Bilateral Dispensing Study of MyDay Toric, 1-day Acuvue Moist for Astigmatism, and Dailies Aquacomfort Plus Toric Lenses
Phase: NA
Conditions: Astigmatism
Sponsor: CooperVision, Inc.

Centre for Contact 
Lens Research 
School of Optometry 
& Vision Science, 
University of Waterloo, 
Waterloo, Ontario, Canada. 
N2L 3G1 
Tel: 519-888-4742 
Fax: 519-888-4303 
http://cclr.uwaterloo.ca
Protocol 
A BILATERAL DISPENSING CLINICAL 
TRIAL OF MYDAY TORIC, 1-DAY 
ACUVUE MOIST FOR ASTIGMATISM, 
AND DAILIES AQUACOMFORT PLUS 
TORIC LENSES (GINGER) 
This protocol remains the exclusive property of the CCLR until it is commissioned by the sponsors. 
Reviewed and approved, name & signature 
Date 
DD/MMM/YYYY 
Sponsor Company 
CooperVision, Inc. 
Sponsor Study number: 
EX-MKTG-72 
CCLR Study number: 
P/569/16/CV 
Version Number: 
3.0 
Document Date: 
14 Oct, 2016 
Document Type: 
Study protocol 
Clinical Site: 
CCLR, University of Waterloo 

EX-MKTG-72 Ginger Protocol_14oct2016 
 2 
Study Personnel 

DOCUMENT CHANGE HISTORY 
Revision# 
Description of change(s) 
Date 
0.0 
Original protocol 
20 Sep, 2016 
1.0 
Page 1: Version Number changed to 2.0; 
05 Oct, 2016 
Document date changed to 05 Oct, 2016 
1.0 
Section 4.3 Ethics Review: Last statement of 05 Oct, 2016 
Paragraph 2 modified in response to ORE 
comment: 
The conduct of this study will be given 
clearance by the Clinical Research Ethics 
Committee at the University of Waterloo, 
Canada. 
1.0 
Section 4.8.4 - bullet point 3, Statement 
05 Oct, 2016 
modified to be same as bullet point 6 in 
Section 4.8.3: "Lens surface .. .following:" 
1.0 
Section 4.8.5 - bullet point 3, Statement 
05 Oct, 2016 
modified to be same as bullet point 6 in 
Section 4.8.3: "Lens surface .. .following:" 
1.0 
Section 4.8.6 - bullet point 4, Statement 
05 Oct, 2016 
modified to be same as bullet point 6 in 
Section 4.8.3: "Lens surface .. .following:" 
1.0 
Section 7.4 - Paragraph 2: Added statement 05 Oct, 2016 
"The lnvestigator will report the event to the 
ORE as per ORE requirements (by fax, 
mail/delivery, phone, or email)." in response 
to ORE comment 
1.0 
Section 9: Added statement "The ORE 
05 Oct, 2016 
would also be notified w;thin 24 hours of any 
device malfunction that may contribute to a 
Serious Adverse Event." in response to ORE 
comment. 
1.0 
Changed footer version to "05oct2016" 
05 Oct, 2016 
1.0 
File name version changed to "05oct2016 
05 Oct, 2016 
2.0 
Section 7.4 - Paragraph 1, modified following 14 Oct, 2016 
statement: ''The lnvestigator will report 
Serious Adverse Events to the ORE within 
24 hours of the investigator becoming aware 
of the event and as per ORE requirements 
(by fax, mail/delivery, phone, or email)." 
2.0 
Section 20 Appendices: Added Appendix 27 14 Oct, 2016 
EX-MKTG-72 Ginger Protocol_ 14oct2016 
3 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              4 
 
Table of contents 
1 
Introduction .......................................................................................................................... 8 
2 
Objectives ............................................................................................................................ 8 
3 
Hypothesis ........................................................................................................................... 8 
4 
Materials and methods ........................................................................................................ 8 
4.1 
Study design ................................................................................................................. 8 
4.1.1 
Overall design ........................................................................................................ 8 
4.1.2 
Randomization ....................................................................................................... 9 
4.1.3 
Masking.................................................................................................................. 9 
4.2 
Statement of compliance ............................................................................................... 9 
4.3 
Ethics review ............................................................................................................... 10 
4.4 
Clinical Trial Registration ............................................................................................. 10 
4.5 
Informed Consent ........................................................................................................ 10 
4.6 
Study population ......................................................................................................... 10 
4.6.1 
Number of participants ......................................................................................... 10 
4.6.2 
Inclusion and exclusion criteria ............................................................................. 10 
4.6.3 
Repeated screenings ........................................................................................... 12 
4.7 
Study materials ........................................................................................................... 12 
4.7.1 
Lenses ................................................................................................................. 12 
4.7.2 
Contact Lens care system .................................................................................... 13 
4.7.3 
Rewetting drops ................................................................................................... 13 
4.7.4 
Contact lens dispensing ....................................................................................... 13 
4.7.5 
Ordering consumables ......................................................................................... 13 
4.7.6 
Disposing of consumables ................................................................................... 13 
4.7.7 
Product accountability .......................................................................................... 14 
4.8 
Scheduled and unscheduled visits .............................................................................. 14 
4.8.1 
Study visits ........................................................................................................... 14 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              5 
4.8.2 
Screening ............................................................................................................. 15 
4.8.3 
Dispensing lens pair #1 ........................................................................................ 16 
4.8.4 
1-week follow-up of pair #1 & Dispensing pair #2 ................................................. 17 
4.8.5 
1-week follow-up of pair #2 & Dispensing pair #3 ................................................. 19 
4.8.6 
1-week follow-up of pair #3 & Study exit ............................................................... 20 
4.8.7 
Unscheduled visits ............................................................................................... 22 
4.9 
Summary of Study procedures .................................................................................... 22 
4.10 
Recording Findings of Interest ................................................................................ 23 
5 
Monitoring protocol adherence .......................................................................................... 23 
6 
Potential Risks and Benefits to Human participants ........................................................... 23 
7 
Adverse events .................................................................................................................. 24 
7.1 
Adverse Event Definitions ........................................................................................... 24 
7.2 
Normal or adaptive symptoms ..................................................................................... 26 
7.3 
Procedures for Adverse Events ................................................................................... 27 
7.4 
Reporting Adverse Events ........................................................................................... 27 
8 
Discontinuation from the study ........................................................................................... 27 
9 
Device Malfunctions ........................................................................................................... 29 
10 
Study completion and remuneration .................................................................................. 29 
11 
Statistical analysis and data management ......................................................................... 29 
11.1 
Sample size calculation ........................................................................................... 29 
11.2 
Statistical analysis ................................................................................................... 30 
12 
Data Quality Assurance ..................................................................................................... 30 
12.1 
Study monitoring ...................................................................................................... 31 
12.2 
Sponsor Responsibilities .......................................................................................... 31 
12.3 
Investigator Responsibilities .................................................................................... 31 
12.4 
Record keeping ....................................................................................................... 32 
12.5 
Retention of study records and data ........................................................................ 32 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              6 
12.6 
Data entry / Data management ................................................................................ 32 
13 
Protocol training ................................................................................................................. 33 
14 
Study monitoring ................................................................................................................ 33 
15 
Study management............................................................................................................ 33 
15.1 
Protocol deviations .................................................................................................. 33 
15.1.1 
Major protocol deviations ..................................................................................... 33 
15.1.2 
Minor protocol deviations ..................................................................................... 34 
15.1.3 
Reporting and documenting protcol deviations ..................................................... 34 
15.2 
Premature termination of the study .......................................................................... 34 
15.3 
Study participant records ......................................................................................... 34 
15.4 
Retention of study records and data ........................................................................ 35 
16 
Confidentiality .................................................................................................................... 35 
17 
Publication ......................................................................................................................... 35 
18 
Study Costs ....................................................................................................................... 35 
19 
Report................................................................................................................................ 35 
20 
Appendices ........................................................................................................................ 36 
 
 
 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              7 
 
 
 Confidentiality 
This is a private document and the property of the Centre for Contact Lens Research. 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 Contact Lens Research. Release of information from this 
document is governed by the research agreement on file. 
 
Disclaimer 
This study will be conducted for research purposes only and is not intended to be used to support safety 
and efficacy in a regulatory submission. 
 
 
 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              8 
1 
INTRODUCTION 
CooperVision is evaluating the clinical performance of the MyDay toric contact lens in 
comparison with1-Day Acuvue Moist for Astigmatism, and Dailies AquaComfort Plus Toric 
lenses, when each lens is worn on a daily disposable wear basis over one (1) week in a 
randomized bilateral, cross-over, dispensing study.  
2 
OBJECTIVES 
The objective of the study is to evaluate the performance of MyDay toric test lens when worn on 
a daily disposable wear modality over 1 week.  
The primary outcome variables are:  
• 
Comfort and lens preference with respect to comfort (subjective ratings) 
• 
Dryness and lens preference with respect to dryness (subjective ratings) 
• 
Visual quality and lens preference with respect to visual quality (subjective ratings) 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3 
HYPOTHESIS 
The study hypothesis is that the MyDay toric test lens (MD-T) will perform as well or better 
clinically than the two control lenses: 1-Day Acuvue Moist for Astigmatism (1-DAM-T) and 
Dailies AquaComfort Plus Toric (DACP-T).  
4 
MATERIALS AND METHODS 
4.1 STUDY DESIGN 
4.1.1 OVERALL DESIGN 
This study is a prospective, double-masked (investigator and participant), bilateral, randomized, 
cross-over dispensing study comparing the MD-T test lens against the 1-DAM-T and DACP-T 
control lenses. Each participant will be randomized to wear either the test or one of the controls 
with similar/comparable lens parameters optimized for vision. Both test and control lenses will be 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              10 
• 
ISO 14155 Clinical Investigation of Medical Devices for Human Subjects, Parts 1 & 2 
• 
ICH Harmonized Tripartite Guideline for Good Clinical Practice 
• 
The University of Waterloo’s Guidelines for Research with Human Participants 
• 
Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2nd 
Edition. http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/ 
• 
Declaration of Helsinki 
 
4.3 ETHICS REVIEW 
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. 
This protocol will be submitted to and reviewed through the Office of Research Ethics (ORE) at 
the University of Waterloo, Canada. Notification of ethics clearance of the application is required 
prior to the commencement of the study. The conduct of this study will be given clearance by the 
Clinical Research Ethics Committee at the University of Waterloo, Canada.  
4.4 CLINICAL TRIAL REGISTRATION 
This study will be registered in the clinical trials registry (https://clinicaltrials.gov/) by the study 
sponsor.  
4.5 INFORMED CONSENT 
Informed consent shall be obtained in writing from all participants prior to their enrolment in the 
study (Appendix 1), and before any procedure specific to the clinical investigation is carried out.  
4.6 STUDY POPULATION 
4.6.1 NUMBER OF PARTICIPANTS 
Up to 52 participants will be dispensed / randomized with study products, with a target of 45 
completing the study. Participants will be recruited using CCLR records and advertising 
approved by the UW Office of Research Ethics (Appendices 2, 3a, and 3b). Each participant will 
be given a unique ID number. Additionally, all participants must meet the study inclusion and 
none of the exclusion criteria listed below.  
4.6.2 INCLUSION AND EXCLUSION CRITERIA 
A person is eligible for inclusion in the study if he/she: 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              11 
1. Is at least 17 years of age and has full legal capacity to volunteer; 
2. Has had a self-reported oculo-visual examination in the last two years.  
3. Has read and signed an information consent letter; 
4. Is willing and able to follow instructions and maintain the appointment schedule; 
5. Is an adapted soft contact lens wearer; 
6. Is willing to wear contact lens in both eyes for the duration of the study;  
7. Has a minimum spectacle astigmatism of - 0.75; 
8. Can be fit with the three study contact lens types in the powers available; 
9. Has a visual acuity of 20/30 or better in each eye with habitual correction, or 20/20 best 
corrected vision (for binocular distance acuity); 
10. Can achieve a distance visual acuity of 20/30 (0.18 logMar) or better in each eye with the 
study contact lenses. 
11. Has clear corneas and no active* ocular disease; 
A person will be excluded from the study if he/she: 
1. Is participating in any concurrent clinical trial; 
2. Has any known active* ocular disease and/or infection; 
3. Has a systemic condition that in the opinion of the investigator may affect a study 
outcome variable; 
4. Is using any systemic or topical medications that in the opinion of the investigator 
may affect a study outcome variable; 
5. Has known sensitivity to fluorescein dye or products to be used in the study; 
6. Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency 
of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;  
7. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal 
confirmation at the screening visit); 
8. Is aphakic; 
9. Has undergone refractive error surgery.  
* For the purposes of this study, active ocular disease is defined as infection or inflammation 
which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              15 
Visit 2 
V2 
1-week follow-up of pair #1 (day 7 -10 
from dispense of pair #1) & dispensing 
pair #2 
Visit 3 
V3 
1-week follow-up of pair #2 (day 7 -10 
from dispense of pair #2) & dispensing 
pair #3 
Visit 4 
V4 
1-week follow-up of pair #3 ( day 7 -10 
from dispense of pair #3) & Study exit 
 
4.8.2 SCREENING  
All participants who sign the informed consent letter will be assigned a study ID number.The 
investigator will determine participant eligibility using the inclusion and exclusion criteria. 
Ineligible participants will be discontinued from the study. The procedures to be performed are 
outlined below: 
• 
The participant is expected to attend the screening / baseline visit not wearing their 
habitual contact lens products. 
• 
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 to be enrolled in to the study. 
• 
Participant demographics and medical history (age, sex, medical conditions, 
medications, allergies) 
• 
Contact lens history (own lens information, and wear time) 
• 
Baseline visual acuity with spectacles or spectacle refraction. 
• 
Auto refraction/auto keratometry: Horizontal and Vertical K readings (D)  
• 
Sphero-cylindrical refraction (D), monocular & binocular distance visual acuity (high 
contrast) (logMAR) 
• 
Palpebral aperture size 
• 
HVID measurements 
• 
Slit lamp biomicroscopy will be assessed according to the approved study biomicroscopy 
CRF (Appendix 9). 
• 
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. 
• 
Trial fitting of all three study lenses will be done: 
 
The contact lens power will be chosen based on the vertexed spectacle 
refraction. For each eye, the test and control lenses will be optimized for vision, 
with similar/comparable lens parameters.  

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              16 
 
The contact lenses will be provided to participants in a manner which does not 
unmask the participant, as described in Section 4.7.4.  
 
The lenses will be inserted by the participant. 
 
Monocular over refraction will be done to determine if a different power is 
needed. If any changes are made, the above procedures will be repeated. 
 
Monocular and binocular logMAR visual acuity will be recorded with high 
contrast letters under high room illumination (300-600 lux), and the final lens 
power will be recorded. 
4.8.3 DISPENSING LENS PAIR #1 
The participant will be assigned a randomization ID and the first pair (lens pair #1) of contact 
lenses (either test or one of the control lenses) will be selected according to the randomization 
table.  
• 
Lens pair #1 will be provided to participants in a manner which does not unmask the 
participant, as described in Section 4.7.4.  
• 
The lenses will be inserted by the participant. 
• 
The contact lenses will be allowed to settle for 10 minutes. 
• 
The participant will be asked to give subjective binocular ratings for: 
 
Comfort at insertion (0-10 scale) 
 
Ease of insertion (0-10 scale)  
 
Speed of settling (0-10 scale)  
 
Visual quality (0-10 scale) 
 
Vision stability (0-10 scale) 
 
Overall satisfaction (0-10 scale) 
• 
Monocular and binocular logMAR visual acuity will be recorded with high contrast 
letters under high (300-600 lux) and low (1-5 lux) room illumination. 
• 
Lens surface and fit will then be assessed and graded according to the CVI grading 
scales for the following: 
 
Lens wettability (0-4 scale) 
 
Centration (mm)  
 
Post-blink movement (mm)  
 
Toric mark visibility 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              17 
 
Lens orientation (3 measurements per lens) 
 
Overall stability of toric mark position 
 
Overall lens fit acceptance (0-4 scale) 
• 
The participant will be given a set of daily subjective questionnaires (Appendix 12) to be 
completed at home on days 1, 3 and 6 starting the morning after the dispensing visit (day 
0), to reflect their lens wear experience at the time of rating. Participant will be given 
careful explanation of how and when to complete them. Questions will include: 
 
Time of lens insertion and removal 
 
Comfort after insertion (i.e. after lens settling), after 4, 8, and 12 hours, and just 
before lens removal (0-10 scale) 
 
Dryness after 4, 8, and 12 hours, and just before lens removal (0-10 scale) 
 
Visual quality/clarity after insertion (i.e. after lens settling), after 4, 8, and 12 
hours, and just before lens removal (0-10 scale) 
 
Vision stability after insertion (i.e. after lens settling), after 4, 8, and 12 hours, and 
just before lens removal (0-10 scale) 
The participant will be asked to wear the study lenses for at least 12 hours per day and 6 
days per week. 
• 
Participant will be provided with sufficient contact lens supply.  
• 
The participant will be discharged and reminded to return for the 1-week visit of lens pair 
#1 and to bring back all lens package foils. 
4.8.4 1-WEEK FOLLOW-UP OF PAIR #1 & DISPENSING PAIR #2  
Participants will be asked to wear lenses for at least 4 hours prior to the visit appointment. 
Participants who attend without lenses in-situ (wearing lenses) for at least four hours will be 
rescheduled. 
• 
The participant will be asked to score their subjective responses by reflecting on a typical 
day during the previous week of lens wear, as detailed in the subjective ratings form 
(Appendix 11) and includes the following: 
o Wear time at this visit (hours) 
o Wear time per day during previous 1 week (hours) 
o Comfortable wear time per day during previous 1 week (hours)  
o Overall comfort (0-10 scale)  

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              18 
o Overall dryness (0-10 scale) 
o Ease of insertion (0-10 scale)  
o Ease of removal (0-10 scale)  
o Overall visual quality/clarity (0-10 scale) 
o Overall visual stability (0-10 scale)  
o Overall satisfaction (0-10 scale)  
o Comments by participants 
• 
Monocular and binocular logMAR visual acuity will be recorded with high contrast 
letters under high and low room illumination. 
• 
Lens surface and fit will then be assessed and graded according to the CVI grading 
scales for the following: 
 
Lens wettability (0-4 scale) 
 
Centration (mm)  
 
Post-blink movement (mm)  
 
Toric mark visibility 
 
Lens orientation (3 measurements per lens) 
 
Overall stability of toric mark position 
 
Overall lens fit acceptance (0-4 scale) 
• 
The lenses will be removed and retained. The disposal procedures are detailed in 
Section 4.7.6. 
• 
Slit lamp biomicroscopy will be assessed according to the CVI approved study 
biomicroscopy CRF. 
• 
There will be a 10 minute wash-out before insertion of lens pair #2. 
• 
Lens pair #2 will be provided to participants in a manner which does not unmask the 
participant, as described in Section 4.7.4.  
• 
The lenses will be inserted by the participant. 
• 
Procedures of fit and assessment will be repeated as detailed in the dispensing visit, 
section 4.8.3.  
• 
The participant will be discharged and reminded to return for the 1-week visit of lens pair 
#2 and to bring back all lens package foils. 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              19 
4.8.5 1-WEEK FOLLOW-UP OF PAIR #2 & DISPENSING PAIR #3  
Participants will be asked to wear lenses for at least 4 hours prior to the visit appointment. 
Participants who attend without lenses in-situ (wearing lenses) for at least four hours will be 
rescheduled. 
• 
The participant will be asked to score their subjective responses by reflecting on a typical 
day during the previous week of lens wear, as detailed in the subjective ratings form 
(Appendix 11) and includes the following: 
 
Wear time at this visit (hours) 
 
Wear time per day during previous 1 week (hours) 
 
Comfortable wear time per day during previous 1 week (hours)  
 
Overall comfort (0-10 scale)  
 
Overall dryness (0-10 scale) 
 
Ease of insertion (0-10 scale)  
 
Ease of removal (0-10 scale)  
 
Overall visual quality/clarity (0-10 scale) 
 
Overall visual stability (0-10 scale)  
 
Overall satisfaction (0-10 scale)  
 
Comments by participants 
• 
Monocular and binocular logMAR visual acuity will be recorded with high contrast 
letters under high and low room illumination. 
• 
Lens surface and fit will then be assessed and graded according to the CVI grading 
scales for the following: 
 
Lens wettability (0-4 scale) 
 
Centration (mm)  
 
Post-blink movement (mm)  
 
Toric mark visibility 
 
Lens orientation (3 measurements per lens) 
 
Overall stability of toric mark position 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              20 
 
Overall lens fit acceptance (0-4 scale) 
• 
The lenses will be removed and retained. The disposal procedures are detailed in 
Section 4.7.6. 
• 
Slit lamp biomicroscopy will be assessed according to the CVI approved study 
biomicroscopy CRF. 
• 
There will be a 10 minute wash-out before insertion of lens pair #3. 
• 
Lens pair #3 will be provided to participants in a manner which does not unmask the 
participant, as described in Section 4.7.4.  
• 
The lenses will be inserted by the participant. 
• 
Procedures of fit and assessment will be repeated as detailed in the baseline and 
dispensing visit, section 4.8.3.  
• 
The participant will be discharged and reminded to return for the 1-week visit of lens pair 
#3 and to bring back all lens package foils. 
4.8.6 1-WEEK FOLLOW-UP OF PAIR #3 & STUDY EXIT  
Participants will be asked to wear lenses for at least 4 hours prior to the visit appointment. 
Participants who attend without lenses in-situ (wearing lenses) for at least four hours will be 
rescheduled. 
• 
The participant will be asked to score their subjective responses by reflecting on a typical 
day during the previous week of lens wear, as detailed in the subjective ratings form 
(Appendix 11) and includes the following: 
• 
Wear time at this visit (hours) 
• 
Wear time per day during previous 1 week (hours) 
• 
Comfortable wear time per day during previous 1 week (hours)  
• 
Overall comfort (0-10 scale)  
• 
Overall dryness (0-10 scale) 
• 
Ease of insertion (0-10 scale)  
• 
Ease of removal (0-10 scale)  
• 
Overall visual quality/clarity (0-10 scale) 
• 
Overall visual stability (0-10 scale)  

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              21 
• 
Overall satisfaction (0-10 scale)  
• 
Comments by participants 
• 
Participants will be asked their preference between lens pair #1, lens pair #2, and lens 
pair #3, for a number of considerations: 
 
Overall comfort preference  
 
Visual quality preference 
 
Vision stability preference  
 
Overall handling (lens insertion and removal) preference  
 
Overall lens preference 
• 
Monocular and binocular logMAR visual acuity will be recorded with high contrast 
letters under high and low room illumination. 
• 
Lens surface and fit will then be assessed and graded according to the CVI grading 
scales for the following: 
 
Lens wettability (0-4 scale) 
 
Centration (mm)  
 
Post-blink movement (mm)  
 
Toric mark visibility 
 
Lens orientation (3 measurements per lens) 
 
Overall stability of toric mark position 
 
Overall lens fit acceptance (0-4 scale) 
• 
The lenses will be removed and retained. The disposal procedures are detailed in 
Section 4.7.6. 
• 
Slit lamp biomicroscopy will be assessed according to the CVI approved study 
biomicroscopy CRF. 
• 
Exit visual acuity will be performed.  
• 
The study exit form will be completed when a participant exits the study. This will occur 
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 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              22 
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.  
• 
The participant will be discharged and will sign the study completion forms and receive 
remuneration for participating in the study. 
4.8.7 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 by the lead investigator.  
4.9 SUMMARY OF STUDY PROCEDURES 
Table 3 summarizes the visits and procedures for the study. 
Table 3: Summary of visits and procedures for the study. 
 
 
Visit 1 
Screening / 
Baseline & 
dispensing 
lens pair #1 
Visit 2 
(+3 days of 
scheduled visit) 
1-wk follow-up of 
lens pair #1 / 
Dispensing lens 
pair #2 
Visit 3 
(+3 days of 
scheduled visit) 
1-wk follow-up of 
lens pair #2 / 
Dispensing lens 
pair #3 
Visit 4 
(+3 days of 
scheduled visit) 
1-wk follow-up of 
lens pair #3 / 
and Exit 
Informed consent (screening) 
√ 
 
 
 
Confirmation of 
inclusion/exclusion criteria 
√ 
 
 
 
Ocular & medical history  
√ 
 
 
 
Demographics 
√ 
 
 
 
VA with spectacles or 
refraction 
√ 
√ 
√ 
√ 
Auto-refraction & keratometry 
√ 
 
 
 
Sphero-cylindrical refraction 
√ 
 
 
 
Best corrected (sphero-cyl) 
VA monocular and binocular 
√ 
 
 
 
HVID, palpebral aperture 
size 
√ 
 
 
 
Biomicroscopy 
√ 
√ 
√ 
√ 
Trial fitting of study lenses 
√ 
 
 
 
Wearing time on visit day 
 
√ 
√ 
√ 
Symptoms & problems 
enquiry 
√ 
√ 
√ 
√ 
Dispense new lenses 
√ 
√ 
√ 
 
Participant ratings 
completed 
√ 
√ 
√ 
√ 
Take-home participant 
√ 
√ 
√ 
 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              23 
 
 
Visit 1 
Screening / 
Baseline & 
dispensing 
lens pair #1 
Visit 2 
(+3 days of 
scheduled visit) 
1-wk follow-up of 
lens pair #1 / 
Dispensing lens 
pair #2 
Visit 3 
(+3 days of 
scheduled visit) 
1-wk follow-up of 
lens pair #2 / 
Dispensing lens 
pair #3 
Visit 4 
(+3 days of 
scheduled visit) 
1-wk follow-up of 
lens pair #3 / 
and Exit 
ratings provided 
Surface assessments 
√ 
√ 
√ 
√ 
Lens fit assessments 
√ 
√ 
√ 
√ 
Over Refraction (dispense) 
√ 
√ 
√ 
 
VA with contact lenses 
√ 
√ 
√ 
√ 
Assessment of adverse 
events 
√ 
√ 
√ 
√ 
Complete take home 
questionnaires 
On days 1, 3, and 6. 
Return questionnaires 
 
√ 
√ 
√ 
Exit Study 
 
 
 
√ 
 
4.10 RECORDING FINDINGS OF INTEREST 
The following variables may be recorded using a digital slit lamp system (video and still images): 
• 
Toric stability or lens fits not considered to be clinically acceptable or associated with 
symptoms 
• 
Relevant corneal and conjunctival staining 
• 
Abnormalities of lens performance (e.g. poor fit) or appearance (e.g. manufacturing 
defect, non-wetting spots/surface issues) 
• 
Additional videos (e.g. wettability, pre-lens tear film appearance, lens movement, etc.) 
may also be recorded in order to better understand on-eye lens performance and to help 
communicate this information to the sponsor. 
5 
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 internally by the CCLR. Deviations 
from the windows described in the protocol will be reported in the weekly reports and study 
report. 
6 
POTENTIAL RISKS AND BENEFITS TO HUMAN PARTICIPANTS 
This is a minimal risk study because of the use of marketed products and standard optometric 
assessments. 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              24 
Contact lenses in this study will be worn on a daily disposable wear basis. Complications that 
may occur during the wearing of contact lenses include discomfort, dryness, aching or itching 
eyes, excessive tearing, discharge, hyperemia and variable or blurred vision. More serious risks 
may include photophobia, iritis, corneal edema or eye infection. Although contact lens-related 
infections are very infrequent, the possibility does exist. The incidence of infection due to 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.  
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. 
Additionally, it is possible that participants may experience temporary discomfort associated with 
the study procedures /products/devices/eye drops (sodium fluorescein) including: burning and 
stinging, blurred vision, sandiness or grittiness, light sensitivity, dryness, itching, crusty eyes and 
foreign body sensation.  
Routine clinical procedures including auto-refraction, auto-keratometry, visual acuity, anterior 
ocular health assessment, and contact lens fitting will be used. In addition, high magnification 
imaging (including video and still images) of the lens fit may be made using 35 mm or digital 
cameras.  
There might not be direct benefits to the participants in this study. However, participation in a 
study may contribute to scientific research information that may be used in the development of 
new contact lens products. In addition, participants 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 at no cost 
to them.  
This study may help the study sponsor to better understand the performance of the products 
being used in this study. 
7 
ADVERSE EVENTS 
7.1 ADVERSE EVENT DEFINITIONS 
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. 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              27 
7.3 PROCEDURES FOR ADVERSE EVENTS 
Treatment of an adverse event will depend on its nature and severity. Based on the clinical 
judgment of the investigator the participant may be referred to an ophthalmologist for treatment. 
The investigator will attempt to determine whether the reaction is related to the test device or a 
result of other factors. An adverse event form (Appendix 18) 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. 
7.4 REPORTING ADVERSE EVENTS 
All potential Serious and Unanticipated Adverse Device Effects that are related or possibly 
related to participant’s participation will be reported to the Principal Investigator and the sponsor 
within 24 hours of the investigator becoming aware of the event. The Investigator will report 
Serious Adverse Events to the ORE within 24 hours of the investigator becoming aware of the 
event and as per ORE requirements (by fax, mail/delivery, phone, or email). All fatal or life 
threatening events will be reported immediately to the ORE. 
Significant and Non-Significant Adverse Events will be reported to the sponsor as soon as 
possible, but no later than 5 working days after the occurrence. The Investigator will report the 
event to the ORE as per ORE requirements (by fax, mail/delivery, phone, or email). 
Sponsor contact details are:  
8 
DISCONTINUATION FROM THE STUDY 
Participants discontinued from a study will be reimbursed 
 (including the initial screening visit). A participant’s study participation 
may be discontinued at any time if, in the opinion of the sponsor or the investigator it is in the 

EX-MKTG-72 Ginger Protocol_14oct2016 
 28 
best interest of the participant. All discontinuations will be fully documented on the appropriate 
study forms and the Discontinuation Form will be completed. The following is a list of possible 
reasons for discontinuation from the study: 
•
Screening failure: Participants will be discontinued if they do not meet the inclusion and
exclusion criteria outlined in section 4.6.2.
•
Unacceptable performance with products to be used in study: Participants may be
discontinued if they are unable to achieve acceptable comfort and /or vision with the
study products.
•
Positive slit lamp finding: Participants may be temporarily or permanently discontinued
from the study depending on the severity of the condition and on the judgement of the
investigator.
•
Adverse event: If a participant experiences an adverse event during the study they may
be discontinued based on the clinical judgement of the investigator.
•
Symptoms: If the participant has persistent symptoms they may be discontinued based
on the clinical judgement of the investigator.
•
Disinterest, relocation or illness: The participant may choose to discontinue due to
reasons within or beyond their control.
•
Violation of protocol or non-compliance: The participant will be discontinued if they are
unable or unwilling to follow the protocol specified visit schedules and/or study
procedures.
•
Instillation of topical ocular medication: The participant will be discontinued if they elect to
use a topical ocular medication during the study unless that topical ocular medication is
prescribed for a limited duration (less than two weeks) to treat a transient condition; in
this case the participant may remain an active participant (at the discretion of the
investigator) after stopping topical ocular medication following resolution of the ocular
condition).
•
Lost to follow-up: The participant will be discontinued if they cannot be contacted and do
not return for a final exit visit, and if the investigator has made a reasonable effort to
contact the participant for a final study visit.
•
Premature termination of the study by the sponsor, the CCLR or the Office of Research
Ethics at the University of Waterloo.
A discontinuation form (Appendix 13) 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.  

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              31 
12.1  STUDY MONITORING 
Site qualification of the investigative site has been completed to ensure that the site facility is 
adequate, personnel are qualified and resources are satisfactory to conduct clinical studies for 
the Sponsor. The protocol will be reviewed by the investigators prior to enrollment of the first 
participant. This will involve an overview of the protocol, which includes information on study 
objectives, inclusion and exclusion criteria, study visits and adverse event reporting. Data 
collection forms will also be reviewed and this will provide an opportunity to discuss any 
questions.  
Central study monitoring will involve regular study updates from the clinical site to the sponsor. 
The updates will include the number of participants enrolled, the number eligible, the number 
completed and whether there have been any unscheduled visits, discontinuations, significant or 
serious adverse events or major protocol deviations. These updates will be provided weekly.  
Prior to final data lock, a close-out visit/discussion may be warranted to check for accuracy and 
completeness of records. The sponsor or sponsor’s representatives will be authorized to gain 
access to the source documentation for the purposes of monitoring and auditing the study. 
12.2 SPONSOR RESPONSIBILITIES 
The Sponsor has the ultimate responsibility for monitoring. The Sponsor is to supply and keep 
an up-to-date signed protocol and protocol amendments, and provide devices which are the 
subject of the clinical investigation. 
The sponsor should ensure: appropriate information is provided to the Investigators to conduct 
the clinical trial; that deviations are reviewed with the Investigator as needed and included in the 
final report. Adverse events are reported by the Investigator, and the sponsor in turn will then 
notify their applicable regulatory authorities, and other investigators as appropriate. The Sponsor 
is to maintain Sponsor-specific clinical trial documentation as required by the regulatory 
authorities and to ensure the Investigator is aware of their record keeping responsibilities. 
12.3 INVESTIGATOR RESPONSIBILITIES 
The Investigator is responsible for ensuring participant safety and data quality by: protocol 
compliance, adherence to GCP and local regulatory requirements, and the Declaration of 
Helsinki. The Investigator should be appropriately qualified and legally entitled to practice, and 
be trained in the proper method of obtaining informed consent.  
The Investigator must have the appropriate resources to conduct the clinical trial, be familiar with 
the protocol and agree to adhere to it, support monitoring and auditing activities, communicate 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              32 
with the Sponsor regarding any clinical trial issues or need for protocol modifications, make the 
necessary arrangements to ensure proper conduct and completion of the clinical trial, and 
ensure the protection and welfare of the participant, including arranging any emergency 
treatment as needed. 
The Investigator must ensure written ORE approval is received prior to the start of the clinical 
trial, that the ORE and Sponsor is kept informed of the clinical trial progress, including adverse 
events and deviations as required by them, and that any changes to the protocol are notified to 
the ORE and review written approval prior to implementation. 
12.4 RECORD KEEPING 
Detailed records of all study visits will be made using the Case Report Forms (CRFs). All data 
recorded on forms will be in ink. Any corrections to the forms will be initialed and dated at the 
time they are modified. 
12.5 RETENTION OF STUDY RECORDS AND DATA 
Following study completion, data will be available in electronic and/or paper format for audit, 
sponsor use, or subsequent analysis. The original clinical raw data (including completed CRFs 
and Informed Consent forms) will be retained according to guidelines set forth in the general 
work agreement with the site. The Sponsor will be notified and consulted if ever the files are to 
be destroyed. Copies of raw data will be forwarded to the sponsor at completion of the final 
report.  
Records and data from this study will be retained for a minimum of 25 years.  
12.6 DATA ENTRY / DATA MANAGEMENT 
Data will be entered into an electronic spreadsheet. Study staff will only be able to modify the 
data file via password entry. The investigators will be responsible for the data integrity, and 
complete data entry for each visit in the CRFs and other relevant forms. The investigator will 
review the take home questionnaires with the participant. At the completion of the study the 
investigator will send the data collected to the study sponsor within approximately 5 business 
days after the study report is finalized.  
Data analysis will not be conducted on comments which have been recorded in the source 
documents. Only pre-defined comments will be entered into the study database. Only relevant 
and applicable comments will be included in the final report as deemed necessary by the lead 
investigator.  

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              33 
13 PROTOCOL TRAINING 
All study personnel will be required to complete training prior to their involvement in the study. 
Records of training will be kept at the CCLR. 
14 STUDY MONITORING 
Status reports will be provided to the study sponsor by email on a regular basis.  
Status reports will include: 
• 
The number of participants screened, enrolled, and randomized (i.e. assigned a study ID 
number), discontinued and completed. 
• 
Details of protocol deviations. 
• 
Reports of unintended events. 
Study monitoring visits may be conducted throughout the study and will be scheduled by the 
study sponsor in conjunction with the lead investigator. In addition study records may be 
inspected at the CCLR by the sponsor, the sponsor's designate, the Office of Research Ethics at 
the University of Waterloo, and by regulatory authorities in Canada and the United States, 
namely Health Canada and the United States Food and Drug Administration (FDA); however, no 
records containing identifiable/personal information will be permitted to leave the custody of the 
CCLR. 
15 STUDY MANAGEMENT 
15.1 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.  
15.1.1 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; 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              34 
• 
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. 
15.1.2 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).  
15.1.3 REPORTING AND DOCUMENTING PROTCOL DEVIATIONS 
Major protocol deviations which require changes to the research protocol or informed consent 
process/document or other corrective actions to protect the safety, welfare, or rights of 
participants or others must be reported to the ORE (as per guidelines of the ORE), using the 
Protocol Deviation Report Form 107 (PDRF). Information from the PDRF is provided to the 
Clinical Research Ethics Committee (CREC) at the next monthly meeting. 
All protocol deviations (major and minor) occurring during the study will be documented and 
included in the final report. 
15.2 PREMATURE TERMINATION OF THE STUDY 
The sponsor, the CCLR or the Office of Research Ethics at the University of Waterloo may 
terminate the study at any time for any reason. 
15.3 STUDY PARTICIPANT RECORDS 
Study participant records will be completed to comply with GCP guidelines. Records will contain: 
• 
Unique study acronym and/or code; 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              35 
• 
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 each participant’s study exit. 
15.4 RETENTION OF STUDY RECORDS AND DATA 
Records and data from this study will be retained for a minimum of 25 years. Details regarding 
storage procedures are given in the CCLR SOP.  
16 CONFIDENTIALITY 
This study is confidential in nature. All information gathered during this study is proprietary and 
should be made available only to those directly involved in the study. Information and reports 
arising from this project are the property of the sponsor.  
17 PUBLICATION 
Due to the confidential and proprietary nature of the clinical study, any presentation and/or 
publication including but not limited to those made at scientific meetings, in-house, in peer-
review journals, professional publications, etc. need to be approved by the sponsor. 
18 STUDY COSTS  
The sponsor will compensate the clinical site and the participants for their time and participation 
in this voluntary study. 
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 
and a written report completed indicating the subsequent treatment and resolution of the 
condition.  
19 REPORT 
A report will be sent to the sponsors according to terms described in the study contract. 
 
 
 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              36 
20 APPENDICES 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
  
 
  
 
  
 
  
 
 
  
 
 
 
  
 
 
  
 
 
 
  
 
 
  
 
  
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

EX-MKTG-72 Ginger Protocol_14oct2016                                                                                                              37