Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent

NCT06071780 | Completed

• 1 other identifier: UKM1.21.3/244/NN-2019-042
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eyes

Keywords

Contact lens; VCO; TBUT; dry eyes

Outcome Measures

Primary Outcomes (4)

• 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

• 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

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

  Fluorescein staining will indicate dry spots

  15 minutes

• 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

Study Arms (2)

VCO contact lens

ACTIVE COMPARATOR

contact lens soaked in VCO

Other: organic product - Virgin Coconut Oil

control contact lens

PLACEBO COMPARATOR

contact lens soaked in saline

Other: organic product - Virgin Coconut Oil

Interventions

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.

VCO contact lens; control contact lens

Eligibility Criteria

• Age: 19 Years - 28 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Dry eye symptoms (according to McMonnies questionaires)
• Written consent

You may not qualify if:

• No ocular diseases
• No systemic diseases
• Not wearing contact lenses regularly for the past 6 months

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Optometry Clinic

Kuala Lumpur, 50300, Malaysia

Location

Related 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.

  PMID: 25802534 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Haliza Abdul Mutalib, MOptom

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Only care provider was not masked as she had to insert the lens and to record the randomization
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof Dr

Model Details: Both eyes of subjects will be instilled with either one of the study contact lens or the control lens at random.

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: October 6, 2023
• Study Start: January 15, 2019
• Primary Completion: December 14, 2021
• Study Completion: March 14, 2023
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

MY (1)