Clinical Validation Study of Biofinity Multifocal Toric Contact Lenses
Phase: NA
Conditions: Presbyopia
Sponsor: CooperVision, Inc.

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Study Implementation document: Protocol 
CLINICAL VALIDATION STUDY OF BIOFINITY MULTIFOCAL TORIC CONTACT 
LENSES 
Study Sponsor Representative:  ______________________ 
Date:_______________ 
CooperVision Sponsor Management:  ______________________ 
Date:_______________ 
. 
Site Principal Investigator: ______________________ 
Date:_______________ 
Sponsor Study Code: 
CV-18-10
Version Number: 
2.0
Implementation document Date: 
09 Feb 2018
Sponsor Company:  
CooperVision, Inc.
Document Type: 
Protocol
Study Category: 
Clinical Sites: 

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TABLE OF CONTENTS 
1 
Introduction ................................................................................................................. 5 
2 
Study Objective ........................................................................................................... 5 
2.1 
Study Hypothesis ........................................................................................................ 5 
3 
Study Design ............................................................................................................... 5 
4 
Ethics Review / Statement of Compliance ................................................................. 6 
4.1 
Relevant Standards / Guidelines ................................................................................ 6 
4.2 
Institutional Review Board .......................................................................................... 6 
4.3 
Informed Consent ....................................................................................................... 6 
5 
Clinical Trial Registration ........................................................................................... 6 
6 
Potential Risks and Benefits to Human Subjects ..................................................... 7 
7 
Materials and Methods ................................................................................................ 7 
7.1 
Subjects...................................................................................................................... 7 
7.2 
Study Materials ........................................................................................................... 9 
7.3 
Visit Schedule and Procedures ..................................................................................10 
8 
Adverse Event Reporting .......................................................................................... 16 
8.1 
Adverse Event Definitions ..........................................................................................16 
8.2 
Procedures for Adverse Events .................................................................................17 
8.3 
Reporting Adverse Events .........................................................................................18 
8.4 
Discontinuation from the Study ..................................................................................18 
9 
Device Malfunctions .................................................................................................. 19 
10 
Statistical Analysis .................................................................................................... 19 
10.1 
Statistical Plan ...........................................................................................................19 
11 
Data Quality Assurance ............................................................................................ 19 
11.1 
Study monitoring ........................................................................................................19 
11.2 
Record keeping .........................................................................................................20 
11.3 
Record retention ........................................................................................................20 
11.4 
Data Entry / Data Management .................................................................................21 
11.5 
Confidentiality ............................................................................................................21 
11.6 
Publication .................................................................................................................21 
12 
Study Costs ............................................................................................................... 21 

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DOCUMENT CHANGE HISTORY 
Version 
Originator 
Description of Change(s) 
Date 
1.0 
Cheryl McKinnon 
Original Protocol 
05 January 2018 
2.0 
Myhanh Nguyen 
09 February 2018 

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1 Introduction 
CooperVision, (CVI) is extending the power range of the commercially available Biofinity silicone 
hydrogel contact lenses to include multifocal toric silicone hydrogel contact lenses (Biofinity MFT). 
This study is to evaluate the clinical performance of the Biofinity MFT lenses. 
2 Study Objective 
The objective of this non-dispensing clinical study is to compare the clinical performance of 
Biofinity Multifocal Toric (BF MFT) with Proclear Multifocal Toric (PC MFT) contact lenses. 
The primary variable of interest is: 
•
Visual acuity (VA)
The secondary variable of interest is: 
•
Subjective assessments of visual performance
2.1 Study Hypothesis 
The study hypothesis is that the Biofinity Multifocal Toric lenses will not be clinically inferior to 
Proclear Multifocal Toric lenses.  
3 Study Design 
This non-dispensing, subject masked, randomized, bilateral crossover study will compare the clinical 
performance of Biofinity Multifocal Toric contact lenses. 
This study will be composed of two parts. Part A will involve a screening/baseline visit for the 
determination of subject’s contact lens prescription based on their spectacle refraction. With the 
information obtained from Part A, Biofinity Multifocal Toric and Proclear Multifocal Toric contact 

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lenses will be made to order on a per-patient basis for use in Part B to assess the clinical 
performance of the lenses. 
Subjects must be able to participate in both parts of the study; Part A of the study will last 
approximately 1-2 hours duration and Part B will last approximately 3-4 hours duration.   
4 Ethics Review / Statement of Compliance 
4.1 Relevant Standards / Guidelines 
This implementation document has been developed in accordance with the following:  
•
ISO 14155 Clinical Investigation of Medical Devices for Human Subjects
•
21 CFR 812.2(b) Investigational Device Exemption – Abbreviated Requirements
•
ISO 11980 Contact Lens and Lens Care products – Guidance for Clinical Investigations
•
ICH Harmonized Tripartite Guideline for Good Clinical Practice
•
Declaration of Helsinki
4.2 Institutional Review Board 
This study will be conducted in accordance with Institutional Review Board regulations (U.S. 21CFR 
Part 56.103) or applicable IEC regulations. Copies of all IRB/IEC correspondence with the 
investigator/sponsor will be kept on file. 
The conduct of this study will be approved by Sterling Institutional Review Board prior to 
commencement. 
4.3 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. 
5 Clinical Trial Registration 
This study will be registered with ClinicalTrials.gov in accordance with Section 801of the Food and 
Drug Administration Act (FDAA) which mandates the registration of certain clinical trials of drugs 
and medical devices. 

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6 Potential Risks and Benefits to Human Subjects 
There might not be direct benefits to the subjects in this study. However, participation in a 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 part of their eyes and 
may have the opportunity to try a different type of soft contact lenses and/or different lens care 
products at no cost to them.  
The investigational contact lenses used in this study are intended for daily wear (NOT extended 
wear) with usage of up to four hours only, in contrast to the average wearing time of 10-16 hours for 
daily wear lenses. In addition, this study is a non-dispensing study, meaning the lenses are not 
dispensed to subjects to take home and lens wear will be monitored closely by the investigators. 
This study is considered to be a non-significant risk study based on United State Food and Drug 
administration (FDA) and International Standards Organization (ISO) guidelines due to no potential 
of serious risk to the health, safety, or welfare of a subject. 
Complications that may occur during the wearing of contact lenses include discomfort, dryness, 
aching or itching eyes, excessive tearing, discharge, hyperemia and variable or blurred vision.  More 
serious risks may include photophobia, iritis, corneal edema and eye infection. Although contact 
lens-related infections are very infrequent, the possibility does exist.  The incidence of infection due 
to day-wear soft lenses is 0.035%. Almost always an infection will occur only in one eye.  This risk 
is assumed by 35 million Americans who currently wear contact lenses. 
Routine clinical procedures including auto-refraction, auto-keratometry, visual acuity, anterior ocular 
health assessment, and contact lens fitting may be used. In addition, high magnification imaging of 
the lens fit may be made using 35 mm or digital cameras. 
7 Materials and Methods 
7.1 Subjects 
Up to twenty subjects will be needed to complete the study. Each subject will be given a unique ID 
number. Additionally, all subjects must meet the study inclusion and exclusion criteria listed below. 
Potential subjects will be identified from the investigators’ clinic database records and/or will be 

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actively recruited by advertisements circulated at the investigational sites approved by the 
appropriate IRB. 
Inclusion criteria 
A person is eligible for inclusion in the study if he/she:  
• 
Has had a self-reported oculo-visual examination in the last two years.    
• 
Is between ages 40–75 years, inclusive and has full legal capacity to volunteer. 
• 
Has read and understood the information consent letter.   
• 
Is willing and able to follow instructions and maintain the appointment schedule.  
• 
Is able to participate in Parts A and B related to this work. 
• 
Has a contact lens spherical prescription between +10.00 to -10.00D (inclusive). 
• 
Has an Add component to their spectacle refraction (between +0.75 and +2.50DS). 
• 
Has astigmatism between of -0.75 and -5.75DC (based on the vertexed ocular refraction in 
each eye. 
• 
Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision 
correction or 20/25 best-corrected.  
• 
Currently wears soft contact lenses.  
• 
Has clear corneas and no active ocular disease. 
• 
Has not worn lenses for at least 12 hours before the examination. 
Exclusion Criteria 
A person will be excluded from the study if he/she: 
• 
Has never worn contact lenses before.  
• 
Has any systemic disease affecting ocular health.  
• 
Is using any systemic or topical medications that will affect ocular health.  
• 
Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe 
dry eyes) that would affect the wearing of contact lenses.  
• 
Has persistent, clinically significant corneal or conjunctival staining using sodium 
fluorescein dye.  
• 
Has any clinically significant lid or conjunctival abnormalities, active neovascularization or 
any central corneal scars.  
• 
Is aphakic.  
• 
Has undergone corneal refractive surgery.  

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• 
Is participating in any other type of eye related clinical or research study. 
7.1.1 Subject Identification 
Each subject will be given a unique ID number.  Subject ID numbers will be assigned to the subjects 
sequentially and in ascending order, and will not be reused in the event of screen failure, subject 
dropout or discontinuation from the study.  
7.2 Study Materials 
7.2.1 Contact lens 
Subjects will be randomized to receive either Test or Control lens as the first pair of contact lenses 
as per the randomization schedule.  The lenses used in this study will be provided by the Sponsor.  
Details of the contact lenses are shown in Table 1. 
Table 1: Study lenses 
 
 Lens 1 
 Lens 2 
Name 
Biofinity Multifocal Toric  
Proclear Multifocal Toric 
Manufacturer 
CooperVision  
CooperVision 
Material 
Comfilcon A 
Omafilcon B 
EWC (%) 
48% 
62% 
Base Curve (mm) 
8.7 
8.4 / 8.8 
Diameter (mm) 
14.5 
14.4 
Spherical powers 
(DS) 
+10.00 to -10.00 
(0.50 steps after ±6.50D) 
+20.00 to -20.00 
(0.50 steps after ±6.50D) 
Cyl Powers (DC) 
-0.75 to -5.75 (0.50 steps) 
-0.75 to -5.75 (0.50 steps) 
Axis (°) 
5 to 180 (5 degree steps) 
5 to 180 (5 degree steps) 
Add (D) 
+1.00, +1.50, +2.00, +2.50  
 (D & N) 
+1.00 to +4.00 
(D & N) 
7.2.2 Contact Lens care 
No contact lens care is required for this study as lenses are to be worn for a single day only. 
7.2.3 Storage of Lenses and Lens Care Solutions 
The study materials must be stored in a secured area. All lenses and lens care solutions should be 
stored at controlled room temperature (59-86°F). 

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7.2.4 Clinical Supply Inventory 
The 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 implementation document by subjects who are under the direct supervision of an 
investigator. 
7.2.5 Disposal of Consumables 
This study dispenses consumables (lenses) to participants for use during the study. All unused and 
used materials will be returned to the Sponsor at the end of the study unless the investigator is 
otherwise directed by the study Sponsor. All worn lenses will be collected at the completion of the 
study in screw top contact lens cases filled with Opti-Free Multi-purpose solution. 
7.2.6 Masking and Control of Study Materials 
The contact lenses coding will be masked to the subject. Masking to the subject will be achieved by 
minimising the exposure to the device label.   
7.2.7 Ordering and Accountability of Study Materials 
The test and control lenses will be provided by the sponsor. The investigator must complete an 
accurate accounting of the study product at the completion of the study. A detailed inventory must 
be completed for study supplies. 
7.3 Visit Schedule and Procedures 
There will be a minimum of two scheduled visits as follows: 
7.3.1 Screening/Baseline Visit (Part A) 
Procedures to be Performed  
The following evaluations will be performed to assess eligibility according to the Inclusion and 
Exclusion Criteria at the baseline visit only:  
 
The subjects should attend this visit wearing their spectacles.  
The following evaluations will be performed on all subjects: 
1. The subject will be required to read and sign an Informed Consent Form prior to enrolment. 
When the subject has signed the consent form, the subject will then be considered to be 
enrolled in the study 

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2. Subject demographics (age, sex, medications, allergies)  
3. Contact lens wearing history including: 
• 
Habitual lenses, modality, average wear time and comfortable wear time 
4. Auto-refraction and Auto-keratometry measures will be recorded  
5. Pupil size measurements (OD, OS) (high and low illuminationat distance (equivalent to 6M) 
and near (40cm) 
6. HVID measurement  
7. Baseline distance high contrast Snellen visual acuity (OD, OS) with spectacles or habitual 
Rx in phoropter or trial frame  
8. Monocular sphero-cylindrical refraction (D) followed by binocular balance (endpoint is the 
most plus or least minus that gives the best binocular distance visual acuity) 
9. Near addition as determined by NRA/PRA/BCC (D)  
10. Dominant eye test (sensory): the dominant eye will be determined using the +2.00D blur 
test  
11. Visual acuities with best correction:  
• 
Best-corrected high contrast, high illumination*, distance (equivalent to 6M), 
logMAR acuity (OD, OS and OU) (natural pupil)  
• 
Best-corrected high contrast, high illumination*, near (40cm), logMAR acuity (OD, 
OS and OU) (natural pupil) 
*High room illumination: Overhead lights on = 300-600 lux 
12. Slit lamp biomicroscopy will be assessed according to the guidelines set out in the CVI 
Grading scales (Appendix 1) 
13. Saline Rinse 
14. Confirm subject meets the inclusion/exclusion criteria 
15. The information required from the spectacle refraction includes: 
o Spectacle refraction (vertex corrected assuming a 15 mm vertex distance) (D) 
o Keratometry readings (D) 
o Dominant eye (sensory) 
o Add power (D) 
16. The information from #15 above will be used to determine the contact lens prescription based 
on the fitting guides (Appendix 2).  
17. The site will send the contact lens prescriptions to the Sponsor who will then order the 
contact lenses.  
18. The subject will then be discharged and asked to return when lenses are available for Part 
B of the study. Subjects will be free to return to wearing their habitual lenses until the follow-
on study begins. Study personnel will contact them to schedule Part B of the study upon lens 
arrival. 

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7.3.2 Lens Performance Assessment Visit (Part B) 
The subjects should attend this visit wearing their spectacles. 
1. Details of ocular history and contact lens wearing history will be checked for any changes
since the last visit.
2. Baseline distance high contrast Snellen visual acuity (OD, OS) with spectacles or habitual
Rx in phoropter or trial frame
3. Slit lamp biomicroscopy will be assessed according to the guidelines set out in the CVI
Grading scales (Appendix 1).
4. Saline Rinse
7.3.3 Lens Pair 1 
7.3.3.1 Lens Insertion 
1. The first lens pair, manufactured from information obtained in Part A, will be fitted according
to the randomization table.
2. Lenses will be allowed to settle for at least 15 minutes.
7.3.3.2 Visual Acuity / Lens Fitting 
1. Binocular and monocular visual acuity will be assessed at distance (equivalent to 6M) and
near (40cm) before over-refraction:
• HIHC* logMAR VA (equivalent to 6M, 40cm) – (OD, OS, OU)
2. 
5.

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6.

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7.3.3.5 Contact lenses to be removed by investigator and retained for return to the Sponsor.  
7.3.4 Lens Pair 2 and Exit 
1. The second lens type will be inserted according to randomization schedule  
2. The same procedures outlined in Section 7.3.3 will be repeated. 
3. Subjects to assess their preference between Lens Pair 1 and 2 for a number of 
considerations according to the CVI guidelines in Appendix 3 (5 point Likert scale) (Strong 
Pair 1, Slight Pair 1, no preference, Strong Pair 2 lens, Slight Pair 2): 
 
 
 
 
 
 
• 
Overall Vision Preference 
• 
 
 
 
 
 
4. Contact lenses to be removed by investigator and retained for return to the Sponsor. 
5. Slit lamp biomicroscopy will be assessed according to the guidelines set out in the CVI 
Grading scales (Appendix 1). 
6. Exit high contrast Snellen visual acuity (OD, OS) with spectacles or habitual Rx in phoropter 
or trial frame  
7. The subject will be discharged and asked to sign the exit statement.. 
 
 
 
 
 

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7.3.5 Summary of Visits and Procedures 
Table 2 summarizes the visits and procedures for the study.   
Table 2: Summary of Visits and Procedures 
 
Screening/ Baseline 
visit 
Lens fitting and exit 
visit 
Informed Consent 
 
 
Meet inclusion/exclusion criteria 
 
 
Demographics  
 
 
History at baseline 
 
 
VA with spectacles or refraction 
 
 
Auto-refraction & keratometry 
 
 
Pupil size / HVID  
 
 
Sphero-cylindrical refraction  
 
 
Best corrected (sphero-cyl) 
logMAR VA monocular and 
binocular 
 
 
Add determination 
 
 
Dominant eye test (+2.00 blur test) 
 
 
Instillation of lens at office 
− 
 
 
 
 
logMAR VA with contact lenses 
− 
 
 
 
 
Slit lamp findings 
 
 
 
 
 
 
Exit study 
 
 
 
    

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8 Adverse Event Reporting 
8.1 Adverse Event Definitions 
An ‘adverse event’ refers to any undesirable clinical occurrence in a participant, whether it is 
considered to be device-related or not. Adverse events (AE) may be classified as ‘unanticipated 
adverse device effects,’ ‘serious adverse events,’ ‘significant adverse events,’ or ‘non-significant 
adverse events,’ as defined below. 
 
 
 
AE classification, coding (for reporting to the sponsor) and examples are provided in the following 
table of Contact Lens Adverse Event Classification and Reporting table:  
 
Code 
Condition 
Reporting 
Serious Adverse Events 
01 
Presumed infectious keratitis or infectious corneal ulcer 
Notify sponsor as 
soon as possible, 
within 24 hours; 
IRB reporting as 
per requirements 
02 
Permanent loss of ≥ 2 lines of best spectacle corrected visual acuity (BSCVA) 
03 
Corneal injury that results in permanent opacification within central cornea 
(6mm) 
04 
Uveitis or Iritis (e.g. presence of anterior segment inflammation as described 
in ISO 11980, Annex B) 
05 
Endophthalmitis 
06 
Hyphema 
Classification 
Definition 
Serious Adverse 
Event 
Those events that are life-threatening, or result in permanent impairment of a body 
function, or permanent damage to a body structure or necessitate medical 
(therapeutic) or surgical intervention to preclude permanent impairment of a body 
function or permanent damage to a body structure. 
Significant 
Adverse Event 
Those non-serious adverse events that occur with contact lens usage that are not 
sight-threatening but are usually symptomatic and may warrant therapeutic 
management and /or temporary or permanent discontinuation of contact lens wear. 
Non-Significant 
Adverse Events 
Those less severe non-serious adverse events that occur with contact lens usage 
that are not sight-threatening, may or may not be symptomatic and may warrant 
palliative management, such as ocular lubricants or temporary interruption of contact 
lens wear. 
Unanticipated 
Adverse Device 
Effect 
Adverse events in a clinical trial that were not previously identified in the protocol in 
terms of nature, severity, or degree of incidence. An Unanticipated Serious Adverse 
Device Effect is an unanticipated adverse event that is serious in nature and caused 
by or associated with the device and is considered reportable. 

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07 
Hypopyon 
08 
Neovascularization within the central 6mm of cornea 
00 
Other serious event 
Significant Adverse Events 
11 
Peripheral (outside central 6mm), non-progressive, non-infectious ulcer 
Notify sponsor as 
soon as possible, 
within 5 working 
days; IRB 
reporting as per 
requirements 
12 
Symptomatic corneal infiltrative event 
13 
Superior epithelial arcuate lesions (SEALs) involving epithelial split 
14 
Corneal staining ≥ dense coalescent staining up to 2mm in diameter (e.g. 
moderate, ISO 11980 grade 3) 
15 
Corneal neovascularization ≥ 1.0mm vessel penetration  
(e.g. ≥ ISO 111980 Grade 2), if 2 grade change from baseline 
16 
Any temporary loss of ≥ 2 lines BSCVA for ≥ 2wks 
17 
Any sign and/or symptom for which subject is administered therapeutic 
treatment or which necessitates discontinuation of lens wear for ≥ 2 weeks 
10 
Other significant event 
Non-significant Adverse Events 
21 
Conjunctivitis (bacterial, viral or allergic) 
Notify sponsor as 
soon as possible, 
within 5 working 
days; IRB 
reporting as per 
requirements 
22 
Papillary conjunctivitis if ≥ mild scattered papillae/follicles approximately 1mm 
in diameter (e.g. ISO 11890 Grade 2), if 2 grade change from baseline 
23 
Asymptomatic corneal infiltrative events 
24 
Any sign and/or symptom for which temporary lens discontinuation for > 1 day 
is recommended (if not already classified) 
20 
Other sign and/or symptom warranting classification as a non-significant 
adverse event 
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 Procedures for Adverse Events 
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. The investigator 
will attempt to determine whether the reaction is related to the test device or a result of other factors. 

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An Adverse Event Form will be completed for each adverse event. If both eyes are involved, a 
separate Adverse Event Form will be completed for each eye. Whenever possible, the adverse 
event will be photo-documented. 
Expenses incurred for medical treatment as part of study participation will be paid by the sponsor 
(bills and prescription receipts kept). The subject must be followed until resolution and a written 
report completed indicating the subsequent treatment and resolution of the condition. 
 
8.3 Reporting Adverse Events 
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 as soon as possible (by fax, mail/delivery, phone, or email).  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 working days after the occurrence. 
Sponsor contact details are: 
Contact:  
Clinical Operations, CooperVision 
Email:  
 
Phone: 
 or 
  /  Fax: 
 
Address:  
5870 Stoneridge Dr.  
 
 
Suite 1 
Pleasanton, CA 94588 
 
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 the Discontinuation Form will be completed. 

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9 Device Malfunctions 
A device malfunction means the failure of the device to meet its performance specification or 
otherwise perform as intended. Any defective lens that is likely to cause or contribute to a Serious 
Adverse Event should be reported to the Principal Investigator and the sponsor within 24 hours of 
the investigator becoming aware of the malfunction. 
 
Other defective lenses should be reported to the Sponsor as soon as possible. 
 
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 complaints or Device Malfunctions. 
 
10 Statistical Analysis  
10.1 Statistical Plan 
Summary statistics will be produced (e.g. mean, standard deviation). Paired t test will be used to 
compare slit lamp biomicroscopy, lens fit and subjective scores between study lens types.  Repeated 
Measures Analysis of Variance (ANOVA) or paired analysis will 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. 
 
All participants who were evaluated will be used in the analysis. In the event of missing data, 
individual data points will be excluded in the analysis and not extrapolated from the collected data. 
11 Data Quality Assurance 
11.1  Study monitoring 
Site qualification of the investigative site has been completed to ensure that the site facility is 
adequate, personnel are qualified and resources are satisfactory to conduct clinical studies for the 
sponsor. The protocol will be reviewed by the investigators prior to enrollment of the first subject. 

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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, verification will be conducted to confirm that written informed consent 
was obtained prior to each subject’s participation in the study using the IRB approved ICF. 
  
 
  
 
 
  
 
 
  
 
 
 
 
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 Record keeping 
Detailed records of all study visits will be made using the Case Report Forms (CRFs). All data 
recorded on forms will be in ink. Any corrections to the forms will be initialed and dated at the time 
they are modified. 
 
11.3 Record retention 
Following study completion, data will be available in electronic and/or paper format for audit, sponsor 
use, or subsequent analysis. The original clinical raw data (including completed CRFs and Informed 

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Consent forms) will be retained according to guidelines set forth in the general work agreement with 
the site. The Sponsor will be notified and consulted if ever the files are to be destroyed.  In the event 
that this implementation document is indicated for design verification and validation purposes, as 
indicated on the title page, all original raw data forms and completed CRFs will be forwarded to the 
sponsor at completion of the final report. 
11.4 Data Entry / Data Management 
Data will be entered into an electronic spreadsheet. Study staff will only be able to modify the data 
file via password entry. The investigators will be responsible for the data integrity, and complete 
data entry for each visit. The investigator will send the data collected to the study sponsor within 
approximately 5 business days after the last subject completes the final visit. 
 
11.5 Confidentiality 
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 also be handled in accordance with HIPAA (1996) standards. 
 
11.6 Publication 
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. need to be approved by the sponsor. 
12 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 participant must be followed until resolution and a written 
report completed indicating the subsequent treatment and resolution of the condition.