Anam Hospital

研究点 (1)

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