Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.

EX-MKTG-114 MIKI Protocol v1.3 20may2020                                                         
              1 
 
 
Centre for Ocular Research & Education (CORE) 
School of Optometry & Vision Science | University of Waterloo, 200 University Avenue West | Waterloo, ON, Canada N2L 3G1 
+1 519 888-4742 | CORE.uwaterloo.ca 
Protocol 
COMPARING THE PERFORMANCE OF TWO DIFFERENT 
DAILY DISPOSABLE LENSES (MIKI) 
 
This protocol remains the exclusive property of CORE until it is commissioned by the sponsor. 
Role & printed name 
Reviewed and approved  (sign) 
Date 
DD/MMM/YYYY 
Principal investigator: Lyndon Jones 
 
 
Lead investigator: Amir Moezzi 
 
 
Protocol author: Amir Moezzi 
 
 
Quality assurance: Jill Woods 
 
 
Sponsor: Jose Vega 
 
  
 
 
 
Sponsor Company:
CooperVision, Inc. 
Sponsor Study number:
EX-MKTG-114 
CORE protocol number:
 
Version Number:
1.3 
Document Date: 
20 May 2020 
Document Type: 
Study protocol 
Clinical Site: 
CORE, University of Waterloo 

EX-MKTG-114 MIKI Protocol v1.3 20may2020  2 
Study Personnel 

EX-MKTG-114 MIKI Protocol v1.3 20may2020  4 
Table of contents 
Document change history ............................................................................................................. 3 
1 
Introduction ........................................................................................................................... 8 
2 
Objectives ............................................................................................................................. 8 
3 
Hypothesis ............................................................................................................................ 9 
4 
Materials and methods .......................................................................................................... 9 
4.1.1 
Study design ............................................................................................................ 9 
4.1.2 
Overall design .......................................................................................................... 9 
4.1.3 
Randomization ....................................................................................................... 11 
4.1.4 
Masking ................................................................................................................. 11 
5 
Study population ................................................................................................................. 11 
5.1.1 
Sample size calculation ......................................................................................... 11 
5.1.2 
Number of participants ........................................................................................... 12 
5.1.3 
Inclusion and exclusion criteria .............................................................................. 12 
5.1.4 
Repeated screenings ............................................................................................. 13 
5.2 
Study materials ............................................................................................................. 13 
5.2.1 
Lenses ................................................................................................................... 13 
5.2.2 
Rewetting drops ..................................................................................................... 14 
5.2.3 
Ordering consumables ........................................................................................... 14 
5.2.4 
Contact lens dispensing ......................................................................................... 14 
5.2.5 
Contact lens disposal ............................................................................................. 14 
5.2.6 
Product accountability ............................................................................................ 15 
5.3 
Scheduled and unscheduled visits ................................................................................ 15 

EX-MKTG-114 MIKI Protocol v1.3 20may2020  5 
5.3.1 
Study visits ............................................................................................................ 15 
5.3.2 
Screening (Visit 1) ................................................................................................. 16 
5.3.3 
Dispensing lens type #1 (Visit 2) ............................................................................ 17 
5.3.4 
1-week follow-up of lens type #1 (Visit 3) ............................................................... 19 
5.3.5 
Dispensing lens type #2 (Visit 4) ............................................................................ 20 
5.3.6 
1-week follow-up of lens type #2 (Visit 5) ............................................................... 21 
5.3.7 
Study exit ............................................................................................................... 22 
5.3.8 
Unscheduled visits ................................................................................................. 22 
5.4 
Study procedures .......................................................................................................... 22 
5.5 
 ...................................................................................... 23 
6 
Monitoring protocol adherence ............................................................................................ 23 
7 
Potential risks and benefits to human participants ............................................................... 24 
8 
Adverse events ................................................................................................................... 24 
8.1 
Normal or adaptive symptoms ...................................................................................... 26 
8.2 
Procedures for adverse events ..................................................................................... 27 
8.3 
Reporting adverse events ............................................................................................. 27 
9 
Discontinuation from the study ............................................................................................ 28 
10 
Device malfunctions ............................................................................................................ 29 
11 
Study completion and remuneration .................................................................................... 29 
12 
Statistical analysis and data management ........................................................................... 30 
12.1 
Statistical analysis ..................................................................................................... 30 
12.2 
Data management ..................................................................................................... 31 
12.3 
Comments on source documents .............................................................................. 31 

EX-MKTG-114 MIKI Protocol v1.3 20may2020  6 
13 
Protocol training .................................................................................................................. 31 
14 
Study monitoring ................................................................................................................. 31 
15 
Study management ............................................................................................................. 32 
15.1 
Statement of compliance ........................................................................................... 32 
15.2 
Ethics review ............................................................................................................. 32 
15.3 
Clinical trial registration ............................................................................................. 32 
15.4 
Protocol deviations .................................................................................................... 32 
15.4.1 
Major protocol deviations ....................................................................................... 33 
15.4.2 
Minor protocol deviations ....................................................................................... 33 
15.4.3 
Reporting and documenting protocol deviations ..................................................... 33 
15.5 
Premature termination of the study ............................................................................ 34 
15.6 
Study participant records ........................................................................................... 34 
15.7 
Retention of study records and data .......................................................................... 34 
16 
Report ................................................................................................................................. 34 
17 
References .......................................................................................................................... 34 
 
 

EX-MKTG-114 MIKI Protocol v1.3 20may2020  7 
 
 
 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 and is not intended to be used to support safety 
and efficacy in a regulatory submission. 
 
 
 

EX-MKTG-114 MIKI Protocol v1.3 20may2020  12 
5.1.2 NUMBER OF PARTICIPANTS 
Participants will be screened using CORE records and advertising approved by the UW Office of 
Research Ethics. Approximately 38 participants will be dispensed with study products in the study, 
with a target of 34 completing the study.  
A documented informed consent process will be conducted with all participants prior to their 
enrolment in the study and prior to any data collection or measurements.  
5.1.3 INCLUSION AND EXCLUSION CRITERIA 
A person is eligible for inclusion in the study if he/she: 
1. Is at least 17 years of age and has full legal capacity to volunteer; 
2. Has read and signed an information consent letter; 
3. Is willing and able to follow instructions and maintain the appointment schedule; 
4. Habitually wears soft contact lenses in daily wear, for minimum of 6-months; 
5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses; 
6. Has an astigmatism of ≤ 1.00 D in subjective refraction; 
7. Can be fit with study contact lenses with a power between -2.00 and -5.00 DS; 
8. Demonstrates an acceptable fit with the study lenses; 
9. Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a 
week, and is willing to wear contact lenses for at least 12 hours a day in the study.  
A person may be excluded from the study if he/she: 
1. Is participating in any concurrent clinical or research study; 
2. Has any known active* ocular disease and/or infection; 
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 the diagnostic pharmaceuticals to be used in the study; 
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment because the 
associated hormonal changes cause changes in the tear layer which impact contact lens 
comfort. Verbal confirmation at the screening visit is sufficient; 
7. Has undergone refractive error surgery or any intraocular surgery, including cataract 
surgery;  

EX-MKTG-114 MIKI Protocol v1.3 20may2020  14 
Dk/t (barrer/cm)
100 
100 
Water content 
54% 
51% 
Sphere power (D)
-2.00 to -5.00 (0.25 steps)
-2.00 to -5.00 (0.25 steps) 
Base curve (mm) 
8.4 
8.3 
Diameter
14.2 
14.2 
Replacement schedule 
Daily disposable 
Daily disposable 
5.2.2 REWETTING DROPS 
Participants who habitually use rewetting drops will be asked to refrain during the study, unless 
necessary for continued lens wear. Participants will keep track of rewetting drop usage, and this 
will be recorded at each visit. Rewetting drops may be used in the event of any clinical observation 
and/or adverse event noted during the study.  
5.2.3 ORDERING CONSUMABLES 
All study lenses (test and control) will be provided by CooperVision.  
5.2.4 CONTACT LENS DISPENSING 
Lenses will be provided to the participant after being transferred, complete with blister pack 
solution, to a contact lens cup; this will maintain participant masking and aid investigator masking. 
The use of saline for rinsing the contact lens prior to insertion is permitted if necessary. Saline will 
not be dispensed during the study.  
5.2.5 CONTACT LENS DISPOSAL  
Participants will be instructed to dispose of the worn lenses daily, and return any unworn lenses in 
their packaging at their next study visit. All contact lenses worn to each 1-week follow up visit will 
be collected and stored at -80C. These collected lenses will be shipped to CooperVision at the end 
of the study. The lens deposits will be evaluated and analysed for composition and quantity, no 
genetic assessments will be conducted.  
Additionally, worn lenses associated with adverse events shall be retained at CORE and returned 
to CooperVision if requested to do so. Typical analysis in these cases relates to inspection for 
damage and/ or bacterial contamination. No genetic assessments will be conducted.  
 

EX-MKTG-114 MIKI Protocol v1.3 20may2020  17 
9. 
 
 
 
 
 
a. 
 
 
 
 
 
 
 
 
 
 
 
12. 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. 
13. Trial fitting of both study lenses: 
a. 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 powers. 
b. The contact lenses will be provided to participants in a manner that does not 
unmask the participant as described in Section 5.2.4. 
c. The participant will insert the lenses. 
d. 
 
 
e. 
 
 
 
5.3.3 DISPENSING LENS TYPE #1 (VISIT 2) 
The procedures to be performed are outlined below: 

EX-MKTG-114 MIKI Protocol v1.3 20may2020  18 
1. The participant will be assigned a randomization ID (by the research assistant) and the 
first pair (lens pair #1) of contact lenses (either test or control lens) will be selected 
according to the randomization table.  
2. Lens pair #1 will be provided to participants in a manner which does not unmask the 
participant or investigator, as described in Section 5.2.4. 
3. The participant will insert the lenses. 
4. The contact lenses will be allowed to settle for 10 minutes. 
5. The participant will be asked to give subjective binocular ratings for: 
a. 
 
 
6. 
 
 
7. 
 
 
8. Lens 
 fit will be assessed and graded according to the following grading 
scales: 
a. 
 
b. 
 
 
c. Lens push-up tightness in primary gaze (0 – 100 scale); 
d. Centration in primary gaze (scale: optimal, slight decentration, moderate 
decentration but not encroaching limbus, excessive & occasionally encroaching 
limbus); 
e. Post-blink movement in primary gaze (mm); 
f. 
Overall fit acceptance (0 – 4 scale, and reason if Grade 2 or less). 
9. 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 

EX-MKTG-114 MIKI Protocol v1.3 20may2020  19 
10. 
 
 
  
 
 
5.3.4 1-WEEK FOLLOW-UP OF LENS TYPE #1 (VISIT 3) 
Participants will be asked to wear lenses for 6 to 8 hours prior to the visit appointment. Participants 
who attend without lenses in-situ (wearing lenses) for 6 to 8 hours will be rescheduled (unless they 
report problems when wearing the lenses). 
1. 
 
2. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3. 
 
 
4. 
 
 
5. Lens 
 fit will then be assessed and graded according to the CVI grading 
scales for the following: 
a) 
 

EX-MKTG-114 MIKI Protocol v1.3 20may2020  20 
b) 
 
 
c) Lens push-up tightness in primary gaze (0 – 100 scale); 
d) Centration in primary gaze (scale: optimal, slight decentration, moderate 
decentration but not encroaching limbus, excessive & occasionally encroaching 
limbus); 
e) Post-blink movement in primary gaze (mm);  
f) Overall fit acceptance (0 – 4 scale and reason if Grade 2 or less).  
6. Study lens collection at 1-week: investigator will remove study lenses from participant 
eyes while wearing a pair of disposable non-latex medical grade gloves. The lenses will 
be rinsed and stored according to sponsor instructions which will be provided at a later 
date. They will be labeled with study name, participant study ID, eye, visit# and date 
without any identifying characteristics. They will be stored in a -80 degrees centigrade 
freezer and shipped to the sponsor when all participants have completed the study.  
7. Slit lamp biomicroscopy assessments (see 5.3.2 for details). 
8. There will be a washout of 10 minutes after lens removal if Visit 4 is to be concurrent with 
this visit. 
5.3.5 DISPENSING LENS TYPE #2 (VISIT 4) 
1. The participant will be assigned the second pair (lens pair #2) of contact lenses (either 
test or control lens), which will be selected according to the randomization table.  
2. Lens pair #2 will be provided to participants in a manner, which does not unmask the 
participant or investigator, as described in Section 5.2.4.  
3. The participant will insert the lenses. 
4. The contact lenses will be allowed to settle for 10 minutes. 
5. The same procedures will be followed as described in Section 5.3.3 DISPENSING LENS 
PAIR #1 (VISIT 2), points 5 to 11. 
 
 
6. The participant will be reminded to return for Visit 5 (1-week follow-up visit of study lens #2) 
and instructed to return used lens foils plus all leftover unworn lenses. 
 

EX-MKTG-114 MIKI Protocol v1.3 20may2020  21 
5.3.6 1-WEEK FOLLOW-UP OF LENS TYPE #2 (VISIT 5) 
Participants will be asked to wear lenses for 6-8 hours prior to the visit. Participants who attend 
without wearing lenses for 6-8 hours will be rescheduled (unless they report problems when 
wearing the lenses).  
1. The same procedures will be carried out as described in Section 5.3.4 1-WEEK FOLLOW-
UP OF LENS TYPE #1 (VISIT 3), points 1 to 5. 
2. Study lens collection at 1-week: investigator will remove study lenses from participant 
eyes while wearing a pair of disposable non-latex medical grade gloves. The lenses will 
be rinsed and stored according to sponsor instructions which will be provided at a later 
date. They will be labeled with study name, participant study ID, eye, visit# and date 
without any identifying characteristics. They will be stored in a -80 degrees centigrade 
freezer and shipped to the sponsor when all participants have completed the study.  
3. 
 
4. 
 
 
 
5. 
 
o 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

EX-MKTG-114 MIKI Protocol v1.3 20may2020  33 
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).  
15.4.3 REPORTING AND DOCUMENTING PROTOCOL DEVIATIONS 
Major protocol deviations must be reported to the ORE within 7 days of the deviation occurring (or 
its discovery) 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.