Clinical trial NCT06071780: Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent
Official title: The Efficacy of Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent on Dry Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eyes
Keywords: Contact lens
VCO
TBUT
dry eyes
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Both eyes of subjects will be instilled with either one of the study contact lens or the control lens at random.
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: To compare the value of Tear Break-Up Time (TBUT) at baseline and 15 minutes after intervention
timeFrame: 15 minutes
measure: To compare the value of Schimer's Test at baseline and 15 minutes after intervention
timeFrame: 15 minutes
measure: To compare the value of Corneal staining at baseline and 15 minutes after intervention
timeFrame: 15 minutes
measure: To measure the oil stained area after intervention and to compare it with the control group
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Optometry Clinic
Study officials:
affiliation: National University of Malaysia
name: Haliza Abdul Mutalib, MOptom
role: PRINCIPAL_INVESTIGATOR
References:
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.