Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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The Efficacy of Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent on Dry Eyes

Conditions
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Dry Eyes

Intervention / Treatment
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* Other: organic product - Virgin Coconut Oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dry eye symptoms (according to McMonnies questionaires) Written consent Exclusion Criteria: No ocular diseases No systemic diseases Not wearing contact lenses regularly for the past 6 months

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Both eyes of subjects will be instilled with either one of the study contact lens or the control lens at random.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VCO contact lens<br>contact lens soaked in VCO | Other: organic product - Virgin Coconut Oil<br>* A commercially available sterilized contact lens was soaked in VCO for 4 hours in a sterile condition to allow absorption of VCO into the contact lens polymer. The contact lens here is a vehicle to transport the VCO into the eye.<br>|
| Placebo Comparator: control contact lens<br>contact lens soaked in saline | Other: organic product - Virgin Coconut Oil<br>* A commercially available sterilized contact lens was soaked in VCO for 4 hours in a sterile condition to allow absorption of VCO into the contact lens polymer. The contact lens here is a vehicle to transport the VCO into the eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the value of Tear Break-Up Time (TBUT) at baseline and 15 minutes after intervention | This is to evaluate the 'oil' component in the tearfilm | 15 minutes | 
| To compare the value of Schimer's Test at baseline and 15 minutes after intervention | This is to evaluate the aqueous component in the tear film | 15 minutes | 
| To compare the value of Corneal staining at baseline and 15 minutes after intervention | Fluorescein staining will indicate dry spots | 15 minutes | 
| To measure the oil stained area after intervention and to compare it with the control group | This oil stain will indicate the residual of VCO left in the eye after 15 minutes. | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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VCO, TBUT, dry eyes, Contact lens