Evaluating the Performance of Precision1 Daily Disposable Contact Lens in a Group of Heavy Digital Device Users
Phase: NA
Conditions: Myopia
Sponsor: University of Waterloo



PUG Protocol 12Dec2019 
1 
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 
EVALUATING THE PERFORMANCE OF 
PRECISION1 DAILY DISPOSABLE CONTACT 
LENS IN A GROUP OF HEAVY DIGITAL DEVICE 
USERS (PUG) 
Funding source: ALCON (IIT) 
Funding study number: IIT Proposal 
 
CORE protocol number: P/706/19/L 
Protocol author: 
 
 
Principal investigator(s): Lyndon Jones  
This protocol remains the exclusive property of CORE until it is commissioned by the sponsors. 
Role & printed name 
Reviewed and approved 
(sign) 
Date 
DD/MMM/YYYY 
Principal investigator: 
 
Protocol author: 
 
Quality assurance: 
 

PUG Protocol 12Dec2019 
 
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DOCUMENT CHANGE HISTORY 
 
Version 
date 
Author 
Description of change(s) 
26Nov2019 
 
Original protocol 
29nov2019 
 
Revisions following IRB review 
12Dec2019 
 
Updated Time to Haze measurement description 
(section 4.5.8) to be done using at 6/19 acuity. 
 
 
 

PUG Protocol 12Dec2019 
 
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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 
Masking.................................................................................................................. 9 
4.2 
Study population ......................................................................................................... 10 
4.2.1 
Sample size calculation ........................................................................................ 10 
4.2.2 
Number of participants ......................................................................................... 10 
4.2.3 
Inclusion and exclusion criteria ............................................................................. 10 
4.2.4 
Repeated screenings ........................................................................................... 11 
4.3 
Study materials ........................................................................................................... 12 
4.3.1 
Lenses ................................................................................................................. 12 
4.3.2 
Rewetting drops ................................................................................................... 12 
4.3.3 
Ordering consumables ......................................................................................... 12 
4.3.4 
Disposing of consumables ................................................................................... 12 
4.3.5 
Product accountability .......................................................................................... 13 
4.4 
Scheduled and unscheduled visits .............................................................................. 13 
4.4.1 
Study visits ........................................................................................................... 13 
4.4.2 
Screening (Visit 1) ................................................................................................ 13 
4.4.3 
Baseline & Dispense (VISIT 2) ............................................................................. 15 
4.4.4 
Day 14 Follow-up & Exit (VISIT 3) ........................................................................ 16 
4.4.5 
Study Exit ............................................................................................................. 16 

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4.4.6 
Unscheduled visits ............................................................................................... 17 
4.5 
Study procedures ........................................................................................................ 17 
4.5.1 
Case history ......................................................................................................... 18 
4.5.2 
Subjective ratings ................................................................................................. 19 
4.5.3 
Visual acuity ......................................................................................................... 20 
4.5.4 
Autorefraction ....................................................................................................... 20 
4.5.5 
Subjective refraction ............................................................................................. 20 
4.5.6 
Slit lamp biomicroscopy ........................................................................................ 20 
4.5.7 
Lens fit & surface assessment .............................................................................. 21 
4.5.8 
Time to haze ........................................................................................................ 21 
5 
Monitoring protocol adherence .......................................................................................... 22 
6 
Potential risks and benefits to human participants ............................................................. 22 
7 
Adverse events .................................................................................................................. 23 
8 
Discontinuation from the study ........................................................................................... 23 
9 
Study completion and remuneration .................................................................................. 24 
10 
Statistical analysis and data management ......................................................................... 25 
10.1 
Statistical analysis ................................................................................................... 25 
10.2 
Data management ................................................................................................... 25 
10.3 
Comments on source documents ............................................................................ 26 
11 
Protocol training ................................................................................................................. 26 
12 
Study monitoring ................................................................................................................ 26 
13 
Study management............................................................................................................ 26 
13.1 
Statement of compliance ......................................................................................... 26 
13.2 
Ethics review ........................................................................................................... 27 
13.3 
Clinical trial registration ............................................................................................ 27 
13.4 
Protocol deviations .................................................................................................. 27 

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13.4.1 
Major protocol deviations ..................................................................................... 27 
13.4.2 
Minor protocol deviations ..................................................................................... 28 
13.4.3 
Reporting and documenting protcol deviations ..................................................... 28 
13.5 
Premature termination of the study .......................................................................... 28 
13.6 
Study participant records ......................................................................................... 28 
13.7 
Retention of study records and data ........................................................................ 29 
14 
Report................................................................................................................................ 29 
15 
References ........................................................................................................................ 29 
 
 

PUG Protocol 12Dec2019 
 
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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. 
 
 
 

PUG Protocol 12Dec2019 
 
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1 
INTRODUCTION 
Approximately 22% of new contact lens (CL) wearers cease contact lens wear within the first 
year, with handling (25%), poor distance (23%) and/or near vision (21%) and discomfort (21%) 
being the main reasons for discontinuation.1 With today’s ever-expanding access to digital 
devices, the number of potential CL wear drop-outs may further be affected by digital device 
use. A recent review found a higher prevalence of symptoms of eye strain, eye fatigue or blurred 
vision in CL wearers compared to non-CL wearers (65% vs 50%) when using digital devices.2 
The symptoms associated with digital device use in contact lens wear may be affected by 
multiple factors, including an insufficient blink rate or a poorly wetting contact lens.  
Time to haze (TTH) is a metric that has been developed at CORE to measure the maximum time 
a contact lens wearer can keep their eye open without their vision becoming hazy (conducted 
just above contrast threshold level); it is a measure of how the drying of the CL surface with 
open eyes affects vision.   
Alcon has recently introduced a new silicone hydrogel (SiHy) daily disposable contact lens (DD 
CL), called Precision1, which is manufactured from the verofilcon A material. Precision1 DD CLs 
use ‘SMARTSURFACE Technology; which Alcon describe as “a permanent, micro-thin, high-
performance layer of moisture at the lens surface that helps support a stable tear film to deliver 
lasting visual performance from morning to night”.3   
The purpose of this study is to evaluate the performance of Precision1 DD CLs with regard to 
subjective symptoms (dryness, comfort, vision), lens fit and time to haze in CL wearers who 
identify themselves as heavy digital devices users (at least 6 hours of digital device use per day). 
 
2 
OBJECTIVES 
The objectives of the study are: 
• 
To assess subjective ratings for contact lens comfort, dryness and clarity of vision after 
insertion, after 6hrs of  digital devices use and at the end of day in heavy digital devices 
users while wearing Precision1 for two weeks. 
• 
To determine subjective satisfaction with Precision1 CLs when using digital devices. 
 
 

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The primary outcome variables for this study are: 
• 
Subjective ratings of CL comfort, dryness, clarity of vision after insertion, after 6hrs or 
more using digital devices, and at the end of day (0 to 100 scale). 
Other outcome variables of interest include 
• 
Likert type questions exploring the satisfaction with Precision1 CLs when using digital 
devices. 
• 
Lens fit 
• 
Lens surface characteristics (wettability, pre-lens tear break-up time & deposits) 
• 
Time to haze 
• 
Conjunctival redness 
• 
Visual acuity 
 
3 
HYPOTHESIS 
Precision1 CLs will provide a satisfactory performance for heavy digital device users as reflected 
in subjective ratings for comfort, dryness and clarity of vision. 
4 
MATERIALS AND METHODS 
4.1 STUDY DESIGN 
4.1.1 OVERALL DESIGN 
This is a prospective, non-masked, open-label, dispensing pilot study with three study visits on 
two study days. CL wearers who identify themselves as using digital devices for at least 6 hours 
on a typical day will be enrolled. Eligible participants will be dispensed with the Precision1 study 
lenses for a duration of 14±2 days, to be worn for at least 5 days a week and at least 10 hours per 
day: 
• 
Visit 1: Screening and fitting of study lens (1.0 hour) 
• 
Visit 2: Baseline & Dispense (0.5 hours; same day as and directly after V1)  
• 
Visit 3: Day 14 Follow-up and study exit (1.0 hour) 
 
4.1.2 MASKING 

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This is an open-label study that will not involve masking.  
4.2 STUDY POPULATION 
4.2.1 SAMPLE SIZE CALCULATION 
The sample size required for a 2-tailed matched paired t-test to detect a change of 5 points in a 
0-100 subjective rating scale, with α=0.05, power = 0.90, and an effect size of 0.60 is 32 to 
complete the study, i.e. a minimum sample size of 32 participants completing the study.   
4.2.2 NUMBER OF PARTICIPANTS 
Participants will be recruited / screened using CORE records and advertising approved by the 
UW Office of Research Ethics. Up to 35 participants who meet all eligibility criteria may be 
dispensed with Precision1 study lenses and asked to wear these lenses for 14±2 days, with a 
target of 32 completing the study. Participants who were screened but did not meet all eligibility 
criteria are not included in the number of participants (n=35) to be dispensed. Informed consent 
will be obtained for all participants prior to their enrolment in the study (Appendix 1). 
4.2.3 INCLUSION AND EXCLUSION CRITERIA 
A person is eligible for inclusion in the study if he/she: 
1. Is between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer; 
2. Has read and signed an information consent letter; 
3. Is willing and able to follow instructions and maintain the appointment schedule; 
4. Is a heavy digital device user (at least 6 hours on a typical day using any combination of 
digital devices such as PC, laptop, smartphone, or tablet); 
5. Is a habitual wearer of daily, spherical, soft contact lenses (no bifocal or multifocal 
contact lenses, no extended wear or monovision, not a current wearer of Precision1 
lenses) for at least 5 days/week and at least 10 hours/day during the month prior to 
enrollment; 
6. Has a vertex corrected spherical equivalent distance refraction that ranges between -
0.50D to -6.00D in each eye;  
7. Has a vertex corrected refractive cylinder of no more than -1.00D cylindrical correction in 
each eye after vertexing to the corneal plane; 
8. Demonstrates an acceptable fit and achieves best corrected visual acuity of at least 0.20 
log MAR in each eye with Precision1 contact lenses; 

PUG Protocol 12Dec2019 
 
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9. Is willing to wear Precision1 CLs at least 5 days per week and 10 hours per day 
throughout the study; 
A person will be excluded from the study if he/she: 
1. Is participating in any concurrent clinical or research study; 
2. Has any known active* ocular disease and/or infection; 
3. Has a systemic condition that in the opinion of the investigator may affect a study 
outcome variable; 
4. Is using any systemic or topical medications that in the opinion of the investigator may 
affect a study outcome variable; 
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; 
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment; 
7. Is aphakic; 
8. Has undergone refractive error surgery; 
 
* 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 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. 
 
Age >40 years is excluded because presbyopia and pre-presbyopia is highly prevalent in this 
population and will cause eyestrain which is unlikely to be improved with a change in contact 
lens material. 
Pregnant and lactating women are not being excluded from the study due to safety concerns but 
due to fluctuations in refractive error and/ or visual acuity that occur secondary to systemic 
hormonal changes. It has further been shown that pregnancy could impact tear production, 
which could impact dry eye symptoms. Such fluctuations could affect data, thereby negatively 
affecting study data integrity. 
4.2.4 REPEATED SCREENINGS 
In some circumstances a repeated screening may need to be scheduled (Visit 1-R). Examples 
include, but are not limited to: 

PUG Protocol 12Dec2019 
 
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Participants will be assigned a study ID number after they sign the consent documentation process 
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 outlined below:  
Participants will attend this visit having not worn their contact lenses for 12hrs prior to the visit.  
1. Informed consent 
2. Participant demographics and medical history: 
• 
Age, Sex 
• 
Medical history/medications, Allergies 
3. CL wear & digital device use history 
• 
Habitual contact lens wear (CL type, cleaning solution (if applicable), wear time 
and comfortable wear time; Eye drop / artificial tear use (if applicable)) 
• 
Digital device use (device kind, combined duration) 
4. Unaided or with habitual spectacles; monocular & binocular logMAR distance high 
illumination high contrast visual acuity (HIHC VA)  
5. Biomicroscopy examination 
6. Auto refraction/auto keratometry 
7. Sphero-cylindrical refraction, monocular & binocular logMAR distance HIHC VA 
8. Best sphere refraction, monocular & binocular logMAR distance HIHC VA 
9. Precision1 study lens fitting 
a. The contact lens power will be chosen based on the vertexed best sphere 
refraction. 
b. The participant will insert the lenses. 
c. Acceptability of lens fit (centration, movement, limbal coverage, overall; YES/NO) 
will be confirmed. 
d. Monocular over-refraction will be performed to determine if a different power is 
needed. If any changes are made, the above procedures will be repeated. 
e. The final lens powers for OD and OS and monocular & binocular logMAR 
distance HIHC VA will be recorded. 

PUG Protocol 12Dec2019 
 
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10. Confirm eligibility. 
 
4.4.3 BASELINE & DISPENSE (VISIT 2) 
Participants who successfully met all eligibility criteria will directly transition to Visit 2, while 
continuing to wear the pair of study lenses that has just been fitted. 
1. Subjective post-insertion ratings (0-100 scale, where 100 means better performance; 
integer steps, both eyes rated together), to assess the first impression of Precision1 
regarding: 
• 
Comfort; 
• 
Dryness; 
• 
Clarity of vision; 
2. Lens fit & surface assessment 
3. Time to haze 
4. Lens dispense: Participants will be provided with a supply of Precision1 CLs to last them 
until their next study visit (12-16 days after V2).  
5. At-home rating scales: Participants will receive at home rating scales, to be completed on 
Day 1, Day 7 and Day 10. 
6. Participant instructions. The participants will be asked to: 
• 
Wear the lenses at least 5 days per week and 10 hours per day throughout the 
study; 
• 
To complete subjective ratings at home to reflect their lens wear experience on 
Day 1 (the day after V2), Day 7 and Day 10 using a 0-100 scale, where 100 
means better performance; integer steps, both eyes rated together). Ratings will 
be completed at lens insertion, after 6 hours of digital device use, and just before 
CL removal. Variables to be assessed are: 
 
Comfort 
 
Dryness 
 
Clarity of vision 
• 
Attend V3 after 6 hours or more of Precision1 study lens wear; 
 

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4.4.4 DAY 14 FOLLOW-UP & EXIT (VISIT 3) 
Participant to attend visit after 6 hours or more of Precision1 study lens wear. 
1. Collect unused study CLs; 
2. Changes in medical history/medications; 
3. Compliance with # of CL wear days/hours per day (total & comfortable) and # hours of 
digital device use over past 2 weeks and for V3 visit day; 
4. Collect and review at-home ratings; 
5. Study CL logMAR HIHC VA for OD, OS and OU; 
6. Subjective ratings (0-100 scale, where 100 means better performance; integer steps, 
both eyes rated together), to assess a typical day in the past 2 weeks for insertion, after 
6 hours of digital device use, and just before CL removal.  
• 
Comfort 
• 
Dryness 
• 
Clarity of vision 
7. Satisfaction (4-point Likert scale: strongly disagree, slightly disagree, slightly agree, 
strongly agree) with Precision1 CLs overall and when using digital devices on a typical 
day in the past 2 weeks 
8. Lens fit & surface assessment 
9. Time to haze 
10. Lens removal 
11. Biomicroscopy examination  
4.4.5 STUDY EXIT 
The study exit form will be completed when a participant exits the study. This form will be 
completed either at study completion, or if the participant is discontinued from the study at 
another time. A study exit form must be completed for all participants who have taken a study ID 
number. If in the opinion of the investigator post-study follow-up visits are required, the exit form 
will be completed after the last follow-up visit.  

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Study lens fitting  
X 
 
 
Eligibility 
X 
 
 
Subjective ratings (Post-insertion re Comfort, Dryness & Vision) 
 
X 
 
Lens performance (fit, wettability, pre-lens TBUT, deposition) 
 
X 
X 
Time to haze 
 
X 
X 
Study lens dispense 
 
X 
 
Subjective at-home ratings (Comfort, Dryness & Vision) provided  
 
X 
 
Review of compliance (CL wear, digital device use, completion of 
home ratings) 
 
 
X 
Subjective ratings (Comfort, Dryness & Vision) 
 
 
X 
Satisfaction ratings (Likert scale for agreement) 
 
 
X 
Collection of unused study lenses 
 
 
X 
Study Exit 
 
 
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 participants about the current medication, allergies, 
and any medical conditions. At visit 3 participants 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 name, 
brand), lens power, lens wear days and use of artificial tears. Participants will be asked their typical 
total wear time (hours/day) and comfortable wear time (hours/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 kind of devices (e.g. smartphone, computer, laptop, tablet) they 
use. 

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4.5.2 SUBJECTIVE RATINGS 
Subjective ratings: 
At visit 2, participants will be provided with subjective rating 0-100 questionnaires to assess their 
first impression with the study CLs post insertion regarding comfort, dryness and clarity of vision. 
At the end of visit 2, they will be provided with at-home questionnaires to subjectively rate the 
experience with the 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 at home on Days 1, 7 and 10 after Visit 2 (i.e. Day 0), at three 
different time-points on each of these days: directly after insertion, after 6 hours of digital device 
use, and at the end of day just before lens removal. In addition, times of lens insertion, first 
notice of discomfort, and lens removal will be collected. 
The same questionnaire will be provided to the participants during V3 to assess their overall 
‘typical day’ experience during the past 2 weeks. 
Satisfaction with study CL: 
Satisfaction (4-point Likert scale: strongly disagree, slightly disagree, slightly agree, strongly 
agree) with Precision1 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;  
• 
I am satisfied with the comfort the study lenses provide when I use digital devices for ≥6 
hours;  
• 
I am satisfied with the vision the study lenses provide when I use digital devices for ≥6 
hours;  
• 
I don’t experience eye strain when I wear the study lenses and use digital devices for ≥6 
hours. 
• 
I don’t experience eye fatigue (tired eyes) when I wear the study lenses and use digital 
devices for ≥6 hours. 
• 
I don’t experience episodes of blurred vision when I wear the study lenses and use digital 
devices for ≥6 hours. 

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• 
Overall, these lenses provide good performance when using digital devices for ≥6 hours. 
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 AUTOREFRACTION 
Participants will be asked to focus on a target while seated at an instrument that measures their 
approximate spectacle prescription and corneal shape. 
4.5.5 SUBJECTIVE REFRACTION 
Participants 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 clarity of their vision between different lenses 
placed in front of their eyes. This procedure aids to determine their spectacle and/or contact lens 
prescription. 
4.5.6 SLIT LAMP BIOMICROSCOPY 
The participant will be seated behind a slit lamp and the following may be assessed at any visit: 
External adnexa anomalies: 
Any current observations of the anterior eye (e.g. pterygium, pinguecula, etc) will be recorded. 
Cornea:  
Any current or past corneal observations (such as infiltrates, old scars, etc) will be documented.  
Conjunctival redness: 
Ocular redness will be assessed for the bulbar and limbal conjunctiva using the EFRON grading 
scale (0 to 4, 0 = normal; 0.1 increments).  
Corneal and conjunctival staining with fluorescein:  
Corneal staining will be assessed for 5 zones, by grading type (0-4, 0.5 steps), extent (0-4, 0.5 
steps) and depth (0-4, integer steps); 
Lens edge related conjunctival staining and conjunctival indentation will be assessed for 4 zones 
(0-4, 0.5 steps); 
Palpebral conjunctival hyperemia and roughness: 

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The redness and roughness of the upper and lower eyelids (tarsal plate zone 2) will be assessed 
using the Efron grading scale (0 to 4, 0 = normal/ uniform satin appearance; 0.25 steps). 
 
4.5.7 LENS FIT & SURFACE ASSESSMENT 
Contact lens fit: 
Lens fit will be assessed to ensure acceptable lens fit with study lenses at the screening visit. 
At V2 and V3, lens centration and movement will be assessed as follows 
• 
Lens centration (scale: optimal, slight decentration, moderate decentration but not 
encroaching limbus, excessive & occasionally encroaching limbus); 
• 
Lens movement for primary gaze (-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, with 50 being optimal; 5-point steps); 
Contact lens wettability, pre-lens tear break-up time 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 being excellent); 
• 
Pre-lens tear break up time (TBUT), average of 3 measures (seconds) 
• 
Surface deposits (0-4 scale in 0.25 steps; 0 being excellent); 
 
4.5.8 TIME TO HAZE 
Time to haze and number of blinks to clear while wearing study CLs will be measured at V2 and 
V3, using a computerized chart capable of displaying letters at varying contrast levels at a 
distance of 1m. Participants will be seated in front of the chart and 5 letters of a given acuity size 
(6/19) will be displayed. Participants will be asked to read the letters while the contrast of the 
letters will be reduced until the participant cannot read all 5 letters anymore. The contrast will be 
adjusted back to the last level where participants can still read all 5 letters. The following 
measurements will be taken: 
• 
Time to haze (seconds): After 3 consecutive blinks, the participant is asked to keep 
their eyes open while continuously looking at the row of letters. The time until at least 
one letter is no longer “legible” is measured using a stopwatch. 

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• 
Blinks to clear (integer count): Starting immediately after first observation of haze, the 
participant is given verbal instructions at 1s intervals to blink until all 5 letters are clear 
again. The number of blinks it takes for the subject to clear the letters is counted. 
 
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 adverse 
events and major protocol deviations will be reviewed by the Principal Investigator. 
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. When contact lenses are worn on an extended wear 
basis, there is a significantly increased risk of an adverse reaction compared with wearing contact 
lenses on a daily wear basis. 
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.   
Participants are advised to inform the investigator of any sensitivities to any ophthalmic drops or 
study products. 

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23 
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.  
Participants may not benefit directly from taking part in this study. Participants will have the 
opportunity to try a different type of soft contact lenses at no cost to them, to see whether it 
provides them with improved symptoms during digital device use.  
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 study sponsor to better understand the 
performance of the products being used in this study, particularly during digital device use. 
 
7 
ADVERSE EVENTS 
See CORE SOP012_v02 for a description of all adverse events, including management and 
reporting. 
Any observations taking place prior to determining that a subject meets all inclusion/ exclusion 
criteria for the study and which are not related to the performed study procedures are not 
considered an AE. An AE can be any unfavourable and unintended sign, symptom, or disease 
temporarily associated with a study procedure, whether there is a causal relationship or not. 
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 4.2.2. 
• 
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. 

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24 
• 
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). 
• 
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.   

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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 includes $50 for active time 
and $10 for completing the at-home questionnaires. 
10 STATISTICAL ANALYSIS AND DATA MANAGEMENT 
10.1 STATISTICAL ANALYSIS 
All data will be analyzed by CORE at the University of Waterloo.  Data analysis will be 
conducted using Statistica, SPSS, or other appropriate software. 
Descriptive statistics will be provided for all primary outcome variables as well as information 
regarding baseline variables (e.g. age, sex).  
Subjective ratings, lens fit assessments and time to haze will be compared between Visit 2 
(Precision1 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 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 eyes. 
Binomial testing will be conducted to analyze Likert questionnaires (strongly agree, slightly 
agree, slightly disagree, strongly disagree) to determine whether participants had a positive or 
negative experience with the test lens. 
Additional analysis may be conducted. 
10.2 DATA MANAGEMENT 
All study data will be recorded on paper CRFs. Data from this study will be entered in an 
electronic database and 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.  
At the completion of the study CORE may 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.  This system provides a 
secure way to transfer files when email is not appropriate, whether because of file size, file type 

PUG Protocol 12Dec2019 
 
26 
or concerns over security. Sendit includes 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. 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 relevant and applicable comments will be included in the final report as 
deemed necessary by the lead investigator. 
11 PROTOCOL TRAINING 
All study personnel will be required to complete training prior to their involvement in the study. 
Records of training will be kept at CORE. 
12 STUDY MONITORING 
Study monitoring will be conducted throughout the study. In addition study records may be 
inspected at CORE by the Office of Research Ethics at the University of Waterloo, and by 
regulatory authorities in Canada and the United States, namely Health Canada and the United 
States Food and Drug Administration (FDA); however, no records containing 
identifiable/personal information will be permitted to leave the custody of CORE. 
Study monitoring will include, but may not be limited to: 
• 
The number of participants screened, enrolled, and randomized (i.e. assigned a study ID 
number), discontinued and completed; 
• 
Consent documentation; 
• 
Details of adverse events and protocol deviations; 
• 
Reports of unintended events. 
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), with the University of 

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27 
Waterloo’s Guidelines for Research with Human Participants and with the Tri-Council Policy 
Statement: Ethical Conduct for Research Involving Humans, 2nd Edition. 
• 
Declaration of Helsinki 
• 
ICH E6 - International Conference on Harmonisation; Good Clinical Practice 
• 
http://iris.uwaterloo.ca/ethics/human/guidelines/index.htm 
• 
http://iris.uwaterloo.ca/ethics/human/ethicsReview/UWStatement.htm 
• 
http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/ 
 
13.2 ETHICS REVIEW 
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; 

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28 
• 
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); 
• 
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 Committee (CREC) 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 
The sponsor, 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; 

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29 
• 
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_v02 Clinical data management.  
 
14 REPORT 
A report will be completed after data collection has been completed. 
15 REFERENCES 
 
1. Sulley A, Young G, Hunt C, et al. Retention rates in new contact lens wearers. Eye & 
Contact Lens. 2018;44:S273-S282 
2. Sheppard AL, Wolffsohn JS. Digital eye strain: prevalence, measurement and 
amelioration. BMJ Open Ophthalmol 2018;3:e000146 
3. Alcon press release; accessible at https://www.alcon.com/media-release/alcon-launch-
precision1-daily-disposable-contact-lenses-it-continues-deliver-vision. Last accessed on 
26-Aug-2019.