Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use
Phase: NA
Conditions: Myopia
Sponsor: University of Waterloo



FOX Protocol 13feb2024 
 
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Centre for Ocular Research & Education (CORE) 
School of Optometry & Vision Science | University of Waterloo, 200 University Avenue West | Waterloo, ON, Canada N2L 3G1 
+1 519 888-4742 | CORE.uwaterloo.ca 
 
Protocol 
 
PERFORMANCE OF DAILIES TOTAL1 DAILY DISPOSABLE 
CONTACT LENSES IN HABITUAL SOFT LENS WEARERS 
WHO REPORT SUBSTANTIAL DIGITAL DEVICE USE  
(CODENAME: FOX) 
Funding source: Alcon (IIT) 
Funding study number: IIT Proposal # 86988863 
CORE protocol number: P/853/23/L 
Protocol author: 
  
Principal investigator(s): Lyndon Jones  
 
This protocol remains the exclusive property of CORE. 
Role & printed name 
 
Reviewed and approved  
(sign) 
Date 
DD/MMM/YYYY 
Principal investigator: 
 
 
 
Protocol author: 
 
 
 
Quality assurance: 
 
 
 

FOX Protocol 13feb2024 
 
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DOCUMENT CHANGE HISTORY 
 
Version 
date 
Author 
Description of change(s) 
21nov2023 
 
Original protocol 
13feb2024 
 
Revisions following IRB review 
 
 
 

FOX Protocol 13feb2024 
 
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Table of contents 
Document change history ............................................................................................................ 3 
1 
Introduction .......................................................................................................................... 8 
2 
Objectives ............................................................................................................................ 8 
3 
Hypothesis ........................................................................................................................... 9 
4 
Materials and methods ........................................................................................................ 9 
4.1 
Study design ................................................................................................................. 9 
4.1.1 
Overall design ........................................................................................................ 9 
4.1.2 
Randomization ....................................................................................................... 9 
4.2 
Study population ......................................................................................................... 10 
4.2.1 
Sample size ......................................................................................................... 10 
4.2.2 
Number of participants ......................................................................................... 10 
4.2.3 
Inclusion and exclusion criteria ............................................................................. 10 
4.2.4 
Vulnerable population........................................................................................... 12 
4.2.5 
Repeated screenings ........................................................................................... 12 
4.3 
Study materials ........................................................................................................... 12 
4.3.1 
Lenses ................................................................................................................. 12 
4.3.2 
Lens care system ................................................................................................. 13 
4.3.3 
Drugs ................................................................................................................... 13 
4.3.4 
Rewetting drops ................................................................................................... 13 
4.3.5 
Ordering consumables ......................................................................................... 13 
4.3.6 
Disposing of consumables ................................................................................... 13 
4.3.7 
Product accountability .......................................................................................... 13 
4.4 
Scheduled and unscheduled visits .............................................................................. 13 
4.4.1 
Study visits ........................................................................................................... 14 
4.4.2 
Pre-screening ....................................................................................................... 14 

FOX Protocol 13feb2024 
 
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4.4.3 
Screening (Visit 1) ................................................................................................ 14 
4.4.4 
Baseline and dispense, Day 0 (Visit 2) ................................................................. 16 
4.4.5 
Day 14 follow-up visit and exit, Day 14+2 (Visit 3) ................................................ 17 
4.4.6 
Study exit ............................................................................................................. 18 
4.4.7 
Unscheduled visits ............................................................................................... 18 
4.5 
Study procedures ........................................................................................................ 18 
4.5.1 
Case history ......................................................................................................... 20 
4.5.2 
CLDEQ-8 questionnaire ....................................................................................... 20 
4.5.3 
Visual acuity ......................................................................................................... 21 
4.5.4 
Non-invasive tear film break-up time (NITBUT) .................................................... 21 
4.5.5 
Auto-refraction and auto-keratometry ................................................................... 21 
4.5.6 
Subjective refraction ............................................................................................. 21 
4.5.7 
Slit lamp biomicroscopy ........................................................................................ 21 
4.5.8 
Lens fit & surface assessment .............................................................................. 22 
4.5.9 
Subjective ratings ................................................................................................. 23 
5 
Monitoring protocol adherence .......................................................................................... 24 
6 
Potential risks and benefits to human participants ............................................................. 24 
7 
Adverse events .................................................................................................................. 25 
8 
Discontinuation from the study ........................................................................................... 26 
9 
Study completion and remuneration .................................................................................. 27 
10 
Statistical analysis and data management ......................................................................... 27 
10.1 
Statistical analysis ................................................................................................... 27 
10.2 
Data management ................................................................................................... 28 
10.3 
Comments on source documents ............................................................................ 28 
11 
Protocol training ................................................................................................................. 28 
12 
Study monitoring ................................................................................................................ 29 

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13 
Study management............................................................................................................ 29 
13.1 
Statement of compliance ......................................................................................... 29 
13.2 
Ethics review ........................................................................................................... 29 
13.3 
Clinical trial registration ............................................................................................ 30 
13.4 
Protocol deviations .................................................................................................. 30 
13.4.1 
Major protocol deviations ..................................................................................... 30 
13.4.2 
Minor protocol deviations ..................................................................................... 30 
13.4.3 
Reporting and documenting protcol deviations ..................................................... 31 
13.5 
Premature termination of the study .......................................................................... 31 
13.6 
Study participant records ......................................................................................... 31 
13.7 
Retention of study records and data ........................................................................ 31 
14 
Report................................................................................................................................ 31 
15 
References ........................................................................................................................ 32 
 
 

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 Confidentiality 
This is a private document and the property of the Centre for Ocular Research & Education. It 
is therefore confidential to the recipient and must not be quoted from or distributed beyond the 
company to which it is sent without the express written permission of the Director (or her/his 
designate) of the Centre for Ocular Research & Education. Release of information from this 
document is governed by the research agreement on file. 
 
Disclaimer 
This study will be conducted for research purposes only. 
 
 
 

FOX Protocol 13feb2024 
 
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1 
INTRODUCTION 
A review published in 2020 reported that an average of 21.7% of contact lens (CL) wearers stop 
wearing lenses,1 with discomfort being the main reason for discontinuation.2-5 One study 
reported 26.6% of new soft CL wearers stopped wearing lenses over the first year. The most 
common reasons for discontinuing CL wear were poor distance vision (38%), poor near vision 
(24%), handling problems (23%) and discomfort (21%).2 A study conducted in Canada found 
23% permanently discontinued lens wear, with the main reasons being discomfort (24%) and 
dryness (20%). As we spend an increasing amount of time on digital devices in our daily lives, 
the number of people potentially dropping out of CL wear may be affected by the use of digital 
devices. CL wearers suffer from computer vision syndrome more frequently than those who do 
not wear lenses (65% to 50%), with lens wearers who use computers for >6 hours per day more 
likely to be symptomatic.6 Symptoms related to use of digital devices may be due to multiple 
reasons, including a decreased blink rate, incomplete blinking, or poor wetting of the lens.7-9  
The importance of choosing a suitable contact lens for digital device users was demonstrated in 
a recent study.  Lens wearers who used digital devices for an average of 9.7 hours per day were 
refit with verofilcon A (PRECISION1®) daily disposable CLs.10 After two weeks of wear, 
participants were asked to rate the overall comfort, dryness, and clarity of vision using 0 to 100 
scale (where 100 was the best rating). Verofilcon A lenses performed well, with mean ± standard 
deviation ratings of 91 ± 11 for comfort, 88 ± 11 for dryness, and 92 ± 9 for clarity of vision. Most 
participants felt verofilcon A provided all-day good comfort (88%) and vision (91%). The majority 
of participants were also satisfied with the comfort (84%), vision (91%), and overall performance 
(81%) of the lenses when using digital devices for at least 6 hours.  
The purpose of this study is to evaluate the performance of delefilcon A (DAILIES TOTAL1®) in 
habitual contact lens wearers who report substantial digital device use (≥ 8 hours on a typical 
day). 
2 
OBJECTIVES 
The objective of the study is:  
• 
To refit habitual soft lens wearers, who use digital devices ≥8 hours on a typical day, 
with DAILIES TOTAL1® daily disposable CLs, and to assess their subjective ratings (0-
100) for overall comfort, overall dryness, and overall clarity of vision during a typical day 
when using digital devices ≥8 hours while wearing DAILIES TOTAL1® CLs, reported 
after two weeks of wear.  

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The primary outcome variables for this study are: 
• 
Subjective ratings (0-100, where 100=best) of overall comfort, overall dryness and 
overall clarity of vision with DAILIES TOTAL1® CLs during a typical day when using 
digital devices ≥8 hours (reported after two weeks of wear). 
Other outcome variables of interest include: 
• 
Likert type questions exploring the satisfaction with DAILIES TOTAL1® CLs when using 
digital devices (after two weeks of wear) 
• 
Subjective ratings (0-100, 100=best) of comfort, dryness, and clarity of vision collected 
using an at home questionnaire on days 1, 7, and 14±1) at three time-points each day: 
after lens insertion, after 8 hours of digital device use, and at the end of day  
• 
Lens wear time 
• 
Lens fit 
3 
HYPOTHESIS 
DAILIES TOTAL1® will provide a satisfactory performance for substantial digital device users  as 
reflected in subjective ratings of ≥75 (0-100 scale, 100=best) for overall comfort, dryness, and 
clarity of vision during a typical day when using digital devices for ≥8 hours, reported after two 
weeks of wear. 
4 
MATERIALS AND METHODS 
4.1 STUDY DESIGN 
4.1.1 OVERALL DESIGN 
This is a prospective, non-masked, open-label dispensing study with three study visits on two 
study days. CL wearers who use digital devices for ≥8 hours on a typical day will be enrolled. 
Eligible participants will be fit and dispensed with DAILIES TOTAL1® study lenses for 14+2 days, 
to be worn for at least 5 days a week and at least 13 hours per day.  
• 
Visit 1: Screening and fitting of study lens (approx. 1.0 hour) 
• 
Visit 2: Baseline & Dispense (approx. 0.5 hours; same day as and directly after Visit 1) 
• 
Visit 3: Day 14 Follow-up and study exit (approx. 1.0 hour) 
4.1.2 RANDOMIZATION 

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There will be no randomization in this study because all participants will be dispensed with 
DAILIES TOTAL1®. 
4.2 STUDY POPULATION 
4.2.1 SAMPLE SIZE 
The sample size in this study is based on the previous study with a similar aim and design, 
involving PRECISION1® contact lenses (PUG, Kuali# 41694).11 That study found meaningful 
results with a sample size of 32 and therefore the sample size for this study is planned to be the 
same, with a minimum of 32 participants to complete the study.  
4.2.2 NUMBER OF PARTICIPANTS 
Participants will be recruited using CORE database and advertising approved by the UW Office 
of Research Ethics. Up to 35 participants may be dispensed with study products, with a target of 
32 completing the study. Informed consent will be obtained for all participants prior to their 
enrolment in the study.  
4.2.3 INCLUSION AND EXCLUSION CRITERIA 
A person is eligible for inclusion in the study if they: 
1. Are between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer; 
2. Have read and signed an information consent letter; 
3. Are willing and able to follow instructions and maintain the appointment schedule; 
4. Are a digital device user (at least 8 hours on a typical day using any combination of 
digital devices such as PC, laptop, smartphone or tablet);  
5. Are a habitual wearer of daily wear, spherical, soft contact lenses (no bifocal or multifocal 
contact lenses, no extended wear or monovision) for at least 5 days/week and at least 
13+ hours/day on a typical day during the month prior to enrolment;  
6. The habitual lens type brand will be restricted such that a maximum of 7 participants will 
be included in the study for each lens brand/material; 
7. Have a vertex corrected spherical equivalent distance refraction within -0.50D to -9.00D 
in each eye; 
8. Have a vertex corrected refractive cylinder ≤ -0.75 cylindrical correction in each eye after 
vertexing to the corneal plane;  
9. Demonstrate an acceptable fit and achieves best corrected visual acuity of at least 0.10 
logMAR in each eye with DAILIES TOTAL1® contact lenses; 

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10. Are willing to wear DAILIES TOTAL1® contact lenses at least 5 days per week and 13+ 
hours per day throughout the study.  
 
A person will be excluded from the study if they: 
1. Are participating in any concurrent clinical or research study involving intervention or 
invasive ocular tests; 
2. Are presbyopic or habitually use a reading addition for close work;  
3. Have any known active* ocular disease and/or infection; 
4. Meet the diagnosis of dry eye disease as per the following combination:  
• 
Meets the symptom criteria of CLDEQ-8 score ≥12 
• 
And they show 1 of the following 2 signs:  
o Either NaFl staining (either [cornea >5 dots] or [conjunctiva >9 dots] or [lid 
margin  >2mm length AND ≥25% width]); 
o Or NITBUT (no contact lens) <10 seconds. 
5. Have a systemic condition that in the opinion of the investigator may affect a study 
outcome variable;+ 
6. Are using any systemic or topical medications that in the opinion of the investigator may 
affect a study outcome variable; 
7. Are a current wearer of DAILIES TOTAL1® daily disposable contact lenses; 
8. Have known sensitivity to the diagnostic pharmaceutical sodium fluorescein to be used in 
the study; 
9. Have undergone refractive error surgery; 
10. Are a member of CORE directly involved in the study. 
* For the purposes of this study, active ocular disease is defined as infection or inflammation 
which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid 
abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival 
staining and mild dry eye are not considered active ocular disease. Neovascularization and 
corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not 
active. 
+ Any potential exclusion will be reviewed with the Lead Investigator or Principal Investigator 
prior to final decision making. 

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Age >40 years is excluded because presbyopia and pre-presbyopia is highly prevalent in this 
population and will cause eyestrain and impact vision irrespective of the contact lens material, 
thus impacting subjective ratings. 
4.2.4 VULNERABLE POPULATION 
This study will not be conducted in vulnerable populations. 
4.2.5 REPEATED SCREENINGS 
In some circumstances a repeated screening may need to be scheduled (V1-R). Examples 
include, but are not limited to: 
1. Incomplete information available at time of screening to determine eligibility (e.g. current 
lens brands worn, history from current eye care practitioner etc.) 
2. Study procedures unable to be completed in the time scheduled for visit; 
3. Study products not available at the time of the screening visit; 
4. A transient health condition which may affect the eye(s) (e.g. a common cold, active 
allergies, fatigue etc;) 
5. The short term use of medications (e.g. antibiotics, antihistamines etc.) 
6. Reassessment of baseline ocular conditions (e.g. corneal and/or conjunctival staining, 
scars etc.) 
The maximum total number of screenings permitted will be 3; i.e. 2 re-screens are permitted. 
4.3 STUDY MATERIALS 
4.3.1 LENSES 
The study lens is approved by Health Canada. Lenses will be worn bilaterally, and on a daily 
disposable basis. 

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Participants will be assigned a study ID number after they sign the consent documentation, i.e. 
before their eligibility for the study has been confirmed. The investigator will determine 
participant eligibility using the inclusion and exclusion criteria. Ineligible participants will be 
discontinued from the study. 
The procedures to be performed are listed below and are explained in more detail in Section 
4.5.:  
Participants will attend the visit wearing spectacles. Participants will not have worn their contact 
lenses for at least 12 hours prior to the visit.   
1. Informed consent; 
2. Participant demographics (age, sex);  
3. Participant history:  
• 
Medical history/medications; 
• 
Habitual contact lens wear; 
• 
Digital device use. 
4. CLDEQ-8 questionnaire; 
5. logMAR distance high illumination, high contrast visual acuity (HIHC VA) with habitual 
spectacles for OD, OS, and OU; 
6. Auto-refraction/auto-keratometry; 
7. Non-invasive break-up time; 
8. Biomicroscopy examination: 
• 
External adnexa anomalies; 
• 
Cornea & anterior eye assessment for scars, infiltrates; 
• 
Bulbar & limbal redness;  
• 
Corneal & conjunctival staining with fluorescein dye;  
• 
Palpebral conjunctival hyperemia and roughness; 
• 
Lid margin staining (horizontal length and sagittal width 0-3 scale; 1 increment). 
9. Subjective sphero-cylindrical refraction, monocular and binocular logMAR distance HIHC 
VA; 
10. Best sphere refraction, monocular and binocular logMAR distance HIHC VA; 

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11. DAILIES TOTAL1® fitting: 
i. 
The contact lens power will be chosen based on the vertexed best sphere refraction; 
ii. 
The participant will insert the lenses which will be allowed to settle for 5 minutes;  
iii. 
Monocular over-refraction will be performed. If a different lens power is needed, the 
new power CL will be inserted and steps ii and iii will be repeated; 
iv. 
The final lens powers for OD and OS will be recorded with the monocular and 
binocular logMAR distance HIHC VA; 
v. 
Acceptability of lens fit (movement, centration; YES/NO) will be confirmed. 
12. Confirm eligibility.  
4.4.4 BASELINE AND DISPENSE, DAY 0 (VISIT 2) 
1. Participants who successfully meet all the eligibility criteria will proceed directly to Visit 2, 
while continuing to wear the pair of study lenses that were just fit in Visit 1.  
2. logMAR distance HIHC VA with study lenses for OD, OS, OU; 
3. Subjective post-insertion ratings (0-100 integer scale, where 100 means best 
performance; both eyes rated together) to assess the initial impression of DAILIES 
TOTAL1® regarding: 
• 
Comfort;  
• 
Clarity of vision.  
4. Lens fit and surface evaluation:  
• 
Lens centration; 
• 
Lens movement in primary gaze;  
• 
Lens tightness on push-up test; 
• 
Surface wettability; 
• 
Surface deposits. 
5. At-home rating scales: Participants will receive at-home rating scales to be completed on 
Day 1, Day 7, and Day 14±1.  
6. Lens wear instructions. The participants will be asked to:  
• 
Wear the lenses at least 5 days per week and >13 hours per day throughout the 
study;  
• 
Complete the subjective at-home ratings to reflect their lens wear experience on 
Day 1 (the day after V2), Day 7, and Day 14±1 using a 0-100 scale. Ratings will 
be completed after insertion, after 8 hours of digital device use, and at the end of 
the day just before lens removal. The final at-home questionnaire will be 

FOX Protocol 13feb2024 
 
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completed the evening before their scheduled Visit 3. Variables to be assessed 
are:  
o Comfort; 
o Dryness; 
o Clarity of vision. 
• 
Attend V3 after 8 hours or more of DAILIES TOTAL1® study lens wear. 
7. Dispense lenses.  
4.4.5 DAY 14 FOLLOW-UP VISIT AND EXIT, DAY 14+2 (VISIT 3) 
Participants will attend the visit after 8 hours of DAILIES TOTAL1® study lens wear.  
1. Collect unused study CLs; 
2. Changes in medication history/medications; 
3. Compliance with # of CL wear days/hour per day with typical # hours of digital device 
use over the past 2 weeks and for V3 visit day; 
4. Collect and review at-home ratings; 
5. logMAR distance HIHC VA with study lenses for OD, OS, and OU; 
6. Subjective ratings (0-100 scales, where 100 means better performance; integer steps, 
both eyes rated together), to assess a typical day in the past 2 weeks 5 minutes after 
insertion, after 8 hours of digital device use, at the end of the day just prior to removal, 
and overall for:  
• 
Comfort; 
• 
Dryness; 
• 
Clarity of vision. 
7. Subjective satisfaction; 
8. Lens fit and surface evaluation:  
• 
Lens centration;  
• 
Lens movement in primary gaze;  
• 
Lens tightness on push-up test; 
• 
Surface wettability and deposits. 
9. Biomicroscopy examination:  
• 
External adnexa anomalies; 
• 
Cornea & anterior eye assessment for scars and infiltrates; 
• 
Bulbar & limbal redness; 
• 
Corneal & conjunctival staining with fluorescein dye; 

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Participant demographics (age, sex) 
X 
 
 
Medical history and medications 
X 
 
 
Changes in medical history/medications 
 
 
X 
Contact lens history 
X 
 
 
Digital device use history 
X 
 
 
CLDEQ-8 questionnaire 
X 
 
 
HIHC VA (logMAR) (habitual spectacles)  
X 
 
 
Auto-refraction/auto-keratometry: horizontal 
and vertical K readings 
X 
 
 
Non-invasive tear film break-up time 
X 
 
 
Biomicroscopy  
X 
 
 
Biomicroscopy (without lid margin staining) 
 
 
X 
Subjective refraction 
X 
 
 
HIHC VA (logMAR) (study CL) 
X 
X 
X 
Study lens fitting 
X 
 
 
Eligibility 
X 
 
 
Subjective ratings (post-insertion comfort & 
vision) 
 
X 
 
Subjective ratings (comfort, dryness, & 
vision) 
 
 
X 
Satisfaction ratings (Likert scale) 
 
 
X 
Lens assessment (fit, wettability, deposits) 
 
X 
X 

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Provide at-home ratings (comfort, dryness, & 
vision) 
 
X 
 
Collect unused study lenses 
 
 
X 
Review of compliance (CL wear, digital 
device use, completion of at-home ratings) 
 
 
X 
HIHC VA (logMAR) (habitual spectacles or 
contact lenses)  
 
 
X 
 
4.5.1 CASE HISTORY 
Demographics: 
Demographic information from the participant will be obtained, including age and sex. 
Medical History: 
At screening, information will be obtained from the participant about the current medication, 
allergies, and any medical conditions.  At the beginning of the Follow-up visits and end of study 
visits, the participant will be asked about changes in their medication or health. 
Contact Lens History: 
• 
Information will be obtained from the participant about the current contact lens type 
(lens brand name, lens power), replacement frequency, contact lens care solution (if 
applicable), typical number of lens wear days per week, typical lens wear time per 
day (total and comfortable), years of lens wear and use of artificial tears, plus 
confirmation that that the subject uses contact lenses ≥13 hours per day; 
Digital device use: 
Participants will be asked about their typical use of digital devices (total hours/day of all devices 
combined) and to identify the type of devices (e.g. smartphone, computer, laptop, tablet) they 
use, with confirmation that the subject uses digital devices ≥8 hours per day. 
4.5.2 CLDEQ-8 QUESTIONNAIRE 
The Contact Lens Dry Eye Questionnaire (CLDEQ-8) is a validated questionnaire recommended 
by the 2013 TFOS Workshop on Contact Lens Discomfort12 as the best approach for detecting 

FOX Protocol 13feb2024 
 
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contact lens discomfort (CLD). Instructions for completion are present on the source documents 
and will be reviewed with the participant prior to completion. The CLDEQ-8 score ranges from 0 
to 37, with higher scores indicating increased symptoms. 
4.5.3 VISUAL ACUITY 
Visual acuity for distance will be measured using high contrast computer-generated acuity charts 
in high illumination. Participants will be asked to read letters that progressively decrease in size 
on a computer screen located at a distance of 6 meters. 
4.5.4 NON-INVASIVE TEAR FILM BREAK-UP TIME (NITBUT) 
The participant will be seated in front of a device that will project rings of light (Placido discs) 
onto the tear film. The participant will be asked to keep their eyes open for as long as they can 
and the time until the rings first begin to distort, or break will be recorded. Three measurements 
will be taken to obtain an average value. The assessment will be carried out without study 
contact lenses.  
4.5.5 AUTO-REFRACTION AND AUTO-KERATOMETRY 
The participant will be asked to focus on a target while seated at an instrument that measures 
their approximate spectacle prescription and corneal shape.  
4.5.6 SUBJECTIVE REFRACTION 
The participant will be asked to read a letter chart from a distance through lenses placed in front 
of their eyes. They will also be asked to compare the clarity of their vision between different 
lenses placed in front of their eyes. This procedure aids in determining their spectacle and/or 
contact lens prescription.  
4.5.7 SLIT LAMP BIOMICROSCOPY 
A slit lamp biomicroscopy examination will be conducted to assess anterior segment ocular 
health. The participant will be seated behind a slit lamp and the ocular findings will be graded 
using Efron grading scale (0-4, 0.1 steps – unless otherwise stated).   
External adnexa anomalies 
The presence or absence of external adnexa anomalies will be recorded.  
Bulbar and limbal hyperemia  

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The redness of each quadrant of the bulbar and limbal conjunctiva of both eyes will be assessed 
(Efron 0-4 scale; 0.1 increments).  
Assessment of cornea and anterior eye for scars, infiltrates and any other abnormalities 
The presence or absence of scars, infiltrates, or other abnormalities will be recorded. The size 
(diameter) of the largest infiltrate (0-4 where 0 = none, 1 = < 0.5mm, 2 = 0.5 – 1mm,  3 = 1 – 1.5 
mm, 4 = >1.5 mm) and the depth of the largest infiltrate will be graded (0-4, 0 = none, 1 = 
epithelial, 2 = sub-epithelial, 3 = mid-stromal, 4 = deep stromal).  
Corneal, conjunctival and lid margin staining  
A sodium fluorescein strip, wetted with a few drops of saline, will be applied to the superior 
bulbar conjunctiva of both eyes. Staining of all five zones of the cornea and four zones of the 
conjunctiva will be graded while viewing with cobalt blue light through a Wratten no. 12 barrier 
filter (Efron 0-4 scale; 0.25 increments). The horizontal length (0-3 where 0 = <2mm, 1 = 2-4mm, 
2 = 5-9mm, 3 = ≥10m) and sagittal width (0-3 where 0 = <25%, 1 = 25-49%, 2 = 50-74%, 3 =  
≥75%; 1 increment) of the staining of the upper and lower lid margins will be assessed.  
Palpebral conjunctival hyperemia and roughness  
The redness and roughness of the upper and lower eyelids (tarsal plate zone 2) will be 
assessed (Efron 0-4 scale; 0.25 increments). 
4.5.8 LENS FIT & SURFACE ASSESSMENT 
CL fit:  
Lens fit will be assessed to ensure acceptable lens fit (centration and movement) with study 
lenses at the screening visit (V1).  
At V2 and V3, lens centration and movement will be assessed as follows:  
• 
Lens centration (0-3 scale; 0 = optimal, 1 = slight decentration, 2 = moderate 
decentration but not encroaching limbus; 3 = excessive & occasionally encroaching 
limbus);  
• 
Lens movement for primary gaze (+2 to -2 scale; -2 = unacceptably tight, -1 = slightly 
tight but acceptable, 0 = optimal, +1 = slightly loose but acceptable, +2 = unacceptably 
loose);  
• 
Lens tightness on push-up test (0-100 scale; 0 = falls from cornea without lid support; 50 
= optimal, 100 = no movement). 

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CL surface wettability and deposits: 
Contact lens wettability and deposits will be graded with study lenses at V2 and V3:  
• 
Surface wettability (0-4 scale in 0.25 steps; 0 = excellent); very low illumination, external 
diffuser in place, x32 magnification, viewing the quality of the Purkinje image; 
• 
Surface deposits (0-4 scale in 0.25 steps; 0 = excellent); using low illumination and a 
moderate beam with direct illumination to scan the contact lens for deposits, x32. 
4.5.9 SUBJECTIVE RATINGS 
Subjective ratings:  
At visit 2, participants will be provided with subjective rating questionnaires using a 0-100 scale 
(where 100 = best performance; integer steps, both eyes rated together) to assess their first 
impression with the study CLs post-insertion regarding comfort and clarity of vision. 
At the end of Visit 2, participants will be provided with at-home questionnaires to subjectively 
rate the experience with study lenses regarding comfort, dryness, and clarity of vision using a 0-
100 scale (integer steps; both eyes together), where 100 means better performance. This 
questionnaire will be completed on Days 1, 7, and 14±1 after Visit 2 (i.e. Day 0), at three 
different time-points on each of these days: after insertion, after 8 hours of digital device use, 
and at the end of the day just before lens removal. The final at-home questionnaire will be the 
evening before their scheduled Visit 3. In addition, times of lens insertion, first notice of 
discomfort, and lens removal will be collected. There will also be a diary entry for the number of 
hours of cumulative digital device use that day.  
At Visit 3, participants will be provided with subjective rating questionnaires to assess a typical 
day over the past 2 weeks, to report their experiences i) 5 minutes after insertion, ii) after 8 
hours of digital device use, iii) at the end of the day just prior to lens removal, and iv) overall. For 
each typical timepoint, comfort, dryness, and clarity of vision will be assessed using a 0-100 
scale (integer steps; both eyes together), where 100 means best performance.  
Satisfaction with study CL:  
Satisfaction (5-point Likert scale: strongly disagree, slightly disagree, neither disagree or agree, 
slightly agree, strongly agree) with DAILIES TOTAL1® CLs overall and while using digital 
devices on a typical day in the past 2 weeks will be assessed for the following questions:  
• 
The study lenses provide good vision all day long. 
• 
The study lenses provide good comfort all day long. 

FOX Protocol 13feb2024 
 
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• 
I am satisfied with the comfort the study lenses provide when I use digital devices for ≥8 
hours. 
• 
I am satisfied with the vision the study lenses provide when I use digital devices for ≥8 
hours. 
• 
I don’t experience eye strain when I wear the study lenses and use digital devices for ≥8 
hours. 
• 
I don’t experience eye fatigue (tired eyes) when I wear the study lenses and use digital 
devices for ≥8 hours. 
• 
I don’t experience episodes of blurred vision when I wear the study lenses and use digital 
devices for ≥8 hours. 
• 
I don’t experience dryness with digital device use. 
• 
Overall, these lenses provide good performance when using digital devices for ≥8 hours. 
5 
MONITORING PROTOCOL ADHERENCE 
All personnel involved in this study will be listed on a delegation log and their training will be 
documented. Consent documentation will be reviewed by personnel not involved in the consent 
process. Visit windows will be reviewed when determining the analysis cohort. All adverse 
events and protocol deviations will be reviewed by the Lead Investigator. Serious and significant 
adverse events and major protocol deviations will be reviewed by the Principal Investigator and 
Head of Clinical Research. 
6 
POTENTIAL RISKS AND BENEFITS TO HUMAN PARTICIPANTS 
This is a minimal risk study because of the use of marketed products and standard optometric 
assessments. 
Contact lenses in this study will be worn on a daily wear and daily disposable basis. Adverse 
events and/ or complications in daily wear of soft contact lenses can occur (e.g.: inflammation 
and infection).  Complications that may occur during the wearing of contact lenses include 
discomfort, dryness, aching or itching eyes, excessive tearing, discharge, hyperemia and 
variable or blurred vision. More serious risks may include photophobia, iritis, corneal edema or 
eye infection. Although contact lens-related infections are very infrequent, the possibility does 
exist. The incidence of infection due to daily-wear soft lenses is 0.035%. Almost always an 
infection will occur only in one eye. Thirty five million Americans who currently wear contact 
lenses assume this risk. 
When contact lenses are worn on a daily wear basis there is a small risk of an adverse event 
compared to not wearing contact lenses. 

FOX Protocol 13feb2024 
 
25 
A dye (fluorescein) normally used for eye exams is being used in this study. Although rare, it is 
possible that participants may have an allergic reaction to the dye. This could cause discomfort 
to their eye.   
Additionally, it is possible that participants may experience temporary discomfort associated with 
the study procedures/ products including: burning and stinging, blurred vision, sandiness or 
grittiness, light sensitivity, dryness, itching, crusty eyes and foreign body sensation.  
This study will be conducted during the ongoing COVID-19 pandemic. Therefore, risks of 
infection with COVID-19 exist through participation. These risks arise due to possible exposure 
during commute to and from the study visit as well as during the study visit, particularly due to 
the closeness of the investigator and participant (within 2m for some assessments). The 
potential effects of COVID-19 are not yet fully known and may include long-term health 
consequences. In a small percentage, infection with COVID-19 can lead to serious illness, 
hospitalization, and in rare cases to complications leading to death. Individuals aged 60 and 
above and those with underlying medical conditions are considered at a greater risk for severe 
illness from the COVID-19 virus however they are excluded from this study for different reasons.   
In consideration of risks associated with COVID-19, CORE has implemented a series of on-site 
safety procedures which have been reviewed and approved by the University of Waterloo. 
These include, but are not limited to, self-screening of investigators, maintaining physical 
distancing as much as possible, frequent handwashing, wearing of face masks by the 
investigator and participant as per University guidelines, and frequent room and equipment 
hygiene. In addition, members of CORE and participants will follow any University policies 
regarding Covid-19 vaccination. 
Participants may not benefit directly from taking part in this study. Information from this study 
may help researchers come up with new soft contact lens designs to help others in the future. 
This study may help the research team to better understand the performance of the product 
being used in this study, particularly during digital device use. 
7 
ADVERSE EVENTS 
See CORE SOP012 AE Reporting for a description of the reporting of adverse events. 
A number of conditions may result in temporary suspension until resolution. These include 
corneal infiltrates, corneal staining, limbal injection, bulbar injection or tarsal conjunctival 
abnormalities.   

FOX Protocol 13feb2024 
 
26 
8 
DISCONTINUATION FROM THE STUDY 
Participants may be discontinued at the discretion of the investigator or sponsor in consideration 
of participant safety or protocol compliance, or at discretion of the participant.  Participants 
discontinued from a study will be reimbursed $20 per hour for their active involvement in the 
study (including the initial screening visit).  Upon discontinuing, a participant will be offered the 
option of their data being withdrawn from future statistical analysis. The following is a list of 
possible reasons for discontinuation from the study: 
• 
Screening failure: Participants will be discontinued if they do not meet the inclusion and 
exclusion criteria outlined in Section 4.2.3. 
• 
Unacceptable performance with products to be used in study: Participants may be 
discontinued if they are unable to achieve acceptable comfort and /or vision with the 
study products. 
• 
Positive slit lamp finding:  Participants may be permanently discontinued from the study 
depending on the severity of the condition and on the judgement of the investigator.   
• 
Adverse event: If a participant experiences an adverse event during the study they may 
be discontinued based on the clinical judgement of the investigator. 
• 
Symptoms: If the participant has persistent symptoms they may be discontinued based 
on the clinical judgement of the investigator. 
• 
Disinterest, relocation or illness: The participant may choose to discontinue due to 
reasons within or beyond their control. 
• 
Violation of protocol or non-compliance:  The participant will be discontinued if they are 
unable or unwilling to follow the protocol specified visit schedules and/or study 
procedures. 
• 
Instillation of topical ocular medication:  The participant will be discontinued if they elect 
to use a topical ocular medication during the study unless that topical ocular medication 
is prescribed for a limited duration (less than two weeks) to treat a transient condition; in 
this case the participant may remain an active participant (at the discretion of the 
investigator) after stopping topical ocular medication following resolution of the ocular 
condition). 

FOX Protocol 13feb2024 
 
27 
• 
Lost to follow-up:  The participant will be discontinued if they cannot be contacted and do 
not return for a final exit visit, and if the investigator has made a reasonable effort to 
contact the participant for a final study visit. 
• 
Premature termination of the study by the sponsor, CORE or the Office of Research 
Ethics at the University of Waterloo. 
A discontinuation form , stating the reason for discontinuation will be completed, which requires 
the signatures of both the participant and the investigator except where the participant is lost to 
follow-up in which case only the signature of the investigator is required.   
All discontinuations including their reasons will be included in the final report. 
9 
STUDY COMPLETION AND REMUNERATION 
At the last scheduled protocol visit a study completion form will be completed, which requires the 
signatures of both the participant and the investigator.  The participants will also be provided 
with a letter of appreciation.    
Once their involvement in the study is complete, participants will be informed about receiving 
feedback following study completion in the Letter of Appreciation. 
Participant remuneration will be $60 for completing the study. This is calculated at $20 per hour 
for the 2.5 hours of scheduled visits plus the 30 minutes of time required to complete the at-
home ratings. Full details are given in the information consent letter. A cheque will be provided 
at the final visit. 
10 STATISTICAL ANALYSIS AND DATA MANAGEMENT 
10.1 STATISTICAL ANALYSIS 
All data will be analyzed by CORE at the University of Waterloo.  Unmasked data analysis will 
be conducted using Statistica, SPSS, or other appropriate software.  Descriptive statistics will be 
provided on information regarding baseline variables (age, sex, refractive error distribution, etc.).  
Descriptive statistics will be provided for all primary and exploratory outcomes as well as 
information regarding baseline variables (e.g. age, sex).  
Subjective ratings and lens fit assessments will be compared between Visit 2 (Dispense) and 
Visit 3 (2-week follow-up) using either paired t-tests or Wilcoxon matched pairs, or using 
ANOVA, as applicable; statistical significance will be set at 5%. The appropriate tests will be 

FOX Protocol 13feb2024 
 
28 
selected based on tests of normality – non-parametric tests will be used for data not showing a 
normal distribution. For assessments conducted for each eye separately, the right eye will be 
used for analysis if there is no difference between the eyes.  
Binomial testing will be conducted to analyze Likert questionnaires. For example, agreement 
questionnaires (strongly disagree, slightly disagree, neither disagree nor agree, slightly agree, 
strongly agree) to determine whether participants had a positive or negative experience with the 
test lens.  
Additional analysis may be conducted.  
10.2 DATA MANAGEMENT 
Data from this study will be retained by CORE for a minimum of 25 years on a password-
protected server. After 25 years, data will be disposed of in accordance with the guidelines laid 
out by the University of Waterloo. More details regarding storage procedures are provided in 
CORE SOP014 Clinical data management. 
At the completion of the study CORE will provide a copy of the study data to the funding 
company. Data will typically be sent using a secure file share system operated by the University 
of Waterloo called Sendit which uses 128bit (or 256bit) SSL encryption, or REDCap.  These 
systems provide a secure way to transfer files when email is not appropriate, whether because 
of file size, file type or concerns over security. Sendit and REDCap include features such as 
password protection, a restricted time period for download, IP logging and email notification of 
download. Files may be encrypted prior to transmission at the request of the funding company. 
Using this method means that data files are only stored on University of Waterloo servers during 
the transfer.  
10.3 COMMENTS ON SOURCE DOCUMENTS 
Data analysis will not be conducted on comments which have been recorded in the source 
documents. Only highlighted comments will be entered into the study database. Only relevant 
and applicable comments will be included in the final report as deemed necessary by the lead 
investigator.  
11 PROTOCOL TRAINING 

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29 
All study personnel will be required to complete training prior to their involvement in the study. A 
series of training modules will be developed for the study and records of training will be kept at 
CORE. 
12 STUDY MONITORING 
Status reports will be provided to the study funding company by email on a regular basis.  
Status reports will include: 
• 
The number of participants screened, enrolled, and randomized (i.e. assigned a study ID 
number), discontinued and completed. 
• 
Details of protocol deviations. 
• 
Reports of unintended events. 
Study monitoring will be conducted by CORE personnel. Consent documentation will be 
reviewed by a person not involved in the consent process. To improve data integrity, data entry 
will be conducted by one person and a second person will visually compare the data entry to the 
source documents to facilitate data monitoring. All adverse events and protocol deviations will 
be reviewed by the Lead Investigator. All serious and significant adverse events and major 
protocol deviations will be reviewed by the Principal Investigator and Head of Clinical Research. 
13 STUDY MANAGEMENT 
13.1 STATEMENT OF COMPLIANCE 
This clinical study is designed to be in compliance with the ethical principles in the Declaration of 
Helsinki, with the ICH guidelines for Good Clinical Practice (GCP) (ICH E6 R2), with ISO 
14155:2020 Clinical Investigation of Medical Devices for Human Subjects, with the University of 
Waterloo’s Guidelines for Research with Human Participants and with the Tri-Council Policy 
Statement: Ethical Conduct for Research Involving Humans, TCPS2 (2022). 
• 
Declaration of Helsinki 
• 
ICH E6 - International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use Guidelines for Good Clinical Practice 
• 
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 
(2022) 
• 
https://uwaterloo.ca/research/office-research-ethics/research-human-participants 
 
13.2 ETHICS REVIEW 

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30 
This protocol will be submitted to and reviewed through the Office of Research Ethics (ORE) at 
the University of Waterloo. Notification of ethics clearance of the application is required prior to 
the commencement of the study. 
13.3 CLINICAL TRIAL REGISTRATION 
CORE will register this study with clinicaltrials.gov.  
13.4 PROTOCOL DEVIATIONS 
Protocol deviations are unanticipated or unintentional changes to a study after it has received 
prior sponsor approval and ethics clearance. Protocol deviations can be major or minor.  
13.4.1 MAJOR PROTOCOL DEVIATIONS 
Major protocol deviations may impact the research protocol, information consent document or 
other study materials, usually cannot be anticipated ahead of time and are often necessary to 
ensure the safety and welfare of the participants. 
The following are examples of protocol deviations that must be reported to the ORE: 
• 
Changes in procedures initiated to eliminate immediate risks/hazards to participants; 
• 
Enrollment of participants outside the protocol inclusion/exclusion criteria whether agreed 
to or not by the sponsor; 
• 
Medication / device / intervention errors (i.e. incorrect drug or dosage of drug / incorrect 
contact lens(es) dispensed / incorrect care system dispensed); 
• 
Inadvertent deviation in specific research intervention procedures or timing of the 
research intervention which could impact upon the safety or efficacy of the study-related 
intervention or upon the experimental design; 
• 
Information consent documentation violations: no documentation of informed consent; 
incorrect version of, or incomplete, informed consent documentation used. 
13.4.2 MINOR PROTOCOL DEVIATIONS 
Protocol deviations caused by or which originate with research participants are considered 
minor, and normally are not reported to the ORE unless these result in increased risk to the 
participant(s). The following are examples of protocol deviations that are considered minor and 
do not require reporting to the ORE: 
• 
Logistical or administrative aspects of the study (e.g., study participant missed 
appointment, change in appointment date); 

FOX Protocol 13feb2024 
 
31 
• 
Inadvertent deviation in specific research intervention procedures or timing of the 
research intervention which would not impact upon the safety or efficacy of the study-
related intervention or upon the experimental design (i.e., missing a measurement during 
a session that is not considered critical for the study).  
13.4.3 REPORTING AND DOCUMENTING PROTCOL DEVIATIONS 
Major protocol deviations must be reported to the ORE within 7 days of the deviation occurring 
(or its discovery) using the Protocol Deviation Report Form 107 (PDRF).  Information from the 
PDRF is provided to the Clinical Research Ethics Board (CREB) at the next monthly meeting. 
All protocol deviations (major and minor) occurring during the study will be documented and 
included in the final report. 
13.5 PREMATURE TERMINATION OF THE STUDY 
CORE or the Office of Research Ethics at the University of Waterloo may terminate the study at 
any time for any reason. 
13.6 STUDY PARTICIPANT RECORDS 
Study participant records will be completed to comply with GCP guidelines. Records will contain: 
• 
Unique study acronym and/or code; 
• 
Participant ID; 
• 
Date enrolled; 
• 
Confirmation by investigator that participant met eligibility criteria; 
• 
Confirmation that participant received a signed and dated copy of informed consent; 
• 
Exit date; 
• 
Investigator’s signature confirming study exit. 
13.7 RETENTION OF STUDY RECORDS AND DATA 
Records and data from this study will be retained for a minimum of 25 years. Details regarding 
storage procedures are given in CORE SOP014 Clinical data management.  
14 REPORT 
A report will be sent to the funding company after data collection and statistical analysis have 
been completed, in accordance with the agreements. 

FOX Protocol 13feb2024 
 
32 
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2. 
Sulley A, Young G, Hunt C, et al. Retention rates in new contact lens wearers. Eye 
Contact Lens. 2018;44 Suppl 1:S273-S282. 
3. 
Young G, Veys J, Pritchard N, et al. A multi-centre study of lapsed contact lens wearers. 
Ophthalmic Physiol Opt. 2002;22(6):516-27. 
4. 
Dumbleton K, Woods CA, Jones LW, et al. The impact of contemporary contact lenses 
on contact lens discontinuation. Eye Contact Lens. 2013;39(1):93-9. 
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Pritchard N, Fonn D, Brazeau D. Discontinuation of contact lens wear: a survey. Int 
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Tauste A, Ronda E, Molina MJ, et al. Effect of contact lens use on computer vision 
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Truong TN, Graham AD, Lin MC. Factors in contact lens symptoms: evidence from a 
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8. 
Sheppard AL, Wolffsohn JS. Digital eye strain: prevalence, measurement and 
amelioration. Bmj Open Ophthalmology. 2018;3(1). 
9. 
Guillon M, Theodoratos P, Patel K, et al. Pre-contact lens and pre-corneal tear film 
kinetics. Contact Lens & Anterior Eye. 2019;42(3):246-252. 
10. 
Schulze MM, Fadel D, Luensmann D, et al. Evaluating the performance of verofilcon A 
daily disposable contact lenses in a group of heavy digital device users. Clinical 
Ophthalmology. 2023;17:3165-3176. 
11. 
Schulze M. Evaluating the performance of Precision1 daily disposable contact lenses in a 
group of heavy digital device users protocol. 2019. 
12. 
Dumbleton K, Woods CA, Jones LW, et al. The impact of contemporary contact lenses 
on contact lens discontinuation. Eye & Contact Lens - Science and Clinical Practice. 
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