Performance Evaluation of Different Daily Disposable Contact Lenses in Habitual Lens Wearers Who Report Frequent Use of Digital Devices
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.



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1 
DOCUMENT CHANGE HISTORY 
 
Version 
number 
Version 
date 
Author 
Description of change(s) 
1.0 
12Dec2022 
Doerte 
Luensmann 
Original protocol 
1.1 
14Dec2022 
Doerte 
Luensmann 
Multiple administrative changes 
1.2 
09Jan2023 
Doerte 
Luensmann 
Sample size calculation added 
1.3 
24Jan2023 
Doerte 
Luensmann 
Computer Vision Syndrome Questionnaire (CVS-Q) added 
1.4 
06Feb2023 
Doerte 
Luensmann 
Lens order procedure updates 
1.5 
23Feb2023 
Doerte 
Luensmann 
Inclusion criteria updated (5.3.3): Participant age range      
18-35 years (inclusively) 
 
 
 

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Table of contents 
1 
Document change history .................................................................................................... 4 
2 
Introduction .......................................................................................................................... 9 
3 
Objectives ............................................................................................................................ 9 
4 
Hypothesis ........................................................................................................................... 9 
5 
Materials and methods ........................................................................................................ 9 
5.1 
Study design ................................................................................................................. 9 
5.1.1 
Overall design ........................................................................................................ 9 
5.1.2 
Randomization ..................................................................................................... 10 
5.1.3 
Masking................................................................................................................ 10 
5.2 
Investigational Sites .................................................................................................... 10 
5.2.1 
Number of Sites ................................................................................................... 10 
5.2.2 
Investigator Recruitment ...................................................................................... 10 
5.3 
Study population ......................................................................................................... 11 
5.3.1 
Sample size calculation ........................................................................................ 11 
5.3.2 
Number of Participants ......................................................................................... 12 
5.3.3 
Inclusion and exclusion criteria ............................................................................. 12 
5.4 
Study materials ........................................................................................................... 14 
5.4.1 
Lenses ................................................................................................................. 14 
5.4.2 
Other products ..................................................................................................... 15 
5.4.3 
Rewetting drops ................................................................................................... 15 
5.4.4 
Disposing of study products ................................................................................. 15 
5.4.5 
Product accountability .......................................................................................... 15 
5.5 
Scheduled and unscheduled visits .............................................................................. 15 
5.5.1 
Visit 0 Screening & fitting visit .............................................................................. 16 
5.5.2 
Repeated screening visits (Visit 0/R1 or Visit 0/R2) .............................................. 18 

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5.5.3 
Visit 1-0 Dispense Lens type #1 ........................................................................... 19 
5.5.4 
Visit 2-0, 1-week follow-up Lens type #1, Dispense Lens type #2 ........................ 20 
5.5.5 
Visit 3-0 1-week follow-up Lens type #2 ............................................................... 20 
5.5.6 
Study Exit ............................................................................................................. 21 
5.5.7 
Unscheduled visits ............................................................................................... 21 
 
 
 
 
 
 
 
 
6 
Monitoring protocol adherence .......................................................................................... 23 
7 
Potential risks and benefits to human participants ............................................................. 23 
8 
Adverse events .................................................................................................................. 24 
8.1 
Normal or adaptive symptoms ..................................................................................... 26 
8.2 
Procedures for adverse events .................................................................................... 26 
8.3 
Reporting adverse events ........................................................................................... 27 
9 
Discontinuation from the study ........................................................................................... 28 
10 
Device malfunctions ........................................................................................................... 29 
11 
Study completion and remuneration .................................................................................. 29 
12 
Statistical analysis and data management ......................................................................... 30 
12.1 
Statistical analysis ................................................................................................... 30 
12.2 
Data management ................................................................................................... 31 
12.3 
Comments on source documents ............................................................................ 31 
13 
Protocol & other training .................................................................................................... 31 
14 
Study monitoring ................................................................................................................ 32 
15 
Study management............................................................................................................ 32 
15.1 
Statement of compliance ......................................................................................... 32 

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15.2 
Ethics review ........................................................................................................... 33 
15.3 
Clinical trial registration ............................................................................................ 33 
15.4 
Protocol deviations .................................................................................................. 33 
15.4.1 
Major protocol deviations ..................................................................................... 33 
15.4.2 
Minor protocol deviations ..................................................................................... 34 
15.4.3 
Reporting and documenting protcol deviations ..................................................... 34 
15.5 
Premature termination of the study .......................................................................... 34 
15.6 
Study participant records ......................................................................................... 35 
15.7 
Retention of study records and data ........................................................................ 35 
16 
Report................................................................................................................................ 35 
17 
References ........................................................................................................................ 35 
 
 

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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. 
 
 
 

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2 
INTRODUCTION 
Daily disposable (DD) contact lenses are popular choices today and are frequently recommended 
by eye care professionals, as this avoids the use of a lens cleaning product and with the goal to 
reduce symptoms of dryness and discomfort.1 As a result, DD lenses account for 45% of all soft 
lens fits today.2 
DD lenses were mainly available in hydrogel materials in the past, however, more and more new 
high oxygen-permeable silicone hydrogel (SiHy) DD lenses are becoming available today.  
The goal of this study is to compare the performance of MyDay Energys, a SiHy DD lens from 
CooperVision Inc., which has successfully been established on the market, with ACUVUE OASYS 
MAX 1-Day, a DD SiHy lens recently launched by Johnson & Johnson Inc.  
3 
OBJECTIVES 
To evaluate and compare the performance of MyDay Energys (CONTROL) (CooperVision Inc.) 
and ACUVUE OASYS MAX 1-Day sphere (TEST) (Johnson & Johnson Inc.) in existing soft lens 
(CL) wearers over one week of wear. 
The primary outcome variable for this study is: 
• 
Lens handling on removal collected on Day 6 on the at-home ratings (0-100 
scale).   
4 
HYPOTHESIS 
The null hypothesis is that there will be no difference for lens handling on removal on Day 6 (At-
home ratings, 0-100 scale) between CONTROL compared to TEST lens.  
5 
MATERIALS AND METHODS 
5.1 STUDY DESIGN 
5.1.1 OVERALL DESIGN 
This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-
wear design involving two different daily disposable lens types. Each lens type will be worn for 
approximately one week, during which participants record their subjective lens-wear experience 
on three different days. 

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5.1.2 RANDOMIZATION 
A randomization schedule will determine the order of CONTROL and TEST CL wear for the 
first/second week for each participant. Participants will be randomized immediately prior to their 
first lens dispense. 
This randomization schedule will be generated for each site using a web-based program: (for 
example www.randomization.com). The lens type that will be worn during the first week is called 
“Lens type #1”, the lens type dispensed for the second week is called “Lens type #2”. The final 
study randomization schedule will be generated by CORE’s Database Administrator and 
provided to the unmasked research assistants at each site.  
5.1.3 MASKING 
This study will be double masked i.e. participants and investigators will be masked to the lens 
type dispensed. In order to achieve this, unmasked research assistants will determine the lens 
order according to the randomization schedule (see section 5.1.2) and will over-label the lens 
packages/foils prior to dispense by placing strongly adhesive stickers on the packages/foils to 
mask the participant and investigator to the lens brand. At the fitting visit both lens types will be 
fit, but only the participant can be masked to the lens type during this process because the 
investigator needs to know which type is being fit in order to follow the fitting guide when making 
changes to the lens. During the lens wear phases both investigators and participants will be 
masked. 
5.2 INVESTIGATIONAL SITES 
5.2.1 NUMBER OF SITES 
This study will be conducted at approximately 4 optometry practice sites in the USA.   
 
5.2.2 INVESTIGATOR RECRUITMENT  
The principal investigator at each site will undergo qualification by CooperVision oversight 
personnel and among other requirements they will be required to fulfil the following criteria: 
• 
Is a licensed eye care professional with at least two years of contact lens fitting 
experience. 
• 
Can demonstrate training in Good Clinical Practice (GCP) by the already trained 
principal investigator. 
• 
Accepts responsibility for the conduct of the study at their site. 

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• 
Has in-office email and document scanning capabilities. 
• 
Will scan and send all study visit documents to CORE, ideally the same day* as the 
visit or at most within 2 days of the study visit.  
• 
Is willing to follow the study protocol and to co-operate with the study monitors at 
CORE. 
* Study documents are required as soon as possible because this allows a timely data review, 
query and entry. 
5.3 STUDY POPULATION 
5.3.1 SAMPLE SIZE CALCULATION 
The sample size calculation was based on “lens handling at removal” using historical data at 1 
week in which participants used a 0-100 scale (100 being best).  
A sample size of 64 is required to detect a mean difference in “handling at removal” of 10 units on 
a 0 to 100 scale using a standard deviation of the paired differences of 24.2 with 90% power and 
alpha 0.05 in a two-tailed t-test. Therefore, up to 73 participants will be dispensed with study 
products with the goal to complete at least 64.  
 

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Figure 1: Sample size calculation graph 
 
 
5.3.2 NUMBER OF PARTICIPANTS 
Participants will be recruited using site records, databases and advertising materials (eg. 
posters, email scripts) approved by the ethics review board. All initial individual-targeted 
recruitment activities, such as any direct mailing of recruitment scripts, will be conducted by 
practice staff that are not directly involved in conducting the research. This separation will 
reduce any undue influence of the optometrist-patient relationship. This process will also 
eliminate opportunity for the investigator to access personal health information before any 
consent for disclosure is provided by the potential participant.  
It is anticipated that up to 73 potential participants may attend a Screening visit and up to 70 
participants may be randomized and dispensed with study products, with a target of at least 64 
completing the study.  
5.3.3 INCLUSION AND EXCLUSION CRITERIA 
A person is eligible for inclusion in the study if he/she: 
1. Is between 18 and 35 years of age (inclusively) and has full legal capacity to volunteer; 
2. Has read and signed an information consent letter; 

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3. Self-reports having a full eye examination in the previous two years; 
4. Self-reports spending on most days at least 6 hours cumulative (not necessarily in one 
single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smart-
phone; 
5. Anticipates being able to wear the study lenses for at least 8 hours a day, 7 days a week; 
6. Is willing and able to follow instructions and maintain the appointment schedule; 
7. Habitually wears soft contact lenses, for the past 3 months minimum; 
a. No more than 1/3 of participants should be habitual wearer of MyDay or MyDay 
Energys 
b. No more than 1/3 of participants should be habitual wearer of ACUVUE® OASYS 
MAX 1-Day or ACUVUE® OASYS 1-Day. 
8. Has refractive astigmatism no higher than -0.75DC in each eye; 
9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens 
parameters are sphere -1.00 to -6.00D, 0.25D steps). 
 
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 that contraindicates contact lens 
wear; 
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 contact lens wear or a study outcome variable; 
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study; 
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; 
7. Has undergone refractive error surgery or intraocular 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. 
 
Pregnant and lactating women are not being excluded from the study due to safety concerns but 
due to fluctuations in refractive error, accommodation and/ or visual acuity that occur secondary 

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to systemic hormonal changes and water retention. 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. 
5.4 STUDY MATERIALS 
Each site will be provided with an inventory of the CONTROL lens which will be used for fitting 
and dispensing the CONTROL lens.  
For the TEST lens, the clinical sites will pre-order two packs of 30 CL in each prescription in the 
range -1.00 to -6.00 inclusively in 0.25D steps for the use in this study. These lenses will be 
used for fitting and dispensing the TEST lens. Reimbursement to practice sites for study product 
expenses for the TEST lens will be provided by CooperVision, after CORE has reconciled the 
invoices. 
CORE will provide all sites with the study paperwork. This will include participant informed 
consent letters and study data collection forms, product accountability logs and the participant 
dispensing logs. CORE will train site personnel to complete the forms correctly and provide 
continued support to answer queries on correct form completion. 
 
 
 
 
 
 
 
 
5.4.1 LENSES 
Both study lenses are cleared by the United States Food and Drug Administration (FDA) and are 
commercially available in the U.S. 
The table below lists the contact lens details for both study lenses including the lens parameters 
available for this study. 

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2. The participant will be required to read and sign an Informed Consent Form prior to 
enrollment. When the participant has signed the consent form, the participant will be 
considered enrolled in the study and will be assigned a study ID. 
3. Participant demographics and medical history (age, sex, medical conditions, 
medications, allergies). 
4. Contact lens history (habitual lens information and wearing habits).  
5. 
 
 
6. 
 
  
7. The participant removes their habitual contact lenses.  
8. 
. 
9. 
 
  
10. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11. After a minimum 5-minute washout time after fluorescein insertion, the participant will be 
fit with the study lenses. 
12. The investigator will fit both study lenses (CONTROL and TEST) using the pre-ordered 
or provided lenses following the manufacturers fitting guidelines. 
Trial fitting of both study lenses: 

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a. The contact lens power will be chosen based on the vertex-corrected spectacle 
refraction.  
b. The contact lenses will be provided to participants in a manner that does not 
unmask the participant as described in Section 5.1.3. 
c. The participant will insert the lenses, allow to settle for at least 10 minutes. 
d. 
  
 
 
e. 
 
 
  
f. If any changes are made to the lens power, the above procedures (b to e) will be 
repeated. 
13. The investigator will confirm that the participant meets the eligibility specifications set out 
in the inclusion criteria and exclusion criteria and is eligible to continue in the study. 
14. If additional fitting lenses need to be ordered to determine the final lens power, schedule 
a re-screening visit. Both study lenses have to be tested on eye in the final power before 
any of the study lens types can be dispensed. 
15. Ensure sufficient lenses are available for dispense in the final prescription with each lens 
type (minimum 12 pairs) before proceeding with Visit 1.0 (Dispense visit). 
 
5.5.2 REPEATED SCREENING VISITS (VISIT 0/R1 OR VISIT 0/R2) 
In some circumstances a repeated screening may need to be scheduled. 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 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. 
 
 

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5.5.4 VISIT 2-0, 1-WEEK FOLLOW-UP LENS TYPE #1, DISPENSE LENS TYPE #2 
Participants will be asked to insert Lens type #1 at least 2 hours prior to the visit. This visit will 
occur 7-10 days (inclusive) after visit 1-0. 
The study procedures are outlined below: 
1. Confirm participant’s health and medications are unchanged. 
2. Review ‘at-home’ ratings for completeness and legibility. 
3. 
 
 
4. 
 
 
 
  
7. The participant will remove the lenses. 
8. 
 
9. Continue with the lens dispense for Lens type #2 as described in visit 1-0 starting at point 
#3 to #8. 
10. Visit 3-0 will be scheduled 7-10 days after Visit 2-0. 
 
5.5.5 VISIT 3-0 1-WEEK FOLLOW-UP LENS TYPE #2  
Participants will be asked to insert Lens type #2 lenses at least 2 hours prior to the visit. This 
visit will occur 7-10 days (inclusive) after visit 2-0. 
The study procedures are outlined below: 
1. Confirm participant’s health and medications are unchanged. 
2. Review ‘at-home’ ratings for completeness and legibility. 
3. 
 
 
4. 
  
5. 
 
 
 
 

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7. 
 
8. The participant will remove the lenses. 
9. 
 
10. Continue with Study Exit. 
 
5.5.6 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.  
 
 
 
After the exit assessments have been completed, the participant and investigator will complete 
the study completion and remuneration forms. At this time the participant will be considered as 
having exited the study. 
 
5.5.7 UNSCHEDULED VISITS 
An unscheduled visit is defined as an interim visit requested by the participant or investigator 
due to an unanticipated problem. Data recorded at these visits will be entered into the database. 
Only relevant and applicable unscheduled visit information will be included in the final report as 
deemed necessary.  
 
 
5.6 STUDY PROCEDURES 
Table 4 summarizes the procedures conducted at each visit.  

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include discomfort, dryness, aching or itching eyes, excessive tearing, discharge, hyperemia and 
variable or blurred vision.  More serious risks may include pain, 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 day-wear soft lenses is 0.035%. Almost 
always an infection will occur only in one eye.  This risk is assumed by 35-million Americans who 
currently wear contact lenses and only current soft lens wearers will be recruited for this study.  
A dye (fluorescein) normally used for eye examinations is being used in this study. Although 
rare, it is possible to have an allergic reaction to the dye. Participants will be asked if they have a 
known allergy or sensitivity to fluorescein. 
The assessments conducted in this study are routine clinical procedures and they include auto-
refraction, auto-keratometry, visual acuity, anterior ocular health assessment, and contact lens 
fitting will be used. In addition, high magnification imaging of the lens fit may be made using 35 
mm or digital cameras. Patients will be monitored frequently until the end of the study to reduce 
the occurrence of adverse or potential adverse events. Patients will be given instructions from 
their investigator regarding early symptoms and signs of adverse events.  
8 
ADVERSE EVENTS 
See CORE SOP012 for a description of all adverse events, including management and reporting. 
An ‘adverse event’ refers to any undesirable clinical occurrence in a participant, whether it is 
considered to be device-related or not. Adverse events (AE) may be classified as ‘unanticipated 
adverse device effects,’ ‘serious adverse events,’ ‘significant adverse events,’ or ‘non-significant 
adverse events,’ as defined below, Table 5.  
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. 

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for each adverse event. If both eyes are involved, a separate adverse event form will be completed 
for each eye. Whenever possible, the adverse event will be photo-documented.  
Expenses incurred for medical treatment as part of study participation will be paid by the sponsor 
(bills and prescription receipts kept). The participant must be followed until resolution or no further 
change is anticipated and/or referred for further care with the appropriate health care professional 
and/or recorded as being under appropriate health care as per investigator’s discretion. A written 
report will be completed indicating the subsequent treatment and resolution of the condition. 
8.3 REPORTING ADVERSE EVENTS 
All potential Serious and Unanticipated Adverse Device Effects that are related or possibly related 
to participant’s participation will be reported to CORE’s lead study coordinator (details below) and 
also to the sponsor (details below) within 24 hours of the investigator becoming aware of the event. 
The site’s Principal Investigator will also report the event to Sterling IRB within 10 days of 
becoming aware of the Serious or Unanticipated event, using the Reportable Events Form. All 
fatal or life-threatening events will be reported immediately to the IRB, CORE and the sponsor. 
Adverse Events will be reported to CORE’s lead study coordinator and the sponsor as soon as 
possible, but no later than 5 working days after the occurrence. Each site’s Principal Investigator 
will report the event to the IRB as per IRB requirements (by fax, mail/delivery, phone, or email). 
 
 
  
 
  
 
 
 
  
 
 
 
  
  
 
  
 
 
 
  
  
 
Details of all adverse events will be included in the study report. 

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9 
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 per visit for their active involvement in the study 
(including the initial screening visit and all lens fitting visits). 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 5.2.3. 
• 
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). 

EX-MKTG-148 SUN Protocol v1.5 23Feb2023 
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• 
Lost to follow-up:  The participant will be discontinued if they cannot be contacted and do 
not return to complete the final study exit, 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 Sterling IRB. 
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.   
When a participant choses to discontinue from the study they will be given the opportunity to 
withdraw their data from the statistical analysis. This choice will be captured on the discontinuation 
form. 
All discontinuations including their reasons will be included in the final report. 
10 DEVICE MALFUNCTIONS 
A device malfunction means the failure of the device to meet its performance specification or 
otherwise perform as intended. Any defective lens that is likely to cause or contribute to a Serious 
Adverse Event should be reported to CORE and the sponsor within 24 hours of the investigator 
becoming aware of the malfunction. Sterling IRB would also be notified within 24 hours of any 
device malfunction that may contribute to a Serious Adverse Event. 
Other defective lenses should be reported to CORE as soon as possible (usually in weekly study 
updates). 
This clinical study will also ascertain satisfaction or preference with subjective attributes such as 
comfort, vision, or lens handling. Responses to these subjective questionnaires will not be 
considered as complaints or device malfunctions. 
11 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.  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 paid as per site contract. 

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12 STATISTICAL ANALYSIS AND DATA MANAGEMENT 
12.1 STATISTICAL ANALYSIS 
All data will be analyzed by CORE at the University of Waterloo.  Unmasked data analysis will 
be conducted using Statistica 10, Statsoft or other suitable software.  Descriptive statistics will 
be provided on demographic data (age, gender, refractive error distribution, etc.). Table 7  lists 
the primary and other outcome variables and anticipated statistical procedures. 
Visual acuity results will be converted to LogMAR for analysis purposes. 
Comparisons will be made between the study lenses for the variables measured at the 1-week 
visits. Additionally the subjective ratings completed on days 1, 3 and 6 with each study lens will 
be compared for differences and equivalence. A binomial test will be used to analyze the results 
for the count data of subjective preferences and experience responses. Where relevant, the 
number of “no preference” responses will be evenly distributed to the two options on the basis 
they would be equally likely to choose either. 
For assessments conducted for each eye separately, the right eye will be used for analysis. If a 
general difference is found (paired t-test / Wilcoxon matched pairs) between OD and OS, a 
comment will be provided 
Where appropriate, data may be presented as both mean and as counts by ‘bucket’ groups. 
Additional analysis may be conducted  

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12.2 DATA MANAGEMENT 
Data will be collected and written on paper forms which will be provided to each site by CORE. 
Each site will be instructed to send completed study forms to CORE using a secure file share 
system operated by the University of Waterloo called Sendit which uses 128bit (or 256bit) SSL 
encryption. The sites will receive their individual accounts and passwords.  
The site will endeavour to send the scanned forms to CORE on the same day as the study 
visit or a maximum of two days after the study visit. 
Within CORE, data will be entered into a REDCap database developed and tested specifically 
for this study and accessible only to trained, authorised users. A data management plan will be 
developed to describe the data handling in more detail, including the personnel involved. 
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 
section 15.7 and also in CORE SOP014 Clinical data management. 
At the completion of the study CORE will provide a copy of the study database in Excel format to 
the sponsor when requested. Data will typically be sent using Sendit. This system provides a 
secure way to transfer files when email is not appropriate, whether because of file size, file type 
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 at the request of the sponsor. Using this method means that data files are 
only stored on University of Waterloo servers during the transfer.  
12.3 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 CORE’s Lead Co-ordinator.  
13 PROTOCOL & OTHER TRAINING 
All study personnel will be required to complete training prior to their involvement in the study. 
This will include training by CORE on the study protocol, study procedures, informed consent 
procedures, and on the randomization and participant masking procedures, as well as training 
for Good Clinical Practice.  

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All site Principal Investigators and co-investigators will provide a scan of their curriculum vitae, 
license to practice optometry and evidence of professional indemnity insurance. Additional 
training and site qualification may be required as indicated by the sponsor. 
14 STUDY MONITORING 
Each site will provide regular status reports to CORE. Status reports will include: 
• 
The number of participants screened, enrolled, and randomized (i.e. assigned a study ID 
number), discontinued and completed. 
• 
Details of all protocol deviations, adverse events, device malfunctions. 
• 
Reports of unintended events. 
CORE will collate the site updates and provide 2-weekly status reports to the study sponsor. 
Study monitoring visits to the sites may be conducted by CORE, the sponsor, or sponsor’s 
designate, throughout the study and will be scheduled in conjunction with the Principal 
Investigator at each site. In addition study records may be inspected by the sponsor, the 
sponsor's designate, Sterling Institutional Review Board, and by regulatory authorities in Canada 
and the United States, namely Health Canada and the United States Food and Drug 
Administration (FDA); however, they will not be permitted to take away any records containing 
identifiable personal information. 
Study data review and data monitoring will be conducted by CORE personnel. 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. Data queries will be reported to the site within 5 working 
days of receipt of initial data. A response resolving the query will be expected from the site within 
5 working days of receipt of the query. 
All adverse events and protocol deviations will be reviewed by the site Principal Investigator and 
CORE’s Lead Coordinator. All serious adverse events and major protocol deviations will be 
reviewed by the site Principal Investigator and CORE’s Director and/or Head of Clinical 
Research. 
15 STUDY MANAGEMENT 
15.1 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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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 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 
(2018) 
• 
https://uwaterloo.ca/research/office-research-ethics/research-human-participants  
 
Informed consent shall be obtained in writing from the participant and the process shall be 
documented before any procedure specific to the clinical investigation is carried out. 
15.2 ETHICS REVIEW 
This protocol will be submitted to and reviewed through the Sterling Institutional Review Board. 
Notification of ethics clearance of the application is required prior to the commencement of the 
study. 
This study will be conducted in accordance with Institutional Review Board regulations (U.S. 
21CFR Part 56.103) or applicable IEC regulations. Copies of all IRB/IEC correspondence with the 
investigator/sponsor will be kept on file. The study will commence upon approval from the following 
Institutional Review Board: Sterling Institutional Review Board; Telephone number: (888) 636-
1062 and email address: info@sterlingirb.com. 
15.3 CLINICAL TRIAL REGISTRATION 
CooperVision will register this study with clinical trials.gov in accordance with section 801 of the 
Food and Drug Administration (FDA) Act which mandates the registration of certain clinical trials 
of drugs and medical devices. They will maintain the information on that site.  
15.4 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.  
15.4.1 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. 

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The following are examples of major (significant) protocol deviations: 
• 
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. 
15.4.2 MINOR PROTOCOL DEVIATIONS 
The following are examples of protocol deviations that are typically considered minor: 
• 
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).  
15.4.3 REPORTING AND DOCUMENTING PROTCOL DEVIATIONS 
Major protocol deviations must be reported to the Sterling Institutional Review Board within 10 
days of the deviation occurring (or its discovery) using the Reportable Events Form. To facilitate 
timely reporting to the sponsor, all sites must notify CORE of a major protocol deviation as soon 
as possible. 
All protocol deviations (major and minor) occurring during the study will be documented and 
included in the final report. 
15.5 PREMATURE TERMINATION OF THE STUDY 
The sponsor, CORE or Sterling Institutional Review Board may terminate the study at any time 
for any reason. 

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15.6 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. 
An enrolment log will be maintained which will list all participants who attended for a screening 
visit. 
15.7 RETENTION OF STUDY RECORDS AND DATA 
When the study has been completed, all sites will send the original study product accountability 
and dispensing logs, and enrolment logs to CORE.  Each site should retain the original consent 
documents and the study data collection forms documentation for ten years following the close 
of the database in case data queries arise during the analysis and report writing stages. CORE 
may request that these originals be sent to them for storage. 
Records and data from this study will be retained at CORE for a minimum of 25 years. Details 
regarding storage procedures are given in CORE SOP014 Clinical data management.  
16 REPORT 
A report will be sent to the sponsor by CORE according to terms described in the study contract.