Biofinity Multifocal Contact Lenses Fitting Methods Comparison
Phase: NA
Conditions: Presbyopia
Sponsor: CooperVision, Inc.



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DOCUMENT CHANGE HISTORY 
Revision 
Originator 
Description of Change(s) 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table of Contents 
1 
OVERALL SYNOPSIS ................................................................................................................. 8 
2 
INTRODUCTION AND RATIONALE ........................................................................................... 12 
2.1 
Background ..................................................................................................................... 12 
2.2 
Objectives ....................................................................................................................... 12 
2.3 
Hypotheses ..................................................................................................................... 12 
2.4 
Endpoints ........................................................................................................................ 13 
3 
STUDY SPONSOR AND INVESTIGATORS ............................................................................... 14 
3.1 
Study Sponsor ................................................................................................................. 14 
3.2 
Clinical Research Organisation ....................................................................................... 14 
3.3 
Study Site & Investigators ............................................................................................... 14 
3.4 
Medical Monitor ............................................................................................................... 14 
3.5 
Data Controller and Statistical Analysis .......................................................................... 14 
3.6 
Independent Ethics Committee ....................................................................................... 14 
4 
STUDY MATERIAL ...................................................................................................................... 16 
4.1 
Introductory Remarks ...................................................................................................... 16 
4.2 
Study Contact Lenses ..................................................................................................... 16 
5 
STUDY POPULATION ................................................................................................................. 17 
5.1 
Recruitment Procedure ................................................................................................... 17 
5.2 
Number of Participants ................................................................................................... 17 
5.3 
Inclusion and Exclusion Criteria ...................................................................................... 17 
5.3.1 
Inclusion Criteria ................................................................................................ 17 
5.3.2 
Exclusion Criteria ............................................................................................... 18 
5.4 
Premature Withdrawal..................................................................................................... 18 
5.5 
Informed Consent ............................................................................................................ 18 
6 
STUDY DESIGN & PROCEDURES ............................................................................................ 19 
6.1 
General Description ........................................................................................................ 19 
6.2 
Experimental Routine ...................................................................................................... 19 
6.3 
Measures to Avoid Bias .................................................................................................. 20 
6.3.1 
Randomisation ................................................................................................... 20 
6.3.2 
Masking .............................................................................................................. 20 
6.3.3 
Participant Instructions ....................................................................................... 20 
6.4 
Procedures ...................................................................................................................... 21 
6.4.1 
Endpoint Procedures ......................................................................................... 21 
6.4.2 
Safety Procedures ............................................................................................. 21 

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6.4.3 
 
6.4.4 
Study Management Procedures ........................................................................ 22 
6.5 
Study Visit routine ........................................................................................................... 22 
Visit 1 – Screening, Enrolment and First Study Contact Lens Dispensing Visit ............. 22 
Visit 2 – First Study Contact Lens Follow-up Visit and Second Study Contact Lens 
Dispensing Visit (7 +2/-0 days after Visit 1) ....................................................... 23 
Visit 3 – Second Study Contact Lens Follow-up Visit (7 +2/-0 days after Visit 2) .......... 24 
7 
SAMPLE SIZE DETERMINATION AND STATISTICAL ANALYSIS ........................................... 25 
7.1 
Sample Size Determination ............................................................................................ 25 
7.2 
Statistical Analysis Plan .................................................................................................. 25 
8 
RISK ANALYSIS .......................................................................................................................... 26 
8.1 
Benefits ........................................................................................................................... 26 
8.2 
Risks ............................................................................................................................... 26 
 
 
9 
ADVERSE EVENTS AND REPORTING ..................................................................................... 27 
9.1 
Adverse Events ............................................................................................................... 27 
9.1.1 
Adverse Event Definitions .................................................................................. 27 
9.1.2 
Normal or Adaptive Symptoms .......................................................................... 28 
9.1.3 
Procedures for Adverse Events ......................................................................... 28 
9.2 
Reporting Adverse Events .............................................................................................. 29 
10 
DEVICE DEFICIENCIES.............................................................................................................. 30 
11 
INVESTIGATOR, SPONSOR AND MEDICAL MONITOR RESPONSIBILITIES ........................ 31 
11.1 
Investigator Responsibilities ........................................................................................... 31 
11.2 
Sponsor Responsibilities ................................................................................................. 31 
11.3 
Medical Monitor Responsibilities ..................................................................................... 32 
12 
GENERAL CLINICAL MANAGEMENT ........................................................................................ 33 
12.1 
Data Recording ............................................................................................................... 33 
12.2 
Clinical Monitoring ........................................................................................................... 33 
12.3 
Study Product Accounting ............................................................................................... 33 
12.4 
Participant Compliance Monitoring ................................................................................. 33 
12.5 
Unmasking of Study Information ..................................................................................... 33 
12.6 
Participant Payments ...................................................................................................... 34 
13 
ADMINISTRATIVE MANAGEMENT ............................................................................................ 35 
13.1 
Relevant Standards......................................................................................................... 35 
13.2 
Deviations from the Protocol ........................................................................................... 35 

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13.2.1 Major Protocol Deviations .................................................................................. 35 
13.2.2 Minor Protocol Deviations .................................................................................. 35 
13.3 
Modifications to the Clinical Investigational Plan ............................................................ 36 
13.4 
Termination of the Study ................................................................................................. 36 
13.5 
Data Protection ............................................................................................................... 36 
13.6 
Data Handling and Record Keeping ............................................................................... 36 
13.7 
Reporting ......................................................................................................................... 36 
13.8 
Publication Policy ............................................................................................................ 36 
 
 
13.10 
Indemnity/Insurance ........................................................................................................ 37 
14 
 
 
 
 

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1 
OVERALL SYNOPSIS 
Study Sponsor 
CooperVision International Limited 
Title of Study 
Biofinity® Multifocal Contact Lenses Fitting Methods Comparison 
Protocol Number 
CV22-19 
 
Type of study 
Single arm, prospective, one-week (7 +2/-0 days), cross-over, double 
masked (participants and research staff carrying out the response 
measurements), randomised order of testing study. 
Study Population  
Up to 30 participants will be screened, with the aim to enrol up to 27 with a 
view to achieve a cohort (participants completing the study as per protocol) 
sample size of 25 which has been determined to be optimal 
Duration of study treatment 
Each contact lens types will be worn for one-week (7+2/-0 days) in total the 
participants will be in the study for up to 18 days. 
Inclusion Criteria 
In order to be enrolled, each participant shall meet the following criteria: 
i. 
At least 40 years old; 
ii. 
Have read and understood the Participant Information Sheet; 
iii. 
Have read, signed and dated the Informed Consent; 
iv. 
Best corrected visual acuity of at least 20/25 in each eye; 
v. 
Have normal eyes with the exception of the need for visual correction; 
vi. 
Current multifocal contact lens wearer; 
vii. Spectacle refraction: 
Distance:  
Sphere:  
-6.00D to + 4.00D 
 
 
Astigmatism: 
 0.00D to -0.75D 
Near Addition: Established Presbyopes:  
+1.50D & +1.75D  
viii. Be willing and able to adhere to the instructions set in the clinical 
protocol and maintain the appointment schedule. 
Exclusion Criteria 
The following are specific criteria that exclude a candidate from enrolment 
in this study: 
i. 
Ocular anterior segment infection, inflammation, abnormality, or active 
disease that would contraindicate contact lens wear; 
ii. 
Use of systemic or ocular medications for which contact lens wear 
could be contraindicated as determined by the investigator; 
iii. 
Monocular participants (only one eye with functional vision) or 
participants fit with only one lens; 
iv. 
Any moderate or severe ocular condition observed during the slit-lamp 
examination at the enrolment visit; 
v. 
History of herpetic keratitis, ocular surgery or irregular cornea; 
vi. 
Known pregnancy or lactation during the study period; 
vii. Enrolment of the investigator or his/her staff, family members of the 
investigator, family members of the investigator’s staff, or individuals 
living in the households of these individuals. 
Planned Start Date 
15th August 2022 
Overall Study Duration 
Six months 
Objective(s) 
The objectives of the study will be to: 
i. 
Compare overall vision satisfaction achieved after one week of wear 
with Biofinity® Multifocal contact lenses fitted in two different manners 
 
 

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ii. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Efficacy Endpoint (S) 
The primary endpoint will be: 
i. 
Overall binocular vision satisfaction after one week of wear; 
ii. 
Overall preference after one week of wear. 
The secondary endpoints will be: 
i. 
Mean binocular visual performance measured by timed logMAR mean 
visual acuity after one week of wear; 
ii. 
Number of contact lenses needed per participant to determine the 
contact lens pair to be dispensed. 
 
 
 
 
 
 
 
 
 
 
 
 
 

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vi. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
Safety Procedure(s) 
The procedures to monitor safety will be: 
i. Identification and prevalence of adverse events; 
 
 

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Experimental Design 
 
 
 
 
 
 
 
 
 Retrospective 
 Prospective 
 Non-Randomized  
 Randomized (order of testing) 
 
 
Single 
masked 
(participant) 
 
Single 
masked 
(investigator) 
 Double masked* 
 Sponsor masked 
 Open label 
* 
Sub-investigators 
collecting 
primary and secondary endpoint 
data and participants will be 
masked. 
 Single group 
 Parallel group 
 Crossover 
 Contralateral 
Control Product 
Biofinity® multifocal CE marked silicone hydrogel contact lenses 
manufactured from comfilcon A by CooperVision Inc. design +1.50D 
(control contact lens) 
Test Products 
Biofinity® multifocal multifocal CE marked silicone hydrogel contact lenses 
manufactured from stenfilcon A by CooperVision Inc designs +1.50D and 
+1.50N (test contact lens) 
Study Products Use 
The study contact lenses will be used as per their CE marking. The contact 
lenses will be worn on a daily wear basis removed every night, stored 
overnight in OPTI-FREE® PureMoist® CE marked storage solution and re-
inserted the following morning. 
Study Visits 
Three study visits over a two-week period: 
• Visit 1: Screening/Enrolment/Fitting and First Lens Dispensing 
• Visit 2 (7 +2/-0 days from Visit 1): First Lens follow up visit, Second Lens 
Dispensing 
• Visit 3 (7 +2/-0 days from Visit 2): Second lens follow up visit/Exit 
 
 
Regulatory Status 
This trial requires Ethics Committee (EC) approval prior to initiation. 
Responsibilities 
Sponsor 
Name: CooperVision International Limited. 
Contact: Dr. Percy Lazon de la Jara 
CRO and Data 
Management 
OCULAR TECHNOLOGY GROUP - International 
Contact: Ned Haigh 
Legal 
Representative 
(where applicable) 
Not Applicable 
 
 
 

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2 
INTRODUCTION AND RATIONALE 
2.1 
Background 
Biofinity® Multifocal CE marked contact lenses are the basis of a well established eight-design multifocal 
system to correct presbyopia.  As for any multifocal contact lenses the performance and acceptance of the 
vision correction depends in part upon the patient’s ocular characteristics leading practitioners to follow 
different fitting approaches to achieve the best results. 
 
 
 
 
 
 
  
The rationale for the study is to compare two common fitting approaches to fit Biofinity® Multifocal contact 
lenses to assess which one achieves the best results to support proposing that fitting approach for the 
selection of the first contact lenses to try. 
2.2 
Objectives 
The objectives of the study will be to: 
i. 
Compare overall vision satisfaction achieved after one week of wear with Biofinity® Multifocal contact 
lenses 
 
 
ii. 
Compare overall preference achieved at the completion of the study with Biofinity® Multifocal contact 
lenses 
 
 
 
iii. 
 
 
 
 
 
 
2.3 
Hypotheses 
The primary hypotheses to be tested will be that: 
i. 
Overall vision satisfaction with Biofinity® Multifocal (Biof MF) contact lens after one week of wear is non-
inferior for the test contact lens 
 
 
 
ii. 
Overall preference between Biofinity® Multifocal (Biof MF) contact lens is non-inferior for the test contact 
lens 
 
 
 
The secondary hypotheses to be tested will be that: 
i. 
Overall binocular visual performance with Biofinity® Multifocal (Biof MF) contact lens after one week of 
wear is non-inferior for the test contact lens 
 

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2.4 
Endpoints 
The primary endpoints will be: 
i. 
Overall binocular vision satisfaction after one week of wear; 
ii. 
Overall preference at the completion of the study. 
The secondary endpoints will be:  
i. 
Mean binocular visual performance measured by timed logMAR mean visual acuity after one week of 
wear; 
ii. 
Number of contact lenses needed per participant to determine the contact lens pair to be dispensed. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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The Investigator will provide the participant with a copy of the consent form written in a language the 
participant understands. The consent document will meet all applicable local laws and will provide participants 
with information regarding the purpose, procedures, requirements, and restrictions of the study, along with 
any known risks and potential benefits associated with participating, the available compensation, and the 
established provisions for maintaining confidentiality of personal, protected health information. Participants 
will be told about the voluntary nature of participation in the study and will be provided with contact information 
for the appropriate individuals should questions or concerns arise during the study. The participant also will 
be told that their records may be accessed by appropriate authorities and Sponsor-designated personnel. 
The Investigator will keep the original, signed copy of the consent and must provide a duplicate copy to each 
participant. 
The study will be submitted to the IRAS centralized National Research Ethics Service for review. The 
investigation will not start until approval has been received at the respective site(s). 
 
 

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4 
STUDY MATERIAL 
4.1 
Introductory Remarks 
The use of the contact lenses in the study will not be associated with a change in patient management / 
treatment, as all the participants will be current multifocal contact lens wearers. 
The study contact lenses will be used as per their CE marking: contact lens fitting will follow the respective 
fitting guides and the contact lens will be worn daily. 
The study contact lenses will be masked to avoid participants’ bias as they will use a new pair of contact 
lenses every day. 
4.2 
Study Contact Lenses  
The study contact lenses will be Biofinity® multifocal CE marked silicone hydrogel contact lenses 
manufactured from comfilcon A by CooperVision Inc
 
 
 
 
 
 
 
 
 
The study contact lenses will be worn as per their CE marking on a daily wear basis, the contact lenses will 
be removed at the end of the day, stored in an approved CE marked contact lens care solution  (OPTI-FREE® 
PureMoist®) and re-inserted the following day. 
As per their CE marking the contact lenses can be worn on a daily wear modality up to one month before 
being replaced
 
 
  
 
 
 
 

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5 
STUDY POPULATION 
5.1 
Recruitment Procedure 
The prospective participants will be selected from the existing clinical populations of the OCULAR 
TECHNOLOGY GROUP- International clinic or via advertising in the local press and/or social media.  The 
participants fulfilling the criteria for inclusion and none of the exclusion criteria will be invited in a sequential 
manner to participate in the study until the test population is achieved. 
The prospective participants from OCULAR TECHNOLOGY GROUP- International will initially be contacted 
by e-mail and if they indicate they are interested in taking part, the investigation will be explained in detail by 
telephone; if they then confirm their interest, a screening / enrolment / dispensing visit will be scheduled. A 
copy of the Participant Information Sheet and Informed Consent will be sent to the prospective participants 
for information at least 24 hours prior to the visit. 
The prospective participants responding to the approved advertisement by contacting the clinic via e-mail or 
telephone and indicating that they are interested in taking part, will be explained the study in detail by 
telephone; if they then confirm their interest a screening / enrolment / dispensing visit will be scheduled. A 
copy of the Participant Information Sheet and Informed Consent will be sent to the prospective participants 
for information at least 24 hours prior to the enrolment visit. 
5.2 
Number of Participants 
Up to 30 participants will be screened, with the aim to enrol up to 27 with a view to achieve a cohort 
(participants completing the study as per protocol) sample size of  25 which has been determined to be 
optimal, balancing the need for sufficient discrimination and limiting inconvenience to participants by not 
inflating the study sample (see section 7.1). 
Up to 30 participants will be screened with a view to achieving a per protocol population of 25 participants. 
Participants will be considered enrolled when they successfully complete the screening visit. 
5.3 
Inclusion and Exclusion Criteria 
5.3.1 Inclusion Criteria 
There are no requirements as to participant race, gender or occupation. 
In order to be enrolled, each participant shall meet the following criteria: 
i. 
At least 40 years old; 
ii. 
Have read and understood the Participant Information Sheet; 
iii. 
Have read, signed and dated the Informed Consent; 
iv. 
Best corrected visual acuity of at least 20/25 in each eye; 
v. 
Have normal eyes with the exception of the need for visual correction; 
vi. 
Current multifocal contact lens wearer; 
vii. Spectacle refraction: 
Distance:  
Sphere:  
-6.00D to + 4.00D 
 
 
Astigmatism: 
 0.00D to -0.75D 
Near Addition: Established Presbyopes:  
+1.50D & +1.75D  
viii. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment 
schedule. 

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5.3.2 Exclusion Criteria 
To be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect 
the results of this study. 
The following are specific criteria that exclude a candidate from enrolment in this study: 
i. 
Ocular anterior segment infection, inflammation, abnormality, or active disease that would 
contraindicate contact lens wear; 
ii. 
Use of systemic or ocular medications for which contact lens wear could be contraindicated as 
determined by the investigator; 
iii. 
Monocular participants (only one eye with functional vision) or participants fit with only one lens; 
iv. 
Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment 
visit; 
v. 
History of herpetic keratitis, ocular surgery or irregular cornea; 
vi. 
Known pregnancy or lactation during the study period; 
vii. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the 
investigator’s staff, or individuals living in the households of these individuals. 
5.4 
Premature Withdrawal 
A participant will be withdrawn from the investigation before completion if: 
i. 
The participant/parent/guardian withdraws his/her consent to be included in the trial;  
ii. 
An adverse event takes place that is considered by the participant/parent/guardian or the investigator to 
warrant withdrawal; 
iii. 
Any event that leads the investigator to believe that it is not in the best interest for the participant to 
continue in the study; 
iv. 
The study is prematurely terminated by the Principal Investigator, local research ethics committee or the 
Sponsor; 
v. 
The participant is lost to follow-up; 
vi. 
The participant no longer meets the eligibility criteria; 
vii. The participant dies. 
5.5 
Informed Consent 
Each participant will give written consent according to local IEC requirements after the nature of the study 
has been fully explained. The consent form must be signed before performance of any study-related activity. 
The consent form that will be used will have been approved by both the Sponsor and by the reviewing IEC. 
The informed consent will be in accordance with principles that originated in the Declaration of Helsinki, 
current ICH and GCP guidelines, applicable regulatory requirements, and sponsor policy. 
Before entry into the study, the Investigator or an authorised member of the investigational staff will have 
explained to potential participant the aims, methods, reasonably anticipated benefits, and potential hazards 
of the study, and any discomfort it may entail. Participants will be informed that their participation is voluntary 
and that they may withdraw consent to participate at any time. They will be informed that choosing not to 
participate will not affect the care the participant will receive.  Finally, they will be informed that if needed their 
records may be accessed by health authorities and authorised sponsor staff without violating the 
confidentiality of the participant, to the extent permitted by the applicable law(s) or regulations.  
The participant will be given sufficient time to read the informed consent form and the opportunity to ask 
questions. After this explanation and before entry into the study, consent will be appropriately recorded by 
means of the participant's dated signature. After having obtained consent, a copy of the informed consent 
form will be given to the participant. 

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6 
STUDY DESIGN & PROCEDURES 
6.1 
General Description 
The study will be a seven day (7 +2/-0 days), cross-over, order of testing randomised (randomised order 
between test then control or control then test), double masked (participants and research staff carrying out 
the response measurements), prospective study.  The investigators carrying out the contact lens fitting will 
not be masked as they will have to carry out the fitting as per the protocol, hence will need to know which 
design they are using. 
The participants will attend a total of three visits and will not take part in any concomitant investigation of any 
type or take concomitant medications not allowed by the exclusion criteria. 
6.2 
Experimental Routine 
Visit 1 – Screening /Enrolment / Baseline / Contact Lens Order 1 Dispensing Visit 
Up to 30 potential participants will attend the research clinic for the first visit to initially obtain their informed 
consent and evaluate their suitability to take part in the investigation. After informed consent has been given, 
the investigator will review the participant’s medical history, ocular history (including concomitant treatments), 
demographics and contact lens wear history. A series of routine optometric assessments and tests will be 
conducted to determine the participant’s prescription and evaluate the participant’s ocular health. 
Once it has been verified that the prospective participants meet the inclusion/exclusion criteria they will be 
enrolled or discharged as applicable. If the participant is eligible, Contact Lens Order 1 fitting and dispensing 
will be carried out: 
✓ All study contact lenses will be selected and fitted according to the protocol and fitting guides and the 
visual acuity 
 Modification to the lens power (up to three 
attempts) to determine the optimal lens powers for the specific contact lens type for the participant will be 
performed.  Participants will wear these contact lenses for a period of approximately 10 minutes in order 
to adapt to the correction and then distance and near visual acuity will be measured according to the 
specific requirements, contact lens fitting characteristics will be evaluated.  If after 3 attempts, no suitable 
contact lens can be prescribed, the participant will be discharged from the study. 
✓ At the conclusion of the visit, if a suitable fit is achieved the participants will be instructed in their use and 
care and the contact lenses which will be dispensed.  The participants will be instructed to wear the study 
contact lenses for at least 8 hours a day, at least 6 days a week and scheduled for their next study visit 
in 7 to 9 days. 
Visit 2 – Contact Lens Order 1 Follow-up / Contact Lens Order 2 Dispensing Visit 
Participants will return for the second study visit after having worn the first study contact lenses for 7 + 2 / -0 
days. They will attend the visit wearing the study contact lenses. 
The participants medical, ocular, contact lens wearing history and concomitant treatments will once again be 
reviewed. 
  A series of measurements of visual 
acuity with the study contact lenses will be conducted for distance, intermediate and near as required. Contact 
lens fitting characteristics will be evaluated, and Order 1 contact lenses will be removed. 
Upon removal of the Order 1 study contact lenses the other study contact lens (either test or control based 
upon the contact lens type used at Order 1) will be inserted and worn for 10 minutes at which time the contact 
lens fit and vision will be assessed and up to three attempts will be made to determine the optimal correction 
following the same protocol as during visit 1. If this is not achieved the participant will be discharged from the 
study, however, if a suitable fit is achieved the participants will be instructed in their use and care and the 

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contact lenses which will be dispensed.  The participants will be instructed to wear the study contact lenses 
for at least 8 hours a day, at least 6 days a week and scheduled for their next study visit in 7 to 9 days.  
Visit 3 – Contact Lens Order 2 Follow-up / Discharge Visit 
Participants will return for their last follow-up visit having worn the last study lenses for 7 +2 / -0 days. They 
will attend the visit wearing the study contact lenses, 
The participants medical, ocular, contact lens wearing history and concomitant treatments will once again be 
reviewed. 
  A series of 
measurements of visual acuity with the study contact lenses will be conducted for distance, intermediate and 
near as required. Contact lens fitting characteristics will be evaluated, and Order 2 study contact lenses will 
be removed. Upon contact lens removal and safety evaluation the participants will be discharged from the 
study. 
6.3 
Measures to Avoid Bias 
6.3.1 Randomisation 
The order that the two study contact lenses (test and control) will be worn will be randomised to minimise 
bias. The randomisation scheme will be computer generated using the appropriate software.  Upon 
enrolment, the subjects will be assigned with a participant ID number (sequentially) and this number will be 
linked to the randomisation assignment. 
6.3.2 Masking 
The sub-investigators collecting the subjective responses and carrying out the visual performance 
measurements, which constitute the primary and secondary endpoints, will be masked with respect to the 
identity of the study contact lenses being worn at each visit.  The investigators carrying out the contact lens 
fitting will not be masked as they will have to follow the test and control contact lenses fitting procedures. 
The participants will be masked via overlabelling of the study contact lenses. 
6.3.3 Participant Instructions 
The participants will be instructed to wear their study contact lenses daily for 7 +2 / -0 days, remove the 
contact lenses at night (prior to sleep), store the contact lenses overnight in the contact lens care solution 
supplied for the study and re-insert the contact lenses the following day.  A spare pair of masked contact 
lenses, identifiable by right and left for correct usage, will be supplied to use in case of the breakage or loss 
of one of the study contact lenses. 
Participants will be advised on normal or adaptive symptoms related to contact lens wear. 
 
 
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. 
 
 
 
The participants will be instructed to follow standard recommendations provided to contact lens wearers: 
i. 
Avoid rubbing their eyes, always wash their hands prior to touching their eyes or handling their contact 
lenses, avoid being in a dusty environment and to use sunglasses when they are outdoors. 
ii. 
Exercise care while washing their face with tap water; avoid splashing tap water into the eyes. 
iii. 
Do not swim with contact lenses whenever possible. 

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iv. 
Immediately contact the investigator and scheduled to come in for a check-up within 24 hours if their 
eyes become red, irritated or painful. 
 
6.4 Procedures 
6.4.1 Endpoint Procedures 
The primary efficacy procedures will be: 
i. 
Rating overall vision satisfaction on a 100-point Visual Analog Scale (VAS) at the completion of one 
week of wear 
 
ii. 
Rating overall preference on a 5-point scale at the completion of the study 
 
The secondary efficacy procedures will be: 
i. 
Measurement of mean binocular visual performance by the calculation of the mean visual acuity 
measured using timed logMAR charts after one week of wear under the following conditions: 
▪ Distance (at 4 meters) at high luminance (250cd/m2) with high (90%) contrast chart and low luminance 
(2.5cd/m2) with high (90%) contrast chart 
▪ Intermediate (at 67cm) at medium luminance (50 cd/m2) with high (90%) contrast chart 
▪ Near (at 40cm) at medium luminance (50 cd/m2) with high (90%) contrast chart 
ii. 
Recording of the number of contact lenses needed per eye to determine the contact lens to be dispensed; 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.4.2 Safety Procedures 
The procedures to monitor safety will be: 
i. 
Identification and prevalence of adverse events; 
ii. 
Measurement of Snellen / LogMAR visual acuity at distance; 
 
 
iv. 
Identification and prevalence of device deficiencies and quality complaints. 
 
 
 
 
 

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▪ 
 
▪ 
Study contact lens prescription suitability evaluation & decision to dispense or change contact lens 
power7 
▪ 
Standard high contrast Snellen visual acuity at distance and near with and without best sphere over 
refraction (monocular & binocular) 
▪ 
ORDER 1 REMOVE SECOND CONTACT LENS & INSERT ORDER 1 THIRD CONTACT LENS AND 
WEAR FOR 10 MINUTES8 
▪ 
 
 
 
▪ 
Study contact lens prescription suitability evaluation & decision to dispense or discharge 
▪ 
Standard high contrast Snellen visual acuity at distance and near with and without best sphere over 
refraction (monocular & binocular) 
▪ 
 
 
 
▪ 
Study product dispensing  
▪ 
Scheduling 
Visit 2 – First Study Contact Lens Follow-up Visit and Second Study Contact Lens Dispensing Visit (7 +2/-0 
days after Visit 1) 
The routine below will be followed: 
▪ 
 
 
 
▪ 
 
▪ 
 
 
 
▪ 
Standard high contrast Snellen visual at distance and near without over refraction (monocular & 
binocular) 
▪ 
Detailed timed logMAR visual acuity without over refraction (monocular & binocular) 
▪ 
 
▪ 
ORDER 1 CONTACT LENS REMOVAL 
▪ 
 
 
▪ 
Standard high contrast Snellen visual at distance and near with sphero-cylindrical correction (monocular 
& binocular) 
▪ 
ORDER 2 STUDY INITIAL CONTACT LENS INSERTION AND WEAR FOR 10 MINUTES10,11 
▪ 
 
▪ 
 
▪ 
Study contact lens prescription suitability evaluation & decision to dispense or change contact lens 
power12 
▪ 
Standard high contrast Snellen visual acuity at distance and near with and without best sphere over 
refraction (monocular & binocular) 
 
7 
 
 
 
 
 
 
 
 
 

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▪ 
ORDER 2 REMOVE INITIAL CONTACT LENS & INSERT ORDER 2 SECOND CONTACT LENS AND 
WEAR FOR 10 MINUTES13 
▪ 
 
 
 
▪ 
Study contact lens prescription suitability evaluation & decision to dispense or change contact lens 
power14 
▪ 
Standard high contrast Snellen visual acuity at distance and near with and without best sphere over 
refraction (monocular & binocular) 
▪ 
ORDER 2 REMOVE SECOND CONTACT LENS & INSERT ORDER 2 THIRD CONTACT LENS AND 
WEAR FOR 10 MINUTES15 
▪ 
 
 
 
▪ 
Study contact lens prescription suitability evaluation & decision to dispense or discharge if third contact 
lens not suitable 
▪ 
Standard high contrast Snellen visual acuity at distance and habitual near position with and without best 
sphere over refraction (monocular & binocular) 
▪ 
 
▪ 
 
 
  
 
 
Visit 3 – Second Study Contact Lens Follow-up Visit (7 +2/-0 days after Visit 2) 
The routine below will be followed: 
▪ 
 
 
 
 
 
▪ 
 
▪ 
 
▪ 
Standard high contrast Snellen visual at distance and near without over refraction (monocular & 
binocular) 
▪ 
Detailed timed logMAR visual acuity distance and near without over refraction (monocular & binocular) 
▪ 
Lens mechanical performance evaluation (subjective rating only) 
▪ 
ORDER 2 CONTACT LENS REMOVAL 
▪ 
 
 
▪ 
Standard high contrast Snellen visual at distance and near with sphero-cylindrical correction (monocular 
& binocular) 
▪ 
Overall, 
 specific contact lens preference questionnaire 
▪ 
Discharge 
 
 
 
13
 
 
 
 
 

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7 
SAMPLE SIZE DETERMINATION AND STATISTICAL ANALYSIS  
7.1 
Sample Size Determination 
 
 
 
 
 
 
 
 
 
 
 
 Based upon this data sample size 
estimation has been performed to demonstrate non-inferiority for the test Biofinity® multifocal fitting 
compared with the control Biofinity® multifocal fitting postulating a true difference of 20% and a margin of 
equivalence 10%.  Calculation based upon a one-sided binomial test with α =0.025, ß = 0.200 gives a minimal 
samples size of 23 participants. 
Based upon the above up to 30 participants will be screened with a view to achieve a per protocol population 
(PPP) of 25 participants. 
Participants will be considered enrolled when they successfully complete the screening visit. 
7.2 
Statistical Analysis Plan 
A detailed statistical analysis plan will be developed before database closure. 
For all the key parameters recorded, summary tables including descriptive and/or distribution statistics will be 
given. For continuous and ordinal variables, the following descriptive statistics will be reported: mean, median, 
standard deviation, minimum, maximum, quartiles and sample size. For ordinal variables, and nominal 
variables distribution tables will be shown. 
 
  
 
 
 
 
 
A detailed statistical analysis plan will be developed prior to database closure. 
 
 

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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 contact lenses or a result of other factors. An Adverse 
Event Form will be completed for each adverse event. If both eyes are involved, each eye will be counted as 
one adverse event and Adverse Event information 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 and a written report completed 
indicating the subsequent treatment and resolution of the condition. 
9.2 
Reporting Adverse Events 
All potential Serious and Unanticipated Adverse Device Effects that are related or possibly related to 
participation will be reported to the Principal Investigator and the sponsor within 24 hours of the investigator 
becoming aware of the event. The Principal Investigator will report the event to the Ethics Committee as soon 
as possible (by fax, mail/delivery, phone, or email) following the site Independent Ethics Committee 
guidelines. All fatal or life-threatening events will be reported immediately to the Independent Ethics 
Committee. 
Significant and Non-Significant Adverse Events will be reported to the sponsor using the Adverse Event 
notification form as soon as possible, but no later than 5 working days after the occurrence.  
 
  
 
    
 
   
 
 
 

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10 DEVICE DEFICIENCIES 
Device deficiencies are defined as inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. 
Note: This definition includes malfunctions, use errors, and inadequate labelling. 
 
 

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11 INVESTIGATOR, SPONSOR AND MEDICAL MONITOR RESPONSIBILITIES 
11.1 Investigator Responsibilities 
The investigator is responsible for ensuring participant safety and data quality by: protocol compliance, 
adherence to GCP and local regulatory requirements, and the Declaration of Helsinki. The investigator must 
ensure that he/she is appropriately qualified and legally entitled to practice and is trained in the proper method 
of obtaining informed consent. 
The investigator must have the appropriate resources to conduct the clinical trial, be familiar with the protocol 
and agree to adhere to it, support monitoring and auditing activities, communicate with the Sponsor regarding 
any clinical trial issues or need for protocol modifications, make the necessary arrangements to ensure proper 
conduct and completion of the clinical trial, and ensure the protection and welfare of the participant, including 
arranging any emergency treatment as needed. 
The investigator must ensure written Independent Ethics Committee approval is received prior to the start of 
the clinical trial, that the Ethics Committee and sponsor is kept informed of the clinical trial progress, including 
serious/adverse events and deviations as required by them, and that any changes to the protocol are notified 
to the Ethics Committee and review written approval prior to implementation. 
The investigator must ensure that the study is posted on ISRCTN public website prior to enrolling any 
participant. 
The investigator must try to ensure adequate participant recruitment; that all necessary and appropriate 
information is given to potential participants to ensure informed consent; is taken and documented; and that 
clinical records indicate the participant is enrolled in a clinical trial. The investigator must ensure that 
participants are provided with emergency contact details along with a procedure to follow in the case of an 
emergency, and that participants are kept informed as pertinent new information becomes available that may 
affect their decision to participate. 
The investigator has primary responsibility for the accuracy, legibility and security of all clinical investigation 
data, video recordings, documents and participant records at the Investigator site during and after the clinical 
trial. CRFs are to be signed by the investigator, and any alterations to data are to be made by authorized 
personnel, initialled and dated by name or, in the instance of electronic data, an audit trail will be in place, 
with no obstruction of the original data. 
The investigator must ensure that data be kept for the minimum time as specified by this protocol. The test 
product must be accounted for (the quantity of the devices received must be reconciled with the quantities of 
the device used, discarded or returned), and must also be responsible for the supervision and assignment of 
duties to all responsible for the conduct and evaluation of the clinical trial for the Investigator centre involved. 
11.2 Sponsor Responsibilities 
The Sponsor has delegated the selection of the Investigator and study site to the CRO, who should also 
select and appoint a monitor. The Sponsor has the ultimate responsibility for monitoring. The Sponsor is to 
supply and keep an up-to-date signed protocol and protocol amendments. 
The sponsor should ensure appropriate information is provided to the Investigators to conduct the clinical 
trial; that deviations are reviewed with the Investigator as needed and included in the final report. Adverse 
events are reported by the investigator, and the sponsor in turn will then notify their applicable regulatory 
authorities, and other investigators as appropriate. The Sponsor is to maintain Sponsor-specific clinical trial 
documentation as required by the regulatory authorities and to ensure the investigator is aware of their record 
keeping responsibilities. 

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11.3 Medical Monitor Responsibilities 
The Medical Monitor will be a physician specializing in ophthalmology. To reduce study bias concerns, the 
Medical Monitor will not have any real or potential conflict of interest with the Sponsor, Study Investigator or 
participating Investigative site.  
The primary purpose of the Medical Monitor is to ensure an independent review all Serious Adverse Events 
(SAE), device-related Adverse Events and AE related to the safety endpoints. When reviewing SAE and 
device-related adverse events, the Medical Monitor will report the relationship between the AE and the study 
device and the study procedure. The results of all events reviewed by the Medical Monitor will be documented. 
The Medical Monitor for the OTG-i Research Clinic will be Ali A. Mearza MB BS, FRCOphth, who is contracted 
to OTG-i Research Clinic for this activity. 
 
 

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12 GENERAL CLINICAL MANAGEMENT 
12.1 Data Recording 
The clinical data will be recorded on dedicated electronic case report forms (eCRFs) specifically designed to 
match the testing routine for each visit.  Entrypoint 16 (Phoenix Software International), will be used for data 
recording. All data captured with this software will be stored in a secure SQL database. The eCRFs will be 
reviewed for accuracy and comprehensiveness once completed and signed by the investigator.  A summary 
of the data will also be recorded in the participants’ clinical records. These constitute the participants’ source 
documents, which will be signed by the investigator.  The content and structure of the eCRFs are compliant 
with ISO14155:2011. 
12.2 Clinical Monitoring 
OCULAR TECHNOLOGY GROUP - International will monitor the study in a manner consistent with ICH GCP 
E6, EN ISO 14155:2011 and the Declaration of Helsinki.  The study monitor will maintain close contact with 
the Principal Investigator and the Investigator’s designated staff. The monitor’s responsibilities will include: 
i. 
Ensuring that the investigation is being conducted according to the protocol; 
ii. 
Ensuring the rights and wellbeing of participants are protected; 
iii. 
Ensuring that protocol deviations are documented with corrective action plans, as applicable; 
iv. 
Clarifying questions regarding the study; 
v. 
Resolving study issues or problems that may arise; 
vi. 
Reviewing the study records to ensure completeness and accuracy; 
vii. Study and participant source document records reviewed will include: 
a. The Information and Consent Form  
b. Source documentation including consenting, medical history, concomitant medications and adverse 
event information as applicable.   
c. Study related Regulatory documents as per ICH E3 section 8 
The clinical monitor will review study data and will perform, at a minimum, one Interim and one Close-Out 
Visit on site. 
12.3 Study Product Accounting 
Study product records include the study contact lens shipping orders, dispensing logs and the physical count 
and disposition of the remaining unused study contact lenses. Used worn lenses collected at the study visits 
will be discarded by the study site personnel.   The clinical monitor will ensure product is reconciled and any 
discrepancies are investigated and either corrected or documented. At study conclusion all study contact 
lenses will be reconciled. 
12.4 Participant Compliance Monitoring 
Throughout the course of the study the clinical monitor will review study data for participant compliance to the 
protocol.  Non-compliances will be documented as protocol deviation(s).  If a deviation is determined to be 
major, the deviation will be reported to the Ethics Committee as per their requirements. 
12.5 Unmasking of Study Information 
Masked information on the identity of the assigned study product(s) should not be disclosed during the study 
unless there are medical or safety reasons to do so, for example knowledge of the product may be necessary 
for the treatment of some adverse advents. The randomisation and masking data is under the control of a 

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designated unmasked member of staff. In the event of any adverse event requiring unmasking, the identity 
of the product can be requested by the Investigator, Medical Monitor or any medical personnel.  In the event 
that unmasking occurs, the following should be recorded: 
i. 
The ID of the unmasked participant, 
ii. 
The reason for unmasking,  
iii. 
The study staff person responsible for unmasking, 
iv. 
A list of person(s) who have been unmasked. 

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13 ADMINISTRATIVE MANAGEMENT 
13.1 Relevant Standards 
This clinical study will be conducted in accordance with the ethical principles that have their origin in the 
Declaration of Helsinki, and in compliance with the International Conference on Harmonization (ICH) E6 Good 
Clinical Practice (GCP) Consolidated Guideline, the International Standards Organization (ISO) Clinical 
investigation of medical devices for human participants – Good clinical practice (ISO 14155:2011(E)), 
Ophthalmic optics – Contact lenses and contact lens care products – Guidance for clinical investigations (ISO 
19980:2012 (E))  and other regulations as applicable. The Investigator and all clinical study staff will conduct 
the clinical study in compliance with the protocol. The Investigator will ensure that all personnel involved in 
the conduct of the study are qualified to perform their assigned responsibilities through relevant education, 
training, and experience. 
13.2 Deviations from the Protocol 
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.  
If the deviation affects participant’s rights, safety and wellbeing, or the scientific integrity of the clinical 
investigation, the ethics committee must be contacted with requests for deviations, and reports of deviations. 
Under emergency circumstances, deviations from the clinical investigational plan to protect the rights, safety 
and well-being of participants may proceed without prior approval of the sponsor and the ethics committee. 
Such deviations shall be documented and reported to the sponsor and the ethics committee as soon as 
possible. 
13.2.1 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 EC and MHRA: 
i. 
Changes in procedures initiated to eliminate immediate risks/hazards to participants; 
ii. 
Enrolment of participants outside the protocol inclusion/exclusion criteria whether agreed to or not by 
the sponsor; 
iii. 
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; 
iv. 
Information consent documentation violations: no documentation of informed consent; incorrect version 
of, or incomplete, informed consent documentation used. 
13.2.2 Minor Protocol Deviations 
Protocol deviations caused by or which originate with research participants are generally considered minor, 
and normally are not reported to the Independent Ethics Committee unless these result in increased risk to 
the participants). The following are examples of protocol deviations that are considered minor and do not 
require reporting to the Independent Ethics Committee and MHRA: 
i. 
Logistical or administrative aspects of the study (e.g., study participant missed appointment, change in 
appointment date); 
ii. 
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 

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experimental design (i.e., missing a measurement during a session that is not considered critical for 
the study).  
13.3 Modifications to the Clinical Investigational Plan 
Any modifications to the clinical investigational plan that are considered necessary can only be effected after 
approval from the principal investigator and the Independent Ethics Committee.  In an emergency situation, 
as indicated in ISO14155, the clinical investigator will exercise his judgement to safeguard the participant's 
interest and may deviate from the clinical investigation plan without the prior approval of the Independent 
Ethics Committee.  In that case, the deviation will not be considered as a breach of agreement but will be 
reported to the ethics committee. 
13.4 Termination of the Study 
The Sponsors reserve the right to terminate the study at any time for any reason. The principal investigator 
has the discretion to initiate stopping the study based on participant safety or if information indicates the 
study’s results may be compromised. The Investigator should promptly notify the IEC of the termination or 
suspension and of the study and the reason.  
13.5 Data Protection 
All information obtained during the course of the investigation will be regarded as confidential and will be 
handled in accordance with the Data Protection Act and the General Data Protection Regulation (GDPR) 
guidelines. All personal data gathered in this trial will be treated in strictest confidence by investigators, 
monitors, OTG-i personnel, the sponsor and the independent ethics committee.  No data will be disclosed to 
any third party without the express permission of the participant concerned, with the exception of OTG-i 
personnel (monitor, auditor), the sponsor, the independent ethics committees and regulatory organisations in 
the context of their investigation related activities which, as part of the investigation will have access to the 
CRFs and source documents. 
13.6 Data Handling and Record Keeping 
The data analysis will be carried out by OTG-i. 
All records, including CRFs, will be kept in the files of the Principal Investigator site for the latter of the two 
dates a period of two years after the date on which the investigation is terminated or completed, or the date 
that the records are no longer required for legal clinical requirements.   
13.7 Reporting 
OTG-i shall submit a final report to the sponsor as per the terms in the Statement of Work. 
OTG-i shall also submit a summary one-year update and/or a summary final report to the Independent Ethics 
Committee. 
OTG-i shall also submit a summary final report to be posted on the public website ISRCTN. 
13.8 Publication Policy 
The study data will be wholly owned by the Sponsor.  The results of the study may not be used in publications 
or presentations without the written permission of the Sponsor. 
13.9 Compensation 

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The Sponsor will compensate the Contract Research Organisation for work carried out as agreed prior to the 
study and will supply or pay for consumables for use in the study as detailed in the contract.   
13.10 Indemnity/Insurance 
The Sponsor will take out indemnity to cover the participants and research staff involved in the study and the 
ethics committee.  This will NOT cover the research staff for clinical negligence.  Investigators will have their 
own professional indemnity. 
 
 

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