Clinical Evaluation of Comfilcon A Contact Lenses
Phase: NA
Conditions: Myopia
Sponsor: CooperVision International Limited (CVIL)

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PROTOCOL TITLE: 
CLINICAL EVALUATION OF COMFILCON A CONTACT LENSES 
Sponsor Study Code: 
CV-23-86
Site Study Code: (if applicable) 
N/A 
Version Number: 
1.1 
Date: 
02 NOV 2023 
Sponsor Company: 
COOPERVISION INTL LTD. 
Clinical Sites: 
Multi-Site Trial, see Appendix 13 
Study Stage: 
Confirmatory 
The information contained in these documents is confidential, privileged and only for the information of the intended recipient and may 
not be used, published or redistributed without the prior written consent of CooperVision. Please destroy/delete this document if you 
have received it in error and are not the intended recipient. 

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Protocol Author: 
Sponsor Management: 
Data Management/Statistician: 
CVI Operations Lead: 
The information contained in these documents is confidential, privileged and only for the information of the intended recipient and may 
not be used, published or redistributed without the prior written consent of CooperVision. Please destroy/delete this document if you 
have received it in error and are not the intended recipient. 

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Overall Synopsis of the Clinical Investigation Plan (Protocol) 
 
 
Sponsor Address: 
 
 
Funding Source: 
CooperVision Intl Ltd – For more details, see Study Agreements 
Investigation Sites: 
See Appendix 13 
Principal Investigators: 
See Appendix 13 
Protocol Synopsis: 
The objective of this study is to confirm the clinical performance of two 
different manufacturing processes for comfilcon A contact lenses. 
Planned Start Date 
Nov 2023 
Estimated Duration 
4 months 
Primary Study Objective 
To assess the clinical performance of comfilcon A lenses 
Overview of Study Design 
30 day refit, parallel arm of comfilcon A with a novel process (Test) vs 
comfilcon A with the current process (Control) 
Primary Outcome(s) 
logMAR visual acuity 
Secondary Outcome(s) 
None 
Visit Schedule 
Baseline & Dispensing, 1-week, 4-weeks 
Study Products 
Supplied by the Sponsor 
 
Subject Population 
# of subjects: A maximum of 79 subjects will be enrolled in order to 
achieve a minimum of 72 completed subjects 
Adults (mix of symptomatic and asymptomatic) 
Inclusion/Exclusion 
Main Inclusion criteria: Standard inclusion criteria 
Main Exclusion criteria: Standard exclusion criteria 

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TABLE OF CONTENTS 
Document Change History ................................................................................................. 3 
Study Personnel ................................................................................................................. 4 
Overall Synopsis of the Clinical Investigation Plan (Protocol) ........................................ 5 
1 
Study Objective ........................................................................................................... 9 
2 
Study Design ............................................................................................................... 9 
3 
Study Devices and Comparator Products ................................................................. 9 
3.1 
Contact Lenses ........................................................................................................... 9 
3.2 
Adjunct Products ....................................................................................................... 10 
4 
Justification for the Study Design ........................................................................... 10 
5 
Benefits/Risks of Study Device and Study Procedures .......................................... 11 
5.1 
Anticipated Clinical Benefits....................................................................................... 11 
5.2 
Anticipated Adverse Device Effects ........................................................................... 11 
5.3 
Risks Associated with Participation in the Clinical Investigation ................................. 11 
5.4 
Risks of Clinical Procedures to be Utilized in the Study ............................................. 11 
5.5 
Possible Interactions with Concomitant Medical Treatments ...................................... 12 
5.6 
Steps That will be Taken to Control or Mitigate the Risks .......................................... 12 
5.7 
Rationale for Benefit-Risk Ratio ................................................................................. 13 
6 
Ethics Review / Statement of Compliance ............................................................... 13 
6.1 
Relevant Standards / Guidelines................................................................................ 13 
6.2 
Institutional Review Board ......................................................................................... 13 
6.3 
Informed Consent ...................................................................................................... 13 
6.4 
Clinical Trial Registration ........................................................................................... 13 
7 
Design of the Clinical Investigation ......................................................................... 14 
7.1 
Study Endpoints ........................................................................................................ 14 
7.2 
Clinical Sites .............................................................................................................. 14 
7.3 
Subjects .................................................................................................................... 14 
7.4 
Procedures to Minimize Bias ..................................................................................... 15 
7.5 
Visit Procedures ........................................................................................................ 16 
8 
Adverse Events ......................................................................................................... 20 
8.1 
Adverse Event Definitions .......................................................................................... 20 
8.2 
Adverse Events Management .................................................................................... 22 
8.3 
Reporting Adverse Events ......................................................................................... 22 
8.4 
Discontinuation from the Study .................................................................................. 23 
9 
Device Deficiency Reporting .................................................................................... 23 
9.1 
Product Defect Reporting (Investigator Responsibility) ............................................... 23 
9.2 
Device Deficiency Reporting (Sponsor Responsibility) ............................................... 24 

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10 Statistical Design and Analysis ................................................................................ 24 
10.1 
Statistical Hypothesis ................................................................................................ 24 
10.2 
Sample Size Calculations .......................................................................................... 24 
10.3 
Statistical Analysis ..................................................................................................... 25 
10.4 
Interim Analysis ......................................................................................................... 25 
10.5 
Data Management ..................................................................................................... 25 
10.6 
Data Quality Assurance ............................................................................................. 26 
11 General Study Management ..................................................................................... 26 
11.1 
Monitoring Plan ......................................................................................................... 26 
11.2 
Amendments ............................................................................................................. 26 
11.3 
Protocol Deviations.................................................................................................... 27 
11.4 
Suspension or Premature Termination of the Clinical Investigation ............................ 27 
11.5 
Record Retention ...................................................................................................... 28 
11.6 
Confidentiality and Privacy ........................................................................................ 29 
12 Device Accountability ............................................................................................... 29 
12.1 
Clinical Supply Inventory ........................................................................................... 29 
12.2 
Disposal of Consumables .......................................................................................... 29 
12.3 
Ordering and Accountability of Study Materials .......................................................... 30 
13 Study Costs ................................................................................................................ 30 
14 Publication Policy ..................................................................................................... 30 
15 References................................................................................................................. 30 
16 Appendix 1 – Adverse Event Case Report Forms ................................................... 31 
17 Appendix 2 – Clinical Trial Product Defect Notification Form ................................ 34 
18 Appendix 3 – Slit Lamp Biomicroscopy Scales ...................................................... 35 
19 Appendix 4 – CLDEQ8 and DEQ5 ............................................................................. 37 
20 Appendix 5 – Habitual Questionnaire ...................................................................... 39 
1. 
OVERALL SATISFACTION ......................................................................................... 39 
2. 
COMFORT .................................................................................................................. 39 
2a.
 
 
 
 
 
 
3. 
HANDLING ................................................................................................................. 44 
4. 
VISION ....................................................................................................................... 45 
20.1 
4a. 
 

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21 Appendix 6 – Lens Surface Assessments ............................................................... 47 
22 Appendix 7 – Lens Fit Assessments ........................................................................ 48 
23 Appendix 8 – Post-Settling Questionnaire ............................................................... 49 
24 Appendix 9 – Interim Questionnaire......................................................................... 50 
25 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
28 Appendix 13 – Principal Investigator and Study Site Information .......................... 64 
28.1 
Site #1 ....................................................................................................................... 64 
28.2 
Site #2 ....................................................................................................................... 65 
28.3 
Site #3 ....................................................................................................................... 66 
28.4 
Site #4 ....................................................................................................................... 67 
28.5 
Site #5 ....................................................................................................................... 68 
28.6 
Site #6 ....................................................................................................................... 69 

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The choice of comparator product was made in order to assess the clinical performance against a currently 
marketed product representative of generally accepted state of the art. 
 
5 Benefits/Risks of Study Device and Study Procedures 
 
5.1 
Anticipated Clinical Benefits 
 
There might not be direct benefits to the subjects in this study, however participation in a new study may contribute 
to scientific research information that may be used in the development of new contact lens products. In addition, 
subjects will receive an examination of the front of their eyes. 
5.2 
Anticipated Adverse Device Effects 
 
Ocular complications that may occur during the wearing of contact lenses include discomfort, dryness, aching or 
itching eyes, burning, grittiness, excessive tearing, discharge, hyperemia and variable or blurred vision. More 
serious risks may include photophobia, iritis, corneal edema or eye infection. Although contact lens-related 
infections are very infrequent, the possibility does exist. The incidence of infection due to daily-wear soft lenses is 
0.035%.1 Almost always an infection will occur only in one eye. This risk is assumed by 35-million Americans who 
currently wear contact lenses. 
5.3 
Risks Associated with Participation in the Clinical Investigation 
 
This is considered a non-significant risk study based on United States Food and Drug Administration (FDA) 
guidelines due to the daily wear nature of the study. The risks associated with the investigational contact lenses 
have been estimated in accordance with ISO 14971. A synopsis of risks associated with this device are discussed 
within the Package Insert. Risk controls to reduce the risk as far as possible have been implemented and any 
residual risks will be further mitigated through close evaluation by the investigators under this clinical protocol and 
communicated via informed consent. 
5.4 
Risks of Clinical Procedures to be Utilized in the Study 
 
Routine, non-invasive procedures will be conducted in this study. Routine clinical procedures include auto- 
refraction, auto-keratometry, visual acuity, anterior ocular health assessment, and contact lens fitting will be used. 
In addition, standard research procedures such as high magnification imaging of the lens fit may be made using 
35 mm or digital cameras, in vivo confocal microscopy, and/or specular microscopy. 

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5.5 
Possible Interactions with Concomitant Medical Treatments 
 
The use of contact lenses can interact with concomitant topical, ocular and/or systemic medical treatments, 
therefore only healthy subjects who are not currently taking concomitant medical treatments will be included in this 
study. Artificial tears, re-wetting drops, and lubricating agents are not considered medical treatments. Only those 
products approved for the use with contact lenses can be used according to their indication under this protocol. 
5.6 
Steps That will be Taken to Control or Mitigate the Risks 
 
The following Information for Safety for contact lens wear during the clinical study will be reviewed with each 
subject: 
Hands should be washed and dried prior to touching the lenses for insertion or removal. If inserting the 
lenses yourself, they should be checked for tears and/or whether they are inside out prior to insertion. Eye 
rubbing should be avoided. Contact lenses should never be worn while swimming or in any other hazardous 
environment. The contact lenses are not to be slept in during the study or worn overnight. Contact lens care 
solution will be provided by the Investigator and should be used according to manufacturer instructions. 
 
Additionally, the contact lens should not be used if there is an active ocular inflammation, any eye disease 
or systemic disease that may affect contact lens wear, or if there is any known allergic reaction to a known 
ingredient in the lens or lens care solution. 
 
The risks associated with contact lens wear are known to increase with the following and will be 
communicated to the subject in the safety instruction pamphlet. 
• 
Overnight wear/sleeping with lenses 
• 
Exposure of lenses or lens case to water 
• 
Smoking 
• 
Exposure to aerosols or noxious stimuli 
• 
Unclean hands for insertion/removal 
• 
Exposure to water (such as using water to rinse a lens) 
• 
Swimming 
• 
Use of lens care solution with daily disposable lens wear 
• 
Cosmetic use 
• 
Eye rubbing 
• 
Insertion of an inverted lens 
• 
Insertion of the wrong lens into the wrong eye 
• 
Use of tools to either remove the lens from the blister pack or to insert the lens onto the eye 
• 
Sharing contact lenses with others 
• 
Improper storage 
• 
Use of a lens from a damaged blister pack 

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5.7 
Rationale for Benefit-Risk Ratio 
 
The knowledge gained from this study may lead to important conclusions regarding the ocular response and 
performance of new contact lens materials and designs. The potential risks for participating in this study are 
minimal, therefore the benefit-risk ratio is acceptable. 
 
6 Ethics Review / Statement of Compliance 
 
6.1 
Relevant Standards / Guidelines 
 
This study was developed in accordance with 21 CFR Part 812 Investigational Device Exemptions and the Good 
Clinical Practice (GCP) principles and ethical considerations of ISO 14155 Clinical Investigation of Medical Devices 
for Human Subjects, Declaration of Helsinki, and 21 CFR Part 50 Protection of Human Subjects. The detailed 
descriptions of ocular Adverse Events details and the biomicroscopy grading scales are adapted from ISO 11980 
Ophthalmic Optics – Contact lenses and lens care products – Guidelines for clinical investigations. 
6.2 
Institutional Review Board 
 
This study will be conducted in accordance with Institutional Review Board regulations (U.S. 21CFR Part 56.103). 
Copies of all IRB correspondence with the investigator/Sponsor will be kept on file. 
This study adheres to a protocol and informed consent document approved by the Institutional Review Board at 
Sterling IRB. 
 
Address: 
Sterling Institutional Review Board 
6300 Powers Ferry Rd Suite 600-351 
Atlanta GA 30339 
Tel: 1-888-636-1062 
 
6.3 
Informed Consent 
 
Informed consent shall be obtained in writing from the subject and the process shall be documented before any 
procedure specific to the clinical investigation is carried out. 
6.4 
Clinical Trial Registration 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. 

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7 Design of the Clinical Investigation 
 
7.1 
Study Endpoints 
 
The primary endpoint is: 
• logMAR distance (4m) high illumination high contrast visual acuity at the 4-week timepoint 
 
 
7.2 
Clinical Sites 
 
The clinical sites were selected based on the availability of representative population of subjects and Investigator’s 
clinical research experience. 
The Investigators will be required to fulfill the following criteria: 
• 
Trained and experienced in the conduct of clinical research 
• 
Willingness to follow the study protocol 
• 
Trained in Good Clinical Practice (GCP) and the study protocol prior to commencing the study. 
 
7.3 
Subjects 
 
A maximum of 79 subjects will be enrolled in this study in order for approximately 72 to complete the study. Each 
subject will be given a unique ID number. ID numbers will not be re-used. All subjects must meet the study inclusion 
and exclusion criteria listed below. 
7.3.1 Inclusion Criteria 
A person is eligible for inclusion in the study if they: 
• 
Have had a self-reported oculo-visual examination in the last year. 
• 
Are at least 18 years of age and has full legal capacity to give their informed consent. 
• 
Have read and understood the informed consent form. 
• 
Are willing and able to follow instructions and maintain the appointment schedule. 
• 
Have a contact lens spherical prescription between -0.50 D to -6.00 D (inclusive) 
• 
Are correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 
20/20 best-corrected. 
• 
Have spectacle cylinder of ≤ 0.75 D in both eyes. 
• 
Is a habitual comfilcon A wearer and worn a comfilcon A lens for at least one month (minimum of 8 hours 
a day, 5 days per week) 
• 
Currently employ the use of a peroxide or multipurpose solution cleaning and disinfecting regimen in one 
of the following brand names: 

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o Bausch and Lomb BioTrue Multi-Purpose Solution 
o Bausch and Lomb BioTrue Hydration Plus Multi-Purpose Solution 
o Bausch and Lomb ReNu Advanced Formulation Multi-Purpose Solution 
o Alcon Opti-Free Puremoist with Hydraglyde Multi-Purpose Solution 
o Alcon Opti-Free Replenish Multi-Purpose Solution 
o Alcon Clear Care Plus Hydrogen Peroxide Solution 
o Acuvue RevitaLens Multi-Purpose Solution 
• 
Have clear corneas and no active ocular disease. 
• 
Have not worn habitual lenses for at least 12 hours before the baseline/screening examination 
• 
Are willing to wear the study contact lenses for at least 8 hours per day, 5 days per week 
 
7.3.2 Exclusion Criteria 
A person will be excluded from the study if they: 
• 
Have never worn contact lenses before. 
• 
Are currently wearing daily disposable contact lenses. 
• 
Have any systemic disease affecting ocular health. 
• 
Are using any systemic or topical medications that will affect ocular health. 
• 
Have any ocular pathology or abnormality that would affect the wearing of contact lenses. 
• 
Have any clinically significant lid or conjunctival abnormalities, active neovascularization or any central 
corneal scars. 
• 
Are aphakic. 
• 
Have undergone corneal refractive surgery. 
• 
Are participating in any other type of eye related clinical or research study. 
• 
Require a change in lens power from more than 1 diopter as dictated by over-refraction with their habitual 
lens prescription. 
7.4 
Procedures to Minimize Bias 
 
7.4.1 Labelling and Masking 
Although approved for use in the country where the clinical study is taking place, the Test and Control lenses will 
all be overlabelled with an investigational label to facilitate investigator and subject masking. 
 
Decoding/Masking Procedures: 
The Principal Investigator will be provided, prior to commencing the study, with the masking codes in a sealed 
envelope and decoding/demasking procedures for use in a medical emergency or where Serious Adverse Events 
are considered to be related to the Investigative or Control devices. 

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24 
Any sign and/or symptom for which temporary lens discontinuation for > 1 day 
is recommended (if not already classified) 
reporting as per 
requirements 
20 
Other sign and/or symptom warranting classification as a non-significant 
adverse event 
 
Normal or adaptive symptoms 
Transient symptoms such as end-of-day dryness, lens awareness, itching or burning or other discomfort may occur 
with contact lens wear and may occasionally reduce wearing time. These are not reported as adverse events 
unless in the investigator’s opinion they are unexpected in nature, severe or have a high rate of occurrence. 
 
This clinical study will also ascertain satisfaction or preference with subjective attributes such as comfort, vision, or 
lens handling. Responses to these subjective questionnaires will not be considered as Adverse Events. 
8.2 
Adverse Events Management 
 
Treatment of an adverse event will depend on its nature and severity. Based on the clinical judgment of the 
investigator the subject may be referred to an ophthalmologist for treatment. 
Expenses incurred for medical treatment as part of study participation will be paid by the Sponsor (bills and 
prescription receipts kept). The subject must be followed until resolution and an Adverse Event Outcome Form 
(Appendix 1) completed indicating the course of treatment and resolution of the condition. 
8.3 
Reporting Adverse Events 
 
An Adverse Event Notification Form (Appendix 1) will be completed for each adverse event. Whenever possible, 
the adverse event will be photo-documented. 
All potential Serious and Unanticipated Adverse Device Effects that are related or possibly related to subject 
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 IRB per the IRB’s reporting 
requirements. All fatal or life threatening events will be reported immediately to the IRB. 
Significant and Non-Significant Adverse Events will be reported to the Sponsor as soon as possible, but no later 
than 5 days after the occurrence. 
Sponsor contact details for adverse events are: 
 
Contact: 
Clinical Operations, CooperVision 
Email: 
adverse.events@coopervision.com 
Phone: 
(925) 730-6766 or (925) 251-6684 / Fax: (925) 251-6641 
Address: 
5870 Stoneridge Drive, Suite 1 
Pleasanton, CA 94588 

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8.4 
Discontinuation from the Study 
 
A subject’s study participation may be discontinued at any time if, in the opinion of the Sponsor or the investigator, 
it is in the best interest of the subject. All discontinuations will be fully documented on the appropriate study forms 
and a discontinuation/exit form will be completed. 
 
9 Device Deficiency Reporting 
 
9.1 
Product Defect Reporting (Investigator Responsibility) 
 
Product Defect is the terminology typically used in contact lens products 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. 
If the Product Defect is associated with an adverse event, the investigator shall report the Product defect via the 
Adverse Event Notification Form (Appendix 1). 
If the Product Defect is not associated with an adverse event, the investigator shall report the Product Defect via 
the Clinical Product Defect Notification Case Report Form (Appendix 2). 
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 Case 
Report Form within 24 hours of becoming aware of the defect. The investigator should report to the IRB per their 
reporting requirements. 
All other Product Defects should be reported to CVI as soon as possible, but no later than 5 working days after 
occurrence. 
Sponsor contact details for Product Defect Notifications are: 
 
Contact: 
Clinical Operations, CooperVision 
Email: 
clinical.operations@coopervision.com 
Address: 
5870 Stoneridge Drive, Suite 1 
Pleasanton, CA 94588 

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9.2 
Device Deficiency Reporting (Sponsor Responsibility) 
 
Device Deficiency is defined as the inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, usability, safety or performance. 
The Sponsor will review the Product Defect Notification Case Report Form, gather additional information if needed 
from the Investigator and determine whether the notification represents a Device Deficiency. Device Deficiencies 
will be reported as per Internal CVI procedures. 
A summary of Device Deficiencies will be documented in the clinical study report. If no Device Deficiencies are 
observed in a study, then a statement stating as such will be included in the clinical study report. 
10 Statistical Design and Analysis 
 
10.1 Statistical Hypothesis 
 
In this confirmatory study, the primary statistical hypothesis is that the logMAR visual acuity performance with the 
Test lens will demonstrate there is no statistical difference comparing to the Control lens over one month of lens 
wear. 
The null and alternative hypotheses are: 
H0: μt = μc 
H1: μt ≠ μc 
Where μt refers to the LogMAR of Test lenses and μc refers to LogMAR of Control lenses. 
 
 
10.2 Sample Size Calculations 
 
The number of subjects that has been chosen in this study is to provide sufficient evidence to demonstrate the 
study hypothesis of “there is no difference between the Test and Control” versus “there is a difference between 
the Test and Control” on visual acuity (LogMAR) measurement. With assumed standard deviation is equal to 
0.06, a sample size of 24 subjects per group will provide adequate power (92%) to detect a visual acuity 
difference of 0.06 (3 letters) at α=0.05 level. 
 
Therefore, for this parallel arm study design with 2:1 ratio, minimum 72 subjects (48 in test arm and 24 in control 
arm) to complete is required. To account for subject attrition of 10%, up to 79 subjects will be enrolled in this study. 

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10.3 Statistical Analysis 
 
Statistical analysis will be undertaken by the study biostatistician. Data for all subjects who have completed the trial 
will be included in the analysis. 
Descriptive statistics (e.g., mean, standard deviation) and/ or frequency of counts for categorical data may be 
produced for primary and/or second interests. Paired t-test may be used to compare slit lamp biomicroscopy, lens 
fit and subjective scores between study lens types. Where applicable, Repeated Measures Analysis of Variance 
(ANOVA) or paired analysis may be used to compare the variables between study visits. The critical alpha level for 
statistical significance will be set at p ≤ 0.05, with adjustment for multiple comparisons. 
10.4 Interim Analysis 
 
An interim analysis is planned to be completed once 30 subjects have completed all visits or on Dec 18, 2023, 
whichever comes first. The Sponsor may stop enrollement for this study if there are obvious signs that the Test 
and Control lenses are not performing similarly. 
10.5 Data Management 
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the clinical site 
Principal Investigator. The Principal Investigator is responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. All source documents should be completed in a neat, legible manner to ensure 
accurate interpretation of data. 
The clinical data for this study may be entered by designated study site personnel onto paper and electronic case 
report forms (CRFs). Case history and symptoms questionnaires may be given to subjects to complete in paper or 
electronic form. 
Unless otherwise documented, the CRFs will be considered the source document. 
 
The Sponsor or Sponsor’s representatives will be authorized to gain access to the source documentation for the 
purposes of monitoring and auditing the study. 
If study information is collected using an automated piece of equipment, the information may be recorded directly 
from the instrument display, captured electronically as output, or printed and entered into the CRF. The CRF will 
become the source document if there is no printout. 

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10.6 Data Quality Assurance 
 
The CRFs will be completed at the time of the visit. All clinical data generated in the study will be submitted to the 
Sponsor for quality assurance review and analysis. All forms will be reviewed for completeness and evident 
recording errors will be rectified by contacting the appropriate clinical site. Computerized editing routines will be 
used to identify missing, invalid, inconsistent, or questionable data entries for verification prior to data analysis. 
These data issues will be resolved by contacting the relevant clinical site. 
 
11 General Study Management 
 
11.1 Monitoring Plan 
 
The Sponsor will ensure site qualification of the investigative site has been completed prior to conducting the clinical 
study in order to ensure that the site facility is adequate, personnel are qualified and resources are satisfactory. 
The protocol will be reviewed by the Principal Investigators prior to enrollment of the first subject. This will involve 
an overview of the protocol, which includes information on study objectives, inclusion and exclusion criteria, study 
visits and adverse event reporting. Data collection forms will also be reviewed and this will provide an opportunity 
to discuss any questions. 
During the course of the study, a site visit may be conducted to verify that written informed consent was obtained 
using the IRB approved ICF prior to each subject’s participation in the study. 
Findings of non-compliance shall be reviewed with the Investigator and disclosed in a written monitoring 
report/document. The Monitor will report to the Sponsor any findings of non-compliance with signed agreements, 
conditions imposed by the IRB and the requirements of the study protocol. The Sponsor shall then either secure 
compliance or discontinue shipments of the lenses to the site and may terminate the Investigator’s participation in 
the investigation, if required. 
Prior to final data freeze, a close-out visit/discussion may be warranted to check for accuracy and completeness of 
records. The Sponsor or Sponsor’s representatives will be authorized to gain access to the source documentation 
for the purposes of monitoring and auditing the study. 
11.2 Amendments 
 
Amendments to this Protocol that may affect the rights, safety, or well-being of subjects will require review and 
approval from IRB before the changes are implemented in the study. Investigators at the site will be provided with 
the revised protocol version, the site trained and the Protocol Signature Page of the amended protocol completed 
prior to enacting the amendments. 

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11.3 Protocol Deviations 
 
A Protocol Deviation is an instance of failure to follow, intentionally or unintentionally, the requirements of the 
protocol. Investigators will not deviate from the protocol except to protect the rights, safety and well-being of 
human subjects or if otherwise pre-approved by the Sponsor in writing for non-emergency circumstances. Under 
emergency circumstances deviations may proceed without prior approval of the Sponsor and the IRB. Deviations 
shall be reported to the Sponsor, IRB and the regulatory bodies, as required. 
Significant deviations which require changes to the research protocol or informed consent process/document or 
other corrective actions to protect the safety, welfare, or rights of patients or others must be reported to the IRB 
within ten business days of the deviation occurring (or its discovery). All deviations shall be reported to the Sponsor 
within five working days. 
All deviations that occurred during the study will be documented on a protocol deviation form and documented in 
the final Clinical Study Report (CSR). 
Sponsor contact details for Protocol Deviations are: 
 
Contact: 
Clinical Operations, CooperVision 
Email: 
clinical.operations@coopervision.com 
Address: 
5870 Stoneridge Drive, Suite 1 
Pleasanton, CA 94588 
 
11.4 Suspension or Premature Termination of the Clinical Investigation 
 
The study may be suspended or prematurely terminated if there is sufficient reasonable cause. Written notification, 
documenting the reason for study suspension or termination, will be provided by the suspending or terminating 
party to the Investigator, the Sponsor and the Institutional Review Board (IRB), as appropriate. If the study is 
prematurely terminated or suspended, the Investigator will promptly inform the IRB and will provide the reasons for 
the termination or suspension. In terminating the clinical investigation, CooperVision and the Principal Investigators 
will assure that adequate consideration is given to the protection of the subjects interests. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to subjects 
• 
Demonstration of efficacy that would warrant stopping 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 

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The blinding/masking code may be broken and communicated to the Principal Investigator only in the case of an 
emergency, such as an Adverse Event that requires knowledge of the identity of the investigational product in order 
to manage the subjects' condition. 
The study may resume once concerns about safety, protocol compliance or data quality are addressed and satisfy 
the Sponsor and IRB. 
Subjects will continue to receive follow-up care until they are able to be exited from the study (in the case of study 
termination) or are able to resume participation in the study (in the case of temporary study suspension), whereupon 
they will also be followed to exit. 
11.5 Record Retention 
 
Following study completion, data will be available in electronic and/or paper format for audit, Sponsor use, or 
subsequent analysis. 
Documents will be retained in a manner which allows for timely retrieval. Where documents are maintained in an 
electronic system, the system will be required to be maintained for the life of the document or the documents 
migrated to a system allowing for the continued retrieval of the document until the retention period has been 
completed. 
Access to the Network, eQMS or other electronic storage is secured to minimize potential loss or unauthorized 
changes. Documents will be stored in a manner to prevent loss and damage. 
Applicable hard copy documents will be secured as appropriate and maintained in a manner to prevent loss or 
damage. 
If hard copy records are retained in an archive store, a log of the content of each pallet and box in the archive 
should be kept in order to enable swift record retrieval. This log should contain the pallet and box owning 
department, record type and date range covered. 
The content of archives should be reviewed periodically. The storage of the records in the archive must be 
appropriate and in good condition to ensure that records inside are not damaged. 
Certain Quality/Regulatory Documented Information is noted as having permanent retention periods due to 
complex regulatory requirements. Permanent records should be held securely. A fireproof room or safe may be 
used. 
Permanent records may be considered for destruction. Consideration will be based on a documented request 
forwarded to the site Quality Assurance leader, or a member of the Global Quality Systems team. The request must 
be reviewed and approved by the Sponsor prior to any destruction. 

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The request and approval will include: 
• 
the requestors name and title, 
• 
date of the request, 
• 
approvers name and title, 
• 
date of approval, 
• 
list of the Documented Information to be destroyed. 
 
 
11.6 Confidentiality and Privacy 
 
This study is confidential in nature. All information gathered during this study is proprietary and should be made 
available only to those directly involved in the study. Information and reports arising from this project are the 
property of the Sponsor. 
All records will be handled in accordance with HIPAA (1996) standards. The privacy of each subject and 
confidentiality of his/her information shall be preserved in reports and when publishing any data. 
Confidentiality of data shall be observed by all parties involved at all times throughout the clinical investigation. All 
data shall be secured against unauthorized access. Documentation containing personal and/or confidential 
identifying information for clinical trial subjects participating in studies will be maintained in a secured locked 
location. The Principal Investigator or investigation site shall provide direct access to source data during and after 
the clinical investigation for monitoring, audits, IRB review and regulatory authority inspections. 
Details on publishing rights are contained in each site’s master clinical services agreement with the Sponsor. 
 
12 Device Accountability 
 
12.1 Clinical Supply Inventory 
 
The Principal Investigator must keep an accurate accounting of the study product during the study. A detailed 
inventory must be completed for study supplies. The study supplies are to be used in accordance with the study 
protocol by subjects who are under the direct supervision of an investigator. 
12.2 Disposal of Consumables 
 
This study dispenses consumables (lenses) to subjects for use during the study. All study lenses, including study 
lenses worn by subjects will be collected at the completion of the study. Unopened contact lens care solutions will 
be returned to the Sponsor; any opened solutions may be discarded or kept by the sites. 

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12.3 Ordering and Accountability of Study Materials 
 
The Test and Control lenses will be provided by the Sponsor. The Principal Investigator must complete an accurate 
accounting of the study product at the completion of the study. All unused and used materials will be returned to 
the Sponsor at the end of the study unless the site is otherwise directed by the study Sponsor. 
 
13 Study Costs 
 
The Sponsor will compensate the clinical site and the subjects for their time and participation in this voluntary study. 
 
Expenses incurred for medical treatment as part of study participation will be paid by the Sponsor (bills and 
prescription receipts kept). The subject must be followed until resolution and a written report completed indicating 
the subsequent treatment and resolution of the condition. 
 
14 Publication Policy 
 
Due to the confidential and proprietary nature of the clinical study, any presentation and/or publication including 
but not limited to those made at scientific meetings, in-house, in peer-review journals, professional publications, 
etc. cannot be published without the written consent of the Sponsor. Details of the publication procedures are in 
the clinical study agreement or within the master clinical services agreements. 
 
15 References 
 
 
1 Cheng K, Leung S, Hoekman H, Beekhuis W, Mulder P, Geerards A, Kijlstra A. Incidence of contact-lens-associated 
microbial keratitisand its related morbidity. The Lancet 1999; 354:181-185. 

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16 Appendix 1 – Adverse Event Case Report Forms 
 
 

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C'IIAE lh,1iilllo111ii,n r- 
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C-llilllln I 
hphf2 

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17 Appendix 2 – Clinical Trial Product Defect Notification Form 
 
 

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18 Appendix 3 – Slit Lamp Biomicroscopy Scales 
 
 
 

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19 Appendix 4 – CLDEQ8 and DEQ5 
 
 

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21 Appendix 6 – Lens Surface Assessments 
 
 

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24 Appendix 9 – Interim Questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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28 Appendix 13 – Principal Investigator and Study Site Information 
 
28.1 Site #1 
 
 
Protocol: CV-23-86 
Study Title: 
Clinical Evaluation of comfilcon A Contact Lenses 
Protocol Version: 1.1, Date: 02 NOV 2023 
 
I have received and read this protocol and agree to adhere to the requirements. I am aware that my 
adherence to the above protocol is mandatory and that any changes in the protocol or informed 
consent form must first be approved by CVI and the Institutional Review Board (IRB), except those 
changes necessary to eliminate apparent immediate hazards to subjects. I will provide copies of 
this protocol and all pertinent information to the study personnel under my supervision. I will discuss 
this material with them and ensure they are fully informed regarding their role in the study and trained 
on this protocol. I will ensure that the study is conducted in compliance with the protocol, Good 
Clinical Practice (GCP), and all applicable regulatory requirements, and with the reviewing (IRB) 
requirements. I agree to commence this study only after documented IRB approval is obtained. 
 
 
 
 
 
Principal 
Investigator 
 
 
  
Signature 
Date 
 
Printed Name 
 
 
Title: 
Study Site: 
Address: 
 
Telephone: 
Email: 

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28.2 Site #2 
 
 
Protocol: CV-23-86 
Study Title: 
Clinical Evaluation of comfilcon A Contact Lenses 
Protocol Version: 1.1, Date: 02 NOV 2023 
 
I have received and read this protocol and agree to adhere to the requirements. I am aware that my 
adherence to the above protocol is mandatory and that any changes in the protocol or informed 
consent form must first be approved by CVI and the Institutional Review Board (IRB), except those 
changes necessary to eliminate apparent immediate hazards to subjects. I will provide copies of 
this protocol and all pertinent information to the study personnel under my supervision. I will discuss 
this material with them and ensure they are fully informed regarding their role in the study and trained 
on this protocol. I will ensure that the study is conducted in compliance with the protocol, Good 
Clinical Practice (GCP), and all applicable regulatory requirements, and with the reviewing (IRB) 
requirements. I agree to commence this study only after documented IRB approval is obtained. 
 
 
 
 
 
Principal 
Investigator 
 
 
  
Signature 
Date 
 
Printed Name 
 
 
 
 
Title: 
Study Site: 
Address: 
 
Telephone: 
Email: 

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28.3 Site #3 
 
 
Protocol: CV-23-86 
Study Title: 
Clinical Evaluation of comfilcon A Contact Lenses 
Protocol Version: 1.1, Date: 02 NOV 2023 
 
I have received and read this protocol and agree to adhere to the requirements. I am aware that my 
adherence to the above protocol is mandatory and that any changes in the protocol or informed 
consent form must first be approved by CVI and the Institutional Review Board (IRB), except those 
changes necessary to eliminate apparent immediate hazards to subjects. I will provide copies of 
this protocol and all pertinent information to the study personnel under my supervision. I will discuss 
this material with them and ensure they are fully informed regarding their role in the study and trained 
on this protocol. I will ensure that the study is conducted in compliance with the protocol, Good 
Clinical Practice (GCP), and all applicable regulatory requirements, and with the reviewing (IRB) 
requirements. I agree to commence this study only after documented IRB approval is obtained. 
 
 
 
 
 
Principal 
Investigator 
 
 
  
Signature 
Date 
 
Printed Name 
 
 
 
 
Title: 
Study Site: 
Address: 
 
Telephone: 
Email: 

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28.4 Site #4 
 
 
Protocol: CV-23-86 
Study Title: 
Clinical Evaluation of comfilcon A Contact Lenses 
Protocol Version: 1.1, Date: 02 NOV 2023 
 
I have received and read this protocol and agree to adhere to the requirements. I am aware that my 
adherence to the above protocol is mandatory and that any changes in the protocol or informed 
consent form must first be approved by CVI and the Institutional Review Board (IRB), except those 
changes necessary to eliminate apparent immediate hazards to subjects. I will provide copies of 
this protocol and all pertinent information to the study personnel under my supervision. I will discuss 
this material with them and ensure they are fully informed regarding their role in the study and trained 
on this protocol. I will ensure that the study is conducted in compliance with the protocol, Good 
Clinical Practice (GCP), and all applicable regulatory requirements, and with the reviewing (IRB) 
requirements. I agree to commence this study only after documented IRB approval is obtained. 
. 
 
 
 
 
 
 
Principal 
Investigator 
 
 
  
Signature 
Date 
 
Printed Name 
 
 
 
 
Title: 
Study Site: 
Address: 
 
Telephone: 
Email: 

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28.5 Site #5 
 
 
Protocol: CV-23-86 
Study Title: 
Clinical Evaluation of comfilcon A Contact Lenses 
Protocol Version: 1.1, Date: 02 NOV 2023 
 
I have received and read this protocol and agree to adhere to the requirements. I am aware that my 
adherence to the above protocol is mandatory and that any changes in the protocol or informed 
consent form must first be approved by CVI and the Institutional Review Board (IRB), except those 
changes necessary to eliminate apparent immediate hazards to subjects. I will provide copies of 
this protocol and all pertinent information to the study personnel under my supervision. I will discuss 
this material with them and ensure they are fully informed regarding their role in the study and trained 
on this protocol. I will ensure that the study is conducted in compliance with the protocol, Good 
Clinical Practice (GCP), and all applicable regulatory requirements, and with the reviewing (IRB) 
requirements. I agree to commence this study only after documented IRB approval is obtained. 
 
 
 
 
 
Principal 
Investigator 
 
 
  
Signature 
Date 
 
Printed Name 
 
 
 
 
Title: 
Study Site: 
Address: 
 
Telephone: 
Email: 

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28.6 Site #6 
 
 
Protocol: CV-23-86 
Study Title: 
Clinical Evaluation of comfilcon A Contact Lenses 
Protocol Version: 1.1, Date: 02 NOV 2023 
 
I have received and read this protocol and agree to adhere to the requirements. I am aware that my 
adherence to the above protocol is mandatory and that any changes in the protocol or informed 
consent form must first be approved by CVI and the Institutional Review Board (IRB), except those 
changes necessary to eliminate apparent immediate hazards to subjects. I will provide copies of 
this protocol and all pertinent information to the study personnel under my supervision. I will discuss 
this material with them and ensure they are fully informed regarding their role in the study and trained 
on this protocol. I will ensure that the study is conducted in compliance with the protocol, Good 
Clinical Practice (GCP), and all applicable regulatory requirements, and with the reviewing (IRB) 
requirements. I agree to commence this study only after documented IRB approval is obtained. 
 
 
 
 
 
Principal 
Investigator 
 
 
  
Signature 
Date 
 
Printed Name 
 
 
 
 
Title: 
Study Site: 
Address: 
 
Telephone: 
Email: