The Efficacy of Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent on Dry Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- To compare the value of Tear Break-Up Time (TBUT) at baseline and 15 minutes after intervention
研究概览
简要总结
This is a clinical trial where 44 subjects dry eyes were instilled with Virgin Coconut Oil (VCO CL) using contact lenses as its vehicle. All subjects are healthy subjects with no other ocular diseases except for having some dry eye symptoms (included with McMonnies questionnaires). Parameters measured at baseline and after 15 minutes of insertion and were compared. The control eyes were inserted with contact lenses soaked in saline (CCL). The eye that wears the VCO CL or the CCL were chosen randomly by masked operator. At the end of this study, the parameters measured will indicate if the VCO CL was able to retain tears in the eye and remove the dry eyes symptoms.
详细描述
A new study using contact lens pre-soaked in virgin coconut oil (VCO CL) was conducted to determine the safety of the agent on dry eye human. Efficacy of the VCO CL was assessed by measuring TBUT, anterior eye assessment, corneal staining, pH, and Schirmer value and the measurement of residual VCO volume in tears before instillation (0 minute) and at 15 minutes after insertion. Wilcoxon Signed Rank and Mann Whitney U Test were used to analyse any changes in all the measurable variables. The differences of the TBUT, corneal staining and residual VCO volume in tears value in both eyes were analyzed. These study data will suggest if the VCO CL is safe and effective and can be recommended to be used as an option for dry eyes in human
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
盲法说明
Only care provider was not masked as she had to insert the lens and to record the randomization
入排标准
- 年龄范围
- 19 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dry eye symptoms (according to McMonnies questionaires)
- •Written consent
排除标准
- •No ocular diseases
- •No systemic diseases
- •Not wearing contact lenses regularly for the past 6 months
结局指标
主要结局
To compare the value of Tear Break-Up Time (TBUT) at baseline and 15 minutes after intervention
时间窗: 15 minutes
This is to evaluate the 'oil' component in the tearfilm
To compare the value of Schimer's Test at baseline and 15 minutes after intervention
时间窗: 15 minutes
This is to evaluate the aqueous component in the tear film
To compare the value of Corneal staining at baseline and 15 minutes after intervention
时间窗: 15 minutes
Fluorescein staining will indicate dry spots
To measure the oil stained area after intervention and to compare it with the control group
时间窗: 15 minutes
This oil stain will indicate the residual of VCO left in the eye after 15 minutes.
次要结局
未报告次要终点
研究者
Assoc Prof Dr Haliza Abdul Mutalib
Assoc Prof Dr
National University of Malaysia