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OpenTrials
Completed

NCT Number: NCT06071780

Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent

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.

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Key information

Conditions

Dry Eyes Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

19 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Optometry Clinic

Kuala Lumpur, 50300, Malaysia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

organic product - Virgin Coconut Oil

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.

Primary outcomes

  1. 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

  2. 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

  3. To compare the value of Corneal staining at baseline and 15 minutes after intervention

    Time frame: 15 minutes

    Fluorescein staining will indicate dry spots

  4. 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.

Sponsors and collaborators

Lead sponsor

National University of Malaysia

Other

Registry information

Official study title

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

Acronym: VCOCL

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Oct 6, 2023
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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