NCT00796926已完成3 期
Randomised Controlled Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes
Louis Tong1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual Analog Score (VAS)
研究概览
简要总结
Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry Eyes
详细描述
Comparison of efficacy of Systane Ultra and Refresh Tears
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject age is between 40 and 65 years old.
- •Corneal fluorescein staining present in at least one/five sectors of at least one cornea
- •At least one question out of 6 questions on dry eye symptom present often or all the time.
- •based on the Salisbury Eye study by Oliver Schein et al. (Does your eye feel dry, gritty, red, watery, crusted, stuck in the morning?) Please see appendix
- •At least one of the following: TBUT <= 5 s or Schirmer I less than 8 mm in at least one eye
- •Yamaguchi score 2 in at least one sector of one of 4 lids (slight advancement of Marx's line in line with Meibomian orifice)
- •Not using non-lubricant ophthalmic drops within the last 30 days and able to abstain from non-trial topical eye medications for 6 weeks.
- •Use of lubricants during the week before recruitment (ranging from 3 times in the week to less than 6 times a day every day).
- •Able to use saline eyedrops during the 7 day 'washout' evaluative phase, between 3 times over week to less than 6 times a day in all days.
排除标准
- •Known history of thyroid disorders (diagnosed by physician).
- •Known history of Sjogren syndrome or rheumatoid arthritis (diagnosed by physician).
- •No ocular surgery within 6 months and LASIK within 1 year.
- •Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
- •Ocular surface diseases such as pterygium, or obvious lid/orbital disease with lagophthalmos.
- •Anticipated necessity to wear contact lens in the duration of the study.
- •Not living in the same household as another participant of the study.
- •Any other specified reason as determined by clinical investigator.
研究组 & 干预措施
Refresh
Active Comparator
Used four times a day topically to each eye
干预措施: Refresh eye drops (Drug)
Systane Ultra
Experimental
Used four times a day topically to each eye
干预措施: Systane Ultra eyedrops (Drug)
结局指标
主要结局
Visual Analog Score (VAS)
时间窗: 6 weeks
Global score calculated from square root( square of (discomfort severityX Sqr(symptom frequency)) Scale from 0 to 100 higher value indicates more adverse symptoms each subscale severity or frequency also has same minimum and maximum
次要结局
- Corneal Fluorescein Staining Score(6 weeks)
- Tear Break Up Time (TBUT)(6 weeks)
- Schirmer I Reading(6 weeks)
- Meibography Grading(6 weeks)
- Tear Osmolarity(6 weeks)
- Superior and Inferior Tear Meniscus Height(6 weeks)
研究者
Louis Tong
Clinician-Scientist, Consultant
Singapore National Eye Centre
研究点 (1)
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