Comparing the Performance of 1 Day Multifocal Contact Lenses
Phase: NA
Conditions: Presbyopia
Sponsor: CooperVision, Inc.



EX-MKTG-109 MANGO Protocol v1.3 05june2020 
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1 
DOCUMENT CHANGE HISTORY 
 
Version 
number 
Version 
date 
Author 
Description of change(s) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.3 
05june2020 
Doerte 
Luensmann 
 
 
 
 
 
 

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
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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 ....................................................................................................... 9 
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 ......................................................................................... 11 
5.3.3 
Inclusion and exclusion criteria ............................................................................. 12 
5.4 
Study materials ........................................................................................................... 13 
5.4.1 
Lenses ................................................................................................................. 14 
5.4.2 
Other products ..................................................................................................... 14 
5.4.3 
Rewetting drops ................................................................................................... 14 
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) .............................................. 19 

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5.5.3 
Visit 1-2 Dispense habitual MF lenses .................................................................. 19 
5.5.4 
Visit 1-3, 2-week follow-up habitual lenses ........................................................... 21 
5.5.5 
Visit 2-0 Dispense Pair #1 .................................................................................... 21 
5.5.6 
Visit 2-1 Optimize Pair #1 ..................................................................................... 22 
5.5.7 
Visit 2-2 Dispense (optimized) Pair #1 .................................................................. 23 
5.5.8 
Visit 2-3, 2-week follow-up Pair #1 ....................................................................... 24 
5.5.9 
Visit 3-0, Dispense Pair #2 ................................................................................... 25 
5.5.10 
Visit 3-1 Optimize Pair #2 ..................................................................................... 25 
5.5.11 
Visit 3-2 Dispense (optimized) Pair #2 .................................................................. 25 
5.5.12 
Visit 3-3, 2-week follow-up Pair #2 ....................................................................... 25 
5.5.13 
Exit visit ................................................................................................................ 26 
5.5.14 
Unscheduled visits ............................................................................................... 26 
5.6 
Study procedures ........................................................................................................ 26 
5.6.1 
Study lens fitting ................................................................................................... 28 
5.6.2 
 
 
 
6 
Monitoring protocol adherence .......................................................................................... 28 
7 
Potential risks and benefits to human participants ............................................................. 28 
8 
Adverse events .................................................................................................................. 30 
8.1 
Normal or adaptive symptoms ..................................................................................... 32 
8.2 
Procedures for adverse events .................................................................................... 32 
8.3 
Reporting adverse events ........................................................................................... 32 
9 
Discontinuation from the study ........................................................................................... 33 
10 
Device malfunctions ........................................................................................................... 34 
11 
Study completion and remuneration .................................................................................. 35 
12 
Statistical analysis and data management ......................................................................... 35 

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12.1 
Statistical analysis ................................................................................................... 35 
12.2 
Data management ................................................................................................... 36 
12.3 
Comments on source documents ............................................................................ 37 
13 
Protocol & other training .................................................................................................... 37 
14 
Study monitoring ................................................................................................................ 37 
15 
Study management............................................................................................................ 38 
15.1 
Statement of compliance ......................................................................................... 38 
15.2 
Ethics review ........................................................................................................... 38 
15.3 
Clinical trial registration ............................................................................................ 38 
15.4 
Protocol deviations .................................................................................................. 39 
15.4.1 
Major protocol deviations ..................................................................................... 39 
15.4.2 
Minor protocol deviations ..................................................................................... 39 
15.4.3 
Reporting and documenting protcol deviations ..................................................... 40 
15.5 
Premature termination of the study .......................................................................... 40 
15.6 
Study participant records ......................................................................................... 40 
15.7 
Retention of study records and data ........................................................................ 40 
16 
Report................................................................................................................................ 41 
 
 

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
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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. 
 
 
 

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
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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.  
CooperVision is interested in comparing the performance of their newly developed daily 
disposable (DD) MyDay Multifocal (Lens A) contact lens to patients’ habitual multifocal lenses 
and to the competitor product DAILIES TOTAL1® Multifocal (Lens B). Of particular interest is the 
comparison of handling the lenses, which includes insertion and removal to and from the eye. 
Ease of lens handling is 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 lens handling and performance of Lens A to 
habitually worn multifocal contact lenses and to the competitor Lens B. 
The primary outcome variable for this study is: 
• 
Subjective at-home ratings of ‘Lens handling for insertion’, using a 0-10 scale, 
collected on Day 13.   
4 
HYPOTHESIS 
The null hypothesis is that there will be no difference between the at-home subjective ratings of 
‘Lens handling for insertion’, collected on Day 13 for Lens A compared to Lens B.  
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 up to 5 clinical practice sites in the United States, listed on page 3. Each lens type 
will be worn for up to 3 weeks. The lens prescription of each lens type will be optimized after 3-7 
days wearing experience, prior to starting a 2-week wear period. 
5.1.2 RANDOMIZATION 
Participants will be wearing their habitual lenses during the first 2-week phase, followed by a 
randomized order of Lens A and Lens B lens wear.  

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A randomization schedule will be generated for each site using a web-based program to 
determine the order of Lens A and Lens B lens wear: (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.  
5.1.3 MASKING 
Participants will wear their habitual lens with an optimized prescription during the first Phase, 
followed by a masked lens wear using Lens A and Lens B. Lens packages/foils will be over-
labeled with strongly adhesive stickers to mask the participant to the lens brand. 
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 0, 2-1, 3-1).  
5.2 INVESTIGATIONAL SITES 
5.2.1 NUMBER OF SITES 
This study will be conducted at 5 optometry practice sites, listed on page 3 of this document.   
 
5.2.2 INVESTIGATOR RECRUITMENT  
The principal investigator at each site will be required to fulfil the following criteria: 
• 
Is a licensed Optometrist 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. 
• 
Has in-office email and either document scanning capabilities or fax. 
• 
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 for prompt lens 
ordering and timely data review, query and entry. 

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5.3 STUDY POPULATION 
5.3.1 SAMPLE SIZE CALCULATION 
The sample size was calculated using lens handling data from a previous study comparing Lens 
A against lens B (CooperVision, data on file). In that study a 0-100 scale was used, not the 0-10 
used in this study. As a way of compensating for fewer step sizes in the 0-10 scale, a target 
difference of 5 units on the 0-100 scale was chosen as a meaningful clinical differences in 0-100 
subjective responses. 
Using the 0-100 scale data described above for ‘lens handling for insertion’, where the data 
showed a standard deviation of 12.7 and when applying requirements of 80% power and alpha 
0.05 in a two-tailed t-test, a minimum sample size of 53 participants is recommended in order to 
detect a mean difference of 5 units. 
To account for dropout, up to 60 participants may be randomized and dispensed with study 
product in total, with the target of at least 53 completing the study.  
Note: this study will use a subjective rating scale of 0-10, integer steps. 
 
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 

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
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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 53 
completing the study.  
 
5.3.3 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 multifocal soft contact lenses, for the past 3 months minimum; 
7. Has refractive astigmatism no higher than -0.75DC; 
8. Is presbyopic and requires a reading addition of at least +0.75D and no more than 
+2.50D; 
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; near addition or LOW, MEDIUM, HIGH). 
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 that contraindicates contact lens 
wear; 
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 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 or intraocular surgery. 

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* 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 ≥42 years is an inclusion criteria because presbyopia is unlikely in persons aged <42 years 
and, if present, may not be due solely to presbyopic changes representative of the wider 
population. 
 
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 
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. 
5.4 STUDY MATERIALS 
Habitual lenses: The optimized prescription of the habitual lenses will be determined by the 
investigator and the clinical site will order a new lens supply to the participant (6-pack for 
frequent replacement MF lenses, 30-pack for daily disposable MF lenses. If the participant 
wears the same prescription in both eyes, only one box will be ordered). If applicable, the clinic 
site will also supply the participant with a new bottle of their habitual care regimen including a 
new lens case.  
Lens A and Lens B: CooperVision will provide each site with a small trial kit of Lens A lenses. 
Sites will source their own trial kit of Lens B. The sites will use these trial kits to fit Lens B and 
Lens A lenses to determine the optimal lens power. Once the final lens has been determined, 
the site will order a pack of 30 lenses for each eye with each lens type. Lens B will be ordered 
through the site’s normal commercial route. CORE will coordinate the Lens A lens orders for 
each participant upon receipt of the lens order form, which is part of the study visit pack. If the 
optimization visit determines a different prescription is needed, a new lens supply will be ordered 
as described previously. 
Reimbursement to practice sites for study product expenses will be provided by CooperVision at 
the end of the study, after CORE has reconciled the invoices and the product accountability and 
dispensing logs. 

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
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5.4.4 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 by participants and at the sites according to local 
regulations. 
5.4.5 PRODUCT ACCOUNTABILITY 
Accountability logs must be kept by each site to include the number of contact lenses received 
and returned to CORE (where relevant). All products dispensed to participants must be recorded 
in participant dispensing logs. 
5.5 SCHEDULED AND UNSCHEDULED VISITS 
This study has a minimum of 12 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. 

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
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Participants will be assigned a unique alpha-numeric study ID after they sign the consent 
documentation i.e. before their eligibility for the study has been confirmed. Each site will use a 
different letter preceding the participant ID number. For example, participant 01 at site W will be 
W-01, and participant 01 at site Z will be Z-01. Ineligible participants will be discontinued from 
the study. 
The investigator will determine participant eligibility using the inclusion and exclusion criteria. 
The study procedures are outlined below: 
1. The participant is expected to insert their habitual multifocal contact lenses at least 2 
hours before attending the visit and if available bring an additional (new) pair of lenses. 
(If participant habitually wears daily disposable MF lenses, ask if a 2-week supply is 
available. All habitual lenses used during the study will be replaced at no charge to the 
participant.) 
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, race, ethnicity, 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. 
 
 

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
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11. 
 
 
 
 
 
 
 
 
 
 
 
 
 
13. The investigator will fit both study lenses (Lens A and Lens B) using fitting sets following 
to the manufacturers fitting guidelines. 
Trial fitting of both study lenses: 
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. 
  
g. If any changes are made to the lens power, the above procedures (b to f) will be 
repeated. 
14. 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. 

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
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15. If the habitual lens prescription is unchanged and the participant was able to bring in an 
extra (new) pair of habitual lenses to the visit, continue with Visit 1-2, otherwise order 
lenses for participant and schedule Visit 1-2.  
 
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. 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. 
 
5.5.3 VISIT 1-2 DISPENSE HABITUAL MF LENSES  
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. 
 
 
 
 
 

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
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5.5.4 VISIT 1-3, 2-WEEK FOLLOW-UP HABITUAL LENSES 
Participants will be asked to insert habitual lenses at least 2 hours prior to the visit. 
This visit will occur 14-16 days (inclusive) after visit 1-2. 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
3. Review ‘at-home’ ratings for completeness and legibility. 
4. 
 
5. 
 
 
6. 
 
7. The participant will remove the lenses. 
8. 
 
 
 
 
 
 
 
 
 
 
9. Continue with visit 2-0. 
 
5.5.5 VISIT 2-0 DISPENSE PAIR #1  
This visit is subsequent to Visit 1-3. 
1. 
 
 
 
2. After lenses have settled for at least 10 minutes continue with assessments 
3. 
 

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
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4. 
 
 
5. 
 
6. The participant will receive a 1-week lens supply and will be instructed to wear the lenses 
for at least 8 hours a day, 5 days a week. 
7. The participant will be scheduled to return for Visit 2-1.  
 
5.5.6 VISIT 2-1 OPTIMIZE PAIR #1  
Participants will be asked to insert study lenses at least 2 hours prior to the visit. 
This visit will occur 3-7 days (inclusive) after visit 2-0. 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
 
 
 
 
  
 
6. If lens power changes are required, and required lens power is not on site, the lens/es 
will be ordered and assessed at an additional visit. If the required lens power is on site, 
participant will remove lens(es) from the eye and insert the new fitting lens(es) on eye.   
a. Allow settling time of 10 minutes before evaluation of vision 
 to 
assess the final lens power needed. 
8. Remove lenses 
9. 
 
 
 
 
 
 
 

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
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e. 
 
 
 
7. If no power change is needed or if a 2-week supply of optimized lenses are available on 
site continue with visit 2-2, otherwise order the lenses and schedule Visit 2-2. If new 
lenses need to be ordered, participants will be allowed to wear habitual MF lenses in the 
meantime. 
 
5.5.7 VISIT 2-2 DISPENSE (OPTIMIZED) PAIR #1  
This visit may be conducted immediately following Visit 2-1 (if no prescription change is needed) 
or can be scheduled after Visit 2-1. 
Participant to attend this visit wearing spectacles. 
Procedures as follows: 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
b. 
 
 
 
 
 
 
 
 
3. 
 
 
 
4. After lenses have settled for at least 10 minutes continue with assessments 
5. 
 
  
8. 
 

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
24 
9. 
 
10. Provide and explain to participant the subjective at-home rating forms to be completed on 
Day  
 13 (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. 
  
b. 
 
c. Ease of lens handling for insertion onto eyes (0 – 10 integer scale); 
 
 
 
 
 
 
 
 
 
 
k. Ease of lens handling for removal from eyes (0 – 10 integer scale); 
 
 
m. 
 
n. Report of any unusual symptoms or problems with lenses. 
11. The participant will receive a 2-week lens supply and will be instructed to wear the lenses 
for at least 8 hours a day, 5 days a week. 
12. The participant will be scheduled to return for Visit 2-3.  
 
5.5.8 VISIT 2-3, 2-WEEK FOLLOW-UP PAIR #1 
Participants will be asked to insert study lenses at least 2 hours prior to the visit. 
This visit will occur 14-16 days (inclusive) after visit 2-2. 
Assessments of lens Pair #1 will be conducted as described for habitual lenses at visit (Visit 1-
3). 
 
 
 

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
29 
opportunity to try a different type of soft contact lenses and/or different lens care products at no 
cost to them. The contact lens materials used in this study are commercially available as daily 
wear. This study will investigate participants’ wearing schedule intended for daily wear (NOT 
extended wear), similar to the average wearing time of 10-16 hours for daily wear lenses.  
This study is considered to be a non-significant risk study based on United State Food and Drug 
administration (FDA) and International Standards Organization (ISO) guidelines, because the 
study devices used as intended in this study (1) do not represent a potential for serious risk to the 
health, safety or welfare of the subject, and (2) are not implants, (3) are not used to support or 
sustain human life, (4) are not of substantial importance in diagnosing, curing, mitigating or treating 
disease or otherwise prevents impairment of human health.  
The habitual lens and the two study contact lens types will be worn as per their approved use; 
on a daily wear, daily disposable basis. 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. 
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 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.  

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
32 
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 managed at the practice, or referred to another 
eye care practitioner 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 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. 
Significant and Non-Significant 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). 
 
CORE contact details for adverse events are: 
  
 

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
33 
  
 
 
 
  
 
 
 
 
Sponsor contact details for adverse events are:  
  
 
  
 
 
 
  
  
 
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 US$20 per hour 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. 

EX-MKTG-109 MANGO Protocol v1.3 05june2020 
34 
• 
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 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. The ORE 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). 

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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 approximately US$165 for completing the study. This is 
calculated at $20 per hour for the 1 hour of at home ratings questionnaires and 7.25 hours of 
predicted scheduled visits, though if additional fitting time is required, this may increase. 
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. 
 
Comparisons will be made between the study lenses for the variables measured at the 2-week 
visits. Additionally the subjective ratings completed on day
 13 of each phase will be 
compared. A binomial test will be used to analyze the results for the count data 
 
 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. 
 
 
 
Where appropriate, data may be presented as both mean and as counts by ‘bucket’ groups. 

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37 
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. 
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 curriculum vitae, 
license to practice optometry and evidence of professional indemnity insurance. They will also 
complete CORE’s Conflict Disclosure Form. 
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 two people and the entries will be compared. 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. 

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38 
All adverse events and protocol deviations will be reviewed by the site Principal Investigator and 
CORE’s Lead Co-ordinator. 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 
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/ 
 
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.  

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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. 
The following are examples of protocol deviations that must be reported to the ORE: 
• 
Changes in procedures initiated to eliminate immediate risks/hazards to participants; 
• 
Enrollment of participants outside the protocol inclusion/exclusion criteria whether agreed 
to or not by the sponsor; 
• 
Medication / device / intervention errors (i.e. incorrect drug or dosage of drug / incorrect 
contact lens(es) dispensed / incorrect care system dispensed); 
• 
Inadvertent deviation in specific research intervention procedures or timing of the 
research intervention which could impact upon the safety or efficacy of the study-related 
intervention or upon the experimental design; 
• 
Information consent documentation violations: no documentation of informed consent; 
incorrect version of, or incomplete, informed consent documentation used. 
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 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).  

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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. 
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 two 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.  

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41 
16 REPORT 
A report will be sent to the sponsor by CORE according to terms described in the study contract.