Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent

NCT ID: NCT06071780

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2023-03-14

Brief 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

Dry Eyes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

VCO contact lens

contact lens soaked in VCO

Group Type: ACTIVE_COMPARATOR

organic product - Virgin Coconut Oil

Intervention Type: OTHER

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.

control contact lens

contact lens soaked in saline

Group Type: PLACEBO_COMPARATOR

organic product - Virgin Coconut Oil

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National University of Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Assoc Prof Dr Haliza Abdul Mutalib

Assoc Prof Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haliza Abdul Mutalib, MOptom

Role: PRINCIPAL_INVESTIGATOR

National University of Malaysia

Locations

Optometry Clinic

Kuala Lumpur, , Malaysia

Countries

Malaysia

References

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.

Reference Type: RESULT

PMID: 25802534 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

UKM1.21.3/244/NN-2019-042

Identifier Type: -

Identifier Source: org_study_id