The Impact of Contact Lens Coefficient of Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE)
Phase: PHASE4
Conditions: Lid Wiper Epitheliopathy
Sponsor: University of Houston

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
Page 1 of 20 
Revised: June 18, 2021 
 
The Impact of Contact Lens Coefficient of Friction (CoF) on the Development of Lid Wiper 
Epitheliopathy (LWE) 
 
  
ClinicalTrials.gov Identifier: NCT03209505 
 
18 June 2021 
 
 

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
Page 2 of 20 
Revised: June 18, 2021 
 
 
 
PRINCIPAL INVESTIGATORS: 
Eric Ritchey, OD, PhD  
Clinical Assistant Professor  
University of Houston College of Optometry  
ERRitche@central.UH.edu   
713-743-1933  
 
Rachel Redfern, OD, PhD 
Assistant Professor 
University of Houston College of Optometry 
Rredfern@central.uh.edu 
713-743-1943 
 
 

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
Page 3 of 20 
Revised: June 18, 2021 
Table of Contents 
1.0 
Objectives ............................................................................................................................ 4 
2.0 
Background .......................................................................................................................... 4 
3.0 
Inclusion and Exclusion Criteria .......................................................................................... 5 
4.0 
Vulnerable Populations ........................................................................................................ 6 
5.0 
Number of Subjects.............................................................................................................. 7 
6.0 
Recruitment Methods ........................................................................................................... 7 
7.0 
Study Endpoints ................................................................................................................... 8 
8.0 
Procedures Involved............................................................................................................. 8 
9.0 
Setting ................................................................................................................................ 15 
10.0 Drugs or Devices................................................................................................................ 15 
11.0 Risks to Subjects ................................................................................................................ 15 
12.0 Potential Benefits to Subjects ............................................................................................ 16 
13.0 Withdrawal of Subjects ...................................................................................................... 16 
14.0 Costs/Payments to Subjects ............................................................................................... 16 
15.0 Compensation for Research-Related Injury ....................................................................... 17 
16.0 Confidentiality ................................................................................................................... 17 
17.0 Provisions to Protect the Privacy Interests of Subjects. ..................................................... 17 
18.0 Informed Consent Process ................................................................................................. 18 
19.0 HIPAA ............................................................................................................................... 18 
20.0    Data Management .............................................................................................................. 18 
21.0    Specimen Use and Banking ............................................................................................... 18 
22.0    Sharing of Results with Subjects ....................................................................................... 18 
23.0    Resources ........................................................................................................................... 18 
 
 
 

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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Revised: June 18, 2021 
1.0 
Objectives 
The primary study objectives are to determine the amount of Lid Wiper 
Epitheliopathy (LWE) induced in subjects after contact lens fitting that do not 
have LWE at study enrollment. Subjects in the trial will be fit in 2 contact lenses 
with different coefficients of friction (CoF). One eye will be fit in a contact lens 
with a low coefficient of friction (Acuvue Oasys®, Johnson & Johnson Vision, 
Jacksonville FL) while the contralateral eye will be fit in a contact lens with a 
high CoF (Air Optix® Night & Day® Aqua, Ft. Worth, TX), as reported in the 
scientific literature. The eye receiving each lens will be assigned randomly. The 
presence of LWE will be assessed at 2 different time points:  
• Approximately 2 hours after contact lens fitting and 
• After 7(±2) days of contact lens wear 
 
Study Hypotheses: Contact lenses with a greater coefficient of friction will induce 
a greater amount of LWE than contact lenses with a lower coefficient of friction. 
The presence of LWE will be assessed at 2 different study time points. As such, 
the following hypotheses will be tested: 
 
After one week of contact lens wear 
• H01: There is no statistically significant difference in the amount of 
LWE between contact lenses with different coefficients of friction  
• Ha1: There is a statistically significant difference in the amount of 
LWE between contact lenses with different coefficients of friction  
After 2 hours of contact lens wear 
• H02: There is no statistically significant difference in the amount of 
LWE between contact lenses with different coefficients of friction  
• Ha2: There is a statistically significant difference in the amount of 
LWE between contact lenses with different coefficients of friction  
 
2.0 
Background 
Today in clinical practice, dropout from contact lens wear remains a significant 
problem, with up to 34% of patients discontinuing lens wear. Contact lens 
discomfort is one of the main causes of contact lens dropout. There are many 
factors that may play a role in contact lens comfort, but the primary factor may be 
the interaction of the eyelid and the contact lens material. It has been proposed 
that reduced contact lens lubricity, a measure of the friction inherent to a contact 
lens material, may lead to increased contact lens discomfort. Contact lens 
lubricity can be described by the coefficient of friction (CoF) of the contact lens 
material. CoF has been reported to be inversely proportional to reported contact 
lens comfort; therefore, materials with a higher CoF tend to be less comfortable. 

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
Page 5 of 20 
Revised: June 18, 2021 
While CoF is a useful laboratory metric, it cannot be measured clinically. 
Therefore, a clinical corollary for CoF may be useful in determining which 
contact lens materials will minimize the potential for contact lens dropout. A 
possible clinical corollary for CoF is Lid Wiper Epitheliopathy (LWE), which has 
been reported to be related to contact lens discomfort. LWE leads to a loss of 
superficial epithelial cells in the lid wiper region of the eyelid. If CoF is indeed 
related to contact lens discomfort, subjects wearing a high CoF lens could 
potentially develop greater amounts of LWE compared to that observed with a 
low CoF lens.  
While previous studies have determined the amount of LWE present in habitual 
contact lens wearers and non-contact lens patients, it is currently unknown how 
quickly LWE may develop in patients after contact lens fitting. Development of 
LWE in the post-contact lens fitting period may allow clinicians to predict the 
potential for contact lens discomfort and future dropout. This pilot study will 
collect data examining the development of LWE in the period immediately 
following contact lens fitting (2 hours post-fit) and after approximately 1 week of 
contact lens wear, corresponding to the time for a typical post-contact lens fitting 
assessment in clinical practice. 
 
3.0 
Inclusion and Exclusion Criteria 
Potential study subjects must meet the following study inclusion criteria: 
1. Must be able to read and understand the study informed consent 
2. Must be a minimum of 18 years of age and less than 46 years of age at 
study enrollment 
3. Must be healthy non-soft contact lens wearers (neophytes), or experienced 
contact lens wearers that have not worn their contact lenses for a minimum 
of 7 days 
4. Have a spherical equivalent refractive error between –0.75 to –6.50DS at 
the spectacle plane  
5. The subject must be able to attend study visits at the prescribed visit times 
and adhere to the study instructions 
Potential study subjects cannot meet any of the following study exclusion criteria:  
1. Pregnant and/or lactating females by self-report 
2. Presence of current LWE on the upper eyelid (>0.5 in height or width)  
3. Has greater than –1.00DC of refractive cylinder 
4. Has greater than 1.00D of anisometropia 
5. Is aphakic 
6. Has clinically significant corneal or conjunctival staining that would 
prevent contact lens fitting, as assessed with sodium fluorescein dye 

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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Revised: June 18, 2021 
7. Has significant ocular surface disease (e.g. Sjögrens Disease, Stevens-
Johnson Syndrome, etc.) or significant Dry Eye Syndrome 
8. Has clinically significant corneal vascularization or central corneal scaring 
9. Has active ocular surface infection (e.g. conjunctivitis) 
10. Has a positive history of eyelid surgery or trauma  
11. Has a positive history of refractive surgery 
12. Takes medications that significantly impact contact lens comfort and/or 
ocular surface health 
13. Has taken part in another contact lens or contact lens solution clinical trial 
within the last 7 days 
14. Is unwilling to have eyes photographed or video recorded 
Potential subjects will be initially screened for study eligibility through collection 
of demographic data and medical history. An upper age limit for study inclusion 
is set at 46 years of age to 1) prevent the inclusion of presbyopic patients (i.e. 
those that need bifocal glasses), given that the contact lenses used in the study are 
single vision contact lenses and 2) reduce the number of individuals who would 
screen fail due to significant dry eye disease. Subjects will complete a 
questionnaire, the Ocular Surface Disease Index (OSDI), and subjects with a 
score ≥23 will be excluded from the study. A slit lamp evaluation will be 
performed to screen for the presence of LWE of the upper lid and for significant 
corneal/conjunctival staining that would prevent contact lens fitting. If the subject 
does not have LWE, the subjects will be refracted to determine eligibility based 
on their refractive error. If the refractive error is within the study specified 
inclusion criteria, the subject will be fit into contact lenses.  
4.0 
Vulnerable Populations 
The following vulnerable populations will be excluded from the study: 
1. Adults unable to consent 
2. Individuals who are not yet adults (infants, children, teenagers under the 
age of 18) 
3. Pregnant/lactating women 
4. Prisoners 
The following vulnerable population may be included in the study: 
1. Students for whom the principal investigators have direct access 
to/influence on grades.  
 
Study subjects may be students for whom the principal investigators have access 
to or influence over their grades. For this reason, the principal investigators will 
not be responsible for recruiting or obtaining consent from students in their own 

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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Revised: June 18, 2021 
courses in order to prevent undue influence or coercion. A study team member 
(e.g. study coordinator) without access to or influence on grades will be 
responsible for these tasks. 
 
5.0 
Number of Subjects 
 
The proposed single-site study will be conducted at The Ocular Surface Institute 
at the University of Houston College of Optometry. Up to 60 subjects will be 
screened for study inclusion, with the goal of completing 20 subjects. Subjects 
that screen fail may be rescreened for study inclusion up to 3 additional times at 
the discretion of the study investigator.  
Currently, there is no information on the time from contact lens fitting to the 
development of LWE. This pilot study is designed to collect data which can be 
used to determine the sample size required to conduct a larger-scale clinical trial. 
It is anticipated that enrolling 20 subjects will approach the requirements of the 
central limit theorem for statistical analysis. Since the subjects in the study will be 
wearing FDA-approved contact lenses on a daily wear modality (i.e. not sleeping 
in contact lenses), the study does not present more than minimal risk to the 
subject and a power analysis is not required.  
 
6.0 
Recruitment Methods 
 
Potential subjects will be recruited from the patients, students and staff of the 
University Eye Institute/University of Houston College of Optometry, as well as 
the surrounding community via verbal communication, print media (e.g. study 
fliers, newspaper adverts), telephone and electronic media (e.g email, The Ocular 
Surface Institute Website, social media). Additionally, potential subjects will be 
identified and recruited via The Ocular Surface Institute’s research database.  
The total duration of an individual subject's participation in the study will be 
approximately 1 week (±2 days). The study will consist of 3 visits on 2 days. Visit 
1.1 will be a pre-fitting clinical assessment and contact lens fitting. Visit 1.2 will 
be a post contact lens insertion assessment completed approximately 2 hours after 
contact lens fitting in Visit 1.1. Visit 2 will be a 7 day (±2 days) post-contact lens 
fitting assessment for LWE. Expected visit timing is summarized in the table 
below: 
Anticipated Visit Duration 
Study Visit 
Duration 
Visit 1.1: Baseline and Contact lens fitting 
90 minutes 
Approximately 2 hour waiting period 
Visit 1.2: 2-hour post contact lens insertion 
55 minutes 

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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Visit 2: 1-week post contact lens fitting  
55 minutes 
The anticipated duration to enroll and complete all study subjects is 
approximately 3 months. The estimated date for the investigators to complete 
primary analyses for this study is October, 2017. 
 
7.0 
Study Endpoints 
The primary study endpoints are as follows: 
• Examine the development of LWE post-contact lens fitting at the 
following time points 
o 1-week post contact lens fitting 
o 2 hours after contact lens fitting 
The secondary study endpoints are as follows: 
• Examine the level of expression in ocular surface tear MMPs post-contact 
lens fitting at the following time points 
o Pre-contact lens fitting 
o 1-week post contact lens fitting 
o 2 hours after contact lens fit 
 
8.0 
Procedures Involved 
The study is a clinical trial. Twenty subjects who are either neophytes or 
experienced soft contact lens wearers who have not worn contacts for at least the 
past 7 days will be enrolled. Patients will be seen for 3 visits over a period of 
approximately 1 week. The pre-contact lens insertion assessment (Visit 1.1) will 
determine subject eligibility for the study and will take approximately 90 minutes. 
Subjects will then be released to a waiting room for a 2-hour waiting period. The 
2-hour post contact lens fitting assessment (Visit 1.2) will take approximately 55 
minutes. The 7 day post-insertion assessment (Visit 2) will take approximately 55 
minutes.  
 
Data from subject’s routine medical care that is pertinent to the study (e.g. topical 
ophthalmic medications, oral medications, etc.) will be collected by querying the 
subject (see Step 1.1.3 below). This data will be considered subject source 
documentation and will be kept as part of the subject’s study binder in a secure 
room in the Ocular Surface Institute (TOSI).  
 
 
Sequence of Events  

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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Revised: June 18, 2021 
Note: Contact Lens wearing subjects should report to Visit 1 after discontinuing SCL wear for at 
least 7 days. Subjects should report to the visit wearing their habitual vision correction.  
 
Visit 1.1: Screening, Enrollment and Baseline  
Step 
Item 
Details 
1.1.1 
Informed Consent 
Review and complete the informed 
consent form 
1.1.2 
Subject Demographics 
Collect subject demographic data 
1.1.3 
History 
Collect subject history 
1.1.4 
Concommitant Medications 
Collect information on concomitant 
medications 
1.1.5 
Habitual Contact Lens Information 
For CL subjects, review habitual lens 
information and verify that they have 
discontinued lens wear for at least 7 
days 
1.1.6 
Preliminary Review of  
Inclusion/Exclusion Criteria 
Review Inclusion/Exclusion Criteria for 
subject study eligibility 
1.1.7 
Distance Visual Acuity 
Perform Distance, High Contrast Visual 
Acuity using Snellen optotype, OD/OS 
with the patient’s habitual correction.  
1.1.8 
Questionnaires: Ocular Surface 
Disease Index (OSDI) 
All Subjects: Administer the OSDI 
• If OSDI scores is ≥ 23; skip to 
2.9, Final Evaluation 
1.1.9 
Auto-refraction 
Perform auto-refraction and record the 
refractive error and keratometry 
readings 
1.1.10 
Oculus Keratograph 
Perform the following procedures using 
Oculus Keratograph, OD/OS 
• Non-invasive Tear Break Up 
Time (NITBUT) 
• Tear Meniscus Height 
1.1.11 
Phenol Red Thread  
Perform Phenol Red Thread test without 
anesthesia, OD/OS.  
1.22 
Ocular Surface Tear Collection 
Collect 10μL surface tears using a 
microcapillary tube. 
1.1.12 
Slit Lamp Exam with vital dye 
staining/LWE evaluation 
Instill 1 drop of NaFL + Lissamine 
Green Combination Drop, wait 5 
minutes, instill an additional drop, wait 
1 minute, then evaluate slit lamp 
findings using the CCLRU grading scale 
and evaluate LWE 

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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Revised: June 18, 2021 
• If no LWE is observed in both 
eyes, skip to Step 2.9: Final 
Evaluation and discontinue the 
subject from the trial   
• If LWE is observed in either eye, 
continue to Step 1.1.13: Digital 
Photography  
1.1.13 
Digital Photography 
Perform Digital Photography of the Lid 
Wiper region OD/OS 
1.1.14 
Subjective Refraction 
Perform Manifest Refraction using 
maximum plus to best visual acuity. 
• If the subject has > 1.00D 
refractive cylinder or greater 
than 1D of anisometropia, skip 
to Step 2.9:  Final Evaluation 
and discontinue the subject from 
the trial  
1.1.15 
Subjective Spherical Equivalent 
Refraction 
Perform Subjective Spherical 
Equivalent using maximum plus to best 
visual acuity. 
1.1.16 
Contact Lens Fitting 
Fit subject in contact lenses based upon 
the randomization schedule. Initial base 
curve should be selected as indicated in 
the fitting guide for each lens. 
• If an acceptable contact lens fit 
cannot be obtained in either eye, 
skip to Step 2.9: Final 
Evaluation and discontinue the 
subject from the trial  
1.1.17 
Contact Lens Over-Refraction 
Perform spherical over-refraction using 
maximum plus to best visual acuity 
1.1.18 
Contact Lens Power Adjustment (if 
necessary) 
Modify contact lens power, based upon 
the Contact Lens Over-Refraction, if the 
subject gains 3 or more letters acuity  
1.1.19 
2 hour Waiting Period 
Subjects released to waiting area for 2 
hours 
 
 
 
 

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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Visit 1.2 
Note: Visit should be performed approximately 2 hours after lens insertion 
1.2.1 
Visual Performance 
Perform logMAR visual acuity 
1.2.2 
Oculus Keratograph 
Perform the following procedures using 
Oculus Keratograph with the contact 
lens on eye, OD/OS 
• Non-invasive Tear Break Up 
Time (NITBUT) 
• Tear Meniscus Height 
• Video Contact Lens Fit 
1.2.3 
Ocular Surface Tear Collection 
Collect 10μL surface tears using a 
microcapillary tube. 
1.2.4 
Contact Lens Removal 
Remove the contact lenses and store in 
solution 
1.2.5 
Slit Lamp Exam with vital dye 
staining/LWE evaluation 
Instill 1 drop of NaFL + Lissamine 
Green Combination Drop, wait 5 
minutes, instill an additional drop, wait 
1 minute, then evaluate slit lamp 
findings using the CCLRU grading scale 
and evaluate LWE  
1.2.6 
Contact lens Insertion and Removal 
Training and Dispense Contact Lens 
Solution  
For Contact Lens Neophytes  
• Train on Insertion and Removal 
of contact lenses 
For all subjects 
• Educate subject on the proper 
use of the contact lens care 
solution 
1.2.7 
Exit Visual Acuity 
Perform Distance, High Contrast Visual 
Acuity using Snellen optotype with the 
patient’s habitual correction or contact 
lenses.  

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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Revised: June 18, 2021 
 
 
Visit 2: 1-Week Follow Up (±2 days) 
Note: Subjects should report to Visit 2 wearing their study assigned soft contact lenses.  
2.1 
History 
Collect subject history, compliance and 
reported wearing time  
2.2 
Visual Performance 
Perform logMAR Visual Acuity  
2.3 
Questionnaires 
Administer the OSDI to the subject 
2.4 
Oculus Keratograph 
Perform the following procedures using 
Oculus Keratograph (lens on eye for CL 
patients, bare eye for non-CL patients, 
OD/OS) 
• Non-invasive Tear Break Up 
Time (NITBUT) 
• Tear Meniscus Height 
• Video Contact Lens Fit 
2.5 
Ocular Surface Tear Collection 
Collect 10μL surface tears using a 
microcapillary tube. 
2.6 
Contact Lens Removal 
Remove the contact lenses and store in 
solution 
2.7 
Slit Lamp Exam with vital dye 
staining/LWE evaluation 
Instill 1 drop of NaFL + Lissamine Green 
Combination Drop, wait 5 minutes, instill 
an additional drop, wait 1 minute, then 
evaluate slit lamp findings using the 
CCLRU grading scale and evaluate LWE 
2.8 
Digital Photography 
Perform Digital Photography of the Lid 
Wiper region OD/OS 
Final Evaluation 
2.9 
Exit Visual Acuity 
Perform Distance, High Contrast Visual 
Acuity using Snellen optotype with the 
patient’s habitual correction.  
2.10 
Final Evaluation Form 
Complete the final evaluation form and 
indicate if the subject successfully 
completed the study 
2.11 
Protocol Deviations 
Ensure any protocol deviations have been 
recorded 
The procedures involved in the study are common clinical procedures found in 
Optometry/Ophthalmology. LWE assessment will occur following installation of 
sodium fluorescein and lissamine green ophthalmic drops. The upper and lower 
lids will be photographed using a slit-lamp biomicroscopy and a camera. 
Photographs will be de-identified and graded subjectively for LWE using the 
Korb scale (see below). Photos may also be analyzed for objective LWE grading 
using custom coding in MATLAB.  

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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Korb LWE Grading 
Grading  
Description 
Height (%) 
Width (mm) 
Final score (grade)  
0  
1  
2  
3  
no LWE 
mild LWE 
moderate LWE 
severe LWE 
<25 
25-50 
50-75 
>75 
<2 
2-4 
5-9  
>10 
<0.25  
0.25-1.00 
1.25-2.00 
2.25-3.00 
*Final LWE score is the average of the LWE Height and Width 
 
The tears collected by capillary tubes will be stored at -80°C until luminex 
multibead analysis. 15 µg of total protein will be analyzed for matrix 
metalloproteinases (MMP)-1, -2, -7, -9, -10. Pre- and post-contact lens wear 
concentrations of MMP will be compared for each subject. MMPs are a family of 
zinc proteases and an increase in MMP expression occurs in response to a wide 
range of stimuli, including adhesion molecules, growth factors, cytokines and 
hormones and is associated with ocular surface damage. The correlation 
coefficient, r, will be determined between LWE and the tear film levels of MMPs.  
A p≤0.05 will be considered statistically significant. 
 
Layman’s Description of Procedures 
Patient demographics 
The subjects will be asked questions about their 
age, sex, race and ethnicity. 
History 
The subjects will be asked questions about their 
systemic health, ocular disease and surgical 
history. 
Concomitant Medications 
The subjects will be asked questions about their 
current ocular and systemic medications. 
Habitual Contact Lens 
Information 
The subjects will be asked questions about how 
they use their current contact lenses, such as 
their current contact lens brand and wear time, as 
performed during a normal eye exam. 
Auto-refraction 
A machine will shine light into a subject's eye 
and will estimate their prescription using 
different powered lenses without making contact 
with the eye. 
Oculus Keratograph 
A machine uses a video camera to determine 
how long it takes for a subject's tear film to 

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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evaporate and the height of the pooled tears 
between the lower lid and the ocular surface 
without making contact with the eye. 
Phenol Red Thread 
A small thread containing a pH indicator that 
turns from red to yellow when it contacts tears 
will be placed at the subject's lower lid margin 
and left for 15 seconds. The length that the tears 
have traveled will be measured. This test does 
not require anesthesia. 
Slit Lamp Exam 
A specialized microscope is used to shine light 
on the eye and to examine the health of the 
eyelids and the front of the eye. 
Subjective 
Refraction/Spherical 
Equivalent Refraction 
The subject’s prescription is determined by 
placing different power lenses in front of the 
subject’s eye, according to the subject’s 
responses.  
Contact Lens Fitting 
A contact lens is placed on the eye and the fit is 
assessed (how much is moves, where it sits on 
the eye, etc.). This is done using a slit lamp 
biomicroscope.  
Contact Lens Over-
Refraction and Power 
Adjustment 
Lenses will be placed in front of the subject’s 
eye while wearing the study contact lenses to 
determine if the prescription needs to be changed 
according to the subject’s responses. The contact 
lens power will be adjusted if needed. 
Questionnaire: Ocular 
Surface Disease Index 
(OSDI)  
The questionnaire asks the subject’s vision 
during various tasks, eye pain, comfort in 
various environments, etc. 

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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9.0 
Setting 
All study visits will be conducted at the University of Houston College of 
Optometry at The Ocular Surface Institute (TOSI) within the Human and 
Biological Sciences Building.  
 
10.0 Drugs or Devices   
No investigational medical devices or investigational ophthalmic pharmaceuticals 
will be assessed in this study. The contact lenses fit in the study (Acuvue Oasys, 
Johnson & Johnson Vision Care; Air Optix Night and Day Aqua, Alcon 
Laboratories) are commercially available, FDA approved contact lenses that will 
be fit per the manufacturers recommended fitting guide on a daily wear basis (i.e. 
subjects will not sleep in lenses). The ophthalmic drops used in the trial to 
evaluate LWE (sodium fluorescein, lissamine green) are commercially available 
ocular diagnostic agents commonly used in clinical practice.  
 
11.0 Risks to Subjects 
The risks to the subjects in the trial are the same risks found in standard clinical 
practice.  During study procedures, there is the risk of mild ocular discomfort 
during clinical procedures due to light being shined on the eye (e.g. Slit lamp 
biomicroscopy), by being asked to not blink for a short period of time during a 
procedure (e.g. Oculus Keratograph NITBUT), during surface tear collection or 
through the use of topical ophthalmic diagnostic agents (sodium fluorescein, 
lissamine green). Potential discomfort from these procedures is transient and self-
limiting.  
Contact lenses will be fit as part of this study. The US Food and Drug 
Administration consider daily wear contact lenses Class II medical devices. While 
most individuals wear contact lenses successfully without incident, problems with 
contact lenses or lens care products can result in serious injury to the eye. 
Ulcerative keratitis (infection of the cornea), can develop rapidly and lead to loss 
of vision.  Ulcerative keratitis is estimated to happen to about 4.1 out of 10,000 
people who use daily wear contact lenses. The overall risk of ulcerative keratitis 
may be reduced by carefully following directions for lens care, and subjects in the 
study will be educated on proper contact lens use and care.   
The following problems may also occur when wearing contact lenses: 
• Burning, stinging, and/or itching of the eyes 
• Less comfort after daily wear than when the lens was first placed on the eye 
• A feeling like there is something in the eye (foreign body, scratched area) 
• Reduced vision or temporary loss of vision due to peripheral infiltrates (white blood 
cells), peripheral corneal ulcers (inflammation of the cornea), and/or corneal erosion 
(defects in the corneal surface) 
• Local or generalized edema (swelling)  

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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• Corneal neovascularization (small blood vessels growing into the cornea)  
• Corneal staining (defect in the corneal surface) 
• Redness  
• Tarsal abnormalities (bumps on the inside upper eye lid) 
• Iritis (internal inflammation of the eye) 
• Conjunctivitis (infection or inflammation of the white part of the eye or under the 
eyelids) 
• Excessive watering, unusual eye secretions, or redness of the eye 
• Poor visual acuity 
• Blurred vision 
• Rainbows or halos around objects 
• Sensitivity to light 
• Dry eyes may also occur if lenses are worn continuously or for too long a time 
Many of the potential problems associated with contact lens wear are self-limiting and 
can be resolved with discontinuation of lens wear.  These problems can be minimized or 
avoided with proper contact lens fitting and follow-up. Subjects in the study will be 
examined approximately 7 days after contact lens fitting, which is typical in clinical 
practice for contact lenses worn in a daily wear modality. 
Subject safety will be monitored in the trial through slit lamp evaluation of the ocular 
surface. Subjects will be educated to potential risk with contact lens wear and instructed 
to discontinue contact lens wear and contact the study investigators if they experience 
any eye discomfort, excessive tearing, vision changes, redness of the eye, or other 
problems. 
Subjects will be instructed that in the event they experience signs or symptoms 
associated with a potential adverse event, they should contact the study personnel 
immediately for evaluation. 
12.0 Potential Benefits to Subjects 
 
There is no direct benefit that the individual subjects may experience from taking part in 
the research; however, participation in the trial may lead to clinical insights that could 
potentially predict future contact lens comfort in patients. 
 
13.0 Withdrawal of Subjects 
Subjects may withdraw consent to participate in the study at any time. Subjects 
may be withdrawn from the trial by the study investigators if they are lost to 
follow up (fail to complete Visit 2 within the allotted time period), become 
pregnant during the trial, have a study-related adverse event that warrants study 
withdrawal or they fail to follow the study instructions.  
 
14.0 Costs/Payments to Subjects 
 

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Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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There are no expected additional costs to subjects that participate in the study. There is no 
cost to subjects for contact lens fitting in this study. Subjects will be provided contact 
lenses and care solution at no cost for the duration of the study. Subjects will be provided 
with a token for parking at each study visit (if necessary). Subjects that complete contact 
lens fitting (i.e. that is completes both study Visit 1.1 and 1.2) will be compensated $30.  
Subjects who complete the 1-week follow up will be compensated $10. If subjects are 
determined ineligible at screening (screen fail), the subject will be compensated $5, with 
the opportunity for a total of 3 re-screenings at the investigators discretion.  Total subject 
reimbursement (without rescreening visits) will be $40. Subjects will be compensated 
using Amazon electronic gift cards in the amounts indicated above, delivered to the 
subject via an e-mail address provided by the subject, after completion of their last study 
visit. Subjects who fail to complete a visit will not be compensated for that visit. Subjects 
will be instructed to contact the study PI in the event that they do not receive the 
electronic gift card.   
 
15.0 Compensation for Research-Related Injury  
 
The risks to subjects from participation in the study are minimal. The clinical procedures 
used in the study (slit lamp biomicroscopy, non-invasive tear break up time) are 
commonly used clinical procedure in optometry and ophthalmology and may cause some 
discomfort due to light shining on the surface of the eye, during ocular surface tear 
collection or during contact lens wear. In the rare case that a subject is injured as part of 
their participation in the study, the subject will be responsible for any associated medical 
bills.  
 
16.0 Confidentiality  
 
Subjects will be assigned a unique subject ID. Subjects IDs are two digits and should start 
at 01 and continue in the order of enrollment. No one outside of the research team will 
have access to the subject identifiers. A key to the study code will be maintained for 3 
years at the time of study completion (i.e. Last Subject, Last Visit).  
 
Any source documents with patient identifiable information will be kept only at the local 
site (informed consent form, linking log). Individual documents will be kept in a secure 
room in the Ocular Surface Institute (TOSI).  
  
17.0 Provisions to Protect the Privacy Interests of Subjects. 
 
Those who are potentially eligible and interested in the study will be referred to a study 
investigator or coordinator who will discuss the study with the patient. This discussion will 
take place in a quiet, private area and as much time as necessary will be spent discussing 
the details of the study.  

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Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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Revised: June 18, 2021 
 
18.0 Informed Consent Process 
 
The participant will be provided an opportunity to read the informed consent and to have 
any questions answered before agreeing to participate. Prior to any testing, the investigator 
or study coordinator will obtain written informed consent from all participants. The consent 
form will be signed and dated by both the participant and a member of the study personnel 
who has been approved to obtain consent. The participant will receive a copy of the signed 
consent documents and the originals will be filed in the subject binder on site in a secure 
location.  
 
19.0 HIPAA  
 
We will be collecting demographic information along with general medical and eye 
health information. Since protected health information will be collected, the Health 
Insurance Portability and Accountability Act (HIPAA) authorization form will be 
included as part of the Informed Consent process.   
 
The linked PHI will be destroyed upon completion of the study. PHI will not be reused or 
disclosed to any other person or entity, except as required by law, for authorized 
oversight of the research study, or for other research for which the use or disclosure of 
protected health information for which an authorization or opportunity to agree or object 
is not required by 45 CFR 164.512.   
 
20.0 Data Management 
 
Paper source documents (i.e. case report forms) will only be associated with a subject ID 
number and will not contain direct subject identifiers. 
 
21.0 Specimen Use and Banking 
The tear specimens will be stored in a -80°C freezer until luminex multibead 
analysis. The specimens will be stored for up to 3 months. The principal 
investigators and other members of the research team will have access to the 
specimens. 
 
22.0 Sharing of Results with Subjects  
 
There are no plans to share study results with subjects as it will not directly benefit their 
eye/vision health. If findings are discovered during the trial that potentially have an 
impact on the subject’s health or wellbeing, the subject will be educated to these findings. 
 
23.0 Resources  
 

FULL PROTOCOL TITLE: The Impact of Contact Lens Coefficient of 
Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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Revised: June 18, 2021 
The study team completed all necessary ethics training requirements. The co-PIs (Eric 
Ritchey, OD, PhD and Rachel Redfern, OD, PhD) have over a decade of clinical research 
experience conducting clinical studies and will oversee the other study personnel.  
The number of subjects to be recruited is based on the typical number of subjects 
needed to approach the central limit theorem. With an abundance of contact lens 
wearers in the surrounding community, we believe that we should be able to 
complete enrollment within 3 months. 
This study utilizes the clinics of The Ocular Surface Institute to see study subjects on the 
campus of the University of Houston.  
 
 
 
 

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Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE) 
 
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Addendum: Statistical Analyses 
 
Statistical analyses were performed in SPSS v26 (IBM) and GraphPad. When data were 
not significantly different from a normal distribution (non-invasive tear break up time, 
tear meniscus height), statistical analyses were conducted using paired t-tests and 
repeated-measures analyses of variance (RM-ANOVA), with adjusted post-hoc t-tests, 
when appropriate. For NITBUT and TMH, the RM-ANOVA included two repeated 
factors—lens type (Acuvue Oasys and Air Optix Night and Day) and time (baseline, 2 
hours post-fitting and 7 days after lens fitting). For data that was not normally distributed 
(LWE staining), Friedman and Mann-Whitney non-parametric statistics were performed. 
MMP concentrations were adjusted by multiplying raw values by the dilution factor. Tear 
film MMP concentrations under the level of detection (LOD) were divided by √2 
(Croghan et al. 2003). Outliers in MMP data sets were analyzed using the ROUT function 
in Graphpad Prism 8.4.1 and were removed prior to analysis.