The Efficacy of Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent on Dry Eyes
Phase: NA
Conditions: Dry Eyes
Sponsor: National University of Malaysia

INVESTIGATION OF VIRGIN COCONUT OIL (VCO) THERAPEUTIC CONTACT LENS ROLE IN CHANGING TEAR 
VOLUME AND STABILITY OF DRY EYE SUBJECTS 
 
UKM1.21.3/244/NN-2019-042 
 
15 August 2019 
 
 
 
 

Exec Summary 
Dry eyes is an extremely common symptom that affects as many as 337 million people globally. Almost 
everyone has probably had or will have dry eyes at some point in their life. Common treatment to dry 
eyes is by using lens lubricant or eye drops which gives short relief and comfort. Sufferers would have to 
endure the discomfort of having to instill drops frequently for which will indirectly affect their work and 
quality of life.  This study will determine the role of VCO therapeutic contact Lens in changing the tear 
volume and improving tear stability on dry eyes patients by giving a long relief and effective remedy. 
The study will be conducted at UKM Optometry Clinic using randomized, double-masked on 50 dry eye 
subjects in 4 different phases. Measurement of tears before and after (15 minutes) the therapeutic VCO 
contact lens are worn by the subjects will be recorded. Similar parameter will be measured 15 minutes 
post wear (Phase 1 & 2). The intra-variability and inter-variability of the parameters will also be measured 
accordingly after 2 months (Phase 3 & 4). 
The outcome of this study is expected to enhance the volume and stability of tears in dry eye subjects. 
Sufferers of these symptoms will find prolonged relief through this new knowledge of management, thus 
will improve the quality of life of people who has dry eyes problems. 
VCO therapeutic contact lens may provide the solution of prolonged relief for dry eye symptoms. This will 
provide a new knowledge amongst eyecare practitioners in managing patients with dry eyes due to ocular 
disease or environmental factors and using a local product will indirectly boost the economic growth of 
Malaysia. 
 
 
Problem statement 
It is known that VCO drops used as ocular rewetting agent on rabbit eyes has been tested and proven 
safe and effective in increasing tear volume. It has also been tested on humans with success. However, 
the use of contact lens as a vehicle to transfer the VCO need to be further investigated. It is significantly 
important to know the role of VCO therapeutic contact lens in changing the tear volume and stability in 
dry eye patients. Hence, this study will determine if VCO Therapeutic Contact Lens changes the tear 
volume and stability in dry eye patients. 
 
Hypothesis 
VCO Therapeutic Contact Lens can be significantly used to improve tear volume and tear stability in dry 
eye subjects. 
 
Objective 
The main aim of research is to investigate the changes of tear volume and tear stability from VCO 
Therapeutic Contact Lens wear. 

 
The following specific objectives are: - 
(i)  To determine the tear break up time (TBUT) and tear volume (Schirmer’s Test) at 0 and 15 minutes 
after therapeutic VCO contact lens wear. 
(ii) To determine the tear break up time (TBUT) and tear volume (Schirmer’s Test) at 15 minutes after 
lens removal. 
(iii) To measure the inter-variability and intra-variability of the parameters measured for TBUT, after 
therapeutic VCO contact lens wear  
 
 
Research Question 
 
Literature review 
Dry eye is an ocular condition which is characterized by reduction in tear volume, tear stability 
and increase in tear osmolarity as well as water evaporation. Visual disturbances including blurriness, 
visual discomfort and damage of the ocular surface are the most common dry eye-related sign and 
symptoms. Previous study had reported that 25 % of patients who visited ophthalmic clinic may report 
symptoms of dry eye. Thus, making this condition as one of the public health.The current study of dry eye 
prevalence of in Kuala Lumpur, Malaysia, showed the results of estimation that around 15% of the sample 
population suffering dry eye (Kaur et.al., 2016). However, the prevalence of dry eye varies between 
countries and was estimated to be around 7.4% to 33.7% (Buckley, 2018). 
To ensure the accuracy of dry eye diagnosis, different tests of tear parameters including tear 
quantity and quality tests are used to detect the pre-existing condition (Masmali et al. 2016). One of the 
ways to assess for tear quality is by assessing the stability of the tear film which can be obtained through 
tear break up time (TBUT) measurement. Tear quantity can be obtained by measuring the tear volume 
and Schirmer’s test is one of the objective measurements that is widely used by the practitioner to 
measure it (Miyake et. al, 2016). It becomes practically important as stability of the tear film and sufficient 
composition of each substances such as lipid, mucin, electrolytes, and including aqueous humor, are 
crucial in order to know the integrity of the tear film layer (Buckley, 2018). 
 
At present, there are few dry eye remedies available in the market. Among all of those remedies, 
artificial tear and eye lubricants are still the most common initial management and prophylaxis that will 
be given by medical practitioners to dry eye patient regardless of the type of dry eye. Artificial tear is well 
known to given temporary relief of dry eye’s sign and symptoms. Though, it might not be an effective 
treatment as they only contain polymers that is able to lubricate ocular surface and lack of numerous 
important biological factors such as antimicrobial growth and anti-inflammatory factors that present in 
natural tear and important to maintain ocular surface homeostasis (Mutalib et al. 2015) 

 
Virgin coconut oil (VCO) is known as a local functional food and contain antiviral and anti-microbial 
agents (Marina & Man 2016). Study has been conducted on efficacy of VCO as ocular rewetting agent on 
rabbit eyes. It has been shown that VCO did not cause harmful effects when used on rabbit’s eyes. The 
fatty acid and anti-inflammatory agents on VCO may act as protective layer over the tear film layers to 
reduce evaporation, which is useful for those with dry eyes problem (Mutalib et al. 2015). Similar study 
was done on human and it was found to increase the tear volume (Macmonnies, 2018) 
However, one of the discomforts when using the VCO, it is oily and messy when used directly on 
eyes and it also causes temporary blurriness. In another successful study, contact lenses were used as a 
medium or vehicle of transportation of VCO to human eyes (Hussin, 2014). The contact lenses were 
immersed in a volume of VCO for several hours before placing it on the human eyes. In this study, VCO 
extracts will be injected out and will be vehicle to the eye by using hydrogel contact lens. This study will 
investigate the role of VCO Therapeutic Contact Lens in changing the tear volume and tear stability in dry 
eye subjects. 
STATISTICAL ANALYSIS 
 
After the data has been collected, IBM SPSS Statistics Version 25 (Armonk, NY, USA) 
will be use to analyze the data. The assessment of the efficacy will be based on the all subjects 
who completed the study. Shapiro-Wilk test will be used to test the normality of the data as the 
sample size is less than 100. All results are expressed as Mean ± SD. Parametric test of Repeated 
Measured Anova will be used to analyze the statistical difference of before, immediately and after 
treatment if the data is normally distributed. A probability value (p-value) <0.05 will indicate that 
the data is statistically significance.  
 
 
Methodology 
The study will be conducted at Optometry clinic UKM KL. Random sampling and double mask 
method will be used as in this study. A total of 50 subjects who meet the inclusion criteria will be invited 
to participate in this study once the ethics has been granted. The purpose of the study will be explained 
to the subjects and consent will be taken if agreeable to participate in the study. Enrollment of subjects 
and clinical trial will be carried out in staggered period within 5 weeks for each phase. 
Inclusion Criteria:  
a. 
Healthy male and female 
b. 
Age: 20 to 40 years old 
c. 
OSDI scores more than 15 
 

Exclusion Criteria:  
a. 
Subjects with ocular surface diseases such as meibomian gland blockage, meibomianitis and 
blepharitis 
b. 
Subjects currently under topical anti-glaucoma and anti-inflammatory eye drops 
c. 
Subjects with autonomic nephropathy and micro vascular disease e.g diabetic mellitus 
d. 
Pregnant woman and woman who currently active in breastfeeding.  
 
Protocol: 
Subjects will be required to fill up the consent form and history taking will be carried out on all 
subjects. Subjects will be tested using the Ocular Surface Disease Questionnaire (OSDI) (Ngo et al., 2017) 
before recruitment in order to classify subjects if they have dry eye symptoms (inclusion criteria).  Visual 
acuity testing using log MAR Acuity Chart (Johnston, 2016) as well as anterior segment assessment using 
slit lamp biomicroscopy will be done prior to the study in order to know the baseline Visual acuity and 
ocular condition of the subjects’ eyes. 
Phase 1 
First measurement of TBUT (Mcmonnies, 2018) on both eyes will be taken before lens insertion. 
Then, subjects will be fitted with therapeutic VCO contact lens on one of their eyes and a placebo 
hydrogel contact lens on the other eye which acts as a control. The contact lenses will be fitted in 
randomized manner by a mask operator. Subjects will wear the contact lenses for 15 minutes. After the 
15th minute, both contact lenses will be removed and second measurements of TBUT will be done.  All 
tear breakup time (TBUT) measurements will be taken three times and the average value will be used as 
the data. These will be the immediate measurement after therapeutic VCO contact lens wear. Subjects 
will be given 15 minutes time interval before a re-measurement of TBUT test again. Once all the 
measurements are taken, subjects will be discharged from the study before being called again in Phase 
2. From the data collected, an analysis will assist to understand the mechanism of tear integrity when 
VCO therapeutic contact lens is used on dry eyes.  
Phase 2 
First measurement using Schimer’s Test (Miyake et al, 2016) on both eyes will be taken before 
lens insertion. Then, subjects will be fitted with therapeutic VCO contact lens on one of their eyes and a 
placebo hydrogel contact lens on the other eye which acts as a control. The contact lenses will be fitted 
in randomized manner by a mask operator. Subjects will wear the contact lenses for 15 minutes. After 
the 15th minute, both contact lenses will be removed and second measurements of Schimer’s Test will 
be done.  All measurements will be taken three times and the average value will be used as the data. 
These will be the immediate measurement after therapeutic VCO contact lens wear. Subjects will be 
given 15 minutes time interval before a re-measurement of Schimer’s Test again. Once all the 
measurements are taken, subjects will be discharged from the study before being called again in Phase 
3. From the data collected, an analysis will assist to understand the mechanism of tear volume changes 
when VCO therapeutic contact lens is used on dry eyes. 
 
Phase 3 

In Phase 3 a repeat will be done to measure the TBUT (2 months after the first fitting) where 
lenses will be refitted at random to check on inter-variability. First measurement using TBUT Test on 
both eyes will be taken before lens insertion. Then, subjects will be fitted with therapeutic VCO contact 
lens on one of their eyes and a placebo hydrogel contact lens on the other eye which acts as a control. 
The contact lenses will be fitted in randomized manner by a mask operator. Subjects will wear the 
contact lenses for 15 minutes. After the 15th minute, both contact lenses will be removed and second 
measurements of TBUT Test will be done.  All measurements will be taken three times and the average 
value will be used as the data. These will be the immediate measurement after therapeutic VCO contact 
lens wear. Subjects will be given 15 minutes time interval before a re-measurement of TBUT Test. Once 
all the measurements are taken, subjects will be discharged from the study before being called again in 
Phase 4. From the data collected, an analysis will assist to understand the inter-variability between the 
measurement done in Phase 1 and Phase 3. 
Phase 4 
In Phase 4 a repeat will be done to measure the TBUT (2 months after Phase 3) where lenses will 
be refitted at random to check on intra-variability. First measurement using TBUT Test on both eyes will 
be taken before lens insertion. Then, subjects will be fitted with therapeutic VCO contact lens on one of 
their eyes and a placebo hydrogel contact lens on the other eye which acts as a control. The contact 
lenses will be fitted in randomized manner by a mask operator. Subjects will wear the contact lenses for 
15 minutes. After the 15th minute, both contact lenses will be removed and second measurements of 
TBUT Test will be done.  All measurements will be taken three times and the average value will be used 
as the data. These will be the immediate measurement after therapeutic VCO contact lens wear. 
Subjects will be given 15 minutes time interval before a re-measurement of TBUT Test. Once all the 
measurements are taken, subjects will be discharged from the study before being called again in Phase 
4. From the data collected, an analysis will assist to understand the inter-variability between the 
measurement done in Phase 1 and Phase 3. 
This study is at low risk as the subjects will not have any 'drop-out' issues and is anticipated to 
be able to go through the clinical trial successfully as the procedure only takes less than half an hour and 
in case of emergency, a medical officer is being put on standby. 
The VCO therapeutic contact lens after used will also be tested for biocompatibility test as per 
ISO 10993 for Ocular Irritation Test (ISO 10993-10:2010 (E), Acute systemic toxicity test  (ISO 10993-10: 
2010 (E), Skin Sensitization Test (ISO 10993-10:2010 (E), In Vitro Cytotoxicity : Direct Contact Method 
(ISO 10993-5:2009 (E) by acrredited laboratory. This will be monitored by a toxicologist (co-researcher) 
and manufacturing is done by Supervision Optimax Sdn Bhd (industry collaborator). 
 
 
References 
1. Buckley RJ  2018. Assessment and management of dry eye disease. Eye 32:200-203 
2. Ngo William, Srinivasan S, Keech A, Keir Nany, Jones Lyndon 2017. Self-versus examiner administration 
of the Ocular Surface Disease Index© Journal of Optometry 10(1): 34-42. 

3. Johnston A. 2016. Measuring distance and near visual acuity using log MAR. YB Section 1 Text.qxp_2006 
pages 1-13 
4. McMonnies, C.W. 2018. Tear instability importance, mechanisms, validity and reliability of assessment. 
Journal of Optometry 11(4):203-210 
5. Marina, A.M. & Man, Y.B.C.  2016. Virgin coconut oil: emerging functional food oil. Trends Food Sci 
Technol Virgin coconut oil: emerging functional food oil. Trends in Food Science & Technology 20(10): 
481–487.  
6. Masmali, A.M., Al-shehri, A., Alanazi, S.A., Abusharaha, A., Fagehi, R. & El-hiti, G.A.  2016. Assessment 
of Tear Film Quality among Smokers Using Tear Ferning Patterns. Journal of Ophthalmology 2016: 5. 
7. Miyake H, Kawano Y, Tanaka H. Iwata A. Imanaka T, Nakamura M 2016. Tear volume estimation using 
a modified Schirmer test: a randomized, multicenter, double-blind trial comparing 3% diquafosol 
ophthalmic solution and artificial tears in dry eye patients. Clinical Ophthalmology 10:879-886  
8. Mutalib, H.A., Kaur, S., Ghazali, A.R., Hooi, N.C. & Safie, N.H.  2015. A Pilot Study: The Efficacy of Virgin 
Coconut Oil as Ocular Rewetting Agent on Rabbit Eyes. Evidence Based Complement Alternative 
Medicines 2015(135987): 1-7 
9. Fong, Yoke Yeng (2013). Kajian keberkesanan minyak kelapa dara (VCO) ke atas mata kering. Degree 
Thesis. Universiti Kebangsaan Malaysia (unpublished) 
10. Hussin, Nabillah (2104). Kesan rendaman kanta sentuh dalam minyak kelapa dara (VCO) terhadap 
kualiti air mata dan tahap. Degree Thesis. Universiti Kebangsaan Malaysia (unpublished) 
11. Sharanjeet-Kaur, Chien Yee Ho, Haliza Abdul Mutalib, Ahmad Rohi Ghazali. 2016. The Relationship 
Between Tear Ferning Patterns and Non-invasive Tear Break-up Time in Normal Asian Population. Journal 
of Optometry, Jul-Sep; 9(3):175-81 
12. Haliza Abdul Mutalib, Lim Yee Vyon. 2018. Ocular Comfort Assessment in Hydrogel and Silicone 
Hydrogel Contact Lens Wearers. Malaysian Journal of Health Sciences. Vol 16(2) 2018: 65-69  
  
 
 

INFORMATION SHEET 
 
Research Title:  
 
THE EFFICACY OF THERAPEUTIC VIRGIN COCONUT OIL (VCO) CONTACT LENS ON 
SUBJECT WITH DRY EYE SYMPTOMS: A PILOT STUDY 
 
Introduction:  
 
You are invited to participate in a research study. Before participating in this study, it is important 
that you take time to read and understand the information in this Information Sheet. 
 
Purpose of Study: 
Dry eye is an ocular condition that characterized by a reduction in tear volume, tear stability and 
increase in tear osmolarity as well as water evaporation. Visual disturbances including blurred 
vision, visual discomfort and damage of the ocular surface are the most common dry eye-related 
sign and symptoms. For diagnosis, different tests of tears parameters including tear quantity and 
quality test can be used to detect the pre-existing condition. Study using VCO on rabbits eyes 
showed that it is effective as ocular rewetting agent and it does not cause harm to the rabbits eyes. 
VCO should be safe for use in human eyes but we do not know yet if it is effective for relief of 
dry eye. Thus, the aim of current study is to determine the ability of therapeutic VCO contact lens 
on relieving the subjects with dry eye symptoms. 
 
 
 
 
 
What will the study involve? 

Two different types of contact lenses will be fitted on each eye. Study eye will be fitted with 
Therapeutic VCO contact lens and control eye will be fitted with normal hydrogel contact lens as 
placebo. Both of contact lenses have to be wear for 15 minutes. Tear Break Up time (TBUT) and 
Schirmer’s test will be measured. TBUT will be measured by slitlamp biomicoscopy and 
Schirmer’s test I will be measured using fluorescein strips. TBUT measurements and Schirmer’s 
test I will be measured before contact lens wear, immediately after the contact lens being removed, 
and 15 minutes after the contact lens being removed. After all the measurements have been taken, 
subjects will be discharged.  
 
Risks and Benefits:   
Improvement such as decrement of dry eye symptoms could be one of the possible benefits of 
participating in this study. Risk of each procedure will be unlikely as procedures that chosen are 
minimally invasive and there will be no drug or topical drops involved in this study. The 
discomfort feeling induce from schirmer’s strips is tolerable.   
 
Do you have to take part? 
Participation in this study is voluntary. If you agree to take part, then you will be asked to sign the 
“Informed Consent Form”. You will be given a copy of the form and this Information Sheet. 
Should you decide to participate, you can still withdraw from the study without penalty. Your data 
will not be used and will be discarded. The researcher may also remove you from the study for a 
variety of reason. In this event, you will not be penalised or lose your rights as a patient.  
 
 
 
 
 
Data & Confidentiality: 

The data from this study will be made into a report which may be published.  Access to the data is 
only by the research team and the REC UKM. The data will be reported in a collective manner 
with no reference to an individual. Hence your identity will be kept private and confidential. 
 
Payment and compensation: 
You do not have to pay nor will you be paid to participate in this study. There will be no any 
compensation or travel allowance given as the participant of this study. However, during the 15 
minutes time interval, light snakes will be provided by the research team.  
 
Who can I ask about the study? 
If you have any questions, you can direct them to the research team.  
 
Research Team 
 
 
 

INFORMED CONSENT FORM 
 
Research Title: The Efficacy of Therapeutic VCO Contact Lens on Subjects With Dry Eye 
Symtoms: A Pilot Study.  
Researcher’s Name: Andi Marwa Armeelah Maurice Amelia Putri 
I, …………………………………………………………………IC No :  …………………......  
• have read the information in the Patient Information Sheet including information 
regarding the risk in this study  
• have been given time to think about it and all of my questions have been answered to my 
satisfaction. 
• understand that I may freely choose to withdraw from this study at anytime without reason 
and without repercussion 
• understand that my anonymity will be ensured in the write-up. 
I voluntarily agree to be part of this research study, to follow the study procedures, and to 
provide necessary information to the doctor, nurses, or other staff members, as requested. 
 
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Witness (if any) 
 
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(Signature)           
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(IC Number) 
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(Date)                               
 
 
Researcher 
 
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(Signature)           
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(P102443) 
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(Date)                               
 
 
 
 
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Saksi (jika ada) 
 
 
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(Tandatangan)           
 
 
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(No. Kad Pengenalan) 
 
 
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(Tarikh)                               
 
Penyelidik 
 
 
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(Tandatangan)           
 
 
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(No. Kad Pengenalan) 
 
 
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(Tarikh)