Evaluating the Success of Habitual Multifocal Wearers When Refit With a New Lens Design
Phase: NA
Conditions: Presbyopia
Sponsor: CooperVision, Inc.



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EX-MKTG-119 BLUEFIN Protocol v1.4 26may2021 
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Study locations 
 
1. Study co-ordination & data management institution (no clinical visits) : 
 
Lyndon Jones (Director) 
CORE 
 
 
School of Optometry & Vision Science 
 
 
University of Waterloo 
 
 
200 Columbia Street West 
 
 
Waterloo, Ontario N2L 3G1 
 
 
CANADA 
 
 
2. Clinical research conducted at several in-practice study sites in the United States. 
Details of sites and PIs will be listed in the final report. 
 
 
 
 
 

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Table of contents 
1 
Document change history ...................................................................................................... 4 
2 
Introduction ............................................................................................................................ 9 
3 
Objectives .............................................................................................................................. 9 
4 
Hypothesis ............................................................................................................................. 9 
5 
Materials and methods .......................................................................................................... 9 
5.1 
Study design ................................................................................................................... 9 
5.1.1 
Overall design .......................................................................................................... 9 
5.1.2 
Randomization ....................................................................................................... 10 
5.1.3 
Masking ................................................................................................................. 10 
5.2 
Investigational Sites ...................................................................................................... 10 
5.2.1 
Number of Sites ..................................................................................................... 10 
5.2.2 
Investigator Recruitment ........................................................................................ 10 
5.3 
Study population ........................................................................................................... 10 
5.3.1 
Sample size calculation ......................................................................................... 10 
5.3.2 
Number of Participants .......................................................................................... 12 
5.3.3 
Inclusion and exclusion criteria .............................................................................. 12 
5.4 
Study materials ............................................................................................................. 13 
5.4.1 
Lenses ................................................................................................................... 14 
5.4.2 
Other products ....................................................................................................... 14 
5.4.3 
Rewetting drops ..................................................................................................... 14 
5.4.4 
Disposing of study products ................................................................................... 14 
5.4.5 
Product accountability ............................................................................................ 15 
5.5 
Scheduled and unscheduled visits ................................................................................ 15 
5.5.1 
Visit 0, Screening & fitting visit ............................................................................... 16 
5.5.2 
Repeated screening visits (Visit 0/R1 or Visit 0/R2) .............................................. 18 

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5.5.3 
Visit 1 Dispense CONTROL .................................................................................. 19 
5.5.4 
Visit 2 Optimize CONTROL ................................................................................... 19 
5.5.5 
Visit 3 Dispense (optimized) CONTROL ................................................................ 20 
5.5.6 
Visit 4, 2-week follow-up CONTROL and FIT TEST .............................................. 22 
5.5.7 
Visit 5, Dispense TEST .......................................................................................... 24 
5.5.8 
Visit 6, Optimize TEST ........................................................................................... 25 
5.5.9 
Visit 7, Dispense (optimized) TEST ....................................................................... 25 
5.5.10 
Visit 8, 2-week follow-up TEST .............................................................................. 25 
5.5.11 
Exit visit .................................................................................................................. 26 
5.5.12 
Unscheduled visits ................................................................................................. 26 
5.6 
Study procedures .......................................................................................................... 26 
 
 
 
 
 
 
6 
Monitoring protocol adherence ............................................................................................ 28 
7 
Potential risks and benefits to human participants .............................................................. 29 
8 
Adverse events .................................................................................................................... 30 
8.1 
Normal or adaptive symptoms ...................................................................................... 32 
8.2 
Procedures for adverse events ..................................................................................... 32 
8.3 
Reporting adverse events ............................................................................................. 32 
9 
Discontinuation from the study ............................................................................................ 33 
10 
Device malfunctions ............................................................................................................ 34 
11 
Study completion and remuneration .................................................................................... 35 
12 
 data management .......................................................................... 35 
12.1 
 ..................................................................................................... 35 
12.2 
Data management ..................................................................................................... 36 

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

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 Confidentiality 
This is a private document and the property of the Centre for Ocular Research & Education. It 
is therefore confidential to the recipient and must not be quoted from or distributed beyond the 
company to which it is sent without the express written permission of the Director (or her/his 
designate) of the Centre for Ocular Research & Education. Release of information from this 
document is governed by the research agreement on file. 
 
Disclaimer 
This study will be conducted for research purposes only. 
 
 
 

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the 0-10 used in this study. A difference of 7 on that 0-100 scale was targeted, which would be 
0.7 on the 0-10 scale. However, in this study, a 0-10 scale will be used with 0.5 steps, and analysis 
is anticipated to be non-parametric, which relies on medians not means, thus a difference between 
medians can only be as low as 0.5. 
Using the 0-100 scale data described above for ‘lens comfort at insertion’, the data showed a 
standard deviation of paired differences of 16.5. With an alpha 0.05 in a paired difference test, 
and power of 84%, a minimum sample size of 51 participants is recommended in order to detect 
a statistical difference between study lenses. 
To account for dropout, up to 60 participants may be randomized and dispensed with study 
product in total, with the target of at least 51 completing the study.  
 
 

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5.3.2 NUMBER OF PARTICIPANTS 
Participants will be recruited using site record and, databases using an email script, where 
consent for contact about research has been provided. There will also be general advertising 
materials (eg. posters, social media posts) and all these, including email scripts, will be 
approved by the ethics review board. All initial individual-targeted recruitment activities, such as 
any direct mailing of recruitment scripts, will be conducted by practice staff that are not directly 
involved in conducting the research. This separation will reduce any undue influence of the 
optometrist-patient relationship. This process will also eliminate opportunity for the investigator 
to access personal health information before any consent for disclosure is provided by the 
potential participant.  
It is anticipated that up to 80 potential participants may attend a Screening visit and up to 60 
participants may be dispensed with study products, with a target of 51 completing the study.  
 
5.3.3 INCLUSION AND EXCLUSION CRITERIA 
A person is eligible for inclusion in the study if he/she: 
1. Is at least 42 years of age and has full legal capacity to volunteer; 
2. Has read and signed an information consent letter; 
3. Self reports having a full eye examination in the previous two years; 
4. Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week; 
5. Is willing and able to follow instructions and maintain the appointment schedule; 
6. Habitually wears multifocal soft contact lenses, for the past 3 months minimum; 
7. Has refractive astigmatism no higher than -0.75DC; 
8. Is presbyopic and requires a reading addition of at least +0.75D and no more than 
+2.50D; 
9. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (or +0.20 
logMAR) which participants also deem to be ‘acceptable’, with the available study lens 
parameters (powers +4.00 to -6.00DS) (see Table 1). 
A person will 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 that contraindicates contact lens 
wear; 

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5.5.1 VISIT 0, SCREENING & FITTING VISIT 
Informed consent shall be obtained in writing from the participant and the process shall be 
documented before any procedure specific to the clinical investigation is carried out. 
Participants will be assigned a unique alpha-numeric study ID after they sign the consent 
documentation i.e. before their eligibility for the study has been confirmed. Each site will use a 
different letter preceding the participant ID number. For example, participant 01 at site A will be 
A-01, and participant 01 at site T will be T-01. Ineligible participants will be discontinued from the 
study and compensated for attending the screening visit. 

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The investigator will determine participant eligibility using the inclusion and exclusion criteria. 
The study procedures are outlined below: 
1. The participant is expected to insert their habitual multifocal contact lenses at least 2 
hours before attending the visit. 
2. The participant will be required to read and sign an Informed Consent Form prior to 
enrollment. When the participant has signed the consent form, the participant will be 
considered enrolled in the study and will be assigned a study ID. 
3. Participant demographics and medical history (age, sex, race, ethnicity, medical 
conditions, medications, allergies). 
4. Contact lens history (habitual lens information and wearing habits).  
5. 
 
  
6. 
 
7. The participant removes their habitual contact lenses.  
8. 
 
9. 
 
 
  
10. Determine ocular dominance according to the instructions described in the respective 
fitting guides. 
11. 
 
 
 
 
 
 
 
 
 
 

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12. After a minimum 5-minute washout time after fluorescein insertion, the participant will be 
fit with the CONTROL study lenses following to the manufacturer’s fitting guidelines. 
Trial fitting of CONTROL study lenses: 
a. The contact lens power will be chosen based on the vertex-corrected spectacle 
refraction.  
b. The participant will insert the lenses, allow to settle for at least 10 minutes. 
c. 
 
d. 
 
 
e. 
  
f. 
If any changes are made to the lens power, the above procedures (b to e) will be 
repeated. 
13. 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. 
If sufficient CONTROL lenses are available then continue to Visit 1 concurrently (ie. 
Dispense CONTROL), otherwise schedule Visit 1 (or Repeat Screening) when CONTROL 
lenses are anticipated to be available.  
 
5.5.2 REPEATED SCREENING VISITS (VISIT 0/R1 OR VISIT 0/R2) 
In some circumstances a repeated screening may need to be scheduled. Examples include, but 
are not limited to: 
1. Incomplete information available at time of screening to determine eligibility (e.g. current 
lens brand worn, history from current eye care practitioner etc.) 
2. Study procedures unable to be completed in time scheduled for visit; 
3. Required CONTROL lens powers for fitting are not available at the time of the screening 
visit; 
4. A transient health condition which may affect the eye(s) (e.g. a common cold, active 
allergies, fatigue etc.) 
5. The short term use of medications (e.g. antibiotics, antihistamines etc.) 
6. Reassessment of baseline ocular conditions (e.g. corneal and/or conjunctival staining, 
scars etc.) 
The maximum total number of screenings permitted will be 3, the initial and two repeat screening 
visits. 
 

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5.5.3 VISIT 1 DISPENSE CONTROL 
This visit is concurrent with Visit 0 if the required CONTROL lenses are available on-site or 
occurs later once lenses are available on site. 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
3. After a minimum 5-minute washout time after fluorescein insertion, participant to insert 
CONTROL multifocal lenses  
4. After lenses have settled for at least 10 minutes continue with assessments to determine 
the final lens order. 
5. 
 
6. 
 
 
 
7. 
. 
8. The participant will receive a 1-week lens supply and will be instructed to wear the lenses 
for at least 8 hours a day, 5 days a week. 
9. The participant will be scheduled to return for Visit 2.  
 
5.5.4 VISIT 2 OPTIMIZE CONTROL  
Participants will be asked to insert study lenses at least 2 hours prior to the visit. 
This visit will occur 3-7 days (inclusive) after visit 1. 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 
3. 
 
 

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4. 
 
 
  
 
6. If lens power changes are required, and required lens power is not on site, the lens/es 
will be ordered and assessed at an additional visit (Visit 2R). If the required lens power is 
on site, participant will remove lens(es) from the eye and insert the new fitting lens(es) on 
eye.   
7. Allow settling time of 10 minutes before evaluation of vision and over-refraction to assess 
the final lens power needed. 
8. 
 
  
10. Remove lenses 
11. 
 
 
 
 
 
 
 
 
 
 
 
12. If sufficient supply of optimized lenses are available on site continue with visit 3, 
otherwise order the lenses and schedule Visit 3. If new lenses need to be ordered, 
participants will be allowed to wear habitual MF lenses in the meantime. 
 
5.5.5 VISIT 3 DISPENSE (OPTIMIZED) CONTROL  
This visit may be conducted immediately following Visit 2 if the required CONTROL lenses are 
available on-site. Otherwise this visit occurs when lenses are available on site. 
Procedures as follows: 
1. Confirm participant’s health and medications are unchanged. 
2. 
 
 

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6.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
After completing the 2-week follow-up procedures for the CONTROL lens participants will be fit 
with the TEST lens. Same procedures as for fitting CONTROL will be followed. 
If sufficient TEST lenses are available on site, then continue to Visit 5 concurrently (ie. Dispense 
TEST), otherwise schedule Visit 5 (or repeat fitting Visit 4-R Fit) when TEST lenses are 
anticipated to be available. 
 
5.5.7 VISIT 5, DISPENSE TEST  
This visit is concurrent with Visit 4 if required lenses are available on-site. 
Assessments of TEST lens will be conducted as described above for Visit 1. 

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5.5.8 VISIT 6, OPTIMIZE TEST  
Participants will be asked to insert study lenses at least 2 hours prior to the visit. 
This visit will occur 3-7 days (inclusive) after visit 5. 
Assessments of TEST lenses will be conducted as described above for Visit 2. 
 
5.5.9 VISIT 7, DISPENSE (OPTIMIZED) TEST  
This visit is concurrent with Visit 6 if required lenses are available on-site. 
Assessments of TEST lenses will be conducted as described above for Visit 3. 
 
5.5.10 VISIT 8, 2-WEEK FOLLOW-UP TEST 
Participants will be asked to insert study lenses at least 2 hours prior to the visit. 
This visit will occur 14-16 days (inclusive) after visit 7. 
Assessments of TEST lenses will be conducted as described above for Visit 4.