Refitting Biofinity Multifocal Contact Lens Wearer With MyDay Multifocal Contact Lenses
Phase: NA
Conditions: Presbyopia
Sponsor: CooperVision International Limited (CVIL)



STRICTLY CONFIDENTIAL                                                  Property of OCULAR TECHNOLOGY GROUP - International 
 
EX-MKTG-155 
ID23-62 
Refitting 
Biofinity® 
Multifocal Contact Lenses Wearers with MyDay® 
Multifocal 
Contact 
Lenses 
CIP 
V1.0 
11th 
December 2023 
Clinical Investigational Plan 
Page 3 of 31 
 
DOCUMENT CHANGE HISTORY 
Revision 
Originator 
Description of Change(s) 
Date 
 
 
 
    
 
 
 
    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

STRICTLY CONFIDENTIAL                                                  Property of OCULAR TECHNOLOGY GROUP - International 
EX-MKTG-155 
ID23-62 
Refitting 
Biofinity® 
Multifocal Contact Lenses Wearers with MyDay® 
Multifocal 
Contact 
Lenses 
CIP 
V1.0 
11th 
December 2023 
Clinical Investigational Plan 
Page 4 of 31 
 

STRICTLY CONFIDENTIAL                                                  Property of OCULAR TECHNOLOGY GROUP - International 
 
EX-MKTG-155 
ID23-62 
Refitting 
Biofinity® 
Multifocal Contact Lenses Wearers with MyDay® 
Multifocal 
Contact 
Lenses 
CIP 
V1.0 
11th 
December 2023 
Clinical Investigational Plan 
Page 5 of 31 
 
Table of Contents 
1 
OVERALL SYNOPSIS ................................................................................................................. 8 
2 
INTRODUCTION AND RATIONALE ........................................................................................... 11 
2.1 
Background ..................................................................................................................... 11 
2.2 
Objective ......................................................................................................................... 11 
2.3 
Hypotheses ..................................................................................................................... 11 
2.4 
Endpoints ........................................................................................................................ 11 
3 
STUDY SPONSOR AND INVESTIGATORS ............................................................................... 12 
3.1 
Study Sponsor ................................................................................................................. 12 
3.2 
Clinical Research Organisation ....................................................................................... 12 
3.3 
Study Site & Investigators ............................................................................................... 12 
3.4 
Medical Monitor ............................................................................................................... 12 
3.5 
Data Controller and Statistical Analysis .......................................................................... 12 
3.6 
Independent Ethics Committee ....................................................................................... 12 
4 
STUDY MATERIAL ...................................................................................................................... 13 
4.1 
Reference Contact Lenses ............................................................................................. 13 
4.2 
Test Contact Lenses ....................................................................................................... 13 
5 
STUDY POPULATION ................................................................................................................. 14 
5.1 
Recruitment Procedure ................................................................................................... 14 
5.2 
Number of Participants ................................................................................................... 14 
5.3 
Inclusion and Exclusion Criteria ...................................................................................... 14 
5.3.1 
INCLUSION CRITERIA ...................................................................................... 14 
5.3.2 
EXCLUSION CRITERIA .................................................................................... 15 
5.4 
Premature Withdrawal..................................................................................................... 15 
5.5 
Informed Consent ............................................................................................................ 16 
6 
STUDY DESIGN & PROCEDURES ............................................................................................ 16 
6.1 
Experimental Design ....................................................................................................... 16 
6.2 
Experimental Routine ...................................................................................................... 17 
6.3 
End of Study .................................................................................................................... 18 
6.4 
Participant Instruction...................................................................................................... 18 
6.5 
Procedures ...................................................................................................................... 18 
6.5.1 
EFFICACY PROCEDURES ............................................................................... 18 
6.5.2 
 
6.5.3 
POPULATION PROFILING PROCEDURES ..................................................... 19 

STRICTLY CONFIDENTIAL                                                  Property of OCULAR TECHNOLOGY GROUP - International 
 
EX-MKTG-155 
ID23-62 
Refitting 
Biofinity® 
Multifocal Contact Lenses Wearers with MyDay® 
Multifocal 
Contact 
Lenses 
CIP 
V1.0 
11th 
December 2023 
Clinical Investigational Plan 
Page 6 of 31 
 
6.5.4 
STUDY MANAGEMENT PROCEDURES ......................................................... 19 
6.6 
Study Visit Routine .......................................................................................................... 19 
6.6.1 
VISIT 1 – SCREENING ENROLMENT FITTING DISPENSING VISIT ............. 19 
▪ 
BIOFINITY® MULTIFOCAL REMOVE INITIAL CONTACT LENS & INSERT BIOFINITY® 
MULTIFOCAL SECOND CONTACT LENS AND WEAR FOR 10 MINUTES ............................. 20 
6.6.2 VISIT 2 – BIOFINITY® MULTIFOCAL CONTACT LENS FOLLOW-UP & 
MYDAY® MULTIFOCAL CONTACT LENS FITTING AND DISPENSING 
VISIT (14 ± 3 DAYS AFTER VISIT 1) ................................................................ 20 
▪ 
MYDAY® MULTIFOCAL REMOVE INITIAL CONTACT LENS & INSERT MYDAY® 
MULTIFOCAL SECOND CONTACT LENS AND WEAR FOR 10 MINUTES ............................. 20 
6.6.3 VISIT 3– MYDAY® MULTIFOCAL CONTACT LENS FOLLOW-UP & 
DISCHARGE VISIT (14 ± 3 DAYS AFTER VISIT 2) ......................................... 21 
7 
SAMPLE SIZE DETERMINATION AND STATISTICAL ANALYSIS ........................................... 21 
7.1 
Sample Size Determination ............................................................................................ 21 
7.2 
Statistical Analysis Plan .................................................................................................. 21 
8 
RISK ANALYSIS .......................................................................................................................... 22 
8.1 
Benefits ........................................................................................................................... 22 
8.2 
Risks ............................................................................................................................... 22 
8.3 
Conclusion ...................................................................................................................... 22 
9 
ADVERSE EVENTS AND REPORTING ..................................................................................... 22 
9.1 
Adverse Events ............................................................................................................... 22 
9.1.1 
ADVERSE EVENT DEFINITIONS ..................................................................... 23 
9.1.2 
NORMAL OR ADAPTIVE SYMPTOMS ............................................................. 24 
9.1.3 
PROCEDURES FOR ADVERSE EVENTS ....................................................... 24 
9.2 
Reporting Adverse Events .............................................................................................. 25 
10 
DEVICE DEFICIENCIES.............................................................................................................. 25 
11 
INVESTIGATOR, SPONSOR AND MEDICAL MONITOR RESPONSIBILITIES ........................ 26 
11.1 
Investigator Responsibilities ........................................................................................... 26 
11.2 
Sponsor Responsibilities ................................................................................................. 26 
11.3 
Medical Monitor Responsibilities ..................................................................................... 27 
12 
GENERAL CLINICAL MANAGEMENT ........................................................................................ 27 
12.1 
Data Recording ............................................................................................................... 27 
12.2 
Clinical Monitoring ........................................................................................................... 27 
12.3 
Study Product Accounting ............................................................................................... 27 
12.4 
Participant Compliance Monitoring ................................................................................. 28 

STRICTLY CONFIDENTIAL                                                  Property of OCULAR TECHNOLOGY GROUP - International 
 
EX-MKTG-155 
ID23-62 
Refitting 
Biofinity® 
Multifocal Contact Lenses Wearers with MyDay® 
Multifocal 
Contact 
Lenses 
CIP 
V1.0 
11th 
December 2023 
Clinical Investigational Plan 
Page 7 of 31 
 
12.5 
 
13 
ADMINISTRATIVE MANAGEMENT ............................................................................................ 28 
13.1 
Relevant Standards......................................................................................................... 28 
13.2 
Deviations from the Protocol ........................................................................................... 29 
13.2.1 GENERAL .......................................................................................................... 29 
13.2.2 MAJOR PROTOCOL DEVIATIONS .................................................................. 29 
13.2.3 MINOR PROTOCOL DEVIATIONS ................................................................... 29 
13.3 
Modifications to the Clinical Investigational Plan ............................................................ 29 
13.4 
Termination of the Study ................................................................................................. 30 
13.5 
Data Protection ............................................................................................................... 30 
13.6 
Data Handling and Record Keeping ............................................................................... 30 
13.7 
Reporting ......................................................................................................................... 30 
13.8 
Publication Policy ............................................................................................................ 30 
13.9 
 
13.10 
Indemnity / Insurance ...................................................................................................... 30 
14 
 
15 
 
 
 
 

STRICTLY CONFIDENTIAL                                                  Property of OCULAR TECHNOLOGY GROUP - International 
 
EX-MKTG-155 
ID23-62 
Refitting 
Biofinity® 
Multifocal Contact Lenses Wearers with MyDay® 
Multifocal 
Contact 
Lenses 
CIP 
V1.0 
11th 
December 2023 
Clinical Investigational Plan 
Page 8 of 31 
 
1 
OVERALL SYNOPSIS 
Study Sponsor 
The Sponsor for this investigation will be CooperVision International Limited 
(CVIL) Delta Park, Concorde Way, Segensworth North, Fareham PO15 
5RL, UK. The sponsor contact will be Dr Jose Vega. 
Title of Study 
Refitting Biofinity multifocal contact lens wearer with MyDay multifocal 
contact lenses. 
Protocol Number 
EX-MKTG-155 ID23-62 
Type of study 
The study will be conducted following an interventional, prospective, open 
label, sequential study design. 
Study Population  
Required: 60 completed participants as per protocol (cohort) with a 
minimum of 66 to be enrolled. 
Planned: Up to 70 screened, with the aim of enrolling 66 participants. 
Duration of study treatment 
14 (-0/+3) days of daily disposable, daily contact lens wear per study contact 
lens type. 
Inclusion Criteria 
In order to be enrolled, each participant shall meet the following criteria: 
i. 
Age 40 years and older; 
ii. 
Current multifocal contact lens wearer (other than MyDay® multifocal 
but can include Biofinity® multifocal); 
iii. 
Spectacle refraction: 
Distance:  
Sphere: -6.00D to + 4.00D 
 
  
Astigmatism: 0.00D to -0.75D 
Near Addition: +0.75D to +2.50D  
iv. 
Best corrected visual acuity of at least 20/25 in each eye. 
The prospective participants will be given a Participant Information Sheet to 
read and an Informed Consent Form to sign prior to any evaluation. 
Exclusion Criteria 
The following are specific criteria that exclude a candidate from enrolment 
in this study: 
i. 
Acute and subacute inflammation or infection of the anterior chamber 
of the eye.  
ii. 
Any eye disease, injury or abnormality that affects the cornea, 
conjunctiva or eyelids that would contraindicate contact lens wear; 
iii. 
Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic 
iv. 
Severe insufficiency of lacrimal secretion (dry eyes). 
v. 
Any systemic disease that may affect the eye or may be exaggerated 
by wearing contact lenses (e.g. acne and eczema). 
vi. 
Allergic reactions of ocular surfaces or adnexa that may be induced or 
exaggerated by wearing contact lenses or use of contact lens solutions  
vii. Any active corneal infection (bacterial, fungal, protozoal or viral).  
viii. Newly prescribed (within the past 30 days) use of some systemic 
medications (such as antihistamines, decongestants, diuretics, muscle 
relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, 
oral contraceptives) or new prescription eyedrops which is not 
rewetting/lubricating eyedrops for which contact lens wear could be 
contraindicated as determined by the investigator; 
ix. 
Monocular participants (only one eye with functional vision) or 
participants fit with only one contact lens; 

STRICTLY CONFIDENTIAL                                                  Property of OCULAR TECHNOLOGY GROUP - International 
 
EX-MKTG-155 
ID23-62 
Refitting 
Biofinity® 
Multifocal Contact Lenses Wearers with MyDay® 
Multifocal 
Contact 
Lenses 
CIP 
V1.0 
11th 
December 2023 
Clinical Investigational Plan 
Page 9 of 31 
 
x. 
Subjects with slit lamp findings greater than grade 1 (e.g. edema, 
infiltrates, 
corneal 
neovascularization, 
corneal 
staining, 
tarsal 
abnormalities, conjunctival, anterior segment inflammation) as per ISO 
11980, any previous history or signs of a contact lens related corneal 
inflammatory event (past corneal ulcers), or any other ocular 
abnormality that may contraindicate contact lens wear at the enrolment 
visit; 
xi. 
History of corneal refractive surgery 
xii.  Enrolment of the family members of the investigator, family members 
of the investigator’s staff, or individuals living in the households of these 
individuals. 
xiii. Current wearer of the test contact lens MyDay® multifocal contact lens. 
Planned Start Date 
January 2023 
Overall Study Duration 
Nine months.  This includes the study enrolment period, active contact lens 
wear period of approximately three months and study close out. 
Objectives 
The primary objective of the study will be to assess handling characteristics 
(insertion and removal). 
The secondary objectives will be to measure logMAR visual acuity. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Efficacy Endpoints 
The primary efficacy endpoints will be ease of handling over the week 
preceding the follow-up visit, calculated as the ease of insertion and ease 
of removal. 
The secondary endpoint will be mean logMAR visual acuity calculated as 
the mean of distance, intermediate and near logMAR visual acuities. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

STRICTLY CONFIDENTIAL                                                  Property of OCULAR TECHNOLOGY GROUP - International 
 
EX-MKTG-155 
ID23-62 
Refitting 
Biofinity® 
Multifocal Contact Lenses Wearers with MyDay® 
Multifocal 
Contact 
Lenses 
CIP 
V1.0 
11th 
December 2023 
Clinical Investigational Plan 
Page 10 of 31 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Population Profiling 
Procedures 
The procedures to profile the population key characteristics will be: 
i. 
Demographics and medical & ocular history (including concomitant 
treatment) questionnaires;  
ii. 
 
 
 
 
 
 
 
Single 
masked 
(participant) 
 
Single 
masked 
(investigator) 
 Double masked* 
 Sponsor masked 
 Open label 
 Single group 
 Parallel group 
 Crossover 
 Contralateral 
Reference Product 
The reference contact lenses will be Biofinity® multifocal CE marked and 
currently marketed in the UK planned replacement contact lenses that can 
worn up to 30 days of daily wear.  The reference contact lenses will be used 
as per their CE marking. 
Test Products 
The test contact lenses will be MyDay® multifocal CE marked daily 
disposable contact lenses currently marketed in the UK. The test contact 
lenses will be used as per their CE marking. 
Study Visits 
The participants will attend a total of three visits over on average a four-
week period (maximum five weeks). 
The visit schedule will be as follow: 
Visit 1 Screening/ enrolment / fitting & dispensing of Biofinity® multifocal 
contact lens visit. 
Visit 2  Biofinity® multifocal contact lens follow-up & MyDay® multifocal 
contact lens fitting and dispensing visit (14 ± 3 days after Visit 1). 
Visit 3 MyDay® multifocal contact lens follow-up & discharge visit (14 ± 3 
days after Visit 2). 
Keywords 
Biofinity ® multifocal, MyDay® multifocal, Refitting. 
Regulatory Status 
The study requires Ethics Committee (EC) approval prior to initiation. 
Responsibilities 
Sponsor 
Name: CooperVision International Limited (CVIL) 
 
CRO and Data 
Management 
OCULAR TECHNOLOGY GROUP - International 
 
 
 
 

STRICTLY CONFIDENTIAL                                                  Property of OCULAR TECHNOLOGY GROUP - International 
 
EX-MKTG-155 
ID23-62 
Refitting 
Biofinity® 
Multifocal Contact Lenses Wearers with MyDay® 
Multifocal 
Contact 
Lenses 
CIP 
V1.0 
11th 
December 2023 
Clinical Investigational Plan 
Page 11 of 31 
 
2 
INTRODUCTION AND RATIONALE 
2.1 
Background 
Biofinity® multifocal contact lenses and MyDay® multifocal contact lenses are two successful contact lenses 
to correct presbyopia currently CE marked and on the UK market.  Biofinity® multifocal contact lenses fitting 
is based upon the selection of the optimal contact lens from the choice of eight different near additions.  
MyDay® multifocal a more recently developed contact lens only uses three near addition designs to fit the 
same population of presbyopes.  The simpler fitting system results in less chair time for both the eyecare 
practitioner and the patient.  A very large number of presbyopes are currently successfully wearing Biofinity® 
multifocal contact lenses, the question is therefore to understand if wearers who have successfully adapted 
to wearing Biofinity® multifocal contact lenses could also be successful wearers of MyDay® multifocal. 
 
 
 
 
 
 
2.2 Objective  
The primary objective of the study will be to assess handling characteristics (insertion and removal). 
The secondary objectives will be to measure logMAR visual acuity. 
 
 
2.3 
Hypotheses 
The primary hypothesis is that the ease of handling (EOH) at both insertion and removal of the test contact 
lens is non-inferior to the reference contact lens. 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
The secondary hypothesis is that high luminance, high contrast logMAR visual acuity at Distance, 
Intermediate and Near (logMAR DIN) of the test contact lens is non-inferior to control contact lens. 
 
 
 
 
 
 
 
 
 
 
 
2.4 
Endpoints 
The primary efficacy endpoints will be ease of handling over the week preceding the follow-up visit, calculated 
as the ease of insertion and ease of removal. 
The secondary endpoint will be mean logMAR visual acuity calculated as the mean of distance, intermediate 
and near logMAR visual acuities. 
 

STRICTLY CONFIDENTIAL                                                  Property of OCULAR TECHNOLOGY GROUP - International 
 
EX-MKTG-155 
ID23-62 
Refitting 
Biofinity® 
Multifocal Contact Lenses Wearers with MyDay® 
Multifocal 
Contact 
Lenses 
CIP 
V1.0 
11th 
December 2023 
Clinical Investigational Plan 
Page 12 of 31 
 
3 
STUDY SPONSOR AND INVESTIGATORS 
3.1 
Study Sponsor 
The Sponsor for this investigation will be CooperVision International Limited (CVIL) Delta Park, Concorde 
Way, Segensworth North, Fareham PO15 5RL, UK. The sponsor contact will be Dr Jose Vega. 
3.2 
Clinical Research Organisation 
The Clinical Research Organisation (CRO) will be OCULAR TECHNOLOGY GROUP - International (OTG-i) 
at: Lower Ground Floor, 66 Buckingham Gate, London. SW1E 6AU. United Kingdom. 
The study director will be Dr Michel Guillon, PhD, FCOptom, FAAO, FBCLA, CPI Lower Ground Floor, 66 
Buckingham Gate, London SW1E 6AU. United Kingdom.  
3.3 
Study Site & Investigators 
The study site will be OCULAR TECHNOLOGY GROUP - International (OTG-i) Clinic at Lower Ground Floor, 
66 Buckingham Gate, London SW1E 6AU. United Kingdom.  
The study Principal Investigator (PI) will be Dr Michel Guillon, PhD, FCOptom, FAAO, BCLA, CPI, and the 
co-investigators 
. 
3.4 
Medical Monitor 
The medical monitor at the OTG-i Research Clinic 
; the medical 
monitor is contracted to OTG-i Research Clinic for this activity. 
3.5 
Data Controller and Statistical Analysis 
The data controller 
 OCULAR TECHNOLOGY GROUP – International. The statistical 
analysis design and statistical analysis will be the responsibility 
 OCULAR 
TECHNOLOGY GROUP – International. 
3.6 
Independent Ethics Committee 
Before clinical study initiation, this protocol, information given to participants (PIS), the informed consent (ICF) 
forms and any advertisements planned for participant recruitment will be submitted to an Independent Ethics 
Committee (IEC) for approval. The IEC will be provided with all information as required by local regulations 
and/or the IEC. At the end of the study, the Investigator will notify the IEC about the study’s completion. The 
IEC also will be notified if the study is terminated prematurely. Finally, the Investigator will report to the IEC 
on the progress of the study at intervals stipulated by the IEC.  
The study will be submitted to the Integrated Research Application System (IRAS) centralised National 
Research Ethics Service for review. The investigation will not start until the no objection notification has been 
received. 
The Investigator will provide documentation of the IEC approval to the sponsor. The approval will be dated 
and will identify the applicable protocol, amendments (if any), informed consent form, all applicable recruiting 
materials, written information for participants, and participant compensation programs. 
 
 

STRICTLY CONFIDENTIAL                                                  Property of OCULAR TECHNOLOGY GROUP - International 
 
EX-MKTG-155 
ID23-62 
Refitting 
Biofinity® 
Multifocal Contact Lenses Wearers with MyDay® 
Multifocal 
Contact 
Lenses 
CIP 
V1.0 
11th 
December 2023 
Clinical Investigational Plan 
Page 13 of 31 
 
4 
STUDY MATERIAL 
4.1 
Reference Contact Lenses  
The reference contact lenses will be Biofinity® multifocal CE marked and currently marketed in the UK 
planned replacement contact lenses that can worn up to 30 days of daily wear.  The reference contact lenses 
will be used as per their CE marking.  Details of the material properties and contact lens design are given in 
Table 1A. 
Table 1A – Reference Contact Lenses 
Biofinity® multifocal 
Manufacturer 
CooperVision Inc. 
USAN material name 
Comfilcon A 
Water content  
48%  
Oxygen Permeability 
142 Dk/t (at -3.00D)   
Diameter (mm) 
14.0mm 
Base curve (mm) 
8.6mm 
Power (D) 
6.00D to -8.00D (0.50D steps 
after -6.00D) 
Add power 
+1.00, +1.50. +2.00. +2.50 
Lens Design 
Multifocal / Balanced 
Progressive™ Technology 
Indications 
Daily wear soft contact lens 
The contact lenses will be worn on a daily disposable modality, that is the contact lenses will be worn during 
the day, removed and discarded at the end of each day before sleep, a similar new pair of contact lenses 
being used each day as per the user instructions 
 
4.2 
Test Contact Lenses  
The test contact lenses will be MyDay® multifocal CE marked and currently marketed in the UK daily 
disposable contact lenses.  The test contact lenses will be used as per their CE marking. Details of the 
material properties and contact lens design are given in Table 1B. 
Table 1B – Test Contact Lenses 
MyDay® multifocal 
Manufacturer 
CooperVision Inc. 
USAN material name 
stenfilcon A 
Water content  
54%  
Oxygen Permeability 
80 x 10-11 
(cm2/sec) x (ml O2)/(ml x mm 
Hg)   
Diameter (mm) 
14.2mm 
Base curve (mm) 
8.4mm 
Power (D) 
 
 Distance 
+4.00 to -6.00D in 0.25 steps 
   Near Add 
Low, medium and high 

STRICTLY CONFIDENTIAL                                                  Property of OCULAR TECHNOLOGY GROUP - International 
 
EX-MKTG-155 
ID23-62 
Refitting 
Biofinity® 
Multifocal Contact Lenses Wearers with MyDay® 
Multifocal 
Contact 
Lenses 
CIP 
V1.0 
11th 
December 2023 
Clinical Investigational Plan 
Page 14 of 31 
 
Lens Design 
Multifocal / Binocular 
Progressive System™ 
Indications 
Daily wear soft contact lens 
The contact lenses will be worn on a daily disposable modality, that is the contact lenses will be worn during 
the day, removed and discarded at the end of each day before sleep, a similar new pair of contact lenses 
being used each day as per the user instructions 
 
5 
STUDY POPULATION 
5.1 
Recruitment Procedure 
The prospective participants will be selected from the existing clinical population of the OCULAR 
TECHNOLOGY GROUP- International clinic.  The participants fulfilling the criteria for inclusion and none of 
the exclusion criteria will be invited in a random fashion to participate in the study until the study population 
is achieved. In addition, the study will be advertised in social media and / or the local press to help with 
recruitment. 
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. 
The prospective participants will be given a Participant Information Sheet to read and an Informed Consent 
to sign prior to any evaluation. 
5.2 
Number of Participants 
Up to 70 participants to be screened, with the aim to enrol up to 66 participants and with a view to achieve a 
cohort (participants completing the study as per protocol) sample size of 60 made up of approximately 20 in 
each of the low (near addition +0.75D to +1.25D), medium (near addition +1.50D and +1.75D) or high (near 
addition+2.00D to +2.50D) spectacle additions groups.  Therefore 66 participants will be enrolled to account 
for drop out based upon a potential 10% drop out rate, 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). 
5.3 
Inclusion and Exclusion Criteria 
5.3.1 
INCLUSION CRITERIA 
In order to be enrolled, each participant shall meet the following criteria: 
i. 
Age 40 years and older 
ii. 
Current multifocal contact lens wearer (other than MyDay® multifocal but can include Biofinity® 
multifocal); 
iii. 
Spectacle refraction: 

STRICTLY CONFIDENTIAL                                                  Property of OCULAR TECHNOLOGY GROUP - International 
 
EX-MKTG-155 
ID23-62 
Refitting 
Biofinity® 
Multifocal Contact Lenses Wearers with MyDay® 
Multifocal 
Contact 
Lenses 
CIP 
V1.0 
11th 
December 2023 
Clinical Investigational Plan 
Page 15 of 31 
 
Distance:  
Sphere: -6.00D to + 4.00D 
 
 
 
Astigmatism: 
0.00D to -0.75D 
Near Addition: 
Low 
 
+0.75D to +1.25D 
 
Medium 
+1.50D and +1.75D 
 
High 
 
+2.00D to +2.50D 
iv. Best corrected visual acuity of at least 20/25 in each eye. 
The prospective participants will be given a Participant Information Sheet to read and an Informed Consent 
Form to sign prior to any evaluation. 
 
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. 
Acute and subacute inflammation or infection of the anterior chamber of the eye.  
ii. 
Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would 
contraindicate contact lens wear; 
iii. 
Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic 
iv. 
Severe insufficiency of lacrimal secretion (dry eyes). 
v. 
Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. 
acne and eczema). 
vi. 
Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact 
lenses or use of contact lens solutions  
vii. Any active corneal infection (bacterial, fungal, protozoal or viral).  
viii. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, 
decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, 
oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which 
contact lens wear could be contraindicated as determined by the investigator; 
ix. 
Monocular participants (only one eye with functional vision) or participants fit with only one contact lens; 
x. 
Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, 
corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, 
any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), 
or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit; 
xi. 
History of corneal refractive surgery  
xii. Enrolment of the family members of the investigator, family members of the investigator’s staff, or 
individuals living in the households of these individuals. 
xiii. Current wearer of the test contact lens, MyDay® Multifocal. 
5.4 
Premature Withdrawal 
A participant will be withdrawn from the investigation before completion if: 
i. 
The participant withdraws his/her consent to be included in the trial;  
ii. 
An adverse event takes place that is considered by the participant 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; 

STRICTLY CONFIDENTIAL                                                  Property of OCULAR TECHNOLOGY GROUP - International 
 
EX-MKTG-155 
ID23-62 
Refitting 
Biofinity® 
Multifocal Contact Lenses Wearers with MyDay® 
Multifocal 
Contact 
Lenses 
CIP 
V1.0 
11th 
December 2023 
Clinical Investigational Plan 
Page 16 of 31 
 
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 requirements after the nature of the study has 
been fully explained. Informed consent will be obtained by a delegated investigator that is GCP trained. The 
consent form will be signed before performance of any study-related activity. The consent form will have 
received approval by both the Sponsor and by the reviewing IEC before its use. 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. Should a participant indicate on their consent form 
that they would like their GP to be notified of their participation in the research, then a letter will be sent to the 
GP. 
Before entry into the study, the investigator or an authorised member of the investigational staff will explain 
to potential participant the aims, methods, reasonably anticipated benefits, and potential hazards of the study, 
and any discomfort it may entail. The potential participant will be informed that his/her participation is voluntary 
and that he/she may withdraw consent to participate at any time. The participant will be informed that choosing 
not to participate will not affect the care the participant will receive.  Finally, the potential participant will be 
told that if needed his/her records may be accessed by health authorities and authorized sponsor staff without 
violating his/her confidentiality, to the extent permitted by the applicable law(s) or regulations. 
The participant will be given sufficient time to read the participant information sheet and the informed consent 
form 
 and will have the opportunity to ask questions.  If he/she requires additional time, the 
participant will be able to sign the consent on a future date and the enrolment visit will be re-scheduled 
accordingly; no research related measurement will be carried out before the potential participant has signed 
the informed consent. 
After this explanation and before entry into the study, consent will be appropriately recorded by means of the 
participants’ dated signature and counter signature of the member of the research team taking consent of two 
originals. After having obtained the consent, a copy of the participant information sheet and of the signed 
informed consent form will be given to the participant; the other signed copy of the informed consent will be 
kept in the study file. 
6 
STUDY DESIGN & PROCEDURES 
6.1 
Experimental Design 
The study will be conducted following an interventional, prospective, open label, sequential study design. 
The design has been developed to represent the clinical situation to be tested, that is the refitting of successful 
Biofinity® multifocal contact lens wearers with MyDay® multifocal contact lenses as per the following routine: 
i. 
Participants will be first fitted with Biofinity® multifocal contact lenses which they will wear for two weeks 
on a daily disposable wearing modality; 
ii. 
At the completion of the two weeks of wear the participants will be refitted with MyDay® multifocal contact 
lenses that they will wear for two weeks on a daily disposable wearing modality. 

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The participants will attend the clinic for three study visits. The participants 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 / Fitting & Dispensing Biofinity® Multifocal Contact Lens 
A prospective participant will attend the clinic for the first visit to initially obtain informed consent and evaluate 
the suitability to take part in the investigation. The potential participant will be asked to attend the clinic 
wearing spectacles and not have worn contact lenses that day.  After informed consent has been given, the 
investigator will review the participant’s medical history, ocular history 
 
demographics and habitual 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 participant meets the inclusion/exclusion criteria Biofinity® 
multifocal contact lenses will be inserted and worn for 10 minutes at which time the contact lens fit and vision 
will be assessed; 
. If this is not achieved 
the participant will be discharged from the study; however, if a suitable fit is achieved the participant will then 
be instructed in the use of the contact lenses which will be dispensed to wear until Visit 2 as the main vision 
correction, aiming for at least 8 hours of wear a day for at least 5 days a week. 
Visit 2 – Biofinity® Multifocal Contact Lens Follow-up & MyDay® Multifocal Contact Lens Fitting and 
Dispensing visit (14 ± 3 days after visit 1) 
The participant will return for the second study visit after having worn the first study contact lenses for 14 ± 3 
days. The participant will attend the visit wearing Biofinity® multifocal contact lenses, having worn the contact 
lenses for a minimum of three hours prior to the appointment. 
The participant’s medical, ocular, contact lens wearing history and concomitant treatments will once again be 
reviewed. 
 
 
 
 
At the completion of the ocular integrity check the MyDay® Multifocal contact lenses will be inserted and worn 
for 10 minutes at which time the contact lens fit and vision will be assessed; 
 
. If this is not achieved the participant will be discharged from the study; 
however, if a suitable fit is achieved the participant will then will be instructed in the use of the contact lenses 
which will be dispensed to wear until Visit 3 as the main vision correction, aiming for at least 8 hours of wear 
a day for at least 5 days a week. 
Visit 3 –MyDay® Multifocal Contact Lens Follow-up & Discharge Visit (14 ± 3 days after Visit 2). 
The participant will return for the third study visit after having worn the second study contact lenses for 14 ± 
3 days. The participant will attend the visit wearing MyDay® multifocal contact lenses contact lenses, having 
worn the contact lenses for a minimum of three hours prior to the appointment. 
The participant’s medical, ocular, contact lens wearing history and concomitant treatments will once again be 
reviewed. 
 
 
Then the MyDay® Multifocal contact lenses contact lenses will be removed. 
 the participant will be discharged 
from the study. 

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6.3 
End of Study 
The end of the study clinical phase is at the discharge of the last participant from the study.  The overall 
completion of the study is when the clinical study reports, EC report and ISCRTN result posting have been 
completed. 
6.4 Participant Instruction 
The participant will be instructed to wear the study contact lenses daily for 14 ± 3 days, remove the contact 
lenses at night (prior to sleep), discard them and use a new identical pair of contact lenses the following day. 
The participant 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, severity or have a high rate of 
occurrence. 
 
 
 
The participant will be instructed to follow standard recommendations provided to contact lens wearers: 
i. 
Avoid rubbing the eyes, always wash hands prior to touching the eyes or handling the contact lenses, 
avoid being in a dusty environment and to use sunglasses when outdoors. 
ii. 
Exercise care while washing the face with tap water; avoid splashing tap water into the eyes. 
iii. 
Do not swim with contact lenses whenever possible. 
iv. 
Immediately contact the investigator and schedule to return to clinic for a check-up within 24 hours if the 
eyes become red, irritated or painful. 
The participant will be provided with instruction sheets 
 
A participant using re-wetting eyedrops in combination with his/her habitual contact lenses will be able to 
continue to do so during the study. 
6.5 Procedures 
6.5.1 
EFFICACY PROCEDURES 
The primary efficacy procedures will be the rating of contact lens handling combining ease of insertion and 
ease of removal both recorded on 100-point visual analog scales. 
The secondary efficacy procedure will be the measurement of high luminance 
 high contrast (> 
90%) logMAR visual acuity at distance 
, intermediate 
 and near 
 using OTG-i Vision 
Suite. 
 
 
 
 
 
 
 
 
 
 

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i. 
 
 
 
 
 
 
. 
6.5.3 
POPULATION PROFILING PROCEDURES 
The procedures to profile the population key characteristics will be: 
i. 
Demographics and Medical & Ocular History 
 
 
ii. 
Habitual contact lenses wearing characteristics; 
iii. 
 
6.5.4 
STUDY MANAGEMENT PROCEDURES 
The procedures to ensure that the study protocol is followed will be: 
i. 
Contact lens fitting as per the Biofinity® multifocal contact lens fitting manual; 
ii. 
Contact lens fitting as per the MyDay® multifocal contact lens fitting manual; 
iii. 
Contact lens fit clinical classification; 
iv. 
Recording of contact lens prescribing time; 
v. 
Recording of number of contact lenses to arrive to the prescription to dispense; 
6.6 Study Visit Routine  
6.6.1 VISIT 1 – SCREENING ENROLMENT FITTING DISPENSING VISIT 
The routine below will be followed: 
▪ 
Explanation of the study1 
▪ 
Signing of the consent form 
▪ 
Participant demographics and ocular history questionnaire 
▪ 
 
▪ 
 
 
 
▪ 
Standard distance visual acuity
 
 
▪ 
 
 
▪ 
Review of inclusion and exclusion criteria 
▪ 
Decision to continue with determination of eligibility 
▪ 
BIOFINITY® MULTIFOCAL INITIAL CONTACT LENS INSERTION AND WEAR FOR 10 MINUTES4 
▪ 
 
 
 
 
 
▪ 
Study contact lens prescription suitability evaluation & decision to dispense or change contact lens 
power3 
 
 
 
 
 
 
 
 
 
 

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▪ 
BIOFINITY® MULTIFOCAL REMOVE INITIAL CONTACT LENS & INSERT BIOFINITY® MULTIFOCAL 
SECOND CONTACT LENS AND WEAR FOR 10 MINUTES4 
▪ 
 
 
 
▪ 
Standard distance, intermediate and near visual acuity with contact lenses (monocular & binocular) 
▪ 
 
 
▪ 
Instruction for use 
▪ 
Study product dispensing 
▪ 
Scheduling 
6.6.2 VISIT 2 – BIOFINITY® MULTIFOCAL CONTACT LENS FOLLOW-UP & MYDAY® MULTIFOCAL 
CONTACT LENS FITTING AND DISPENSING VISIT (14 ± 3 DAYS AFTER VISIT 1)  
The routine below will be followed: 
▪ 
 
 
 
 
 
▪ 
 
▪ 
LogMAR visual acuity measurement at distance, intermediate and near (monocular and binocular) 
▪ 
BIOFINITY® MULTIFOCAL CONTACT LENS REMOVAL 
▪ 
 
 
▪ 
Standard distance visual acuity 
 
▪ 
MYDAY® MULTIFOCAL INITIAL CONTACT LENS INSERTION AND WEAR FOR 10 MINUTES7,8 
▪ 
 
▪ 
 
▪ 
Standard distance, intermediate and near visual acuity with contact lenses (monocular & binocular) 
▪ 
Study contact lens prescription suitability evaluation & decision to dispense or change contact lens 
power9 
▪ 
MYDAY® MULTIFOCAL REMOVE INITIAL CONTACT LENS & INSERT MYDAY® MULTIFOCAL 
SECOND CONTACT LENS AND WEAR FOR 10 MINUTES9 
▪ 
 
 
 
▪ 
Standard distance and near visual acuity with contact lenses (monocular & binocular) 
▪ 
Study contact lens prescription suitability evaluation & decision to dispense or change contact lens 
power10 
▪ 
Instruction for use 
▪ 
Study product dispensing  
▪ 
Scheduling 
 
4 
  
 
 
 
 
 
 
 
 
  
 

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6.6.3 VISIT 3– MYDAY® MULTIFOCAL CONTACT LENS FOLLOW-UP & DISCHARGE VISIT (14 ± 3 DAYS 
AFTER VISIT 2) 
The routine below will be followed: 
▪ 
 
 
 
 
 
▪ 
 
▪ 
 
▪ 
LogMAR visual acuity measurement at distance, intermediate and near (monocular and binocular) 
▪ 
MYDAY® MULTIFOCAL® CONTACT LENS REMOVAL 
▪ 
Safety ocular integrity11 
▪ 
Standard distance visual acuity 
 
▪ 
Discharge 
7 
SAMPLE SIZE DETERMINATION AND STATISTICAL ANALYSIS  
7.1 
Sample Size Determination 
Sample size calculations took into consideration that the two co-primary endpoints to assess contact lens 
handling, inserting and removal, will be both required to be met at the completion of the study to demonstrate 
the study hypothesis.  Accordingly non-inferiority testing was carried out considering a power of 90% in order 
to achieve a final power of 80% to test simultaneously the two primary endpoints. No adjustment is required 
for α. 
The results of a previous study involving similar population which measured contact lens handling (0-100 
points visual analogue scale) achieved a standard deviation of the difference between two study contact 
lenses of 9.6 and 14.7 for insertion and removal respectively [1].  To demonstrate non-inferiority at both 
insertion and removal , considering a margin of non-inferiority of -7.00 and assuming no difference between 
test and control, for a one-sided paired t-test with α = 2.5% and ß = 10%, 49 participants are required to 
complete the study as per the protocol. 
The reference study being conducted in the USA and involving a slightly different protocol (masked vs. open 
label) and considering that to be representative of the full range of presbyopes with similar number of young 
emergent, established and older advanced presbyopes with possible different levels of dexterity, the aim is 
to achieve a per protocol total population of 60 participants made up of approximately 20 in each of emergent 
low addition presbyopes (near addition +0.75D to +1.25D),established medium addition presbyopes (near 
addition +1.50D and +1.75D) and advanced high addition presbyopes (near addition+2.00D to +2.50D). 
7.2 
Statistical Analysis Plan 
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. 
The comparison between test and reference contact lenses, in terms of ease of insertion (0-100 VAS) and 
ease of removal (0-100VAS) will be carried out using Generalized Linear Mixed Model.  The model will include 
 
11 Eye rinse after ocular evaluation with fluorescein 

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contact lens (test, reference) and order (Visit1, Visit2) as fixed factor. Their interaction will be included in the 
analysis. The covariance structure that best models the residuals errors will be selected according to the 
AICC. The comparison between test and reference contact lens will be carried out using the 95% confidence 
interval (CI) of the mean difference estimated by GLMM.  Non-inferiority will be demonstrated if the 2-sided 
95% CI of the mean difference lies entirely above the margin of non-inferiority of -7.0.  In the event that non-
inferiority is demonstrated testing for equivalence will be carried out. 
A detailed statistical analysis plan will be developed prior to database closure. 
8 
RISK ANALYSIS 
8.1 
Benefits 
There might not be direct benefits to the participants in this study. However, participation in a study may 
contribute to scientific research information that may be used to optimise the refitting procedure of multifocal 
contact lenses.  In addition, participants, who all have presbyopia and are current multifocal contact lens 
wearers, will have the opportunity to try the two contact lens vision alternatives, at no cost to them and identify 
if they prefer one type vs. the other and / or prefer either type to their own contact lenses.  Any participant 
that prefers one of the two contact lens types to their own and wishes to switch contact lens type will be able 
to purchase the preferred contact lenses from their own eyecare practitioner at the end of the study. 
8.2 
Risks 
All the assessments are routine clinical procedures or more detailed procedures, none presenting any 
increased risk to participants compared with normal clinical routine. 
All participants will be current soft contact lens wearers. The risks of taking part in the study are no greater 
than those associated with wearing their own contact lenses.  The reference and the test contact lenses are 
CE marked, currently marketed daily disposable contact lenses.  The risks associated with wearing the 
reference and the test contact lenses are similar to wearing any type of approved marketed soft contact lens. 
Complications may occur due to non-compliant behaviour. This will be mitigated by the investigator providing 
the participant with indications for use for the contact lenses prior to dispensing.  The participants will be 
under the care of the research investigators for the four weeks study period and the investigators will be 
present to deal with any unexpected event. 
The participants will have their vision checked at the onset of the study and prior to exiting the study to ensure 
that their vision remained unchanged. 
8.3 
Conclusion 
OCULAR TECHNOLOGY GROUP - International has determined that the proposed clinical investigation, 
based on the users and products effectiveness risks and the risk management strategy in place (preventative 
and corrective), given that the severity of problems will be mostly minor, non-permanent and the likelihood of 
occurrence is unlikely with likelihood of non-detection if problem occurs being low, this study is justified as 
the overall potential benefit to the population outweighs its risks. 
9 
ADVERSE EVENTS AND REPORTING 
9.1 
Adverse Events 

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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. 
Sponsor contact details are: 
    
 
 
 
 
       
 
 
10 DEVICE DEFICIENCIES 
Device deficiencies are defined as inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance.  For contact lens products “Product Defect” is the terminology 
typically used for an unexpected observation related to the identity, quality, durability, reliability, or usability 
of the product under investigation. 
NOTE: Observations on study products that are anticipated as a part of the device development process are 
not considered to be Product Defects or Device Deficiencies. 
Product Defects or Device Deficiencies reporting depends upon its severity and association with any 
concurrent adverse event as follows: 
i. 
If the Product Defect is associated with an adverse event, the investigator shall report the Product defect 
via the Adverse Event Notification Form.  
ii. 
If the Product Defect is not associated with an adverse event, the investigator shall report the Product 
Defect via the Clinical Product Defect Notification Form.  
iii. 
If the investigator judges that the Product Defect could have led to a Serious Adverse Event if no 
preventative action was taken, the Product Defect should be reported to the Sponsor via the Product 
Defect Notification t Form within 24 hours of becoming aware of the defect. The investigator should report 
to the IRB/EC per their reporting requirements. 
iv. 
All other Product Defects should be reported to Sponsor as soon as possible, but no later than 5 working 
days after occurrence.  
Sponsor contact details for Product Defect Notifications are: 

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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 should 
be appropriately qualified and legally entitled to practice and be trained in the proper method of obtaining 
informed consent. 
The investigator must have the appropriate resources to conduct the clinical trial, be familiar with the protocol 
and agree to adhere to it, support monitoring and auditing activities, communicate 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 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 try to ensure adequate participant recruitment; that all necessary and appropriate 
information is given to potential participants and consent is taken and that documents and clinical records 
indicate the participant is enrolled in a clinical trial.  
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 authorised 
personnel, initialled and dated by same 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 study 
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. Product Defect reporting are reported by the investigator 
and shall be report via the Clinical Product Defect Notification Form and will be included in the final report. 

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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. 
11.3 Medical Monitor Responsibilities 
The Medical Monitor will be a medical practitioner specialising 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 
 contracted 
to OTG-i Research Clinic for this activity. 
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.  
 
  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, ENISO14155:2020 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 

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13.2 Deviations from the Protocol 
13.2.1 GENERAL 
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. 
13.2.2 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. 
13.2.3 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 
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.