Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Johnson & Johnson Vision Care, Inc.
Clinical Study Protocol
Evaluation of senofilcon A with New UV-blocker on a Neophyte Population
Protocol CR-6241
Version: 2.0, Amendment 1
Date: 11 October 2018 
Investigational Products: senofilcon A with new UV-blocker 
Key Words: senofilcon A, daily wear, dispensing, subjective responses, neophyte 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155,1the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements. 
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc.  
The information may not be disclosed to others except to the extent necessary to obtain 
Institutional Review Board/Independent Ethics Committee approval and informed consent, or 
as required by International, Federal and State Laws, as applicable. Persons to whom this 
information is disclosed must be informed that this information is privileged and confidential 
and that it should not be further disclosed without the written permission of Johnson & 
Johnson Vision Care, Inc.  Any supplemental information that may be added to this document 
is also confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept 
in confidence in the same manner as the contents of this document. 
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TABLE OF CONTENTS
PROTOCOL TITLE, NUMBER, VERSION .......................................................................... 6 
SPONSOR NAME AND ADDRESS ...................................................................................... 6 
MEDICAL MONITOR ............................................................................................................ 6 
AUTHORIZED SIGNATURES .............................................................................................. 7 
CHANGE HISTORY............................................................................................................... 8 
SYNOPSIS ............................................................................................................................... 8 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS ................... 13 
1. 
INTRODUCTION AND BACKGROUND .................................................................. 15 
1.1. 
Name and Descriptions of Investigational Products ............................................ 15 
1.2. 
Intended Use of Investigational Products ............................................................ 15 
1.3. 
Summary of Findings from Nonclinical Studies ................................................. 15 
1.4. 
Summary of Known Risks and Benefits to Human Subjects .............................. 15 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study..................................................................................................................... 15 
2. 
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ..................................... 16 
2.1. 
Objectives ............................................................................................................ 16 
2.2. 
Endpoints ............................................................................................................. 17 
2.3. 
Hypotheses ........................................................................................................... 17 
3. 
TARGETED STUDY POPULATION .......................................................................... 17 
3.1. 
General Characteristics ........................................................................................ 17 
3.2. 
Inclusion Criteria ................................................................................................. 17 
3.3. 
Exclusion Criteria ................................................................................................ 18 
3.3.1. 
Systemic Medications ...................................................................................... 19 
3.4. 
Enrollment Strategy ............................................................................................. 20 
4. 
STUDY DESIGN AND RATIONALE ......................................................................... 20 
4.1. 
Description of Study Design ................................................................................ 20 
4.2. 
Study Design Rationale........................................................................................ 20 
4.3. 
Enrollment Target and Study Duration ................................................................ 20 
5. 
TEST ARTICLE ALLOCATION AND MASKING .................................................... 20 
5.1. 
Test Article Allocation ......................................................................................... 20 
5.2. 
Masking................................................................................................................ 21 
5.3. 
Procedures for Maintaining and Breaking the Masking ...................................... 21 
6. 
STUDY INTERVENTION ............................................................................................ 21 
6.1. 
Identity of Test Articles ....................................................................................... 21 
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6.2. 
Ancillary Supplies/Products................................................................................. 21 
6.3. 
Administration of Test Articles ........................................................................... 22 
6.4. 
Packaging and Labeling ....................................................................................... 22 
6.5. 
Storage Conditions ............................................................................................... 22 
6.6. 
Collection and Storage of Samples ...................................................................... 22 
6.7. 
Accountability of Test Articles ............................................................................ 23 
7. 
STUDY EVALUATIONS ............................................................................................. 23 
7.1. 
Time and Event Schedule .................................................................................... 23 
7.2. 
Detailed Study Procedures ................................................................................... 24 
VISIT 1 .......................................................................................................................... 25 
VISIT 2 .......................................................................................................................... 29 
VISIT 3 .......................................................................................................................... 31 
VISIT 4 .......................................................................................................................... 35 
VISIT 5 .......................................................................................................................... 37 
FINAL EVALUATION ................................................................................................. 38 
7.3. 
Unscheduled Visits .............................................................................................. 38 
7.4. 
Laboratory Procedures ......................................................................................... 40 
8. 
SUBJECTS COMPLETION/WITHDRAWAL............................................................. 40 
8.1. 
Completion Criteria ............................................................................................. 40 
8.2. 
Withdrawal/Discontinuation from the Study ....................................................... 40 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................ 41 
10. 
DEVIATIONS FROM THE PROTOCOL ................................................................. 41 
11. 
STUDY TERMINATION .......................................................................................... 41 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS ............. 42 
13. 
ADVERSE EVENTS .................................................................................................. 43 
13.1. 
Definitions and Classifications ............................................................................ 43 
13.2. 
Assessing Adverse Events ................................................................................... 45 
13.2.1. 
Causality Assessment ................................................................................... 45 
13.2.2. 
Severity Assessment ..................................................................................... 46 
13.3. 
Documentation and Follow-Up of Adverse Events ............................................. 46 
13.4. 
Reporting Adverse Events ................................................................................... 47 
13.4.1. 
Reporting Adverse Events to Sponsor ......................................................... 48 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health 
Authorities...................................................................................................................... 48 
13.5. 
Event of Special Interest ...................................................................................... 49 
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13.6. 
Reporting of Pregnancy ....................................................................................... 49 
14. 
STATISTICAL METHODS ....................................................................................... 49 
14.1. 
General Considerations ........................................................................................ 49 
14.2. 
Sample Size Justification ..................................................................................... 50 
14.3. 
Analysis Populations ............................................................................................ 50 
14.4. 
Level of Statistical Significance .......................................................................... 50 
14.5. 
Primary Analysis .................................................................................................. 50 
14.6. 
Secondary Analysis .............................................................................................. 50 
14.7. 
Other Exploratory Analyses ................................................................................. 50 
14.8. 
Interim Analysis ................................................................................................... 51 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ........................................ 51 
14.10. Procedure for Reporting Deviations from Statistical Plan ................................... 51 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ............................... 51 
15.1. 
Electronic Case Report Form/Data Collection .................................................... 51 
15.2. 
Subject Record ..................................................................................................... 52 
16. 
DATA MANAGEMENT............................................................................................ 52 
16.1. 
Access to Source Data/Document ........................................................................ 52 
16.2. 
Confidentiality of Information ............................................................................. 52 
16.3. 
Data Quality Assurance ....................................................................................... 53 
17. 
MONITORING ........................................................................................................... 53 
18. 
ETHICAL AND REGULATORY ASPECTS ........................................................... 53 
18.1. 
Study-Specific Design Considerations ................................................................ 53 
18.2. 
Investigator Responsibility .................................................................................. 54 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) ......... 54 
18.4. 
Informed Consent................................................................................................. 55 
18.5. 
Privacy of Personal Data ...................................................................................... 55 
19. 
STUDY RECORD RETENTION............................................................................... 56 
20. 
FINANCIAL CONSIDERATIONS ........................................................................... 57 
21. 
PUBLICATION .......................................................................................................... 57 
22. 
REFERENCES ........................................................................................................... 58 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) .... 59 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................ 69 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ........................................ 70 
APPENDIX D: 
 ..................................... 71 
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 LENS FITTING CHARACTERISTICS .............................................................. 72 
SUBEJCT REPORTED OCULAR SYPMTOMS/PROBLEMS ......................... 79 
 FRONT AND BACK SURFACE LENS DEPOSIT GRADING PROCEDURE 81 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
................................................................................................................................................ 87 
 BIOMICROSCOPY SCALE ............................................................................... 94 
 DISTACNE AND NEAR VISUALACUITY EVALUATION ......................... 100 
 PATIENT REPORTED OUTCOMES............................................................... 105 
APPENDIX E: IRIS COLOR SCALE ................................................................................ 107 
APPENDIX F: LENS SELECTION GUIDE ...................................................................... 108 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ....................... 109 
TABLE OF CONTENTS
Figure 1: Study Flowchart ..................................................................................................... 12 
TABLE OF CONTENTS
Table 1: Disallowed Systemic Medications ........................................................................... 19 
Table 2: Test Articles ............................................................................................................. 21 
Table 3: Ancillary Supplies ................................................................................................... 21 
Table 4: Time and Events ...................................................................................................... 23 
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PROTOCOL TITLE, NUMBER, VERSION
Title: Evaluation of senofilcon A with New UV-blocker on a Neophyte Population  
Protocol Number:  CR-6241 
Version: 2.0, Amendment 1 
Date: 11 October 2018 
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care (JJVC)
7500 Centurion Parkway  
Jacksonville, FL 32256 
MEDICAL MONITOR
Name:  John R. Buch. O.D., M.S.
Title: Senior Principal Research Optometrist
Address:  7500 Centurion Parkway, Suite 100, Mail Drop W-2A, Jacksonville, FL 32256 
Email: jbuch@its.jnj.com
The Medical Monitor must be notified by the clinical institution/site by e-mail, fax, or 
telephone within 24 hours of learning of a Serious Adverse Event. The Medical Monitor may 
be contacted during business hours for adverse event questions. General study related 
questions should be directed towards your assigned clinical research associate. 
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
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Study Design
This is a 5-visit, single-arm, open-label, dispensing study.  
Each subject will be bilaterally fit with the test article for 
approximately 4 weeks of reusable daily wear (DW) with lens 
replacement occurring 2-weeks after initial dispensing. After 
4 weeks of study lens wear, subjects will return to their 
habitual spectacles for one week.
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1).
Sample Size
Approximately 135 subjects will be enrolled with the intent 
of completing 100.  A higher than usually drop-out rate is 
expected due to the study population, therefore the enrollment 
number has been adjusted based on the observed drop-out rate 
in previous studies.  The drop-out rate will be monitored 
throughout the enrollment period.  
Study Duration
Subjects will be in the study for approximately five weeks.  
Given the potential difficulty of enrolling neophytes, the 
enrollment period will be four weeks, making the maximum 
duration of the study approximately nine weeks.
Anticipated Study 
Population 
Healthy adult males and females of any race or ethnicity that 
have never worn a contact lens outside of the doctor’s office.
All subjects will have an updated pair of spectacles within the 
prior six months and have worn them for at least two weeks. 
Eligibility Criteria
Potential subjects must satisfy all of the following criteria to 
be enrolled in the study: 
Inclusion Criteria after Screening:
1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and 
receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions 
set forth in this clinical protocol.
3. Between 18 and 39 (inclusive) years of age at the time 
of screening. 
4. They are a contact lens ‘neophyte’. In this work 
‘neophyte’ is taken to mean any subject who has never 
been dispensed contact lenses.  A subject who had 
taken part in a non-dispensing clinical study or had 
been fitted with contact lenses in practice but never 
went on to actually wear the lenses, is also classified 
as a ‘neophyte’.
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5. Habitual spectacles must have resulted from an eye 
exam within the past six months. 
6. The subject must have worn the updated spectacles 
for at least two weeks.
Inclusion Criteria after Baseline
7. Be a current wearer of prescription spectacles that 
provide corrected monocular visual acuity of 20/25 or 
better in each eye.
8. The subject’s vertex corrected spherical equivalent 
distance refraction must be in the range of -1.00 to 
-6.00 D (inclusive) in each eye. 
9. The subject’s refractive cylinder must be -1.00 D or 
less in each eye.
10. Have spherocylindrical best corrected distance 
Snellen visual acuity of 20/25 or better in each eye. 
Potential subjects who meet any of the following criteria 
will be excluded from participating in the study:
Exclusion Criteria after Screening:
1. Currently pregnant or lactating. 
2. Any active or ongoing systemic disease (e.g., 
Sjögren’s Syndrome), allergies, infectious disease 
(e.g., 
hepatitis, 
tuberculosis), 
contagious 
immunosuppressive 
diseases 
(e.g., 
HIV), 
autoimmune disease (e.g. rheumatoid arthritis), or 
other diseases, by self-report, which are known to 
interfere with contact lens wear and/or participation 
in the study. 
3. Use of systemic medications that have a high 
likelihood to interfere with contact lens wear 
(estrogens, 
antihistamines, 
anticholinergics, 
beta-blockers, and psychotropics). 
4. Any current use of ocular medication.
5. Any known hypersensitivity or allergic reaction to 
any ingredient in Opti-Free£ PureMoist£. 
6. Any previous, or planned (during the course of the 
study) ocular surgery (e.g., radial keratotomy, PRK, 
LASIK, etc.). 
7. Employee or immediate family member of an 
employee 
of 
clinical 
site 
(e.g., 
Investigator, 
Coordinator, Technician) 
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Exclusion Criteria after Baseline
8. Any ocular allergies, infections or other ocular 
abnormalities that are known to interfere with contact 
lens wear and/or participation in the study.  This may 
include, but not be limited to entropion, ectropion, 
extrusions, chalazia, recurrent styes, glaucoma, 
history of recurrent corneal erosions, aphakia, or 
corneal distortion. 
9. Any Grade 3 or 4 slit lamp findings (e.g., edema, 
corneal neovascularization, corneal staining, tarsal 
abnormalities, conjunctival injection) on the FDA slit 
lamp classification scale.
10. Binocular vision abnormality or strabismus.  
Disallowed 
Medications/Interventions  
Subjects taking an ocular medication will be excluded from 
participation.  Subjects taking the following oral medications
will 
also 
be 
excluded:
estrogens, 
antihistamines,
anticholinergics, beta-blockers, and psychotropics. 
Measurements and 
Procedures
Subjective questionnaires will be administered for all 
hypotheses.  Slit lamp examinations will monitor ocular 
health.
Microbiology or Other 
Laboratory Testing
None 
Study Termination
The occurrence of one or more Unanticipated Adverse 
Device Effect (UADE), or any SAE where relationship to 
study agent cannot be ruled out, will result in stopping 
further dispensing investigational product.  In the event of a 
UADE or SAE, the Sponsor Medical Monitor may unmask 
the treatment regimen of subject(s) and may discuss this 
with the Principal Investigator before any further subjects 
are enrolled.
Ancillary Supplies/ Study-
Specific Materials
Lens care solution, lens case, and rewetting drops will be 
provided.  
Principal Investigator(s) 
and Study 
Institution(s)/Site(s)
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.  
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Figure 1: Study Flowchart
135 subjects to enroll, 100 subjects to complete
x
Available powers:  -1.00 to -6.00 D in 0.25 D steps
x
Subjects that have never worn contact lenses outside of the doctor’s office.
x
Spectacles updated within past 6 months and wearing for at least 2 weeks
x
t 18 and < 40 years of age. 
Visit 1  Informed Consent
Eligibility Criteria
Baseline Information
¾ Baseline questionnaires (Light sensitivity VAS)
¾ Iris color
¾ Subjective refraction
¾ Physiology
Trial Period 1
¾ Subjects will wear the study lens on both eyes
¾ Modify powers to obtain a 0.00 D spherical distance over-refraction
10-Minute Evaluation
¾ Symptoms
¾ Snellen distance VA, Fitting characteristics
Visit 2  Follow-up 1
(6-8 Days)
¾ Compliance
¾ Symptoms
¾ Entering visual acuity 
¾ Fitting characteristics, surface characteristics, physiology
¾ Reinsert same lenses
Final Evaluation
Lens Dispensing
¾ For dispensing, the lenses must provide:
¾ Appropriate fitting characteristics on both eyes
¾ 20/30 or better vision in both eyes
¾ Investigator approval
¾ Insertion and removal training
Visit 3   Follow-up 2
(6-8 Days)
¾ Compliance
¾ Collect any unworn lenses from initial dispensing
¾ Symptoms, home storage question
¾ Entering visual acuity 
¾ Fitting characteristics, surface characteristics, physiology
¾ Collect worn lenses
¾ Fit with new pair of the same lenses and dispense
Visit 4   Follow-up 3
(12-16 Days)
¾ Compliance
¾ Symptoms
¾ Entering visual acuity 
¾ Fitting characteristics, surface characteristics, physiology
¾ Collect worn lenses
¾ Subjects will return to habitual spectacles
Visit 5   Follow-up 1
(6-8 Days)
¾ Compliance
¾ Symptoms, Patient reported outcomes (Questionnaires)
¾ Entering visual acuity
¾ Physiology
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS
ADD  
 
Plus Power Required for Near Use
ADE  
 
Adverse Device Effect
AE 
 
 
Adverse Event/Adverse Experience
BCVA  
 
Best Corrected Visual Acuity
BSCVA 
 
Best Spectacle Corrected Visual Acuity
CFR 
 
 
Code of Federal Regulations 
CLUE  
 
Contact Lens User Experience
COAS  
 
Complete Ophthalmic Analysis System
COM  
 
Clinical Operations Manager
CRA  
 
Clinical Research Associate
CRF 
 
 
Case Report Form
CRO  
 
Contract Research Organization
CT 
 
 
Center Thickness
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee
eCRF  
 
Electronic Case Report Form
EDC  
 
Electronic Data Capture
ETDRS 
 
Early Treatment Diabetic Retinopathy Study
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice
HEV  
 
High Energy Visible
HIPAA 
 
Health Insurance Portability and Accountability Act 
IB 
 
 
Investigator’s Brochure
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Council for Harmonization
IDE 
 
 
Investigational Device Exemption
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board 
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution
MedDRA© 
 
Medical Dictionary for Regulatory Activities
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health
OD 
 
 
Right Eye
OHRP  
 
Office for Human Research Protections
OHSR  
 
Office for Human Subjects Research
OS 
 
 
Left Eye
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
PHI 
 
 
Protected Health Information 
PI 
 
 
Principal Investigator
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PIG 
 
 
Patient Instruction Guide 
PQC  
 
Product Quality Complaint 
PRO  
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience
SAP 
 
 
Statistical Analysis Plan
SAS 
 
 
Statistical Analysis System
SD 
 
 
Standard Deviation 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect
USADE 
 
Unanticipated Serious Adverse Device Effect
UV 
 
 
Ultra Violet
VA 
 
 
Visual Acuity
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1.
INTRODUCTION AND BACKGROUND
The Test contact lens used in this study has a new ultraviolet (UV)-blocking additive.  The 
additive darkens to a gray-indigo hue when exposed to UV and/or high energy visible (HEV) 
light in a dose-dependent manner.  The additive reverses back to a clear state when UV/HEV 
light is no longer present. 
In 2015, approximately 76% of adult Americans use some form of vision correction.  Among 
these, only about 40% wear contact lenses.  This study will evaluate the acceptance of the 
Test lens on a population of subjects that do not wear contact lenses.5
1.1.
Name and Descriptions of Investigational Products  
This study will evaluate a senofilcon A based contact lenses containing a new UV-blocker.  
The lenses are investigational. Further details about the test articles are found in Section 6 of 
this protocol.  
1.2.
Intended Use of Investigational Products
The intended use of the investigative product is for correcting myopia and the attenuation of 
bright light.  During the study, each test article will be worn bilaterally in daily wear (DW),
reusable modality for at least five days per week and six hours per day for approximately one 
month.  The lenses will be replaced after approximately two weeks.
1.3.
Summary of Findings from Nonclinical Studies
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans. For the most comprehensive nonclinical information regarding senofilcon 
A with new UV-blocker refer to the latest version of the Investigator’s Brochure (IB).6
1.4.
Summary of Known Risks and Benefits to Human Subjects
Potential benefits to the subject includes the correction of their refractive error and the 
attenuation of bright light.
Possible risks to the subject includes those that are anticipated with the wearing of soft contact 
lenses.  The investigational lenses pose no known additional risk to the subject.  The subject 
is advised of these risks in the Informed Consent, and the investigator is advised of these risks 
in the IB.  The potential benefits outweigh the potential risks. 
For the most comprehensive risk and benefit information regarding senofilcon A with new 
UV-blocker refer to the latest version of the IB.6
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study
Prior clinical data is summarized in the IB.   
The literature is absent of any articles pertaining to soft contact lenses containing the new type 
of UV-blocker.  A list of relevant literature references pertaining to glare, eyestrain, and light 
filtering is provided: 
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1. Agarwal S, Goel D, Sharma A. Evaluation of the factors which contribute to the ocular 
complaints in computer users. J Clin Diagn Res. 2013;7(2):331-335. 
2. Eperjesi F, Fowler CW, Evans BJ. Do tinted lenses or filters improve visual 
performance in low vision? A review of the literature. Ophthalmic and Physiological 
Optics. 2002;22(1):68-77. 
3. Hickcox KS, Narendran N, Bullough JD, Freyssinier JP. Effect of different coloured 
luminous surrounds on LED discomfort glare perception. Lighting Research and 
Technology. 2013; 1477153512474450. 
4. Leguire LE, Suh S. Effect of light filters on contrast sensitivity function in normal and 
retinal 
degeneration 
subjects. 
Ophthalmic 
and 
Physiological 
Optics.
1993;13(2):124-128. 
5. Morse RS. Glare filter preference: influence of subjective and objective indices of 
glare, sharpness, brightness, contrast and color. In Proceedings of the Human Factors 
and Ergonomics Society Annual Meeting. 1985, October. Vol. 29, No. 8, pp. 782-786. 
SAGE Publications. 
6. Pérez-Carrasco MJ, Puell MC, Sánchez-Ramos C, López-Castro A, Langa A. Effect 
of a yellow filter on contrast sensitivity and disability glare after laser in situ 
keratomileusis under mesopic and photopic conditions. Journal of Refractive Surgery.
2005;21(2):158-165. 
7. Sheedy JE, Hayes J, ENGLE J. Is all asthenopia the same?. Optometry & Vision 
Science. 2003;80(11):732-739. 
8. Steen R, Whitaker D, Elliott DB, Wild JM. Age-related effects of glare on luminance 
and color contrast sensitivity. Optometry & Vision Science. 1994;71(12):792-796. 
9. Vincent AJ, Spierings EL, Messinger HB. A controlled study of visual symptoms and 
eye strain factors in chronic headache. Headache: The Journal of Head and Face Pain.
1989;29(8):523-527. 
10. Wilkins AJ, Evans BJ. Visual stress, its treatment with spectral filters, and its 
relationship 
to 
visually 
induced 
motion 
sickness. 
Applied 
Ergonomics.
2010;41(4):509-515. 
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
The objective of this study is to determine the proportion of subjects that are successfully fit
with the investigational contact lens on a population that has never worn contact lenses outside 
of a doctor’s office.  
Primary Objective
The primary objective is to determine the proportion of subjects that can be successfully fit 
with the Test contact lens.
Secondary Objective
Not applicable. 
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Exploratory Objective 
Subject’s responses to individual patient reported outcome (PRO) items. 
2.2.
Endpoints 
Primary Endpoint 
Proportion of subjects that can be successfully fit in the Test lens
Successful fit is determined by the eye care practitioner (ECP/investigator) and includes the 
following criteria; (1) physiological responses (No Grade 3 or higher slit lamp findings), (2) 
mechanical lens fitting (no unacceptable lens fitting in either eye), (3) subjects’ assessment of 
comfort, vision and handling. 
Secondary Endpoint 
Not Applicable.  
Other Exploratory Endpoints 
Subjects’ responses to individual PRO Items
2.3.
Hypotheses
Primary Hypothesis
1. The proportion of subjects that can be successfully fit with the Test lens exceeds 0.50. 
Secondary Hypothesis 
Not applicable. 
Other Hypothesis 
Not applicable.  
3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
The study will enroll healthy adult males and females of any race or ethnicity that have never 
worn a contact lens outside of the doctor’s office.  All subjects will have an updated pair of 
spectacles within the prior six months and at least for two weeks.
Habitual wearers of 
Transitions spectacle lenses will comprise 15-20% of the sample. 
3.2.
Inclusion Criteria
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
Inclusion Criteria after Screening 
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form. 
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Between 18 and 39 (inclusive) years of age at the time of screening.
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4. They are a contact lens ‘neophyte’. In this work ‘neophyte’ is taken to mean any 
subject who has never been dispensed contact lenses. A subject who had taken part 
in a non-dispensing clinical study or had been fitted with contact lenses in practice but 
never went on to actually wear the lenses, is also classified as a ‘neophyte’.
5. Habitual spectacles must have resulted from an eye exam within the past six months. 
6. The subject must have worn the updated spectacles for at least two weeks. 
Inclusion Criteria after Baseline
7. Be a current wearer of prescription spectacles that provide corrected monocular visual 
acuity of 20/25 or better in each eye.
8. The subject’s vertex corrected spherical equivalent distance refraction must be in the
range of -1.00 to -6.00 D (inclusive) in each eye. 
9. The subject’s refractive cylinder must be -1.00 D or less in each eye. 
10. Have spherocylindrical best corrected distance Snellen visual acuity of 20/25 or better 
in each eye. 
3.3.
Exclusion Criteria
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
Exclusion Criteria after Screening:
1. Currently pregnant or lactating. 
2. Any active or ongoing systemic disease (e.g., Sjögren’s Syndrome), allergies, 
infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive 
diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, 
by self-report, which are known to interfere with contact lens wear and/or participation 
in the study. 
3. Use of systemic medications that have a high likelihood to interfere with contact lens 
wear (estrogens, antihistamines, anticholinergics, beta-blockers, and psychotropics).  
See Section 3.3.1.
4. Any current use of ocular medication.
5. Any known hypersensitivity or allergic reaction to any ingredient in Opti-Free£
PureMoist£.
6. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial 
keratotomy, PRK, LASIK, etc.). 
7. Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician). 
Exclusion Criteria after Baseline
8. Any ocular allergies, infections or other ocular abnormalities that are known to 
interfere with contact lens wear and/or participation in the study. This may include, 
but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, 
glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion. 
9. Any Grade 3 or 4 slit lamp findings (e.g., edema, corneal neovascularization, corneal 
staining, tarsal abnormalities, conjunctival injection) on the FDA slit lamp 
classification scale.
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3.4.
Enrollment Strategy
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials. 
4.
STUDY DESIGN AND RATIONALE
4.1.
Description of Study Design
This is a 5-visit, multi-site, single-arm dispensing trial. Approximately 135 subjects will be 
screened and enrolled to ensure that 100 subjects complete.  
The study begins with an initial Visit 1 (Day 0). If a subject is found to meet all eligibility 
criteria, they will be enrolled into the study. Subjects will wear the Test contact lens in a 
bilateral fashion as DW, reusable format for approximately 4-weeks.  After the 4-week 
follow-up visit (Visit 4), subjects will wear their habitual spectacles for a period of 1-week.
If a subject is dispensed the study lens at the initial visit, 4 follow-up visits will be conducted. 
The follow-up visit occurs approximately 1-, 2-, 4- and 5-weeks after the initial visit. 
Unscheduled follow-up visits may occur during this study.  Subjects will be advised to wear 
the study lens at least 5 days per week and 6 hours per day.  Lens replacement is scheduled at 
the 2-week follow-up visit.    
4.2.
Study Design Rationale 
This is a 5-visit, single-arm study. Subjects will wear the Test lens for a period of 4 weeks. 
Since subjects in this study are new contact lens wearers (neophytes), the study lens is worn 
for a total period of 4-weeks to allow a 2-week adaptation period. After 4-weeks of contact 
lens wear, subjects will return to their habitual spectacles for 1-week. Returning to their 
habitual spectacles will allow subjects to be able to make comparisons between the study 
lenses and their spectacles. 
4.3.
Enrollment Target and Study Duration
Approximately 135 new contact lens wearers (neophytes) are targeted to be enrolled with a 
target of 100 subjects to complete. Enrolled subjects will be spectacle wearers that have never 
worn contact lenses. Subjects must also have had an eye exam and an updated spectacle 
prescription in the last 6 months. Subject also are required to have worn the updated spectacle 
prescription for the previous 2 weeks prior to their first visit. All subjects will be 18 to 39 
(inclusive) years old. Subjects will wear the study lens for a total period of 4-weeks, and 
1 week of habitual spectacle wear, for a total duration of approximately 5-weeks per subject.   
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
This is a single-arm study; therefore, all eligible subjects will be assigned the Test lens in a 
bilateral fashion.  
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An additional subject will be enrolled if a subject discontinues from the study prematurely.  
In cases where a subject is lost to follow-up, every possible effort must be made to contact 
the subject and determine the reason for discontinuation/withdrawal.  The measures taken to 
follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt. 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications for this study include: any ocular topical medication and systemic 
medication that have a higher likelihood of affecting the tear film.  See Section 3.3.
Concomitant therapies that are disallowed include: see Section 3.3.
10. DEVIATIONS FROM THE PROTOCOL
Investigator will notify study sponsor upon identification of a protocol deviation. Major 
protocol deviations must be reported to the sponsor within 24 hours after discovery of the 
protocol deviation.  The Investigator will report deviations per IRB/IEC requirements.  All 
deviations will be tracked and corrective actions implemented as appropriate.  
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB.  
11. STUDY TERMINATION
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article.  In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled. 
The Sponsor will determine when a study will be stopped.  The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason.  Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined.  The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.   
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JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events.  If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated, as soon as possible. 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO)” 
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site
x
Lens replacements that occur due to drops/fall-outs 
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in 
use is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness)
x
Who received the complaint 
x
Study number 
x
Clinical site information (contact name, site ID, telephone number) 
x
Lot number(s) 
x
Unique Subject Identifier(s) 
x
Indication of who first observed complaint (site personnel or subject) 
x
OD/OS indication, along with whether the lens was inserted
x
Any related AE number if applicable
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.) 
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x
Eye Care Provider objective (slit lamp) findings if applicable
x
Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return (Refer to 
for test article return instructions)
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE).  If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, 
these procedures also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error.  In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must 
be documented. 
13. ADVERSE EVENTS
13.1. Definitions and Classifications
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.  
Note 1 to entry: This definition includes events related to the investigational medical device 
or the comparator. 
Note 2 to entry: This definition includes events related to the procedures involved. 
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices.”1
An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study  
2. Was present prior to the study, but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states  
3. Pregnancy must be documented as an adverse event and must be reported to the 
clinical monitor and to the Sponsor immediately upon learning of the event 
Serious Adverse Event (SAE) – An SAE is any untoward medical occurrence that:
x
Results in death
x
Is life threatening
x
Requires in-patient hospitalization or prolongation of existing hospitalization
x
Results in persistent or significant disability/incapacity (e.g., a sight threatening event, 
a significant persistent or permanent change, impairment, damage, or disruption to the 
subject’s body)
x
Is a congenital anomaly/birth defect, or
x
Requires intervention to prevent permanent damage (the use of the test article resulting 
in a condition which requires medical or surgical intervention to preclude permanent 
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impairment of the body structure or a body function).  Important medical events that 
may not result in death, be life-threatening, or require hospitalization may be 
considered an SAE when, based upon appropriate medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in the above definition 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity 
lines or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis 
x
Hypopyon 
x
Hyphemia
x
Penetration of Bowman’s Membrane 
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – Those events that are usually symptomatic and warrant 
discontinuation (temporary or permanent) of the test article (excluding Serious Adverse 
Events).   
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU) 
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of >2 Lines of BSCVA
x
Other grade 3 or higher corneal findings, such as abrasions or edema 
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation >2 weeks
Non-Significant Adverse Events – Those conditions that are usually asymptomatic and 
usually do not warrant discontinuation (temporary or permanent) of the test article.  However, 
the Investigator may choose to treat as a precautionary measure.  
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following:
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
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x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation <2 weeks 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.
Note 1 to entry: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device.
Note 2 to entry: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.”1
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the test article, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure or protocol, or any other 
unanticipated serious problem associated with the test article that relates to the rights, safety 
and welfare of subjects.
13.2. Assessing Adverse Events
In conjunction with the medical monitor, the Investigator will evaluate adverse events to 
ensure the events are categorized correctly.  Elements of categorization will include:
x
Seriousness/Classifications (see definition in Section 13.1) 
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related; unlikely related; possibly
related; related - see definition in Section 13.2.1) 
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild; moderate; severe for all events - see definition in 
Section 13.2.2)
x
Outcome – not recovered or not resolved; recovering or resolving; recovered or 
resolved with sequelae; recovered or resolved; death related to adverse event;
unknown 
x
Actions Taken – none; temporarily discontinued; permanently discontinued; other 
13.2.1. Causality Assessment
Causality Assessment – A determination of the relationship between an adverse event and 
the test article. The test article relationship for each adverse event should be determined by 
the investigator using these explanations: 
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures 
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x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely 
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. 
concomitant treatment, concomitant disease(s), is inconclusive.  The relationship in 
time is reasonable.  Therefore, the causal relationship cannot be excluded
x
Related – An adverse event that is listed as a possible adverse effect (device) or 
adverse reaction (drug) and cannot be reasonably explained by an alternative 
explanation, e.g. concomitant treatment of concomitant disease(s).  The relationship 
in time is very suggestive, e.g. it is confirmed by de-challenge and re-challenge
13.2.2. Severity Assessment
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject.  The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
x
Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities
13.3. Documentation and Follow-Up of Adverse Events
The recording and documenting of adverse events (ocular and non-ocular) begins when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the 
study it will be recorded and reported as an AE. Untoward medical events reported after the 
subject’s exit from the study will be recorded as adverse events at the discretion of the 
Investigator. 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.   
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data 
system. All adverse events occurring while the subject is enrolled in the study must be 
documented appropriately regardless of relationship.   
It is the Investigator’s responsibility to maintain documentation of each reported adverse 
event. All adverse events will be followed in accordance with applicable licensing 
requirements.  Such documentation will include the following: 
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x
Adverse event (diagnosis not symptom) 
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.)  
x
Date the clinical site was notified 
x
Date and time of onset
x
Date and time of resolution
x
Adverse event classification, severity, and relationship to test articles, as applicable
x
Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements
x
Any referral to another health care provider if needed
x
Outcome, ocular damage (if any)
x
Likely etiology
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF.  Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature.  If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed.  Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved.  If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider.  The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study.  
If a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation.  The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event.  In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (Section 13.4.2).  The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures.
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13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
hours following discovery of the event.  The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. 
All subjects experiencing a serious/significant adverse event must be followed up and all 
outcomes must be reported. 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received.  The Sponsor and study monitor should 
be notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must: 
x
Notify the Sponsor immediately
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations 
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no 
later than 24 hours after the Investigator first learns of the effect.  This report is in addition to 
the immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported
to the sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set 
forth by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines 
set forth by their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according 
the written guidelines, including reporting timelines. 
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13.5. Event of Special Interest
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set 
forth by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines 
set forth by their local governing Health Authorities.
The Sponsor will report applicable Adverse Events to the local health authorities according 
the written guidelines, including reporting timelines. 
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event.  Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes.  At the Investigator’s discretion, the 
study participant may be followed by the Investigator through delivery. However, this data 
will not be collected as part of the clinical study database.  Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use.  Specifically, pregnant women 
are discontinued due to fluctuations in refractive error and/or visual acuity that occur 
secondary to systemic hormonal changes, and not due to unforeseen health risks to the mother 
or fetus.
14. STATISTICAL METHODS
14.1. General Considerations
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. 
A general description of the statistical methods to be implemented in this clinical trial is 
outlined below.
A stand-alone Statistical Analysis Plan (SAP) will be provided and finalized prior to database 
hard-lock, for more details regarding the statistical analysis methods refer to the SAP. 
All data summaries and statistical analyses will be performed using the Statistical Analysis 
System (SAS) software Version 9.4 (SAS Institute, Cary, NC). Throughout the analysis of 
data, the results for each subject/eye will be used when available for summarization and 
statistical analysis.  Unscheduled visits will be summarized separately and will be excluded
from the statistical analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all 
baseline variables, efficacy variables and safety variables as appropriate.  Continuous 
variables will be summarized with descriptive statistics (n, mean, standard deviation [SD],
median, minimum and maximum). Frequency count and percentage of subjects or eyes within 
each category will be provided for categorical data.
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14.2. Sample Size Justification
This study was designed and powered to test the primary hypothesis. Assuming a true 
successful rate of 65% (PT), the sample size was calculated to test whether the true rate is 
superior to 50% (P0) with 80% power and 2-sided type I error of 5%. The estimated sample 
size to test the primary hypothesis (H0 PT  P0, H1: PT > P0) is 100. The sample size was 
calculated using PROC POWER for one sample proportion using an exact Test of a Binomial 
Proportion.
The plan is to enroll approximately 135 subjects with a target completion of 100 subjects. Due 
to high drop-out rates observed in a previous neophyte study CR-0806.13 The required sample 
size for enrollment was increased by 35% to account for this drop-out rate. 
14.3. Analysis Populations 
Safety Population: 
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded. 
Per-Protocol Population: 
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population). Justification of excluding subjects with protocol deviations in the 
per-protocol population set will be documented in a memo to file. 
Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from study 
or deviation from protocol. At least one observation should be recorded. 
14.4. Level of Statistical Significance
All planned analysis for this study will be conducted with an overall type I error rate of 5%.  
14.5. Primary Analysis  
Proportion of subjects with Successful Fit 
Successful fit is a binary response where X=1 if a subject can be successfully fit with the Test 
lens and X=0 otherwise. Successful fit is on a binocular level, therefore, the proportion of 
subjects that can successfully fit with the Test lens will be compared to the threshold 0.50. A 
95% confidence interval using the Agresti-Coull method will be used. Superiority will be 
concluded in the lower limit of the 95% confidence interval is above 0.50. 
14.6. Secondary Analysis  
Not applicable.  
14.7. Other Exploratory Analyses 
All patient reported outcomes will be descriptively summarized. 
Further exploratory analysis may be conducted. 
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14.8. Interim Analysis
There will be no interim analysis conducted for this study.  
14.9. Procedure for Handling Missing Data and Drop-Outs
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric 
regression method used to make at least10 imputations.
14.10. Procedure for Reporting Deviations from Statistical Plan
The analysis will be conducted according to that specified in above sections.  There are no 
known reasons for which it is planned to deviate from these analysis methods.  If for any 
reason a change is made, the change will be documented in the study report along with a 
justification for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING
15.1. Electronic Case Report Form/Data Collection
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC 
system (Bioclinica). An authorized data originator will enter study data into the eCRFs using 
the EDC system. Data collected on equipment that is not captured in EDC will be formatted 
to the specification of the JJVC database manager and sent to JJVC for analysis.  
No external data will be collected of the study. 
The clinical data will be recorded on dedicated eCRFs specifically designed to match the 
study procedures for each visit.  Once completed, the eCRFs will be reviewed for accuracy 
and completeness and signed by the Investigator.  The sponsor or sponsor’s representatives 
will be authorized to gain access to the subject recordation for the purposes of monitoring and 
auditing the study.  
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all 
of the study data. The IPP must be retained in the study files as a certified copy of the source 
data for the study.  
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The content and structure of the eCRFs are compliant with ISO14155:2011.1  
15.2. Subject Record
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion 
x
provision of and date of informed consent 
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion 
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record.  The author of an entry in the subject 
record must be identifiable.  The first point of entry is considered to be the source record. 
Adverse event notes must be reviewed and initialed by the Investigator. 
16. DATA MANAGEMENT
16.1. Access to Source Data/Document
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents.  Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, 
scientific data or other pertinent information is confidential and remains the property of JJVC.  
The Investigator may use this information for the purposes of the study only. It is understood 
by the Investigator that JJVC will use information developed in this clinical study in 
connection with the development of the investigational product and therefore may disclose it 
as required to other clinical investigators and to regulatory agencies. In order to allow the use 
of the information derived from this clinical study, the Investigator understands that he/she 
has an obligation to provide complete test results and all data developed during this study to 
the Sponsor. 
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16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator.  The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific
procedures and have appropriate knowledge of the study article. 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study.  The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management.  Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the 
conduct of clinical trials.  The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
17. MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel.  The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent amendments, and regulatory requirements are maintained 
x
Ensuring the rights and wellbeing of subjects are protected 
x
Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable
x
Ensuring that the clinical site has sufficient test article and supplies 
x
Clarifying questions regarding the study 
x
Resolving study issues or problems that may arise
x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan 
18. ETHICAL AND REGULATORY ASPECTS
18.1. Study-Specific Design Considerations
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation.  Subjects will be told that their consent to participate in the study is voluntary 
and may be withdrawn at any time with no reason given and without penalty or loss of benefits 
to which they would otherwise be entitled.  Only subjects who are fully able to understand the 
risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled.
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18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP 
is an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible.  The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements. 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
x
Final protocol and, if applicable, amendments 
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
x
Investigator’s Brochure (or equivalent information) and amendments 
x
Sponsor-approved subject recruitment materials 
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB)
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects 
x
Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, 
amendments (if any), the informed consent form, applicable recruiting materials, and subject 
compensation programs, and the Sponsor has received a copy of this approval. This approval 
letter must be dated and must clearly identify the documents being approved. 
During the study, the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate: 
x
Protocol amendments 
x
Revision(s) to informed consent form and any other written materials to be provided 
to subjects 
x
If applicable, new or revised subject recruitment materials approved by the Sponsor 
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure amendments or new edition(s) 
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
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x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study 
x
Major protocol deviations as required by the IEC/IRB 
x
Report of deaths of subjects under the Investigator's care 
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB 
For protocol amendments that increase subject risk, the amendment and applicable informed 
consent form revisions must be submitted promptly to the IEC/IRB for review and approval 
before implementation of the change(s). 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing. 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion.  Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable. 
18.4. Informed Consent
Each subject must give written consent according to local requirements after the nature of the 
study has been fully explained. The consent form must be signed before performance of any 
study-related activity. The consent form that is used must be approved by both the Sponsor 
and by the reviewing IEC/IRB. The informed consent is in accordance with principles that 
originated in the Declaration of Helsinki,3 current ICH2 and ISO 141551 guidelines, 
applicable regulatory requirements, and Sponsor Policy. 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits,
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any 
time. 
The subject will be given sufficient time to read the informed consent form and the 
opportunity to ask questions. After this explanation and before entry into the study, consent 
should be appropriately recorded by means of the subject's dated signature. After having 
obtained the consent, a copy of the informed consent form must be given to the subject. 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States14 and other applicable personal data protection and security laws and 
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regulations.  Appropriate measures will be employed to safeguard these data, to maintain the 
confidentiality of the person’s related health and medical information, to properly inform the 
concerned persons about the collection and processing of their personal data, to grant them 
reasonable access to their personal data and to prevent access by unauthorized persons. 
All information obtained during the course of the investigation will be regarded as 
confidential. All personal data gathered in this trial will be treated in strictest confidence by 
Investigators, monitors, Sponsor’s personnel and IEC/IRB.  No data will be disclosed to any 
third party without the express permission of the subject concerned, with the exception of 
Sponsor personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of 
their investigation related activities that, as part of the investigation will have access to the 
CRFs and subject records. 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility 
of the investigational product(s) used in this study. 
These data must be collected and processed with adequate precautions to ensure 
confidentiality and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
x
processed fairly and lawfully
x
collected for specified, explicit, and legitimate purposes and not further processed in 
a way incompatible with these purposes 
x
adequate, relevant, and not excessive in relation to said purposes 
x
accurate and, where necessary, kept current
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries. 
The subject has the right to request through the Investigator access to his personal data and 
the right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the 
request, the conditions of the study, and the applicable laws and regulations. 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to 
prevent accidental or premature destruction of these documents. 
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Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports. 
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Clinical 
Research Agreement.  The Research Agreement will be signed by the Principal Investigator 
and a JJVC management representative prior to study initiation. 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible subject in the study 
x
Scheduling a study visit outside the subject’s acceptable visit range
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as:
x
Query resolution 
x
Case Report Form signature
x
Completion of any follow-up action items 
21. PUBLICATION
This study will be registered on ClinicalTrials.gov by the Sponsor. 
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22. REFERENCES
1.
ISO 14155:2011: Clinical investigation of medical devices for human subjects – 
Good clinical practice.
2.
International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP): 
http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html   
3.
Declaration of Helsinki – Ethical principles for Medical Research Involving Human 
Subjects. http://www.wma.net/en/30publications/10policies/b3/index.html.  
4.
United States (US) Code of Federal Regulations (CFR). In 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR (Ed.). 
5.
Kodey, S. US Optical Overview and Outlook December 2015; Available from: 
https://www.thevisioncouncil.org/sites/default/files/Q415-Topline-Overview-
Presentation-Stats-with-Notes-FINAL.PDF).   
6.
Buch, J. 
 Investigator 
Brochure CR-6241. June 14, 2018 
7.
Silbert, J.A., A review of therapeutic agents and contact lens wear. J Am Optom 
Assoc, 1996;. 67(3): p. 165-172. 
8.
Muntingh, G.L., Drug and Contact Lens Interactions. South African Family 
Practice., 2005;. 47(8): p. 24-28. 
9.
Fraunfelder, F.W. (2014). Ocular Side Effects of Prescription Medications Mann's 
Pharmacovigilance (pp. 557-565): John Wiley & Sons, Ltd.
10.
Mannis, M.J., Anterior Segment Repair and Reconstruction: Techniques and 
Medico/Legal Issues. Cornea., 2003;. 22(3): p. 284. 
11.
Lima, C.A., Kara-José, M.; Nichols, J.J. Indications, Contraindications, and 
Selection of Contact Lenses. Contact Lenses in Ophthalmic Practice (pp. 7-16): 
Springer-Verlag.
12.
Bartlett, J.D., Jaanus, S.D. (1989). Local Anesthetics Clinical Ocular Pharmacology 
(pp. 149-162): Elsevier. 
13.
Chamberlain, P. 
 A long 
term clinical assessment of daily disposable silicone hydrogel contact lenses on a 
group of neophytes. July 14, 2010. 
14.
Health Information Portability and Accountability Act (HIPAA). In 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html (Ed.). 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
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PRO SPECIFICATION
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1
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PRO SPECIFICATION 
2 Final  2018-08-09
Protocol 6241                 Johnson & Johnson Vision Care, Inc.                  Confidential
2
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PRO SPECIFICATION
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Protocol 6241                 Johnson & Johnson Vision Care, Inc.                  Confidential
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PRO SPECIFICATION
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Protocol 6241                 Johnson & Johnson Vision Care, Inc.                  Confidential
4
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PRO SPECIFICATION 
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5
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PRO SPECIFICATION 
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6
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PRO SPECIFICATION
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7
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PRO SPECIFICATION 
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PRO SPECIFICATION
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
The Patient Instruction Guide (PIG) will be provided separately.
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
Not Applicable for Investigational Products. 
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LENS FITTING CHARACTERISTICS
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Page 4 of 6 
 
 
 
 
 
 
 
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Page 6 of 6 
 
 
 
 
 
 
 
 
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SUBEJCT REPORTED OCULAR SYPMTOMS/PROBLEMS
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FRONT 
AND 
BACK 
SURFACE 
LENS 
DEPOSIT 
GRADING 
PROCEDURE
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DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS
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BIOMICROSCOPY SCALE
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DISTACNE AND NEAR VISUALACUITY EVALUATION
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 PATIENT REPORTED OUTCOMES
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Page 1 of 1
Patient Reported Outcomes 
  
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VCT
APPENDIX E: IRIS COLOR SCALE
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-6241 Evaluation of Senofilcon A with New UV-blocker on a 
Neophyte Population       
Version and Date: 2.0, Amendment 1 11 October 2018
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that 
all clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and GCP 
guidelines regarding clinical trials during and after study completion.
I will assure that no deviation from, or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators 
adhere to all ICH2 regulations and GCP guidelines regarding clinical trials during and after 
study completion. 
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training.  
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization. 
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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