An interventional study of organic product - Virgin Coconut Oil in Dry Eyes, sponsored by National University of Malaysia. Completed at 1 site in Malaysia. Open to participants aged 19 Years to 28 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by National University of Malaysia · Not applicable, Interventional, and Diagnostic
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.
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
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 44 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →National University of Malaysia is the lead sponsor of 119 studies on the registry; 42 are open to participants now.
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Exclusion Criteria:
contact lens soaked in VCO
Other: organic product - Virgin Coconut Oil
contact lens soaked in saline
Other: organic product - Virgin Coconut Oil
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.
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
Time frame: 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
Time frame: 15 minutes
To compare the value of Corneal staining at baseline and 15 minutes after intervention
Fluorescein staining will indicate dry spots
Time frame: 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.
Time frame: 15 minutes
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Plan to share: Undecided — when requested will be considered
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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National University of Malaysia