Clinical Trials Directory

Trials / Completed

CompletedNCT06071780

Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
44 (actual)
Sponsor
National University of Malaysia · Academic / Other
Sex
All
Age
19 Years – 28 Years
Healthy volunteers
Accepted

Summary

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

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

Conditions

Interventions

TypeNameDescription
OTHERorganic product - Virgin Coconut OilA 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.

Timeline

Start date
2019-01-15
Primary completion
2021-12-14
Completion
2023-03-14
First posted
2023-10-06
Last updated
2023-10-06

Locations

1 site across 1 country: Malaysia

Source: ClinicalTrials.gov record NCT06071780. Inclusion in this directory is not an endorsement.