Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent

Dry Eyes Clinical Trial

— VCOCL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06071780
• Other study ID #: UKM1.21.3/244/NN-2019-042
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: March 14, 2023

Study information

• Verified date: October 2023
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 14, 2023
• Est. primary completion date: December 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Dry Eyes
• Keratoconjunctivitis Sicca

Intervention

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.

Locations

Country	Name	City	State
Malaysia	Optometry Clinic	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (1)

Mutalib HA, Kaur S, Ghazali AR, Chinn Hooi N, Safie NH. A pilot study: the efficacy of virgin coconut oil as ocular rewetting agent on rabbit eyes. Evid Based Complement Alternat Med. 2015;2015:135987. doi: 10.1155/2015/135987. Epub 2015 Feb 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	To compare the value of Corneal staining at baseline and 15 minutes after intervention	Fluorescein staining will indicate dry spots	15 minutes
Primary	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

External Links

•   A Pilot Study: The Efficacy of Virgin Coconut Oil as Ocular Rewetting Agent on Rabbit Eyes