Performance of Somofilcon A Over One Week in Wearers Adapted to Omafilcon A
Phase: NA
Conditions: Myopia
Sponsor: CooperVision, Inc.

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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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 
PERFORMANCE OF CLARITI 1 DAY OVER ONE WEEK IN WEARERS 
ADAPTED TO PROCLEAR 1 DAY (OBOE) 
Sponsor: CooperVision, Inc. 
     6150 Stoneridge Mall Road, 
     Suite 370, Pleasanton, CA 94588 USA 
Sponsor study number: EX-MKTG-84 
CCLR protocol number: P/597/17/CVI 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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Study Personnel 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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DOCUMEN T CH AN G E HIS T ORY 
 
 
 
version # 
 
Originator 
Description of change(s) 
 
Date 
 
1.0 
 
 
 
Original protocol 
 
08 June 2017 
 
1.1 
 
 
 
Minor edits following review 
 
15 June 2017 
 
1.2 
 
 
 
Minor edits following review by Office 
of Research Ethics: 
 
 
Section 4.2.3 – “study measures” 
instead of “study outcome 
variables” 
 
Added Health Canada license 
number for Proclear 1 Day 
 
Addition of Appendix 29, 
Unscheduled visit form 
 
04 July 2017 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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Table of contents 
 
Document change history ............................................................................................................ 3 
 
1 
Introduction.......................................................................................................................... 8 
 
2 
Objectives............................................................................................................................ 8 
 
3 
Hypothesis........................................................................................................................... 8 
 
4 
Materials and methods ........................................................................................................ 9 
 
4.1 
Study design ................................................................................................................. 9 
 
4.1.1 
Overall design ........................................................................................................ 9 
 
4.1.2 
Randomization ..................................................................................................... 10 
 
4.1.3 
Masking................................................................................................................ 10 
 
4.2 
Study population ......................................................................................................... 10 
 
4.2.1 
Sample size calculation ........................................................................................ 10 
 
4.2.2 
Number of participants ......................................................................................... 10 
 
4.2.3 
Inclusion and exclusion criteria............................................................................. 11 
 
4.2.4 
Repeated screenings ........................................................................................... 12 
 
4.3 
Study materials ........................................................................................................... 12 
 
4.3.1 
Lenses ................................................................................................................. 12 
 
4.3.2 
Lens care system ................................................................................................. 13 
 
4.3.3 
Rewetting drops ................................................................................................... 13 
 
4.3.4 
Ordering consumables ......................................................................................... 13 
 
4.3.5 
Disposing of consumables ................................................................................... 13 
 
4.3.6 
Product accountability .......................................................................................... 13 
 
4.4 
Scheduled and unscheduled visits .............................................................................. 14 
 
4.4.1 
Study visits ........................................................................................................... 14 
 
4.4.2 
Unscheduled visits ............................................................................................... 19 
 
4.5 
Study procedures ........................................................................................................ 19 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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4.5.1 
Demographics ...................................................................................................... 20 
 
4.5.2 
LogMAR visual acuity........................................................................................... 20 
 
4.5.3 
Auto-refraction and keratometry ........................................................................... 20 
 
4.5.4 
Subjective refraction............................................................................................. 21 
 
4.5.5 
Study lens optimized fitting (Proclear 1 Day and Clariti 1 Day) ............................. 21 
 
4.5.6 
Study lens fit assessment..................................................................................... 21 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.5.10 Investigator refit Agreement ratings...................................................................... 23 
 
4.5.11 Biomicroscopy...................................................................................................... 23 
 
5 
Monitoring protocol adherence .......................................................................................... 24 
 
6 
Potential Risks and Benefits to Human participants ........................................................... 24 
 
7 
Adverse events .................................................................................................................. 25 
 
7.1 
Normal or adaptive symptoms ..................................................................................... 27 
 
7.2 
Procedures for Adverse Events ................................................................................... 27 
 
7.3 
Reporting Adverse Events........................................................................................... 27 
 
8 
Discontinuation from the study........................................................................................... 28 
 
9 
Device malfunctions........................................................................................................... 29 
 
10 Study completion and remuneration .................................................................................. 30 
 
11 Statistical analysis and data management ......................................................................... 30 
 
11.1 
Statistical analysis ................................................................................................... 30 
 
11.2 
Data management ................................................................................................... 31 
 
11.3 
Comments on source documents ............................................................................ 31 
 
12 Data Quality Assurance ..................................................................................................... 31 
 
12.1 
Study monitoring...................................................................................................... 31 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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12.2 
Sponsor Responsibilities.......................................................................................... 32 
 
12.3 
Investigator Responsibilities .................................................................................... 32 
 
12.4 
Record keeping ....................................................................................................... 33 
 
12.5 
Retention of study records and data ........................................................................ 33 
 
13 Protocol training................................................................................................................. 33 
 
14 Study management............................................................................................................ 33 
 
14.1 
Statement of compliance ......................................................................................... 33 
 
14.2 
Ethics review ........................................................................................................... 34 
 
14.3 
Clinical Trial Registration ......................................................................................... 34 
 
14.4 
Protocol deviations .................................................................................................. 34 
 
14.4.1 Major protocol deviations ..................................................................................... 34 
 
14.4.2 Minor protocol deviations ..................................................................................... 35 
 
14.4.3 Reporting and documenting protcol deviations ..................................................... 35 
 
14.5 
Premature termination of the study .......................................................................... 35 
 
14.6 
Study participant records ......................................................................................... 35 
 
14.7 
Retention of study records and data ........................................................................ 36 
 
15 Confidentiality .................................................................................................................... 36 
 
16 Publication ......................................................................................................................... 36 
 
17 Study Costs ....................................................................................................................... 36 
 
18 References ........................................................................................................................ 36 
 
19 Report................................................................................................................................ 36 
 
20 Appendices........................................................................................................................ 36 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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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-84 OBOE protocol v1.2 04jul2017
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1 
INTRODU C TION 
 
CooperVision’s Proclear material (omafilcon A) has been longstanding, successful hydrogel lens 
material available in a daily disposable modality. The popularity of silicone hydrogels materials in 
a daily disposable modality has increased over time, offering superior oxygen delivery to the eye 
and the convenience of single-use lenses. One recent publication has found no clinically 
significant physiological differences in five retrospective studies where patients were refit from a 
range of hydrogel lenses to silicone hydrogel lenses.1 
 
This aim of this study is to determine if habitual or adapted contact lens wearers of Proclear 1 Day 
(omafilcon A) can be confidently refit into Clariti 1 Day (somofilcon A) lenses and be successful 
after one week of daily wear. The primary target population for this study will ideally be habitual 
wearers of Proclear 1 Day. However, as a secondary target population, habitual wearers of other 
lens types will be recruited and will be adapted to Proclear 1 Day lenses for at least 7 days before 
being refit into Clariti 1 Day. 
 
2 
OBJEC TIV ES 
 
The objective of the study is to determine if habitual or adapted contact lens wearers of Proclear 
 
1 Day can be confidently refit into Clariti 1 Day (somofilcon A) lenses and be successful after one 
week of daily wear. 
 
The primary outcome variables for this study are: 
 
 
Investigator responses to refit questions; 
 
 
Lens fit. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3 
HYPO THESIS 
 
The null hypothesis for this study is that there is no difference in lens fit performance between 
 
Proclear 1 Day (omafilcon A) and Clariti 1 Day (somofilcon A) lenses. 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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4 
M ATE RI AL S AN D ME THOD S 
 
 
4.1 ST UDY D ESIGN 
 
4.1.1  OVERAL L DE SIGN 
 
This is a prospective, single-site, dispensing, bilateral wear, open label, daily wear switch study, 
with the test lens (Clariti 1 Day) being worn for 7 (+5) days. 
 
Participants will attend a screening visit (Visit 1), at which consent will be obtained and eligibility 
to participate will be confirmed. The number of visits is dependent the participant’s habitual lens 
type (i.e. whether it is Proclear 1 Day, or another lens type) and whether the power of the habitual 
lens needs to be changed. All subjects will be fit with Clariti 1 Day at the screening visit to ensure 
they can successfully wear the product. 
 
Habitual wearers of Proclear 1 Day lenses will be reviewed at Visit 1 to ensure optimal visual 
acuity is being achieved. If the visual acuity and power of the habitual Proclear 1 Day lens is 
optimal, participants will be fit with Clariti 1 Day and asked to return for evaluation after 7 days of 
lens wear. 
 
If an amendment of the power of the habitual Proclear 1 Day is required, participants will be 
dispensed with the new power of the Proclear 1 Day lenses to be worn for at least 7 days. 
Participants will return after wearing the Proclear 1 Day lenses to collect baseline variables. The 
participant will then be dispensed with Clariti 1 Day and asked to return for evaluation after 7 days 
of lens wear. 
 
In the instance where the participant habitually wears lenses which are not Proclear 1 Day, the 
participant will be fit and dispensed Proclear 1 Day lenses to be worn for at least 7 days. After 
experiencing Proclear 1 Day lenses for at least 7 days, the participant will return for baseline 
variables to be evaluated and will be then be dispensed with Clariti 1 Day. The participant will be 
asked to return for evaluation after 7 days of lens wear. Participants will exit the study following 
the final evaluation of Clariti 1 Day. 

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Figure 1 Study flow chart (C1D = Clariti 1 Day; P1D = Proclear 1D). * Visit 1A applicable only if habitual Proclear 1 Day 
wearers require a change in lens power OR if participant is a habitual lens wearer of other types (see Section 4.4 for further 
details) 
 
4.1.2  RAN DO MIZAT ION 
 
There is no randomization in this study. All participants will be habitual (or adapted) Proclear 1 
 
Day lens wearers that will be switched into Clariti 1 Day lenses. 
 
4.1.3  MAS KING 
 
Due to the design of the study, there is no masking of participants or investigators. 
 
4.2 ST UDY POPU LAT ION 
 
4.2.1   SA MPLE  SIZE CA LC ULAT ION 
 
A sample size calculation was provided by CooperVision based on the combined data for comfort 
scores in the BEETHOVEN 2 study (CooperVision EX-MKTG-61, data on file). For an alpha level 
of 0.05 and power of 0.8, a sample size of 67 participants will detect a difference of 7 units on a 
0-100 scale. Seven units is accepted as a minimum meaningful difference in comfort between 
lenses for this scale range.2 
 
4.2.2  NU MBE R OF PART IC IPANT S 
 
Participants will be recruited using CCLR records and advertising approved by the UW Office of 
 
Research Ethics (Appendices 25, 26, 27). Up to 75 participants will be dispensed with study 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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products, with a target of 67 completing the study. Informed consent will be obtained for all 
participants prior to their enrolment in the study (Appendix 1). 
 
4.2.3  INCLU SION AND EX CLU S ION CRIT ERIA 
 
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 spherical contact lenses with a power between +6.00 to -10.00D 
(inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty 
wearing contact lenses for 7 days per week, 10 hours per day; 
5.  Habitually wears, or is able to be adequately refit into Proclear 1 Day lenses; 
 
6.  Demonstrates an acceptable fit with Proclear 1 Day and Clariti 1 Day contact lenses; 
 
7.  Is correctable to a visual acuity of 0.20 LogMAR (approximately 20/30) or better (in each 
eye) with the study lenses or habitual correction; 
8.  Manifest cylindrical spectacle refraction does not exceed -1.00DC in either eye. 
 
 
 
A person will be excluded from the study if he/she: 
 
1.  Is participating in any concurrent clinical 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 
measure; 
4.  Is using any systemic or topical medications that in the opinion of the investigator may 
affect a study measure; 
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 (by verbal 
communication); 
7.  Is aphakic; 
 
8.  Has undergone refractive error surgery; 
 
9.  Is an employee of the Centre for Contact Lens Research; 
 
10. Has taken part in another clinical or (pharmaceutical) research study within the last 7 
days. 

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4.3.2  LENS CA RE SY ST E M 
 
No lens care systems are required as this study involves the use of daily disposable contact 
lenses. 
 
4.3.3  REW ET TING DROPS 
 
Participants will not be encouraged to use rewetting drops; however, those who habitually used 
rewetting drops will be allowed to continue using their normal drops. Rewetting drop use will be 
recorded at the follow-up visit. In the event of an adverse event, rewetting drops may be given to 
participants. 
 
4.3.4  ORDERING CON SU MABLE S 
 
Clariti 1 Day will be supplied by the sponsor. If they have difficulty sourcing product in good time 
then lenses may instead be purchased by the CCLR through a commercial route. Proclear 1 Day 
may be sourced from the sponsor or through a commercial route, depending on delivery times 
and urgency of need. 
 
4.3.5  DISPOSING OF CONSU MABL ES 
 
This study provides contact lenses to participants for use during the study. Participants will be 
instructed to dispose of worn lenses daily, but retain the foils of all used lens packs and return 
them together with any unworn lenses, at their next study visit. Lenses worn for the scheduled 
visits will be collected from the participants and they will be disposed according to UW guidelines. 
Worn lenses associated with adverse events may be retained either at the CCLR or returned to 
CooperVision. Typical analysis in these cases relates to inspection for damage and/ or bacterial 
contamination. Upon completion of the study, all worn lenses will be destroyed, unless otherwise 
directed by the study Sponsor. 
 
4.3.6   PRODU CT  ACCOU N T ABILI TY 
 
Accountability logs will be kept to include the number of lenses received, dispensed, unused and 
returned to sponsor (where relevant). All products dispensed to participants will be recorded in the 
study binder. 

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4.4 SCH ED ULE D AN D U NSC HE DUL ED VISIT S 
 
4.4.1  ST UDY VISIT S 
 
This study has 4 to 6 scheduled study visits (including the screening visit), depending on the 
participant’s habitual lens type and lens power needs (Table 2). The total time commitment for 
scheduled visits is expected to be 2.75 to 3.75 hours. 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table 2: Summary of visits 
 
Visit 
code 
Visit schedule 
 
Visit Description 
Duration 
(hrs) 
1 
 
Screening and establish optimum power of Proclear 1 Day; fit 
Proclear 1 Day (if applicable) and Clariti 1 Day. 
1 (1.25 if 
fitting both 
lenses) 
1A*  
Dispense new or modified power Proclear 1 Day** 
0.5 
1B*** 
≥7 days after V1A 
or concurrent to 
V1 
Review Proclear 1 Day and baseline data collection 
 
0.5 
2 
 
Dispense Clariti 1 Day**** 
0.5 
3 
7-12 days after V2 
Review Clariti 1 Day  
1 
4 
 
Study exit 
 
0.25 
*Note: Visit 1A is only necessary if a change in Proclear 1 Day lens power is required, or if a fit with Proclear 1 Day is required for 
adaptation 
**Note: Visit 1A can be concurrent to Visit 1 
***Note: Visit 1B can also be concurrent to Visit 1 if a habitual Proclear 1 Day wearer does not require a change in lens power 
****Note: For habitual Proclear 1 Day wearers that do not require a change in lens power, Visit 2 can be concurrent to Visit 1 
 
 
4.4.1.1  VISIT 1: SCREENING AND ESTABLISH OPTIMI MUM POW ER OF PROCLEA R 
 
1 DAY 
 
Participants will attend a screening visit during which informed consent will be obtained and the 
investigator will determine participant eligibility using the inclusion and exclusion criteria. 
Participants will be assigned a study ID number when they sign the informed consent document, 
and before their eligibility for the study has been confirmed. Ineligible participants will be 
discontinued from the study. Depending on the participant’s habitual lens type, participants may 
follow the following procedures and visits outlined (illustrated in Figure 2). 

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Figure 2: Flow chart for visits depending on habitual lens type (P1D = Proclear 1 Day; C1D = Clariti 1 Day). 
*Following Visit 1A, participant also completes Visit 1B before proceeding the Visit 2 
 
 
 
 
Habitual Proclear 1 Day wearers: 
 
Participants that habitually wear Proclear 1 Day lenses will attend Visit 1 wearing their own 
Proclear 1 Day lenses. Participant demographics, including their contact lens history, wear 
schedule, health and medication will be recorded. Monocular and binocular distance visual acuity 
(high contrast, high illumination) and an over-refraction will be conducted with the participant’s 
habitual Proclear 1 Day lenses in situ. The lenses will be assessed for fit acceptance. 
 
If the power of the participant’s habitual Proclear 1 Day lenses is confirmed to be optimal, the 
following procedures will be conducted: 
 
 
Visit 1B will be completed immediately (specifically: fit assessment and collection of 
subjective ratings for Proclear 1 Day) 
 
Remove contact lenses 
 
 
Visual acuity with habitual spectacles (high contrast, high illumination) 

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 
Automated refraction and keratometry 
 
 
Subjective sphero-cyclindrical and best-vision sphere refraction plus distance visual acuity 
 
(high contrast, high illumination), monocular and binocular 
 
 
Ocular health assessment 
 
 
The participant will be fit with Clariti 1 Day 
 
 
Investigator refit ratings 
 
 
Eligibility will be confirmed and the participant continues to Visit 2 
 
If the power of the participant’s habitual Proclear 1 Day lenses requires amendment, the following 
procedures will be conducted: 
 
 
Remove contact lenses 
 
 
Visual acuity with habitual spectacles (high contrast, high illumination) 
 
 
Automated refraction and keratometry 
 
 
Subjective sphero-cyclindrical and best-vision sphere refraction plus distance visual acuity 
 
(high contrast, high illumination), monocular and binocular 
 
 
An ocular health assessment will be conducted 
 
 
The participant will be fit with Clariti 1 Day 
 
 
Investigator refit ratings 
 
 
Eligibility will be confirmed and the participant continues to Visit 1A 
 
Habitual wearers of other lenses: 
 
Participants that habitually wear other soft lens types will be asked to attend Visit 1 wearing their 
glasses. Participant demographics, including their contact lens history, wear schedule, health and 
medication will be recorded. The following procedures will then be conducted: 
 
 
Visual acuity with habitual spectacles (high contrast, high illumination) 
 
 
Automated refraction and keratometry 
 
 
Subjective sphero-cyclindrical and best-vision sphere refraction plus distance visual acuity 
 
(high contrast, high illumination), monocular and binocular 
 
 
Ocular health assessment 
 
 
The participant will be fit with Clariti 1 Day 
 
 
Investigator refit ratings 
 
 
Eligibility will be confirmed and the participant continues to Visit 1A 

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4.4.1.2  VISIT 1A: DISPENSE PROCLEAR 1 DAY 
 
Visit 1A only occurs for participants that: a) required an amendment to the power of their habitual 
Proclear 1 Day lenses or b) are habitual wearers of other lenses. This visit may be scheduled to 
be on the same day as Visit 1. The following procedures will be conducted during this visit: 
 
 
Changes to health or medication* 
 
 
Ocular health assessment* 
 
 
Dispense Proclear 1 Day 
 
 
Monocular and binocular distance visual acuity (high contrast, high illumination) with 
contact lenses 
 
Fit assessment of contact lenses 
 
 
Provide sufficient Proclear 1 Day to wear daily for at least 7 days 
 
 
Participant advised to return for Visit 1B wearing Proclear 1 Day 
 
*These procedures are not required if Visit 1A is concurrent to Visit 1. 
 
 
4.4.1.3  VISIT 1B: BASELINE PROCLEAR 1 DAY REVIEW 
 
Visit 1B documents the baseline Proclear 1 Day performance. It may occur: a) during Visit 1 for 
participants where their habitual Proclear 1 Day lenses are of an optimal power, or b) after Visit 
1A after the dispensed Proclear 1 Day lenses have been used for at least the past 7 days. The 
following procedures will be conducted during this visit: 
 
 
Changes to health or medication* 
 
 
Monocular and binocular distance visual acuity (high contrast, high illumination) 
 
 
Fit assessment of Proclear 1 Day 
 
 
 
 
 
  
 
 
 
 
 
 
Remove contact lenses 
 
 
Ocular health assessment* 
 
 
Visual acuity with habitual spectacles (high contrast, high illumination)* 
 
 
Participant continues to Visit 2 
 
*These procedures are not required if Visit 1B is concurrent to Visit 1. 

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4.4.1.4  VISIT 2: DISPENSE CLARITI 1 DAY 
 
Visit 2 occurs after Baseline Proclear 1 Day data has been collected (Visit 1B). At this visit, Clariti 
 
1 Day will be dispensed. The following procedures will be conducted during this visit: 
 
 
Changes to health or medication* 
 
 
Ocular health assessment* 
 
 
Insert Clariti 1 Day 
 
 
Monocular and binocular distance visual acuity (high contrast, high illumination) with 
contact lenses 
 
Fit assessment of contact lenses 
 
 
 
 
 
  
 
 
 
Provide sufficient Clariti 1 Day to wear daily for at least 7 days (maximum 12 days) 
 
 
 
 
 
 
 
 
 
 
 
 
Participant advised to return for Visit 3 wearing Clariti 1 Day 
 
*These procedures are not required if Visit 2 is concurrent to Visit 1, or Visit 1B. 
 
 
4.4.1.5  VISIT 3: REVIEW CLARITI 1 DAY 
 
Visit 3 occurs after the participant has worn Clariti 1 Day for 7-12 days. Participants will attend this 
visit wearing Clariti 1 Day for at least 2 hours. The following procedures will be conducted at this 
visit: 
 
 
Changes to health or medication 
 
 
Collect at-home diaries 
 
 
Monocular and binocular distance visual acuity (high contrast, high illumination) 
 
 
Fit assessment of Clariti 1 Day lenses 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
Remove contact lenses 
 
 
Ocular health assessment 
 
 
Participant continues to the Study Exit Visit 

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4.4.1.6 VISIT 4: STUDY EXIT 
 
Visit 4 is completed when the participant exits the study. This may occur after study completion 
(i.e. after Visit 3), or if the participant discontinues from the study. The following procedures will 
be conducted at this visit: 
 
 
Remove study lenses 
 
 
Ocular health assessment* 
 
 
Visual acuity with habitual spectacles or refraction (high contrast, high illumination) 
 
 
Study completion or discontinuation form (as appropriate) 
 
 
Remuneration form 
 
*These procedures are not required if Visit 4 is concurrent to a visit where an ocular health 
assessment has already been conducted. 
 
 
 
4.4.2  UNS CH ED ULE D VISI T S 
 
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. 
 
4.5 ST UDY P ROCED UR E S 
 
Table 3 summarizes all the study procedures that are conducted in this study. 

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4.5.4  SUBJ ECT IVE R EFR A CT IO N 
 
A subjective sphero-cylindrical distance refraction will be conducted with the participant viewing 
letters at the computer-generated logMAR visual acuity chart at a viewing distance of 6 metres. 
 
4.5.5  ST UDY LE NS OPT IMI ZED FIT T ING (PROCLEAR 1 DAY AND CL ARIT I 1 
 
DAY) 
 
The overall fit of Proclear 1 Day (habitual or new fitting) and Clariti 1 Day will be assessed for the 
following, after at least 2 minutes settling time: 
 
 
Lens wettability (0-4, 0.25 steps, where 0 = excellent, 4 =  very poor) 
 
 
Lens deposition (0-4, 0.5 steps, where 0 = no deposits, 4 = deposits ≥ 0.5mm or film > 
 
75% of surface) 
 
 
Decentration (optimum / decentration acceptable / decentration unacceptable) 
 
 
Corneal coverage in primary gaze (yes / no) 
 
 
Post-blink  movement  (0-4,  1  step,  where  0  =  insufficient,  unacceptable  movement, 
 
2=optimal movement, 4=excessive, unacceptable movement) 
 
 
Tightness on push-up (0-100%, 5% steps, where 0% = falls from the cornea, 50% = 
 
optimum, 100% = no movement) 
 
 
Overall fit acceptance (0-4, 1 step, where 0 = should not be worn, 4 = perfect), providing a 
reason if Grade 2 or less 
 
 
4.5.5.1  SPHERICAL OVER-REFRACTION WITH CONT ACT LENSES 
 
A spherical over-refraction will be conducted during the fitting of Proclear 1 Day and Clariti 1 Day 
for each eye to optimize the power of the lenses. Distance logMAR visual acuity will be recorded 
with the over-refraction. If the need to change lens power is found, a new lens with the appropriate 
power will be obtained. Distance logMAR visual acuity will be  reassessed and a spherical 
over-refraction will be conducted. 
 
4.5.6  ST UDY LE NS FIT AS SES S MENT 
 
The study lenses will be assessed for the following during the lens fit assessment at Visit 1B and 
 
Visit 3: 
 
 
Lens wettability (0-4, 0.25 steps, where 0 = excellent, 4 = very poor) 
 
 
Lens deposition (0-4, 0.5 steps, where 0 = no deposits, 4 = deposits ≥ 0.5mm or film > 
 
75% of surface) 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
22
 
 
Decentration (optimum / decentration acceptable / decentration unacceptable) 
 
 
Corneal coverage in primary gaze (yes / no) 
 
 
Post-blink movement (0-4, 1 step, where 0 = insufficient, unacceptable movement, 2 = 
 
optimal movement, 4 = excessive, unacceptable movement) 
 
 
Tightness on push-up (0-100%, 1% steps, where 0% = falls from the cornea, 50% = 
 
optimum, 100% = no movement) 
 
 
Overall fit acceptance (0-4, 1 step, where 0 = should not be worn,  4 = perfect), providing 
a reason if Grade 2 or less 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
  
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
  
 
 
 
 
  
 

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4.5.11 BIOMIC ROSCOP Y 
 
A slit lamp biomicroscopy examination will be conducted to assess anterior segment ocular health. 
Ocular findings will be graded using the BHVI grading scale (0-4, 0.25 steps – unless otherwise 
stated): 
 
 
External adnexa anomalies (absent / present & describe) 
 
 
Hyperemia: 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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o Overall bulbar 
 
o Overall limbal 
 
 
Corneal examination: 
 
o Scars or other corneal observations (absent / present & describe) 
 
o Infiltrates (absent / present & number, size, depth) 
 
o Sectoral corneal staining with fluorescein (type and extent [using CCLR 0-100 
scale, 1 step] and depth [0-4, 1 step]) 
 
Overall conjunctival staining and indentation (0-4, 0.5 steps) 
 
 
Palpebral conjunctiva: 
 
o Hyperemia 
 
o Roughness 
 
5 
MONITORING PRO TOCOL AD HE RE NCE 
 
Adherence to study visit windows, lens wearing schedule and time windows around other data 
collection points (e.g. subjective ratings) will be monitored internally by the CCLR. Deviations from 
the windows described in the protocol will be reported in the final study report. Major protocol 
deviations will be reported to the Sponsor and the University of Waterloo’s Office of Research 
Ethics (ORE) within 7 days of becoming aware of them (as per ORE’s guidelines). 
 
6 
POTEN TI AL RISK S AND BE NE FI TS TO H UM AN P AR TICI P AN T S 
 
This is a minimal risk study because of the use of marketed products and standard optometric 
assessments. 
 
Contact lenses in this study will be worn on a daily wear basis. Adverse events and/ or 
complications in daily wear of soft contact lenses can occur (e.g. inflammation and infection). 
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. 
 
It is possible that participants may experience temporary discomfort associated with the study 
procedures or products including: burning and stinging, blurred vision, sandiness or grittiness, light 
sensitivity, dryness, itching, crusty eyes and foreign body sensation. 
 
A dye (fluorescein) normally used for eye exams will be used in this study. Although rare, it is 
possible that participants may have an allergic reaction to the dye. This could cause discomfort to 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
27
 
 
 
21 
 
Conjunctivitis (bacterial, viral or allergic) 
 
 
 
 
Notify sponsor as 
soon as possible, 
within 5 working 
days; ORE 
reporting as per 
requirements 
 
22 
 
Papillary conjunctivitis if ≥ mild scattered papillae/follicles approximately 1mm 
in diameter (e.g. ISO 11890 Grade 2), if 2 grade change from baseline 
 
23 
 
Asymptomatic corneal infiltrative events 
 
24 
 
Any sign and/or symptom for which temporary lens discontinuation for > 1 day 
is recommended (if not already classified) 
 
20 
 
Other sign and/or symptom warranting classification as a non-significant 
adverse event 
 
 
 
7.1 NOR MA L OR ADA PT IVE S Y MPT O MS 
 
Transient symptoms such as end-of-day dryness, lens awareness, itching or burning or other 
discomfort may occur with contact lens wear and may occasionally reduce wearing time. These 
are not reported as adverse events unless in the investigator’s opinion they are unexpected in 
nature, severe or have a high rate of occurrence. 
 
7.2 PROCE DU RES FOR ADV ER S E EV ENT S 
 
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 20 and 21) 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. 
 
7.3 REPORT ING ADV ER SE EV ENT S 
 
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 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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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: 
 
Contact: 
Jose A. Vega, CooperVision 
 
Email: 
JVega2@coopervision.com 
 
Phone: 
(925) 621-3761 / Fax: (925) 621-2487 
Address: 
6150 Stoneridge Mall Rd, Suite 370, 
Pleasanton, CA 94588 
 
8 
DISCON TIN U ATION FROM TH E S TUDY 
 
Participants discontinued from a study will be reimbursed $20 per hour for their active involvement 
in the study (including the initial screening visit). Participants will be discontinued at the discretion 
of the investigator, sponsor or participant. A participant’s study participation may be discontinued 
at any time, if in the opinion of the sponsor or investigator it is in the best interest of the participant. 
All discontinuations will be fully documented on the appropriate study forms, including the 
Discontinuation Form (Appendix 18). The Discontinuation Form 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. 
 
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 4.2.3. 
 
 
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. 

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 
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. 
 
9 
DEVIC E M ALF UNC TI ONS 
 
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 the Principal Investigator and 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 the Sponsor as soon as possible (usually in regular 
study updates to the Sponsor). 

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All data will be tested for normality of distribution using Shapiro-Wilk tests. The appropriate 
statistical test will be selected based on tests of normality. Statistical significance will be set at 5%, 
with no adjustments for multiple comparisons. In the event of missing data, individual data points 
will be excluded in the analysis and not extrapolated from the collected data. 
 
A binomial test will be used to analyze the results for the count data of subjective preferences and 
investigator refit agreement ratings. The number of “no preference” (if featured on the scale) will 
be evenly distributed to the two options on the basis respondents would be equally likely to choose 
either. 
 
11.2 DAT A MA NAGE MENT 
 
Data  from  this  study  will  be  retained  by  the  CCLR  for  a  minimum  of  25  years  on  a 
password-protected server. After 25 years, data will be disposed of in accordance with the 
guidelines laid out by the University of Waterloo. 
 
At the completion of the study the CCLR will provide a copy of the study data to the sponsor when 
requested. Data will typically be sent using a secure file share system operated by the University 
of Waterloo called Sendit which uses 128bit (or 256bit) SSL encryption. This system provides a 
secure way to transfer files when email is not appropriate, whether because of file size, file type 
or concerns over security. Sendit includes features such as password protection, a restricted time 
period for download, IP logging and email notification of download. Files may be encrypted prior 
to transmission at the request of the sponsor. Using this method means that data files are only 
stored on University of Waterloo servers. 
 
 
11.3 CO MMENT S ON SOU RCE D OC U MENT S 
 
Data analysis will not be conducted on comments which have been recorded in the source 
documents. Only highlighted 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. 
 
12   D AT A QU AL I TY  AS S UR AN CE 
 
 
12.1  ST UDY MONIT ORING 
 
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 

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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 CCLR 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. 
 
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. 
 
12.2 SPONSOR R ES PON SIBILIT IES 
 
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 study; 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 study documentation as required by the regulatory authorities and to 
ensure the Investigator is aware of their record keeping responsibilities. 
 
12.3 INVEST IGAT OR RES PONS IBILIT IES 
 
The CCLR 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 CCLR must have the appropriate resources to conduct the study, be familiar with the protocol 
and agree to adhere to it, support monitoring and auditing activities, communicate with the 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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Sponsor regarding any study issues or need for protocol modifications, make the necessary 
arrangements to ensure proper conduct and completion of the study, and ensure the protection 
and welfare of the participant, including arranging any emergency treatment as needed. 
 
The CCLR must ensure written ORE approval is received prior to the start of the study, that the 
ORE and Sponsor is kept informed of the study 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 RECOR D KE EPING 
 
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 RET ENT ION OF ST UDY R E CORD S AN D D AT A 
 
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 by the CCLR for a minimum of 25 years. 
 
13  PRO TOCOL TR AI NIN G 
 
All study personnel will be required to complete training prior to their involvement in the study. A 
series of training modules will be developed for the study and records of training will be kept at 
the CCLR. 
 
14  S TU DY M AN AG EME N T 
 
 
14.1 ST AT EMENT OF COMPLIA NC E 
 
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 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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 
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/ 
 
 
14.2 ET HICS RE VIEW 
 
This protocol will be submitted to and reviewed through the Office of Research Ethics (ORE) at 
the University of Waterloo. Notification of ethics clearance of the application is required prior to 
the commencement of the study. 
 
14.3 CLINICA L T RIAL RE GIS T RAT ION 
 
This study will be registered in the clinical trials registry (https://clinicaltrials.gov/) by the study 
 
sponsor. 
 
14.4 PROT OCOL DEVIAT IONS 
 
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. 
 
14.4.1 MAJOR P ROT OCOL DEVIA T IONS 
 
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. 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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14.4.2 MI NOR PROT OCOL DEVIA T IONS 
 
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). 
 
14.4.3 REPORT ING AND D OCU ME NT ING PROTCOL DEVIAT IONS 
 
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. 
All protocol deviations (major and minor) occurring during the study will be documented and 
included in the final report. 
 
14.5 PRE MAT UR E T ER MI NAT IO N OF T HE ST UDY 
 
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. 
 
14.6 ST UDY PA RT ICIPAN T RE CORDS 
 
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 lead investigator that participant met eligibility criteria; 
 
 
Confirmation that participant received a signed and dated copy of informed consent; 
 
 
Exit date; 
 
 
Investigators signature confirming study exit. 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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14.7 RET ENT ION OF ST UDY R E CORD S AN D D AT A 
 
Records and data from this study will be retained for a minimum of 25 years. Details regarding 
 
storage procedures are given in CCLR SOP014. 
 
15  CONFIDE N TI ALI TY 
 
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. 
 
16  PUB LIC ATION 
 
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 peer-review journals, 
professional publications, etc. need to be approved by the sponsor. 
 
17  S TU DY COS TS 
 
 
The sponsor will compensate CCLR for the conduct of this study. CCLR will compensate the 
participants for their time and participation in this voluntary study. 
 
Expenses incurred by participants 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. 
 
18  REFE RE NC ES 
 
1. 
Diec J, Tilia D, Thomas V. Comparison of Silicone Hydrogel and Hydrogel Daily 
Disposable Contact Lenses. Eye & contact lens 2017. 
 
2. 
Papas EB, Keay L, Golebiowski B. Estimating a just-noticeable difference for ocular 
comfort in contact lens wearers. Invest Ophthalmol Vis Sci 2011;52:4390-4. 
 
19  REPOR T 
 
A report will be sent to the sponsors according to terms described in the study contract. 
 
20  AP P EN DICE S 
 
Appendix 1 Informed consent letter 
Appendix 2 Screening Form 
Appendix 3 Dispense Proclear 1 Day 

EX-MKTG-84 OBOE protocol v1.2 04jul2017
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Appendix 4 Baseline Proclear 1 Day 
Appendix 5 Dispense Clariti 1 Day 
Appendix 6 Review Clariti 1 Day 
Appendix 7 Lens fitting characteristics 
Appendix 8 Biomicroscopy form 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
Appendix 15 Medical history form 
Appendix 16 Study exit form 
Appendix 17 Letter of Appreciation 
Appendix 18 Discontinuation form 
Appendix 19 Study completion form 
Appendix 20 CVI Adverse event notification form 
Appendix 21 CVI Adverse event outcome form 
Appendix 22 Product observation form 
Appendix 23 Protocol deviation form 
 
Appendix 24 CCLR SOP012_v01 Adverse event management and reporting 
 
Appendix 25 Recruitment email script 
Appendix 26 Social media advertisements 
Appendix 27 Recruitment poster 
Appendix 28 Emergency Wallet Card 
 
Appendix 29 Unscheduled visit form