Comparing Biofinity Toric Multifocal to Ultra Multifocal for Astigmatism
Phase: NA
Conditions: Astigmatism, Presbyopia
Sponsor: CooperVision, Inc.



EX-MKTG-110 DINGO Protocol v1.7 21dec2020 
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Study Personnel 

EX-MKTG-110 DINGO Protocol v1.7 21dec2020 
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EX-MKTG-110 DINGO Protocol v1.7 21dec2020 
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1 
DOCUMENT CHANGE HISTORY 
 
Version 
number 
Version 
date 
Author 
Description of change(s) 
1.0 
22dec2019 
Jill Woods 
Original protocol 
1.1 
02jan2020 
Jill Woods 
Changes to Inclusion Criteria, section 5.2.3: changed minimum 
age to 42 yrs; added minimum refractive astigmatism of -
0.75DC. Expanded section 5.4 to provide more detail 
regarding assessments to be conducted at each study visit. 
Other minor edits following sponsor review. 
1.2 
10feb2020 
Doerte 
Luensmann 
Administrative changes 
1.3 
11mar2020 
Jill Woods 
Added Health Canada DIN for Biofinity Toric Multifocal (Table 
1) and clarified objectives and visit windows (Table 3). 
1.4 
16apr2020 
Jill Woods 
Several minor corrections to improve consistency and aid 
clarifications throughout plus, specifically: corrected address 
for site A.; removed site F who are now unable to participate; 
updated and clarified Section 5.3.5; corrected procedure for 
determining ocular dominance, Section 5.4.1. 
1.5 
19may2020 
Jill Woods 
Removed the note under Table 1 “* Study will not commence until 
the Health Canada license has been assigned to Biofinity Toric 
Multifocal.” because the HC license has now been approved. 
1.6 
14sep2020 
Doerte 
Luensmann 
Minor text updates throughout to reflect the change that CORE 
will be the only research site that seeks ethics approval 
through the Office of Research Ethics (ORE) at the University 
of Waterloo, for all other sites this study will be reviewed by 
either the Sterling Institutional Review Board (IRB) or the 
Health Research Ethics Board of Alberta – Clinical Trials 
Committee (HREBA-CTC). 

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1.7 
21dec2020 
Doerte 
Luensmann 
Two new clinical sites were added (Dr. Foster and Dr. Cymbor) 
and one clinical site which was never initiated was removed 
(Dr. Nelson) 
Other administrative changes 
 
 
 

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Table of contents 
1 
Document change history .................................................................................................... 4 
2 
Introduction ........................................................................................................................ 10 
3 
Objectives .......................................................................................................................... 10 
4 
Hypothesis ......................................................................................................................... 10 
5 
Materials and methods ...................................................................................................... 10 
5.1 
Study design ............................................................................................................... 10 
5.1.1 
Overall design ...................................................................................................... 10 
5.1.2 
Randomization ..................................................................................................... 11 
5.1.3 
Masking................................................................................................................ 11 
5.2 
Study population ......................................................................................................... 11 
5.2.1 
Sample size calculation ........................................................................................ 11 
5.2.2 
Number of participants ......................................................................................... 12 
5.2.3 
Inclusion and exclusion criteria ............................................................................. 13 
5.3 
Study materials ........................................................................................................... 14 
5.3.1 
Lenses ................................................................................................................. 14 
5.3.2 
Lens care system ................................................................................................. 15 
5.3.3 
Other products ..................................................................................................... 15 
5.3.4 
Rewetting drops ................................................................................................... 15 
5.3.5 
Ordering study products ....................................................................................... 15 
5.3.6 
Disposing of study products ................................................................................. 16 
5.3.7 
Product accountability .......................................................................................... 16 
5.4 
Scheduled and unscheduled visits .............................................................................. 16 
5.4.1 
VISIT 0, Screening VISIT ..................................................................................... 17 
5.4.2 
Repeated screening VISITs.................................................................................. 19 
5.4.3 
VISIT 0-1, lens fitting ............................................................................................ 19 

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5.4.4 
Repeated lens fitting visits .................................................................................... 20 
5.4.5 
visit 1-0, lens dispensing pair #1 .......................................................................... 21 
5.4.6 
visit 1-1, lens power optimization pair #1 .............................................................. 22 
5.4.7 
visit 1-2, 1 month follow-up pair #1 ....................................................................... 23 
5.4.8 
visit 2-0, lens dispensing pair #2 .......................................................................... 24 
5.4.9 
visit 2-1, lens power optimization pair #2 .............................................................. 24 
5.4.10 
visit 2-2, 1 month follow-up pair #2 ....................................................................... 24 
5.4.11 
EXIT visit .............................................................................................................. 24 
5.4.12 
Unscheduled visits ............................................................................................... 25 
5.5 
Study procedures ........................................................................................................ 25 
5.5.1 
Study lens fitting ................................................................................................... 27 
5.5.2 
 ......................................................................................................... 27 
5.5.3 
 ............................................................................................. 27 
6 
Monitoring protocol adherence .......................................................................................... 28 
7 
Potential risks and benefits to human participants ............................................................. 28 
8 
Adverse events .................................................................................................................. 29 
8.1 
Normal or adaptive symptoms ..................................................................................... 31 
8.2 
Procedures for adverse events .................................................................................... 31 
8.3 
Reporting adverse events ........................................................................................... 31 
9 
Discontinuation from the study ........................................................................................... 32 
10 
Device malfunctions ........................................................................................................... 33 
11 
Study completion and remuneration .................................................................................. 34 
12 
Statistical analysis and data management ......................................................................... 34 
12.1 
Statistical analysis ................................................................................................... 34 
12.2 
Data management ................................................................................................... 35 
12.3 
Comments on source documents ............................................................................ 36 

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13 
Protocol & other training .................................................................................................... 36 
14 
Study monitoring ................................................................................................................ 36 
15 
Study management............................................................................................................ 37 
15.1 
Statement of compliance ......................................................................................... 37 
15.2 
Ethics review ........................................................................................................... 37 
15.3 
Clinical trial registration ............................................................................................ 37 
15.4 
Protocol deviations .................................................................................................. 37 
15.4.1 
Major protocol deviations ..................................................................................... 38 
15.4.2 
Minor protocol deviations ..................................................................................... 38 
15.4.3 
Reporting and documenting protocol deviations ................................................... 38 
15.5 
Premature termination of the study .......................................................................... 39 
15.6 
Study participant records ......................................................................................... 39 
15.7 
Retention of study records and data ........................................................................ 39 
16 
Report................................................................................................................................ 40 
 
 

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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 
Multifocal contact lenses provide correction for vision at near as well as in the distance. This 
segment of the contact lens market has been slowly growing as more products become 
available. In the past year, two monthly replacement, multifocal contact lenses have come to 
market that also correct the astigmatism component of a prescription.  
CooperVision are interested in comparing their contact lens (Biofinity Toric Multifocal) with a 
competitor lens (Ultra Multifocal for Astigmatism, Bausch & Lomb). Of particular interest is the 
comparison of handling the lens to insert onto the eye. A previous study sponsored by 
CooperVision compared the non-multifocal lenses of these lens brand families, and showed that 
the Biofinity Toric lens was easier to insert than the Ultra for Astigmatism lens. Ease of handling 
a lens for insertion is arguably more critical in a presbyopic population who require specific 
prescription for seeing well up close. 
3 
OBJECTIVES 
The objective of the study is to compare the handling and performance of Biofinity Toric 
Multifocal to Ultra Multifocal for Astigmatism. 
The primary outcome variable for this study is: 
1. Subjective at-home ratings of ‘Lens handling for insertion’, using a 0-10 scale, collected 
on Day 28.   
4 
HYPOTHESIS 
The null hypothesis is that there will be no difference between the subjective at-home ratings of 
‘Lens handling for insertion’, collected on day 28 for each lens type. 
5 
MATERIALS AND METHODS 
5.1 STUDY DESIGN 
5.1.1 OVERALL DESIGN 
This is a prospective, randomized, participant masked, crossover, bilateral dispensing study 
conducted at CORE and seven other clinical practice sites in Canada and the USA. Each lens 
type will be worn for approximately one month. The lens prescription of each lens type will be 
optimized after 3-7 days before the one month wear period. 

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5.1.2 RANDOMIZATION 
A randomization schedule will be generated using a web-based program: 
(www.randomization.com). The final study randomization schedule will be generated by CORE’s 
Database Administrator and provided to the research assistants at each site for the study.  
5.1.3 MASKING 
Participants will be masked to the lens type they are wearing during the study. Foils will not be 
visible to participants when the lenses are removed from the blister packs and information 
specifying which lens is being worn will not be shared with the participant. 
It is not possible for the study investigators to be masked because of the need to follow the 
specific lens fitting guide during the lens prescription optimization visit (visits 1-1 and 2-1).  
5.2 STUDY POPULATION 
5.2.1 SAMPLE SIZE CALCULATION 
The sample size was calculated using the end of month subjective ratings for ‘lens handling for 
insertion’ from a previous study.  
In order to detect a mean difference of 0.7 units on the 0 to 10 scale for the end of month ratings 
of ‘lens handling for insertion’, using a standard deviation of 1.7 with 80% power and alpha 0.05 
in a two-tailed t-test, a minimum sample size of 49 participants is recommended. To account for 
dropout, up to 60 participants may be randomized and dispensed with study product in total, with 
the target of at least 49 completing the study.  

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Figure 1: Sample size calculation graph 
 
5.2.2 NUMBER OF PARTICIPANTS 
Participants will be recruited using site records, databases and advertising materials (eg. 
posters, email scripts) approved by the relevant research 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 80 potential participants may attend a Screening visit and up to 60 
participants may be randomized and dispensed with study products, with a target of 49 
completing the study. Informed consent will be obtained for all participants prior to their 
enrolment in the study (Appendix 1). 
 

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5.2.3 INCLUSION AND EXCLUSION CRITERIA 
A person is eligible for inclusion in the study if he/she: 
1. Is at least 42 years of age and has full legal capacity to volunteer; 
2. Has read and signed an information consent letter; 
3. Self reports having a full eye examination in the previous two years; 
4. Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week; 
5. Is willing and able to follow instructions and maintain the appointment schedule; 
6. Habitually wears soft contact lens for the past 3 months minimum; 
7. Has refractive astigmatism of at least -0.75DC; 
8. Is presbyopic and requires a reading addition of at least +0.75D; 
9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 
logMAR) which participants also deem to be ‘acceptable’, with the available study lens 
parameters (sphere +4 to -6; cylinder -0.75 to -1.75DC; near addition +0.75 to +2.50). 
A person will be excluded from the study if he/she: 
1. Is participating in any concurrent clinical or research study; 
2. Habitually wears one of the study contact lenses; 
3. Has any known active* ocular disease and/or infection; 
4. Has a systemic condition that in the opinion of the investigator may affect a study 
outcome variable;  
5. Is using any systemic or topical medications that in the opinion of the investigator may 
affect contact lens wear or a study outcome variable; 
6. Has known sensitivity to the diagnostic sodium fluorescein and/or the care product Opti-
Free PureMoist being used in the study; 
7. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment; 
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. 
 

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5.3.6 DISPOSING OF STUDY PRODUCTS 
At the end of the study, all sites will return all unused products to CORE, unless otherwise 
directed. Worn lenses will be disposed of at the sites according to local regulations. 
5.3.7 PRODUCT ACCOUNTABILITY 
Accountability logs must be kept by each site to include the number of contact lenses and lens 
care system bottles received, dispensed and returned. (where relevant). All products dispensed 
to participants must also be recorded in participant dispensing logs. All logs should be sent to 
CORE on request. 
5.4 SCHEDULED AND UNSCHEDULED VISITS 
This study has a minimum of 9 scheduled study visits, including the screening visit, though some 
visits may be scheduled concurrently on the same day. There is an option for repeated 
screening and lens fitting visits as needed. 
A scheduled follow-up visit may only take place when the participant attends wearing the 
study lenses for at least two hours. If this is not the case and the participant is not experiencing 
any problems with the lenses, the appointment will be rescheduled, ideally within the visit window.   
Visits that fall outside of the specified visit windows will be designated as protocol deviations and 
at the end of the study, the data collected during protocol deviations will be assessed for their 
suitability to be included in the analysis population. Table 3 summarizes the scheduled study visits 
and study codes. 

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6. The participant removes their habitual contact lenses.  
7. 
 
 
 
  
9. 
 
 
 
 
10. 
 
 
 
 
 
 
 
 
 
 
 
11. 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. 
12. From both fitting sets, the investigator will chose lenses that are close to the required 
prescription to determine the axis rotation of the lenses on each eye. The investigator will 
complete their lens order sheet after giving consideration to the axis rotation of this initial 
fitting lens. 
13. Schedule Visit 0-1 in approximately 4-6 weeks time or schedule once lenses are 
available on site. 

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5.4.2 REPEATED SCREENING VISITS 
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. Reassessment of baseline ocular conditions (e.g. corneal and/or conjunctival staining, 
scars etc.) 
The maximum total number of screenings permitted will be 3, the initial and two repeat screening 
visits. 
 
5.4.3 VISIT 0-1, LENS FITTING  
This visit may or may not be subsequent to the screening visit, depending on lens 
availability. 
Participant to attend this visit wearing spectacles. 
Procedures as follows: 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
 
 
 
 
 
 
 
 

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3. Trial fitting of study lenses: 
a. 
 
  
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. 
d. 
 
 
e. 
 
 
 
 
f. The final lens power to be dispensed will be recorded.  
g. 
 
 
 
h. If lens prescriptions of both lens types are final today, place lenses in OptiFree 
PureMoist solution and continue with the dispense visit 1-0. 
i. 
If more lenses need to be ordered to complete the lens fitting process then 
complete a lens ordering form. Schedule a repeat visit in approximately 2-3 
weeks time or wait until lenses arrive on site. 
5.4.4 REPEATED LENS FITTING VISITS 
Because it is not possible to provide each site with a complete fitting set of all available power 
combinations, multiple lens power combinations will be ordered to maximize the likelihood of a 
successful lens fit at visit 0-1. However if this initial lens fitting is unsuccessful and further lens 
powers are required, they will be ordered and a repeated visit, visit V0-1/R1, will be scheduled. 
There is no limit to the number of repeated visits allowed within the protocol. They will be 
numbered successively eg. V0-1/R1, then V0-1/R2, then V0-1/R3 etc.  
 

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5.4.5 VISIT 1-0, LENS DISPENSING PAIR #1 
The procedures to be performed are outlined below: 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
 
 
 
 
 
 
 
 
3. 
 
 
 
 
 
 
 
 
7. 
 
 
.  
9. Remind the participant to wear the study lenses for at least 8 hours per day and 5 days 
per week. 
10. Provide the participant with OptiFree PureMoist and provided verbal and written 
instructions on how to store and care for the contact lenses.  
11. The participant will be scheduled/reminded to return for Visit 1-1 to optimize the lens 
prescription, having worn their study contact lenses for at least 2-hours. 
 

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5.4.6 VISIT 1-1, LENS POWER OPTIMIZATION PAIR #1 
This visit will occur 3-7 days after the lenses were dispensed at visit 1-0. Participants will be 
asked to insert lenses at least 2 hours prior to the visit. 
The contact lens power optimization procedures to be performed are outlined below: 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
3. 
 
4. 
 
 
 
 
.  
6. 
 
 
  
 
 
 
 
 
 
 
11. If final lenses were determined today and are available for dispense, provide and explain 
to participant the subjective at-home rating forms to be completed on Days 7, 14 and 28 
(Note: Day 1 is the day after the dispensing visit). Fill in the days and dates on these 
forms. Explain the ratings will include: 
a. 
  
 
c. Ease of lens handling for insertion onto eyes (0 – 10 integer scale); 
d. 
 
 

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f. 
 
 
 
 
 
 
 
 
 
 
 
 
12. The participant will be scheduled/reminded to return for Visit 1-2 having worn their study 
contact lenses for at least 2-hours. 
 
NOTE: If any power changes are required and the new power lenses are not available on 
site to assess, complete a lens order form (on CRF 5). When the lenses arrive on site, 
schedule an additional optimization visit to assess and dispense the new lens powers 
ordered. If new lenses need to be ordered, participants should wear their habitual lenses in 
the mean time and attend the nest optimization visit wearing spectacles. 
 
5.4.7 VISIT 1-2, 1 MONTH FOLLOW-UP PAIR #1 
This visit will occur on day 29-31 (inclusive) after the pair #1 lenses have been dispensed, 
following visit 1-1. 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
3. 
 
4. 
 
5. 
 
 
 
 
 
 

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b. 
 
 
 
 
 
 
 
 
 
 
5.4.8 VISIT 2-0, LENS DISPENSING PAIR #2 
Repeat steps 2-11 as listed for visit 1-0. 
 
5.4.9 VISIT 2-1, LENS POWER OPTIMIZATION PAIR #2 
This visit will occur 3-7 days after the lenses were dispensed at visit 2-0. Repeat steps 1-12 as 
listed for visit 1-1. 
 
5.4.10 VISIT 2-2, 1 MONTH FOLLOW-UP PAIR #2 
This visit will occur on day 29-31 (inclusive) after the pair #2 lenses have been dispensed 
following visit 2-1. 
Repeat steps 1-9 as listed for visit 1-2.  
Participants will also complete preference questionnaires to compare the two study lens pairs. 
 
5.4.11 EXIT VISIT 
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. 

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5.5.1 STUDY LENS FITTING  
Both lens types will be fit according to the manufacturers fitting guide, using the vertex-corrected 
spectacle refraction as a guide. Learnings from the first lens fit will not be applied to the second 
lens fit because it is of interest to determine how many lenses were needed to achieve the final 
lens prescription at V0-1 and at each optimization visit (V1-1 and V2-1).  
For both lens types, the multifocal contact lenses may need to be ordered to conduct and 
complete the trial fitting. Lenses will be ordered through CORE, see section 5.3 for details. If 
necessary, the same brand of ‘non-multifocal’ toric lens (ie. Biofinity Toric or Ultra for 
Astigmatism) may be used to determine the orientation and possibly the sphere and cylinder 
powers required for the respective brand of multifocal contact lens. These toric lenses will not be 
recorded in lens accountability logs but their prescription, expiry date and Lot# details will be 
recorded on the study data collection forms. 
This protocol allows for an unrestricted number of lens fitting visits and they will be numbered as 
follows:  
• 
V0-1 (first fitting visit) 
• 
V0-1/R1 (first repeated fitting visit)  
• 
V0-1/R2 (second repeated fitting visit) 
• 
V0-1/R3 (third repeated fitting visit) 
• 
Etc.  
No lenses will be dispensed until the final prescriptions for each lenses have been determined 
during a fitting visit.  
 
 
 
 
  
  
  
  
  
 

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2. 
 
 
 
 
 
6 
MONITORING PROTOCOL ADHERENCE 
Adherence to study visit windows, lens wearing schedule, and time windows around other data 
collection points (i.e. subjective ratings) will be monitored by CORE. Deviations from the study 
plan as described in the protocol will be reported in the study report. As described in Section 
15.4.3, major protocol deviations will be reported to the Sponsor and the relevant research ethics 
review board within 7 days of the Principal Investigator becoming aware of them (or as per 
research ethics review board guidelines).  
7 
POTENTIAL RISKS AND BENEFITS TO HUMAN PARTICIPANTS 
This is a minimal risk study because of the use of marketed products and standard optometric 
assessments. 
The two contact lens types in this study will be worn as per their approved use; on a daily wear 
basis, for up to 1 month each. Adverse events and/ or complications in daily wear of soft contact 
lenses can occur (eg: 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 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. 
Participants will be provided with OptiFree PureMoist to care for the study contact lenses. 
Participants will be asked if they have a known allergy or sensitivity to this product. 

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20 
Other sign and/or symptom warranting classification as a non-significant 
adverse event 
 
8.1 NORMAL OR ADAPTIVE SYMPTOMS 
Transient symptoms such as end-of-day dryness, lens awareness, itching or burning or other 
discomfort may occur with contact lens wear and may occasionally reduce wearing time. These 
are not reported as adverse events unless in the investigator’s opinion they are unexpected in 
nature, severe or have a high rate of occurrence.  
8.2 PROCEDURES FOR ADVERSE EVENTS 
Treatment of an adverse event will depend on its nature and severity. Based on the clinical 
judgment of the investigator the participant may be referred to an ophthalmologist for treatment. 
The investigator will attempt to determine whether the reaction is related to the test device or a 
result of other factors. An adverse event form will be completed 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 the site Principal Investigator and CORE’s contact 
below within 24 hours of becoming aware of the event.  Reporting to the IRB will be completed by 
the respective site Principal Investigator, overseen by CORE’s contact, within 24 hours, via the 
IRB specified method (by fax, mail/ delivery, phone or email, unless otherwise specified by the 
IRB. CORE’s contact will inform the sponsor immediately upon becoming aware of the event, at 
least within 24 hours. All fatal or life threatening events will be reported immediately to the IRB.  
CORE sub-investigators and all sites will report all other Adverse Events to CORE’s contact below 
who will report them to the sponsor as soon as possible, but no later than 5 working days after the 

EX-MKTG-110 DINGO Protocol v1.7 21dec2020 
32 
occurrence. CORE will ensure all adverse events are reported to all IRBs involved in this study 
approval, as per IRB requirements (by fax, mail/delivery, phone, or email). 
 
  
 
  
 
 
 
  
 
 
 
  
  
 
  
 
 
 
  
  
 
 
Details of all adverse events will be included in the study report. 
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 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.   

EX-MKTG-110 DINGO Protocol v1.7 21dec2020 
33 
• 
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 a research ethics review 
board. 
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 

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Adverse Event should be reported to CORE and the sponsor within 24 hours of the investigator 
becoming aware of the malfunction. The research ethics review board 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 provided at the end of their study involvement. 
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 month 
visits. Additionally the subjective ratings completed on days 7, 14 and 28 of each phase will be 
compared. 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 “neither agree or 
disagree” responses will be evenly distributed to the two options on the basis they would be 
equally likely to choose either. 

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36 
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 Investigator.  
13 PROTOCOL & OTHER 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. 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.  
All site Principal Investigators and co-investigators will provide a scan of their license to practice 
optometry and evidence of professional indemnity insurance.  
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 may be conducted by 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, the relevant 
research ethics 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 two people and the entries will be compared. Data 

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37 
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. All serious adverse events and major protocol deviations will be reviewed by the site 
Principal Investigator and CORE’s Head of Clinical Research and/ or CORE’s Principal 
Investigator. 
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 
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/ 
 
15.2 ETHICS REVIEW 
This protocol will be submitted to and reviewed through the Office of Research Ethics (ORE) at 
the University of Waterloo for study site H (CORE), the Health Research Ethics Board of Alberta 
– Clinical Trials Committee (HREBA-CTC) for study site G and the Sterling Institutional Review 
Board (IRB) for all other clinical study sites. Notification of ethics clearance of the application is 
required prior to the commencement of the study the respective provinces and sites. 
15.3 CLINICAL TRIAL REGISTRATION 
CooperVision will register this study with clinicaltrials.gov and maintain the information.  
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.  

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38 
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. 
The following are examples of major protocol deviations that require reporting to research ethics 
review boards:: 
• 
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 
Protocol deviations caused by or which originate with research participants are considered 
minor, and normally are not reported to the research ethics review board 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 research ethics review board:: 
• 
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 PROTOCOL DEVIATIONS 
Protocol deviations must be reported to the site Principal Investigator and CORE’s contact 
below. CORE will inform the sponsor within 7 days of any major protocol deviations that 
occurred during the study. Major protocol deviations must be reported by the site Principal 

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39 
Investigator, overseen by CORE’s contact, to the research ethics review board via the IRB 
specified method (by fax, mail/ delivery, phone or email)  within 7 days of the deviation occurring 
(or its discovery) unless otherwise specified by the IRB.   
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 the relevant research ethics review board may terminate the study at any 
time for any reason. 
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 the original consent documentation and enrolment logs to CORE.  
Each site should retain the original study data collection forms documentation for one year 
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. 

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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.