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

National University of Malaysia

Status: Completed

Conditions: Dry Eyes

Treatments: Other: organic product - Virgin Coconut Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT06071780

UKM1.21.3/244/NN-2019-042

Details and patient eligibility

About

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.

Full 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

Enrollment: 44 patients

Sex: All

Ages: 19 to 28 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

VCO contact lens

Active Comparator group

Description:

contact lens soaked in VCO

Treatment:

Other: organic product - Virgin Coconut Oil

control contact lens

Placebo Comparator group

Description:

contact lens soaked in saline

Treatment:

Other: organic product - Virgin Coconut Oil