Assessment of Tear Production, Corneal Staining, and Comfort Level After One Day of Wearing FDA Group I, II, III, IV, and V Contact Lenses Among Pre-Graduate Students at UKM Kuala Lumpur Campus
Phase: NA
Conditions: Dry Eye, Dry Eye Syndromes, Contact Lens-induced Corneal Fluorescein Staining
Sponsor: National University of Malaysia

 
 
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PROJECT TITLE: 
ASSESSMENT OF TEARS, CORNEAL STAINING AND COMFORT LEVEL 
AFTER ONE DAY WEAR OF CONTACT LENSES OF DIFFERENT FDA 
CATEGORIES AMONG UNDERGRADUATE STUDENTS OF UKM KUALA 
LUMPUR CAMPUS 
INVESTIGATORS: 
ASSOC PROF DR. HALIZA ABDUL MUTALIB (Chief Investigator) 
DR. BASHIRAH ISHAK (Co-Investigator) 
MR MOHD NORHAFIZUN MOHD SAMAN (Clinic Researcher) 
MR ASYRAF ZULHAKIM BIN SHAMSUL (Site Investigator) 
MS NUR NALIESYA BINTI ASHA’RI (Site Investigator) 
MS NUR NATASHA SOFEA BINTI NICK HAMASHOLDIN (Site Investigator) 
 
 

 
 
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CONTENT 
                   TOPICS                                                                 Page 
 
1.0 
  
Research Topics 
  
2.0 
Introduction 
  
2.1 
Research Background 
1 
2.2 
Problem Statement and Research Justification  
3 
2.3 
Research Question 
3 
2.4 
Hypothesis 
3 
2.5 
Conceptual framework 
4 
2.6 
Research Objective 
5 
3.0 
Methodology 
  
3.1.1 
Research Design 
6 
3.1.2 
Sampling Methods 
6 
3.1.3 
Study Location 
6 
3.1.4 
Study Sample Calculation 
6 
3.1.5 
Subject 
7 
3.1.6 
Participation Criteria 
7 
3.1.7 
Exclusion Criteria 
7 
3.1.8 
Instrument 
7 
3.1.9 
Study Protocol 
8 
3.1.10 
Flowchart 
11 
3.1.11 
Data Analysis 
12 
4.0 
Ethical Approval 
12 
5.0 
Gantt chart 
13 
6.0 
Reference 
14 
 
 
 

 
 
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1.0 
STUDY TITLE  
Assessment of Tears, Corneal Staining and Comfort Level After One Day Wear Of Contact 
Lenses Of Different FDA Categories Among Undergraduate Students of UKM Kuala Lumpur 
Campus. 
 
2.0 INTRODUCTION  
2.1 The Food and Drug Administration (FDA) classifies soft contact lens materials into 5 groups, 
where hydrogels are in Group I, II, III, and IV, while silicone hydrogel (SH) is in Group V. 
Hydrogel silicone contact lenses are one of the results of contact lens innovations that were first 
introduced in the market in the late 90s (Sulley & Dumbleton, 2020). Silicone material allows for 
high oxygen permeability while hydrogel components maintain the softness and comfort of 
contact lenses (Gasson & Morris, 2003). The Group I FDA contact lens is a non-ionic hydrogel 
with the water content of <50%. Group II, on the other hand, is a non-ionic hydrogel with the 
water content of >50% (Peral et al. 2020). As for group III and IV contact lenses, they are ionic 
contact lenses. Group III contact lenses have a low water content of less than 50% compared to 
group IV with high water content of more than 50% (Peral et al. 2020). There are several examples 
of soft contact lens materials for each group, Polymacon and Crofilcon are examples of group I 
while Nelfilcon A and Omafilcon A are material examples of group II soft contact lenses. 
Examples of group III soft contact lens materials are Bufilcon A and Deltafilcon A while 
Ocufilcon B and Ocufilcon C are examples of group IV soft contact lens materials (Chatterjee et 
al. 2020). Material Lotrafilcon A and Balafilcon A are examples of group V soft contact lens 
material (Efron et al., 2010).  
Protein deposits can result in multiple immune responses, including giant papillary 
conjunctivitis. Silicone hydrogel (SH) material contact lenses provide comfort and better 
performance compared to hydrogel material. The data show that very low protein deposits are 
present in silicone hydrogel material contact lenses after wear when compared with hydrogel 
material (Subbaraman et al., 2006). The application of contact lenses can cause changes in the 
level of production and tear quality. This can cause a feeling of discomfort in the eyes when 
wearing contact lenses (Fonn 2007; Maruyama et al., 2004). Based on the classification of dry 
eye diagnostics from the National Eye Institute and Industry Workshop, dry eye problems 
during contact lens wear are related to tear loss through evaporation (Lemp 1995; Pflugfelder 
et al., 2000). Studies from Asharlous et al. (2016) have also shown that there are significant 

 
 
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changes in the quality and quantity of tears after 6 hours of wearing hydrogel silicone contact 
lenses of the Air Optix Aqua brand, Lotrafilcon B from CIBA Vision. The level of tear 
production can be measured by the Schirmer test; together or without anesthetic, in which it 
represents the secretion of tears on the lower part of the eyelid and tear reflexes. The Schirmer 
test is still used for the measurement of tear production in primary eye care as it is simple, fast, 
cheap and practical (Razak et al., 2018). The Non-Invasive Breakup Time (NIBUT) test allows 
stability and tear quality to be studied without inserting foreign material into the eye. This 
method is more patient-friendlier and more accurate than the Tear Breakup Time (TBUT) Test 
method. The TBUT method is considered to have a deficiency because the presence of sodium 
fluorescein alters the physiology of tears (Mohidin et al., 2002). Finally, a questionnaire will 
be used to study the level of comfort throughout the wearing of contact lenses using the Contact 
Lens Discomfort Index (CLDI) questionnaire, Cristina Arroyo-del Arroyo et al. (2022). The 
choice of questions in this questionnaire is based on the existing questionnaire Contact Lens 
Dry Eyes Questionnaire (CLDEQ)-8. CLDI is a strong and reliable questionnaire and this 
questionnaire is designed to measure the comfort level of contact lens wearing (Arroyo-del 
Arroyo et al., 2022).  
Contact lenses are not only used to replace the wearing of glasses but are also used for 
treatments and cosmetic purposes. It is estimated that there are 140 million contact lens wearers 
worldwide (Cope et al. 2017). Therefore, it is not surprising that the wearing of contact lenses 
is the latest follow-up. However, contact lens wearers need to know which type of contact 
lenses are suitable for everyday activities. This is because, as soon as the contact lenses are 
placed on the eye, the lens will be on the tear film. 
The ability of a tear film to maintain its integrity in the presence of lenses is a prerequisite basis 
for the successful application of contact lenses. Lack of interaction between tears and lenses is 
the most common reason for contact lens wear failure (Downie & Craig., 2017). The most 
common symptoms reported by contact lens wearers are dryness and discomfort in the eyes 
(Nursyuhada. 2021). 
 
 

 
 
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2.1 LITERATURE REVIEW 
 
Contact lens materials are classified by the Food and Drug Administration (FDA) and 
international organizations based on water content and balanced ionic properties, aligning with 
their clinical performance impact. Group I lenses, with low water content and non-ionic 
properties, tend to be the most stable and least influenced by tear film and environmental factors. 
Conversely, Group IV lenses, characterized by high water content and ionic properties, are more 
reactive and prone to interaction with positively charged proteins like lysozyme, with potential 
impacts from different pH solutions. Group II and III lenses fall between these extremes and 
exhibit varying performances (Jones & Dumbleton, 2019). 
  
Over recent decades, the evolution of contact lens materials to meet consumer demands has 
posed a significant challenge for manufacturers. Consequently, numerous studies have been 
undertaken to evaluate ocular comfort levels associated with various types of contact lenses, 
such as hydrogel and hydrogel silicone lenses. Mutalib et al. (2018) demonstrated no significant 
difference in comfort levels between female students at Universiti Kebangsaan Malaysia KL 
Campus when wearing hydrogel versus silicone hydrogel lenses. 
 
Assessment of contact lens application typically occurs before and after lens wear. Ocular 
comfort during lens wear depends on the interaction between the lens and ocular tissue, the 
wearer's ocular physiological state, and their adherence to lens wear. Mutalib et al. (2018) 
highlighted the significant impact of mechanical interaction between lens and ocular surfaces 
on comfort levels. Additionally, a study by Santodomingo, Rubito et al. (2010) found no 
significant difference in comfort levels between hydrogel and hydrogel silicone lenses, with 
both showing a decrease in comfort after a day of wear. 
 
Conventional hydrogel lenses often feature high water content to enhance oxygen permeability, 
yet this can lead to increased dehydration and potential physiological eye disorders (Ruiz-
Alcocer et al., 2018). Ruiz-Alcocer et al. (2018) demonstrated that disposable contact lenses 
can mitigate some issues associated with prolonged wear. Efforts to improve conventional 
lenses include the introduction of new hydrogels with a water content of 78%. Furthermore, 

 
 
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studies by Ruiz-Alcocer et al. (2018) found no difference in tear osmolality between contact 
lenses, suggesting that tear dryness symptoms may not be significantly impacted by lens type. 
 
The corneal epithelium and conjunctiva play crucial roles in protecting the cornea and 
conjunctival layers. It's widely acknowledged that epithelial disorders can predispose 
individuals to fungal, viral, or bacterial eye infections. However, research also indicates that 
corneal infections can stem from conditions involving cellular epithelium, tear film 
biochemistry, and bacterial resistance to epithelial basal lamina (Brautaset et al., 2008).  
 
In wearers of hydrogel soft contact lenses, staining on the conjunctival epithelium may result 
from various physical factors such as pressure from the lens edge, edge defects, and lens 
removal techniques (Brautaset et al., 2008). 
 
Lakkis and Brennan (1996) conducted a study involving 50 hydrogel contact lens wearers and 
50 non-contact lens wearers, revealing that 98% of lens wearers exhibited some degree of 
corneal staining compared to only 12% of non-wearers. Moreover, 62% of lens wearers 
experienced corneal staining exceeding grade 1 on the Efron scale. 
 
Corneal staining in hydrogel contact lens wearers is attributed to tear film dysfunction, hypoxia, 
mechanical forces, exposure, metabolic disorders, toxic or allergic reactions, and infectious 
reactions. The prevalence of corneal staining in hydrogel contact lens wearers ranges from 
approximately 30% to 55.7% (Brautaset et al., 2008). Nicholas et al. (2000) also noted 
associations between staining presence and levels with non-compliance regarding contact lens 
care systems, use of rewetting drops, and absence of a lens replacement plan. However, no 
associations were found with age, gender, medications, continued wear versus daily wear, 
wearing time, lens type, water content, or contact lens care system (Brautaset et al., 2008). 
 
Research by Nicholas and Sinnott (2006) revealed a higher likelihood of dry eyes associated with 
the use of high water content contact lenses. However, lens ionization was not found to be linked 
to dry eye symptoms. In a subsequent analysis, they demonstrated that compared to Group I FDA 
contact lenses, both Group II and IV FDA lenses were associated with a 2-3 times increase in the 
likelihood of dry eyes for contact lens wearers. Additionally, in a small study involving 10 
subjects by Wilson et al. (1998), better comfort was reported for patients using randomly paired 

 
 
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lenses from Group II (high water content but non-ionic) and Group IV (high water content and 
ionic) FDA contact lenses (Jones et al., 2013). 
Maïssa et al. (2012) conducted a study to investigate the impact of silicone hydrogel contact lenses 
on the ocular surface. They compared circumlimbal conjunctival staining and comfort levels 
among wearers of ACUVUE OASYS hydrogel silicone lenses (knife edge design), AIR OPTIX, 
Biofinity (chisel edge rounded edge combination), PureVision (rounded edge design), and 
ACUVUE 2 hydrogel lenses (knife edge design). Their findings indicated that rounded edge 
design lenses produced minimal circumlimbal staining but lower comfort levels, whereas knife 
edge design lenses resulted in higher circumlimbal staining but greater wearer comfort. However, 
the observed conjunctival staining and comfort levels were attributed to lens design rather than 
focusing solely on the material effects of different silicone hydrogel compositions. 
Similarly, Efron et al. (1986), as cited in Jones et al. (2013), compared comfort levels among 
contact lenses based on water content. They found that lenses with lower water content (38%) 
were more comfortable than those with higher water content. Notably, the study excluded 
potential confounding factors such as lens edge design or surface finish, as all lenses were cut to 
the same shape and sourced from the same manufacturer. 
Additionally, Young et al. (1997) conducted a study assessing comfort to predict successful 
contact lens wear. They evaluated lenses with low (38%), medium (54%-58%), and high (69%-
74%) water content. Their findings recommended lenses with lower water content for greater 
wearing comfort. 
Research on the evaluation of contact lens-related dehydration during initial application is 
extensive, as understanding the hydrating properties of hydrogel lenses is crucial due to various 
clinical implications. Dehydration can lead to changes in lens fit, discomfort, reduced oxygen 
transmission, and increased corneal drying (Nichols et al., 2002). Andrasko et al. (1983) reported 
that hydrogel lenses can dehydrate by 7%-11% during the first 30 minutes of wear, with thicker 
lenses exhibiting lower dehydration rates compared to thinner ones. Additionally, lenses with 
high water content experience more significant water loss than those with low water content, even 
at the same thickness. 
The rate of oxygen absorption in the cornea is influenced by oxygen transmission (Dk) and lens 
thickness (t), with thinner lenses allowing more oxygen to reach the cornea (Jones & Dumbleton, 
2019). Ideally, hydrogel lenses should have high oxygen transmission and thin central thickness. 

 
 
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However, this combination is impractical as it tends to lead to rapid dehydration and significant 
corneal staining (Jones & Dumbleton, 2019). 
Maintaining a healthy ocular surface is essential for comfortable contact lens wear and to avoid 
serious complications. However, many contact lens wearers, even without underlying conditions 
such as blepharitis or meibomian gland dysfunction, report higher rates of dryness (Chalmers, 
2014). The stability of the tear film and ocular surface greatly influences the success of contact 
lens 
While there is no specific classification for hydrogel silicone contact lens groups, various 
materials such as somofilcon A, comfilcon A, fanfilcon A, samfilcon A, hilafilcon B, and others 
are utilized in their manufacture. Numerous studies have investigated the effects of wearing 
different material contact lenses on wearers. For instance, Iskeleli et al. (2013) compared tear 
evaluation before and after three months of wearing hydrogel silicone contact lenses from two 
different generations: Focus-Night & Day™  hydrogel silicone lenses for Group 1 and Air 
Optix ™ silicone lenses for Group II. Statistical analysis indicated no significant differences 
between the two groups in terms of tear break-up time (TBUT) and Schirmer test values. 
Similarly, Uğurlu et al. (2019) examined tear quantity and quality before the initial use of 
contact lenses and after one month and three months of wear. They compared Bausch & Lomb 
Ultra (samfilcon A) hydrogel silicone lenses on the right eye with Johnson-Johnson Vision 
Acuvue Oasys hydrogel silicone lenses (senofilcon A) on the left eye. No significant 
differences were observed in TBUT and Schirmer test values between the application of 
hydrogel silicone lenses made from samfilcon A and senofilcon A materials. 

 
 
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2.2    Problem statement and study justification  
Since 2019, there has been limited research conducted in Malaysia regarding tear quality, corneal 
effects, and comfort levels associated with FDA contact lens groups. Recent studies in the realm 
of soft contact lenses have predominantly focused on silicone hydrogel varieties. 
Existing literature indicates that contact lens application can alter tear layer parameters, although 
quantitative data on tear production resulting from contact lens wear has received scant attention 
(Downie & Craig, 2017; Razak et al., 2018). Information regarding tear quantity following 8 
hours of contact lens wear is particularly lacking, necessitating further investigation into the 
effects of different contact lens types over longer durations (Razak et al., 2018). 
Various contact lens brands exhibit differences in water content and thickness, with hydrogel 
lenses typically thinner than soft lenses with higher water content (Jones & Dumbleton, 2019). 
Notably, individuals may respond differently to lens thickness and water content variations. 
While some wearers may prefer thin lenses with low water content, others may find thicker lenses 
with medium or high water content more comfortable (Jones et al., 2013). 
Since 2019, there has been limited research conducted in Malaysia regarding tear quality, corneal 
effects, and comfort levels associated with FDA contact lens groups. Recent studies in the realm 
of soft contact lenses have predominantly focused on silicone hydrogel varieties. 
Existing literature indicates that contact lens application can alter tear layer parameters, although 
quantitative data on tear production resulting from contact lens wear has received scant attention 
(Downie & Craig, 2017; Razak et al., 2018). Information regarding tear quantity following 8 
hours of contact lens wear is particularly lacking, necessitating further investigation into the 
effects of different contact lens types over longer durations (Razak et al., 2018). 
Various contact lens brands exhibit differences in water content and thickness, with hydrogel 
lenses typically thinner than soft lenses with higher water content (Jones & Dumbleton, 2019). 
Notably, individuals may respond differently to lens thickness and water content variations. 
While some wearers may prefer thin lenses with low water content, others may find thicker lenses 
with medium or high water content more comfortable (Jones et al., 2013). 
 

 
 
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Differences in water content within soft contact lenses may contribute to corneal dehydration, 
leading to dryness in the eyes. Despite advancements in soft contact lens manufacturing, instances 
of corneal allergies or sensitivities to such lenses have been reported (Moreddu et al., 2019). 
Studies suggest that changes in the tear film may occur within the first hour of contact lens wear, 
but quantitative data on tear film thickness post-application is lacking (Nichols et al., 2004). 
Furthermore, there is limited data available for tear assessment, corneal staining, and comfort 
levels among FDA contact lens groups I, II, III, and IV, with recent studies predominantly 
focusing on silicone hydrogel lenses. Therefore, this study aims to compare tear quality and 
quantity, as well as comfort levels, between these contact lens groups and silicone hydrogel 
lenses. 
While tear assessment before and after wearing silicone hydrogel lenses may reveal significant 
changes, no substantial differences are observed between different silicone hydrogel materials. 
However, factors such as water content, material composition, wearing duration, and lens 
deposition are more closely associated with corneal staining than contact lens care solutions, 
ocular surface characteristics, tear composition, demographics, or medical factors (Nichols & 
Sinnott, 2011). 
In response to consumer needs, advancements in contact lens technology continue, with efforts 
aimed at enhancing wearer comfort. Innovations such as the incorporation of wetting agents, 
hydrophilic monomers, surface treatments, and water gradient surface technology are introduced 
to mitigate the impact of wearing silicone hydrogel lenses on the tear layer (Sulley & Dumbleton, 
2020). Therefore, ongoing research into technological and material developments in contact lens 
manufacturing is essential to understand their effects on consumers and to facilitate future 
improvements. 
 
 
 
 
 
 
 

 
 
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2.3   Research Questions 
Is there a discrepancy in tear assessment, corneal staining, and comfort levels before and after 
one day (8 hours) of wearing FDA contact lenses Group I, II, III, IV, and V among undergraduate 
students at UKM Kuala Lumpur Campus? 
2.4   Research Hypothesis 
Among UKM undergraduate students at the Kuala Lumpur Campus, there was no significant 
disparity observed in tear assessment, corneal staining, and comfort levels before and after one 
day (8 hours) of wearing Group I, II, III, IV, and silicone hydrogel contact lenses. 
 
2.5   Conceptual framework 
Figure 1 illustrates the conceptual framework for assessing tear quantity, corneal staining,  
and comfort levels during the wear of FDA contact lenses Group I, II, III, IV, and V materials. 
 
 
 
 

 
 
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Clifficasi Kanta Lakep American Food & Drugs 
Association (FDA) 
Silicone hydrogel 
Ionic Hydrogel 
Non-Ionic 
Hydrogel 
Corneal staining before and after 8 
hours of contact lens application 
using fluorescein strips and 
biomicroscope slitlamp 
 
Assessment of tears before and after 
8-hour contact lens application 
using Schirmer test and NIBUT test 
 
Comparison between FDA I, II, III, IV and V contact 
lenses 
FDA II 
Contact Lens 
H2O > 50%  
FDA IV 
Contact Lens 
H2O > 50%  
FDA III 
Contact Lens 
H2O < 50% 
Material 
Vb 
Material 
Va 
FDA I 
Contact Lens 
H2O < 50%  
Comfort level after 8 hours of 
contact lens wearing using Contact 
Lens Discomfort Index 
questionnaire 

 
 
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2.6      Objectives  
 
2.6.1    General Objectives: 
The objective is to examine the impact of FDA contact lenses Group I, II, III, IV, and silicone 
hydrogel on tear assessment, corneal staining, and comfort levels among undergraduate students 
at UKM Kuala Lumpur Campus. 
 
2.6.2    Specific Objectives: 
i. 
Assessing tear quantity, corneal staining, and comfort levels before and after 8 hours of 
wearing FDA contact lenses Group I, II, III, IV, and silicone hydrogel. 
ii. 
Contrasting tear evaluation and corneal staining pre- and post-8-hour application of FDA 
contact lenses Group I, II, III, IV, and silicone hydrogel. 
iii. 
Comparing comfort levels pre- and post-8-hour wear among FDA contact lenses Group I, 
II, III, IV, and silicone hydrogel (Va and Vb). 
 
3.0 METHODOLOGISTS 
3.1.1 
Study Design 
The studies is a mixed, clinical trials and cross-sectional studies. 
3.1.2 
Sampling Method 
Random sampling is used in this study. 
3.1.3        Study Location 
The study will take place at the Optometry Clinic within the Optometry and Vision Sciences 
Programme, Faculty of Health Sciences, Universiti Kebangsaan Malaysia. This location was 
selected due to its status as the primary clinic for optometry practice within the Faculty of Health 
Sciences, equipped with all necessary equipment for the study. Situated centrally within the 
Faculty of Health Sciences, it offers convenient access for undergraduate subjects participating 
in the study. 
 

 
 
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3.1.4 Study Sample Calculation 
The sample size for this study was determined using the Daniel formula (1999), with a total of 
10% of the overall sample size allocated for the study. Considering a dropout rate of 10%, a total 
of 18 subjects were required for the study. 
n = 
𝑍2𝑃(1−𝑃)
𝑑2
 
n = 
(1.96) (0.3)(1−0.3)
(0.05)
2
 
n = 
 0.4116 
0.0025  
n = 164.64 
n study = 10% x 164.64 
              = 16.46 
              = 16 
Dropout rate = 10% x 16  
                                = 1.6 
                                = 2 
Total subjects = 16 + 2  
                       = 18 subjects 
 
n = required sample size  
      = 1.96, the value of Z when the confidence level is 95% 𝑍2 
     P = 0.3, prevalence of contact lens clinic patients at UKM Optometry Clinic in semester 2,          
session 2022/2023 
     d = 0.05, margin of error  

 
 
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3.1.5    Subject 
UKM undergraduate students' Kuala Lumpur Campus was chosen as the subject of study 
because the location of the study was at the UKM Optometry Clinic located at the Kuala 
Lumpur Campus of UKM.  
3.1.6 Participation Criteria 
1. 
Healthy volunteered individuals between 19 and 29 years old. 
2. 
Individuals with a refraction power of less than -6.00 spherical diopters and astigmatism 
power of less than -1.00 cylindrical diopters. 
3. 
Experienced contact lens wearers. (Participants are asked to lay off contact lenses for at 
least 2 weeks before the clinical trial starts (McKernan et al., 2014)) 
3.1.7    Exclusion Criteria 
1. 
Individuals who smoke (Ward et al. 2010) 
2. 
Individuals with history of diseases on the ocular surface, ocular trauma, refractive  
surgery, intraocular and extraocular surgery. 
3. 
Pregnant individuals (Yenerel &; Kucumen, 2015). 
4. 
Individuals taking systemic drugs that can cause dry eyes (Fraunfelder et al. 2012). 
 
3.1.8     Instruments 
1. 
Hydrogel soft contact lenses Group I, II, III, IV, Va and Vb 
2. 
Schirmer Strip 
3. 
Fluoresine Strip 
4. 
Saline solution 
5. 
Multipurpose solution – Maxvue  
6. 
Slitlamp Biomicroscope 
7. 
Bausch & Lomb Keratometer 
8. 
Contact Lens Discomfort Index Questionnaires (CLDI) 

 
 
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3.1.9 
Study Protocol 
 
Participants for this study will be recruited from among UKM undergraduate students at the Kuala 
Lumpur Campus based on the inclusion and exclusion criteria. Recruitment of volunteers will be 
conducted through advertisement. Simple random sampling will be used for participant selection, 
with those meeting the inclusion criteria being eligible for the study, while those meeting the 
exclusion criteria will be dismissed. 
 
Before the commencement of the clinical trial, all participants will be provided with a consent 
form to review. The study will take place at the UKM Optometry Clinic, Jalan Raja Muda Abdul 
Aziz, Kuala Lumpur, Malaysia. 
 
Participants will be required to attend the UKM Optometry Clinic for three sessions, each lasting 
8 hours, during which they will wear FDA hydrogel contact lenses (groups I, II, III, IV, Va and 
Vb). Each lens will be placed on one eye only. Hence, the study will involve three wearing 
sessions, with the first session focusing on groups I and II FDA contact lenses, the second session 
on groups III and IV FDA contact lenses, and the third session on hydrogel silicone contact lenses 
Va and Vb. A 2-week rest period will be provided between each session. 
The complete study procedure is outlined as follows: 
 
Care for Contact Lenses Leaflet. 
 
Ensuring proper hygiene and technique is crucial to prevent eye health complications while 
wearing contact lenses. Subjects will receive thorough guidance on essential practices, including: 
maintaining hygiene care, correctly utilizing contact lens solution, applying and removing contact 
lenses, and adhering to permissible actions during wear. Additionally, subjects will be provided 
with a hotline for any inquiries or emergencies arising during contact lens use. Furthermore, they 
will receive a pamphlet titled "Soft Contact Lens Instructions" available at the UKM KL 
Optometry Clinic. 
 
 

 
 
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. 
 
Figure 1 & 2. Soft contact lens use instructions 
Pre-Assessment 
A pre-assessment will precede the contact lens application during the initial session. The 
parameters measured will include these three tests: a) assessment of tear quantity using the 
Schirmer Test, b) evaluation of tear quality with the NIBUT Test, and c) examination of corneal 
staining using the Efron Grading Scale. These same tests will be conducted after the contact lenses 
have been worn for 8 hours and subsequently removed. 
 
a) Tear Quantity Assessment (Schirmer Test) 
To assess tear quantity, the Schirmer test will be employed using a 5mm x 30mm Schirmer strip. 
The strip will be positioned in the temporal area of the subject's lower eyelid. The subject will be 
instructed to look upwards and blink naturally for 5 minutes, after which the Schirmer strip will 
be removed. The length of the wet portion of the strip will be measured and documented. Three 
readings will be obtained in millimeters (mm), and the average reading will be calculated for data 
analysis (Kallarackal et al., 2002). 
 
b) Tear Quality Assessment (NIBUT Test) 
The assessment of tear quality was conducted using the Non-Invasive Break Up Time Test 
(NIBUT) technique with the Bausch & Lomb keratometer. The subject was instructed to rest their 

 
 
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chin on the designated chin rest and align their forehead with the headrest. Initially, the subject 
blinked several times and then refrained from blinking. Time was measured from the last blink 
until the appearance of any distortion or break in the "mires." This time interval was recorded as 
the NIBUT measurement. If the subject blinked during the measurement, the test was paused 
briefly, and resumed after a few blinks. A one to two-minute break was provided between each 
measurement. Three readings were taken, and the average of these readings was utilized for 
subsequent statistical analysis (Mohidin et al., 2002). 
 
c) Corneal Coloring Assessment (Efron Grading Scale) 
The evaluation of corneal staining will involve using the Efron Grading Scale to assess any marks 
or damage on the subject's cornea before applying contact lenses. Initially, fluorescein dye will 
be applied to the subject's eyes using fluorescein strips moistened with saline solution. The subject 
will be instructed to look up, and the moistened fluorescein strip will be gently touched to the 
lower eyelid, followed by blinking. Using a biomicroscopic slit lamp equipped with a blue cobalt 
light, any staining or markings on the cornea will be examined. Any observed findings will be 
documented according to the Efron Grading Scale. Subsequently, the subject's eyes will be rinsed 
with saline solution to remove the fluorescein dye. The cornea will be divided into five zones 
(central, superior, inferior, temporal, and nasal) for recording observations, as depicted in Figure 
1. The Efron Grading Scale, recognized for its suitability in assessing corneal coloring, will guide 
the evaluation process (Dundas et al., 2001; Woods & Fonn, 2018). (Dundas et al., 2001; Woods 
& Fonn, 2018). 
 

 
 
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Figure 3. Grading Scale Based on 5 Corneal Zones 
 
i. 
Contact lens application 
The placement of group I FDA contact lenses will occur on one side of the subject's eye, while 
group II FDA contact lenses will be positioned on the opposite side, with the positioning being 
randomized and unknown to the subjects. Researchers will delicately insert the contact lenses, 
providing clear instructions and precautions to the subjects regarding their wear. Subjects will be 
advised to remain near the UKM KL Campus throughout the contact lens application and return 
to the UKM Optometry Clinic after 8 hours for lens removal. Additionally, subjects will be 
instructed to promptly notify the researcher of any discomfort, pain, or unforeseen issues related 
to the wearing of contact lenses. 
 
ii. 
Post-Wear Assessment 
The researcher will remove the contact lenses from the subject's eyes. Subsequently, a post-
wearing examination of the contact lenses will be conducted. This examination mirrors the pre-
use assessment and includes a) evaluating tear quantity using the Schirmer Test, b) assessing tear 
quality with the NIBUT Test, and c) grading corneal staining based on the Efron Grading Scale. 
Following the removal of contact lenses, subjects will be required to complete the Contact Lens 
Discomfort Index (CLDI) questionnaire twice at each appointment: once for the right eye and 
once for the left eye. This allows for the measurement of comfort levels separately for each eye. 
 
d) Contact Lens Discomfort Index Questionaires (CLDI) 
The CLDI questionnaire will be employed to evaluate the comfort level during the usage of Group 
I and II FDA contact lenses. This questionnaire's selection of questions is rooted in the Contact 
Lens Dry Eyes Questionnaire (CLDEQ)-8. Known for its robustness and reliability, the CLDI 
questionnaire is specifically crafted to gauge comfort levels associated with contact lens wear 
(Arroyo-del Arroyo et al., 2022). 

 
 
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Figure 4.   Contact Lens Discomfort Index (CLDI)  Questionnaire  

 
 
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i. 
Rest Period 
A "washout period," also known as a rest period, lasting for two weeks will be provided to the 
subjects to prevent any unauthorized observations. 
 
ii. 
Second and Third Appointments 
Subjects will be required to attend a second appointment following a rest period for the 
application of group III and IV FDA contact lenses. This appointment will involve the repetition 
of the procedure, including pre-application examination, contact lens wear, post-use examination, 
and subsequent rest period. The same procedure will be replicated for a third appointment 
involving the wearing of silicone hydrogel contact lenses Va and Vb. 
 
 
 

 
 
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Lens III 
On one eye 
Lens I 
On one eye 
3.1.10 Flow Chart  
 
 
 
 
 
 
 
 
 
 
 
Wash-off period 
(2 weeks) 
Phase 2 
Tear assessment and corneal staining 
before lens wear 
Lens IV 
On One Eye 
Tears and Corneal Staining Assessment 
after 8 hrs of wearing 
Questionnaires after 8 hrs of lens wearing 
Data Analysia 
Phase 1 
Tear assessment and corneal staining 
before lens wear 
Lens II 
On One Eye 
Tears and Corneal Staining Assessment 
after 8 hrs of wearing 
Questionnaires after 8 hrs of lens wearing 
Data Analysia 

 
 
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Lens Va 
On one eye 
                                                                                                                                                 
 
 
 
 
 
 
 
 
 
 
 
 
 
3.1.11 Data Analysis 
The forthcoming study will employ IBM SPSS Statistics Version 27 for data analysis. The 
normality of the data will be assessed utilizing the Shapiro-Wilk test. Subsequently, the 
distribution of the data will be examined accordingly. 
 
i. 
Utilize the Paired t-test for normally distributed data or the Wilcoxon signed-rank test for 
non-normally distributed data to assess the disparities in tear quality and quantity before and after 
ii. 
Employ the Paired t-test for normally distributed data or the Wilcoxon signed-rank test 
for non-normally distributed data to compare the mean quality and quantity of tears between FDA 
contact lens application groups I and II, groups III and IV, as well as silicone hydrogel materials 
A and B. 
Phase 3 
Tear assessment and corneal staining 
before lens wear 
Lens Vb 
On One Eye 
Tears and Corneal Staining Assessment 
after 8 hrs of wearing 
Questionnaires after 8 hrs of lens wearing 
Data Analysia 
Manuscript & Thesis 

 
 
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iii. 
Employ the Paired t-test for normally distributed data or the Wilcoxon signed-rank test 
for non-normally distributed data to assess the comfort levels associated with the application of 
FDA contact lenses within groups I and II, groups III and IV, as well as silicone hydrogel 
materials A and B. 
4.0 ETHICAL APPROVAL 
Ethical approval has been approved by the UKM Research Ethics Committee, The National 
University of Malaysia JEP-2023_679 (18 Dec 2023 – 18 March 2025). 
 

 
 
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5.0 GANTT CHART 
 
Year 
2024 
Activity (Month) 
JAN 
FEB 
MAR 
APR 
MAY 
JUN 
JUL 
AUG 
SEP 
OCT 
NOV 
DEC 
Proposal Submission 
  
  
  
  
  
  
  
  
  
  
  
  
Ethics Approval 
  
  
  
  
  
  
  
  
  
  
  
  
Material Preparation 
  
  
  
  
  
  
  
  
  
  
  
  
Clinical Trial 
  
  
  
  
  
  
  
  
  
  
  
  
Data Analysis 
  
  
  
  
  
  
  
  
  
  
  
  
Manuscript Writing 
  
  
  
  
  
  
  
  
  
  
  
  
Presentation 
  
  
  
  
  
  
  
  
  
  
  
  
Manuscript 
Submission 
  
  
  
  
  
  
  
  
  
  
  
  
 
 
 

 
 
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