Evaluation of the Performance of Different Daily Disposable Lens Designs in Habitual Soft Contact Lens Wearers
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.



EX-MKTG-118 TANGERINE Protocol v2.0 23oct2020 
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EX-MKTG-118 TANGERINE Protocol v2.0 23oct2020 
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EX-MKTG-118 TANGERINE Protocol v2.0 23oct2020 
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1 DOCUMENT CHANGE HISTORY 
 
Version 
number 
Version 
date 
Author 
Description of change(s) 
1.0 
22oct2020 Doerte 
Luensmann 
Original protocol 
2.0 
23oct2020 Doerte 
Luensmann 
Renaming of “Exit visit” to “Study exit” for clarification. The 
study exit is completed subsequent to the last study visit. 
Removed from Section 13: “They will also complete CORE’s 
Conflict Disclosure Form.”  
Changed site code “G” to site code “E”. 
 
 
 

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

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5.5.3 Visit 1-0 Dispense Lens type #1 
........................................................................... 
18 
5.5.4 Visit 2-0, 1-week follow-up Lens type #1, Dispense Lens type #2 ........................ 
20 
5.5.5 Visit 3-0 1-week follow-up Lens type #2 ............................................................... 
21 
5.5.6 Study Exit 
............................................................................................................. 
23 
5.5.7 Unscheduled visits ............................................................................................... 
23 
5.6 Study procedures 
........................................................................................................ 
24 
5.6.1 Study lens fitting 
................................................................................................... 
24 
5.6.2 
 
......................................................................................................... 
25 
5.6.3 
 
..................................................................................... 
25 
5.6.4 
 ............................................................................................. 
25 
6 Monitoring protocol adherence .......................................................................................... 
26 
7 Potential risks and benefits to human participants ............................................................. 
26 
8 Adverse events 
.................................................................................................................. 
27 
8.1 Normal or adaptive symptoms 
..................................................................................... 
29 
8.2 Procedures for adverse events 
.................................................................................... 
29 
8.3 Reporting adverse events ........................................................................................... 
30 
9 Discontinuation from the study 
........................................................................................... 
31 
10 Device malfunctions 
........................................................................................................... 
32 
11 Study completion and remuneration .................................................................................. 
32 
12 Statistical analysis and data management 
......................................................................... 
33 
12.1 
Statistical analysis ................................................................................................... 
33 
12.2 
Data management 
................................................................................................... 
34 
12.3 
Comments on source documents ............................................................................ 
35 
13 Protocol & other training .................................................................................................... 
35 
14 Study monitoring 
................................................................................................................ 
35 
15 Study management............................................................................................................ 
36 

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15.1 
Statement of compliance ......................................................................................... 
36 
15.2 
Ethics review ........................................................................................................... 
36 
15.3 
Clinical trial registration 
............................................................................................ 
36 
15.4 
Protocol deviations .................................................................................................. 
37 
15.4.1 Major protocol deviations ..................................................................................... 
37 
15.4.2 Minor protocol deviations ..................................................................................... 
37 
15.4.3 Reporting and documenting protcol deviations 
..................................................... 
38 
15.5 
Premature termination of the study 
.......................................................................... 
38 
15.6 
Study participant records 
......................................................................................... 
38 
15.7 
Retention of study records and data ........................................................................ 
38 
16 Report................................................................................................................................ 
39 
17 References 
........................................................................................................................ 
39 
 
 

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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 
Contact  
lens  
(CL)  discomfort  affects  up  
to  50%  of  contact  
lens  wearers and  continues  
to  be  a 
major factor impacting long-term  lens  wearing  success.
1 Daily  disposable  (DD)  lenses  are 
frequently recommended by practitioners to avoid the use of a lens cleaning product and with the 
goal to reduce symptoms of dryness and discomfort. As a result, DD lenses account for 45% of 
all soft lens fits today.2 
In the past these DD 
lenses were mainly available 
in hydrogel materials, however, more and more 
new high oxygen-permeable silicone hydrogel (SiHy) DD lenses are becoming available now.  
The goal of this study is to compare the performance of MyDay (Lens A), a SiHy DD lens from 
CooperVision Inc.,  which  has  successfully been  established  on  
the  market with  B+L  
INFUSE 
(Lens B), a DD SiHy lens recently launched by Bausch+Lomb Inc.  
3 OBJECTIVES 
To refit existing soft lens wearers with two different daily disposable contact lens types, Lens A 
and Lens B, to determine their performance after one week of wear. 
The primary outcome variable for this study is: 
• Lens wettability after at least 2 hours of wear at 1 week (6-8 days).   
4 HYPOTHESIS 
The null hypothesis is that there will be no difference for lens wettability after 1 week (6-8 days) 
of daily disposable lens wear between Lens A compared to Lens B.  
5 MATERIALS AND METHODS 
5.1 STUDY DESIGN 
5.1.1 OVERALL DESIGN 
This study is a prospective, bilateral eye, double-masked, randomized, 1-week cross-over, daily-
wear design involving two different daily disposable lens types. Each lens type will be worn for 
approximately one week, during which participants record their subjective lens-wear experience 
on three different days. 

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5.1.2 RANDOMIZATION 
A randomization schedule will determine the order of Lens A and Lens B wear for the 
first/second week for each participant. Participants will be randomized immediately prior to their 
first lens dispense. 
This randomization schedule will be generated for each site using a web-based program: 
(www.randomization.com). The lens type that will be worn during the first week is called “Lens 
type #1”, the lens type dispended for the second week is called “Lens type #2”. The final study 
randomization schedule will be generated by CORE’s Database Administrator and provided to 
the research assistants at each site.  
5.1.3 MASKING 
At the fitting visit, only the participant will be masked of the lens type, the investigator will know 
which type is fit in order to make changes to the lens at this visit if needed. Strongly adhesive 
stickers will be placed on the packages/foils to mask the participant to the lens brand. At both 
dispense visits, participants and investigators will be masked to the lens type dispensed. In order 
to achieve this, unmasked study personnel will determine the lens order according to the 
randomization schedule and will over-labeled the lens packages/foils prior to dispense. 
5.2 INVESTIGATIONAL SITES 
5.2.1 NUMBER OF SITES 
This study will be conducted at 4 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. 

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* Study documents are required as soon as possible because this allows for prompt lens 
ordering and timely data review, query and entry. 
5.3 STUDY POPULATION 
5.3.1 SAMPLE SIZE CALCULATION 
The sample size calculation was based on “comfort during the day” using data at 2 weeks from 
the B+L Ultra 
lens (Bausch+Lomb) compared to Biofinity (CooperVision) in which participant used 
a 0-10 scale (10 being best).  
A sample size of 59 is required to detect a mean difference in “comfort during the day” of 0.7 units 
on a 0 to 10 scale using a standard deviation of paired differences of 1.88 with 80% power and 
alpha  0.05  
in  a two-tailed  
t-test.  Therefore, up  
to  68  participants  will  be  dispensed  with  study 
products with the goal to complete at least 59.  
 
Figure 1: Sample size calculation graph 
 

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The primary outcome variable in this study is lens wettability after 1 week.  Based on previous 
study data collected at 2 weeks, a minimum sample size of 46 participants is required to detect a 
mean difference in lens wettability of 0.25 units on a 0 to 10 scale for a standard deviation of 
0.51 with 90% power and alpha 0.05 in a two-tailed t-test. 
 
5.3.2 NUMBER OF PARTICIPANTS 
Participants will be recruited using site records, databases and advertising materials (eg. 
posters, email scripts) approved by the ethics review board. All initial individual-targeted 
recruitment activities, such as any direct mailing of recruitment scripts, will be conducted by 
practice staff that are not directly involved in conducting the research. This separation will 
reduce any undue influence of the optometrist-patient relationship. This process will also 
eliminate opportunity for the investigator to access personal health information before any 
consent for disclosure is provided by the potential participant.  
It is anticipated that up to 80 potential participants may attend a Screening visit and up to 68 
participants may be randomized and dispensed with study products, with a target of at least 59 
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 18 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, 7 days a week; 
5. Is willing and able to follow instructions and maintain the appointment schedule; 
6. Habitually wears soft contact lenses, for the past 3 months minimum; 
7. Has refractive astigmatism no higher than -0.75DC in each eye; 
8. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens 
parameters are sphere -1.00 to -6.00D, 0.25D steps). 
A person will be excluded from the study if he/she: 
1. Is participating in any concurrent clinical or research study; 
2. Habitually wears one of the study contact lenses; 

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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. 
* For the purposes of this study, active ocular disease is defined as infection or inflammation which 
requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, 
meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered 
active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or 
inflammation and are therefore not active. 
 
Pregnant and lactating women are not being excluded from the study due to safety concerns but 
due to fluctuations in refractive error, accommodation and/ or visual acuity that occur secondary 
to systemic hormonal changes and water retention. It has further been shown that pregnancy 
could impact tear production, which could impact dry eye symptoms. Such fluctuations could 
affect data, thereby negatively affecting study data integrity. 
5.4 STUDY MATERIALS 
Sites will be provided (if needed) with a trial kit of Lens A and 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 may order a pack of 30 lenses for 
each eye and each lens type (If both eyes require the same prescription, only one box with 30 
lenses will be ordered.) 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.  
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. 
CORE will provide all sites with the study paperwork. This will include participant informed 
consent letters and study data collection forms, product accountability logs and the participant 

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5.5.1  VISIT 0 SCREENING & FITTING VISIT 
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. 
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 T will be 
T01, and participant 01 at site N will be N01. 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 contact lenses at least 2 hours before 
attending the visit.  
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. Lens fit with habitual lenses will be assessed: 
• Lens wettability (0-4 descriptive scale, 0.5 steps) 
• 
  
• 
  
• 
 
8. The participant removes their habitual contact lenses.  
9. 
 

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10. 
 
  
11. 
 
 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
12. 
 
 
13. The investigator will fit both study lenses (Lens A and Lens B) using fitting sets following 
to the manufacturers fitting guidelines. 
 
 
  
 
 
 
  
 
 
 
 
  
 
 
 
. 
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. 

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15. Schedule dispense visit (0-21 days after Visit 0) and order both study lens types in the 
final prescriptions.  
 
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 2, the initial and one repeat 
screening visit. 
 
5.5.3  VISIT 1-0 DISPENSE LENS TYPE #1 
This visit may or may not be subsequent to the screening visit, depending on lens availability but 
will occur no later than 21 days after Visit 0. Participant to attend this visit wearing spectacles. 
The study procedures are outlined below: 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
 
 
 
 
 
 
 
 
 
 
 

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• 
 
3. 
 
 
4. 
 
 
 
 
 
 
 
5. 
 
  
6.  Assess lens surface and fit: 
• Lens wettability (0-4 descriptive scale, 0.5 steps) 
• 
  
• 
  
• 
 
7. 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
 
 
 
8. The participant will receive lens supply (if applicable) and will be instructed to wear the 
lenses for at least 8 hours a day, 7 days a week. 
9. Visit 2-0 will be scheduled 6-8 days after Visit 1-0. 

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5.5.4  VISIT 2-0, 1-WEEK FOLLOW-UP LENS TYPE #1, DISPENSE LENS TYPE #2 
Participants will be asked to insert Lens type #1 at least 2 hours prior to the visit. This visit will 
occur 6-8 days (inclusive) after visit 1-0. 
The study procedures are outlined below: 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
 
4. Ask participant to complete Subjective ratings at the visit to reflect a typical day in the last 
week with the study lenses:  
• 
 
 
 
 
 
 
 
 
 
• Comfort during the day (after 4-6 hours of wear) (0-10 scale); 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5. 
 
 
6. Assess lens surface and fit:  
• Lens wettability (0-4 descriptive scale, 0.5 steps) 
• 
  
 
  
 
 

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7. The participant will remove the lenses. 
8. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9. Continue with the lens dispense for Lens type #2 as described in visit 1-0 starting point 
#3 to #8. 
10. Visit 3-0 will be scheduled 6-8 days after Visit 2-0. 
 
5.5.5  VISIT 3-0 1-WEEK FOLLOW-UP LENS TYPE #2  
Participants will be asked to insert Lens type #2 lenses at least 2 hours prior to the visit. This 
visit will occur 6-8 days (inclusive) after visit 2-0. 
The study procedures are outlined below: 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
 
4. Ask participant to complete Subjective ratings at the visit to reflect a typical day in the last 
week with the study lenses:  
• 
 
 
 
 
 
 
 
 
 
• Comfort during the day (after 4-6 hours of wear) (0-10 scale); 
• 
 
 
 

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• 
 
 
 
 
 
 
 
 
 
 
 
 
 
5. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6. 
 
 
11. Assess lens surface and fit:  
• Lens wettability (0-4 descriptive scale, 0.5 steps) 
• 
  
 
  
 
 
7. The participant will remove the lenses. 
8. 
 
 
 
 
 
 
 
 

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• 
 
 
 
 
 
 
9. Continue with Study Exit 
 
5.5.6 STUDY EXIT 
The  study  exit  form  will  be  completed  when  a  participant  exits  the  study.  This  form  will  be 
completed either at study completion, or 
if the participant 
is discontinued from the study at another 
time. A study exit form must be completed for all participants who have taken a study ID number. 
If in the opinion of the investigator post-study follow-up visits are required, the exit form will be 
completed after the last follow-up visit.  
Exit visual  acuity  will  be  
recorded  with  either  
the  participant’s  spectacles,  
refraction  or  habitual 
contact lenses. An exit biomicroscopy assessment will be conducted if not already completed on 
the same day for a concurrent study visit. 
After the exit assessments have been completed, the participant and investigator will complete 
the study completion and remuneration forms. At this time the participant will be considered as 
having exited the study. 
 
5.5.7 UNSCHEDULED VISITS 
An unscheduled visit is defined as an interim visit requested by the participant or investigator 
due to an unanticipated problem. Data recorded at these visits will be entered into the database. 
Only relevant and applicable unscheduled visit information will be included in the final report as 
deemed necessary.  
 
 
 
 
 

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5.6.2 
 
 
 
5.6.3 LENS SURFACE ASSESSMENT 
Lens Wettability (0-4, 0.5 steps) 
0  Very poor:  
Immediately displaying non-wetting areas on the lens surface, 
immediate drying time  
1  Poor:   
 
Irregular surface appearance, drying time << blink time 
2  Acceptable:  
Smooth surface appearance immediately after the blink becoming 
irregular after a while, drying time ≤ blink time 
3  Good:   
 
Typical soft lens appearance with long drying time 
4  Excellent:    
Appearance similar to a healthy cornea with very long drying time 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 

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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 13.4, 
major protocol deviations will be reported to the Sponsor and Sterling Institutional Review Board 
within 7 days of becoming aware of them (as per Sterling Institutional Review Board guidelines).  
7 POTENTIAL RISKS AND BENEFITS TO HUMAN PARTICIPANTS 
There may be no direct benefits to the subjects 
in this study. Participation 
in a study may contribute 
to  scientific  research  information  that  may  be  used  in  the development of  new  contact  lens 
products. The subjects will receive an examination of the front part of their eyes and may have the 
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 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 

EX-MKTG-118 TANGERINE Protocol v2.0 23oct2020 
27 
always an infection will occur only in one eye.  This risk is assumed by 35-million Americans who 
currently wear contact lenses and only current soft lens wearers will be recruited for this study.  
A dye (fluorescein) normally used for eye examinations is being used in this study. Although 
rare, it is possible to have an allergic reaction to the dye. Participants will be asked if they have a 
known allergy or sensitivity to fluorescein. 
The assessments conducted in this study are routine clinical procedures and they include auto-
refraction,  auto-keratometry, visual  acuity,  anterior  ocular  health  assessment,  and  contact  
lens 
fitting will be used. In addition, high magnification imaging of the lens fit may be made using 35 
mm or digital cameras. Patients will be monitored frequently until the end of the study to reduce 
the  occurrence  of  adverse  or  potential  adverse  events.  Patients  will  be  given  
instructions  
from 
their investigator regarding early symptoms and signs of adverse events.  
8 ADVERSE EVENTS 
See CORE SOP012 for a description of all adverse events, including management and reporting. 
An  
‘adverse  event’  refers  
to  any  undesirable  clinical  occurrence  
in  a  participant,  whether  
it  
is 
considered to be device-related or not. Adverse events (AE) may be classified as ‘unanticipated 
adverse device effects,’ ‘serious adverse events,’ ‘significant adverse events,’ or ‘non-significant 
adverse events,’ as defined below, Table 5.  
A number of conditions may result 
in temporary suspension until resolution. These 
include corneal 
infiltrates, corneal staining, limbal injection, bulbar injection or tarsal conjunctival abnormalities. 

EX-MKTG-118 TANGERINE Protocol v2.0 23oct2020 
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for each adverse event. If both eyes are 
involved, a separate adverse event form will be completed 
for each eye. Whenever possible, the adverse event will be photo-documented.  
Expenses incurred for medical treatment as part of study participation will be paid by the sponsor 
(bills and prescription receipts kept). The participant must be followed until resolution or no further 
change is anticipated and/or referred for further care with the appropriate health care professional 
and/or recorded as being under appropriate health care as per investigator’s discretion. A written 
report will be completed indicating the subsequent treatment and resolution of the condition. 
8.3 REPORTING ADVERSE EVENTS 
All potential Serious and Unanticipated Adverse Device Effects that are related or possibly related 
to participant’s participation will be reported to CORE’s lead study coordinator (details below) and 
also to the sponsor (details below) within 24 hours of the 
investigator becoming aware of the event. 
The site’s  Principal Investigator  will also report  the  event  to Sterling IRB within  10  days  of 
becoming  aware  of  
the Serious  or  Unanticipated  event,  using  
the  Reportable  Events  Form. All 
fatal or life threatening events will be reported immediately to the IRB. 
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). 
 
 
  
 
   
 
 
 
  
 
 
 
 
  
  
 
   
 
 
 
  
  

EX-MKTG-118 TANGERINE Protocol v2.0 23oct2020 
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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  
 per visit for their active involvement in the 
study (including the initial screening visit and all lens fitting visits).  Upon discontinuing, a 
participant will be offered the option of their data being withdrawn from future statistical analysis. 
The following is a list of possible reasons for discontinuation from the study: 
• Screening failure: Participants will be discontinued if they do not meet the inclusion and 
exclusion criteria outlined in section 5.2.3. 
• Unacceptable performance with products to be used in study: Participants may be 
discontinued if they are unable to achieve acceptable comfort and /or vision with the 
study products. 
• Positive slit lamp finding:  Participants may be permanently discontinued from the study 
depending on the severity of the condition and on the judgement of the investigator.   
• Adverse event: If a participant experiences an adverse event during the study they may 
be discontinued based on the clinical judgement of the investigator. 
•  Symptoms: If the participant has persistent symptoms they may be discontinued based 
on the clinical judgement of the investigator. 
• Disinterest, relocation or illness: The participant may choose to discontinue due to 
reasons within or beyond their control. 
• Violation of protocol or non-compliance:  The participant will be discontinued if they are 
unable or unwilling to follow the protocol specified visit schedules and/or study 
procedures. 
• Instillation of topical ocular medication:  The participant will be discontinued if they elect 
to use a topical ocular medication during the study unless that topical ocular medication 
is prescribed for a limited duration (less than two weeks) to treat a transient condition; in 
this case the participant may remain an active participant (at the discretion of the 

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32 
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 to complete the final study exit, and if the investigator has made a reasonable 
effort to contact the participant for a final study visit. 
• Premature termination of the study by the sponsor, CORE or Sterling IRB. 
A discontinuation form, stating the reason for discontinuation will be completed, which requires 
the signatures of both the participant and the investigator except where the participant is lost to 
follow-up in which case only the signature of the investigator is required.   
When  a  participant  choses  
to  discontinue  
from  
the  study  
they  will  be  given  
the  opportunity to 
withdraw their data from the statistical analysis. This choice will be captured on the discontinuation 
form. 
All discontinuations including their reasons will be included in the final report. 
10 DEVICE MALFUNCTIONS 
A  device  malfunction  means  
the  
failure  of  
the  device  
to  meet  
its  performance  specification  or 
otherwise perform as intended. Any defective lens that is likely 
to cause or contribute to a Serious 
Adverse Event should be reported to CORE and the sponsor within 24 hours of the investigator 
becoming aware of the malfunction. 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). 
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. 

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Participant remuneration will be approximately US$90 for completing the study. This is 
calculated at $20 per study visit and 30minutes for completing the at home ratings 
questionnaires, 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. 
Visual acuity results will be converted to LogMAR for analysis purposes. 
Comparisons will be made between the study lenses for the variables measured at the 1-week 
visits. Additionally the subjective ratings completed on days 1, 3 and 5 with each study lens 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 “no preference” 
responses will be evenly distributed to the two options on the basis they would be equally likely 
to choose either. 
Because of the phenomenon of binocular summation, binocular visual acuity will be analysed, 
not right eye data. For other variables, such as the primary outcome variable lens wettability, or 
secondary outcome variables including lens centration and lens movement, the right eye data 
will be reported and compared. 
Where appropriate, data may be presented as both mean and as counts by ‘bucket’ groups. 
Additional analysis may be conducted. 

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35 
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.  
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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36 
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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38 
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 and study data collections forms 
may be sent to the sponsor for storage. 

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39 
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. 
17 REFERENCES 
1. Dumbleton K, Caffery B, Dogru M, et al. The TFOS International Workshop on Contact 
Lens Discomfort: report of the subcommittee on epidemiology. Invest Ophthalmol Vis Sci. 
2013;54(11):TFOS20-36. 
2. Morgan PB, Woods C, Tranoudis I, Efron N, Jones L, Merchan N, Grupcheva CN, Jones 
D, Beeler-Kaupke M, Krasnanska J, et al. International contact lens prescribing in 2019. 
Contact Lens Spectrum 2020;35:26-32. doi.