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

Primary Purpose

Dry Eyes

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
organic product - Virgin Coconut Oil
Sponsored by
National University of Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dry Eyes focused on measuring Contact lens, VCO, TBUT, dry eyes

Eligibility Criteria

19 Years - 28 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Optometry Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

VCO contact lens

control contact lens

Arm Description

contact lens soaked in VCO

contact lens soaked in saline

Outcomes

Primary Outcome Measures

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
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
To compare the value of Corneal staining at baseline and 15 minutes after intervention
Fluorescein staining will indicate dry spots
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.

Secondary Outcome Measures

Full Information

First Posted
September 16, 2023
Last Updated
October 4, 2023
Sponsor
National University of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT06071780
Brief Title
Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent
Acronym
VCOCL
Official Title
The Efficacy of Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent on Dry Eyes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
December 14, 2021 (Actual)
Study Completion Date
March 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eyes
Keywords
Contact lens, VCO, TBUT, dry eyes

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Both eyes of subjects will be instilled with either one of the study contact lens or the control lens at random.
Masking
ParticipantInvestigator
Masking Description
Only care provider was not masked as she had to insert the lens and to record the randomization
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VCO contact lens
Arm Type
Active Comparator
Arm Description
contact lens soaked in VCO
Arm Title
control contact lens
Arm Type
Placebo Comparator
Arm Description
contact lens soaked in saline
Intervention Type
Other
Intervention Name(s)
organic product - Virgin Coconut Oil
Intervention Description
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.
Primary Outcome Measure Information:
Title
To compare the value of Tear Break-Up Time (TBUT) at baseline and 15 minutes after intervention
Description
This is to evaluate the 'oil' component in the tearfilm
Time Frame
15 minutes
Title
To compare the value of Schimer's Test at baseline and 15 minutes after intervention
Description
This is to evaluate the aqueous component in the tear film
Time Frame
15 minutes
Title
To compare the value of Corneal staining at baseline and 15 minutes after intervention
Description
Fluorescein staining will indicate dry spots
Time Frame
15 minutes
Title
To measure the oil stained area after intervention and to compare it with the control group
Description
This oil stain will indicate the residual of VCO left in the eye after 15 minutes.
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haliza Abdul Mutalib, MOptom
Organizational Affiliation
National University of Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Optometry Clinic
City
Kuala Lumpur
ZIP/Postal Code
50300
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
when requested will be considered
Citations:
PubMed Identifier
25802534
Citation
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.
Results Reference
result
Links:
URL
http://doi.org/10.1155/2015/135987
Description
A Pilot Study: The Efficacy of Virgin Coconut Oil as Ocular Rewetting Agent on Rabbit Eyes

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Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent

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