Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent (VCOCL)

October 4, 2023 updated by: Assoc Prof Dr Haliza Abdul Mutalib, National University of Malaysia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 50300
        • Optometry Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: VCO contact lens
contact lens soaked in VCO
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.
Placebo Comparator: control contact lens
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.

What is the study measuring?

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
Time Frame: 15 minutes
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
Time Frame: 15 minutes
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
Time Frame: 15 minutes
Fluorescein staining will indicate dry spots
15 minutes
To measure the oil stained area after intervention and to compare it with the control group
Time Frame: 15 minutes
This oil stain will indicate the residual of VCO left in the eye after 15 minutes.
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Investigators

  • Principal Investigator: Haliza Abdul Mutalib, MOptom, National University of Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

December 14, 2021

Study Completion (Actual)

March 14, 2023

Study Registration Dates

First Submitted

September 16, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKM1.21.3/244/NN-2019-042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

when requested will be considered

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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