Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens
Phase: NA
Conditions: Refractive Error
Sponsor: Johnson & Johnson Vision Care, Inc.

Johnson & Johnson Vision Care
7500 Centurion Parkway
Jacksonville, FL 32256
Protocol: CR-5856
Version: 2.0, Amendment 1.0
Date: 22 SEP 2016
Clinical Study Protocol 
Evaluation Of The Effects Of A Black 
Annulus Within A Hydrogel Contact Lens 
On Visual Performance
Distribution:
Marina Archer (DHF)  
 
 
 
 
 
 
CONFIDENTIAL
This document contains confidential information, which should not be copied, referred to, released or published 
without written approval from Johnson and Johnson Vision Care.  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 and Johnson Vision Care.  Any 
supplemental information that may be added to this document is also confidential and proprietary to Johnson 
and Johnson Vision Care and must be kept in confidence in the same manner as the contents of this document.
Key Words: 
Methafilcon A  
Time Controlled Visual Acuity
Non-dispensing 
Daily Wear
Annulus 
Vision Effects
 
 
 
 
 
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TABLE OF CONTENTS
1.1 
PROTOCOL TITLE, NUMBER, DATE ...................................................................................................... 5 
1.2 
NAME AND ADDRESS OF SPONSOR .................................................................................................... 5 
1.3 
AUTHORIZED SIGNATURES ................................................................................................................. 6 
1.4 
MEDICAL MONITOR ............................................................................................................................ 7 
1.5 
INVESTIGATOR(S) SIGNATURE PAGE ................................................................................................... 8 
1.7 
CHANGE HISTORY ............................................................................................................................... 9 
1.8   
PROTOCOL SYNOPSIS .......................................................................................................................... 9 
2.1 
NAME AND DESCRIPTION OF TEST ARTICLES ................................................................................... 12 
2.2 
SUMMARY OF FINDINGS FROM NONCLINICAL STUDIES .................................................................. 12 
2.3 
SUMMARY OF KNOWN RISKS AND BENEFITS TO HUMAN SUBJECTS ............................................... 12 
2.4 
DESCRIPTION OF TRIAL TREATMENTS .............................................................................................. 13 
2.5 
STATEMENT OF COMPLIANCE TO PROTOCOL, GCP, AND APPLICABLE REGULATORY GUIDELINES . 13 
2.6 
DESCRIPTION OF POPULATION TO BE STUDIED, ENROLLMENT TARGETS, AND STUDY DURATION 13 
2.7 
RELEVANT LITERATURE REFERENCES AND PRIOR DATA ................................................................... 13 
3.1 
DESCRIPTION OF OBJECTIVES AND PURPOSE ................................................................................... 13 
4.1 
PRIMARY AND SECONDARY ENDPOINTS .......................................................................................... 14 
4.2 
INCLUSION CRITERIA ......................................................................................................................... 16 
4.3 
EXCLUSION CRITERIA ........................................................................................................................ 16 
4.4 
STUDY DESIGN, TIME AND EVENT SCHEDULE, FLOWCHART ............................................................ 16 
4.4.1 
TIME AND EVENTS SCHEDULE .......................................................................................................... 17 
4.5 
RANDOMIZATION AND MASKING ..................................................................................................... 19 
4.6 
WEAR AND REPLACEMENT SCHEDULES, INCLUDING FORM, PACKAGING AND LABELING .............. 19 
4.7 
DETAILED STUDY PROCEDURES ........................................................................................................ 20 
4.7.1 
SEQUENCE OF EVENTS ...................................................................................................................... 20 
4.8 
DISCONTINUATION CRITERIA ............................................................................................................ 27 
4.9 
ACCOUNTABILITY PROCEDURES FOR INVESTIGATIONAL PRODUCT AND CONTROL ........................ 27 
4.10 
PROCEDURES FOR MAINTAINING AND BREAKING RANDOMIZATION CODES .................................. 28 
4.11  
REPORTING PRODUCT QUALITY COMPLAINTS ................................................................................. 28 
5.1 
WITHDRAWAL CRITERIA ................................................................................................................... 29 
6.1 
PRESTUDY AND CONCOMITANT THERAPY ....................................................................................... 29 
6.2 
MONITORING TREATMENT COMPLIANCE ........................................................................................ 30 
6.3 
UNSCHEDULED VISITS ....................................................................................................................... 31 
7.1 
EFFICACY PARAMETERS .................................................................................................................... 31 
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7.2 
METHODS FOR ASSESSING, RECORDING, AND ANALYZING EFFICACY ............................................. 32 
8.1 
SAFETY PARAMETERS........................................................................................................................ 32 
8.2 
ADVERSE EVENTS .............................................................................................................................. 32 
8.3 
ADVERSE EVENT DEFINITIONS .......................................................................................................... 34 
8.4 
METHODS FOR ASSESSING, RECORDING, AND ANALYZING SAFETY ................................................. 36 
8.5 
ADVERSE EVENTS FOLLOW-UP ......................................................................................................... 37 
9.1 
STATISTICAL METHODS TO BE EMPLOYED ....................................................................................... 38 
9.2 
NUMBER OF SUBJECTS BY SITE AND JUSTIFICATION FOR SAMPLE SIZE ........................................... 40 
9.3 
LEVEL OF STATISTICAL SIGNIFICANCE ............................................................................................... 40 
9.4 
CRITERIA FOR STUDY TERMINATION ................................................................................................ 40 
9.5 
PROCEDURE FOR ACCOUNTING FOR MISSING, UNUSED, AND SPURIOUS DATA ............................. 40 
9.6 
PROCEDURE FOR REPORTING DEVIATIONS FROM STATISTICAL PLAN ............................................. 40 
9.7 
EVALUABLE SUBJECTS ....................................................................................................................... 40 
10.1 
ELECTRONIC CASE REPORT FORM/DATA COLLECTION ..................................................................... 41 
10.2 
SOURCE DOCUMENTATION .............................................................................................................. 41 
10.3 
ACCESS TO SOURCE DATA/DOCUMENTS .......................................................................................... 42 
10.4 
CONFIDENTIALITY OF INFORMATION ............................................................................................... 42 
11.1 
DATA QUALITY ASSURANCE .............................................................................................................. 42 
12.1 
STUDY-SPECIFIC DESIGN CONSIDERATIONS ..................................................................................... 43 
12.2 
INVESTIGATOR RESPONSIBILITY........................................................................................................ 43 
12.3 
INDEPENDENT ETHICS COMMITTEE OR INSTITUTIONAL REVIEW BOARD (IEC/IRB)......................... 43 
12.4 
INFORMED CONSENT ........................................................................................................................ 44 
12.5 
PRIVACY OF PERSONAL DATA ........................................................................................................... 45 
13.1 
DATA HANDLING AND RECORD KEEPING ......................................................................................... 46 
14.1 
FINANCIAL CONSIDERATIONS ........................................................................................................... 46 
15.1 
PUBLICATION .................................................................................................................................... 47 
16.1 
PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ........................................................... 47 
16.2 
 ....................................................................................... 52 
16.3 
PATIENT INSTRUCTION GUIDE (APPROVED PRODUCT) .................................................................... 52 
16.4 
PACKAGE INSERT ............................................................................................................................... 52 
17.1 
LIST OF ABBREVIATIONS ................................................................................................................... 53 
APPENDIX A: SITE INSTRUCTIONS FOR TEST ARTICLE RECEIPT AND TEST ARTICLE ACCOUNTABILITY ........... 54 
APPENDIX B: LENS PACKAGE INSERT ............................................................................................................... 61 
APPENDIX C: 
 LIMBAL AND CONJUNCTIVAL (BULBAR) REDNESS ..................................................... 64 
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APPENDIX D: 
 LENS FITTING CHARACTERISTICS ............................................................................... 72 
APPENDIX E: 
 OCULAR SYMPTOMS .................................................................................................. 79 
APPENDIX F: 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS ....................... 81 
APPENDIX G: 
 BIOMICROSCOPY SCALE ............................................................................................ 88 
APPENDIX H: 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION ................................................. 94 
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1.1
PROTOCOL TITLE, NUMBER, DATE
TITLE: Evaluation Of The Effects Of A Black Annulus Within A Hydrogel Contact Lens On Visual 
Performance
PROTOCOL NUMBER: CR-5856
VERSION: 2.0, Amendment 1.0 
 
DATE: September 22, 2016
1.2
NAME AND ADDRESS OF SPONSOR
Johnson & Johnson Vision Care
7500 Centurion Parkway, Jacksonville, FL 32256
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1.4
MEDICAL MONITOR
NAME:  Mr. Ali A. Mearza MB BS, FRCOphth
TITLE: Consultant Ophthalmologist
ADDRESS: 22 Wimpole Street, London W1G 8GQ, UK
E-MAIL:  
The Medical Monitor should be notified by the clinical site in writing and by 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.
 
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1.5
INVESTIGATOR(S) SIGNATURE PAGE 
 
Principal Investigator:
Signature
______________________________________
Name (Printed)
Date
Institution Name ___________________________________________________
The Principal Investigator is responsible for ensuring that all study site personnel, including sub-
investigators and other staff members, adhere to all ICH regulations and GCP guidelines regarding clinical 
trials during and after study completion.
I have read and understand the protocol specified above and agree on its content.  I agree to conduct this 
study according to this protocol and GCP and ICH guidelines, the Declaration of Helsinki, and the pertinent 
individual country laws/regulations and to comply with its obligations, subject to ethical and safety 
considerations. I shall not disclose the information contained in this protocol or any results obtained from 
this study without written authorization.
 
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Primary Objective:
The primary objective of the study will be to measure the binocular functional visual performance of the 
test and control contact lenses under distance day time conditions (250 cd/m2) for centrally presented high 
contrast (HC) time controlled visual acuity (TCVA) targets.
Secondary Objective:  
The secondary objectives of the study will be to measure the binocular functional visual performance of the 
test and control contact lenses for the following conditions:
i.
Distance night time conditions (2.5 cd/m2) for centrally presented HC TCVA targets;
ii.
Intermediate vision indoor conditions (50cd/m2) for centrally presented HC TCVA targets. 
Additional Measurements:
In addition to the primary and secondary objectives, the following will be measured:
i.
Monocular functional visual performance for centrally presented high contrast (HC) time 
controlled visual acuity (TCVA) targets.
a.
Distance day time conditions (250 cd/m2)
b.
Distance night time conditions (2.5 cd/m2)
c.
Intermediate vision indoor conditions (50cd/m2)
ii.
Distance monocular and binocular functional visual performance of the test and control contact 
lenses under night time conditions (2.5 cd/m2) for HC TCVA targets presented at 5° eccentricity;
iii. Intermediate vision monocular and binocular functional visual performance of the test and control 
contact lenses under indoor conditions (50cd/m2) for HC TCVA targets presented at 5° 
eccentricity;
iv. Distance monocular and binocular functional visual performance of the test and control contact 
lenses under night time conditions (2.5 cd/m2) for decreasing contrast  targets presented at 20° 
eccentricity;
v.
Intermediate vision monocular and binocular functional visual performance of the test and control 
contact lenses under indoor conditions (50cd/m2) for decreasing contrast targets presented at 10°
eccentricity; 
vi. Monocular and binocular horizontal visual fields when wearing the test and control contact lenses 
with an Esterman perimetry test.
vii. Subjective rating of performance following driving simulation while wearing test and control 
contact lenses under night time conditions;
viii. Subjective rating of performance following PC based reaction time game while wearing test and 
control contact lenses.
Study Design: The study will be a bilateral, subject-masked, randomized, 2x2 cross-over, non-dispensing 
pilot study involving three clinic visits.   Investigators who collect measurements for primary and 
secondary endpoints will also be masked to the identity of the study lenses.  Each subject will be assigned 
to a unique sequence of the lens types per the randomization scheme (Test/Control or Control/Test). 
Lenses will be worn for approximately three to four hours each with a 2-14 day washout period in between 
lenses.
Sample Size: A minimum of 20 eligible subjects are targeted to complete the study as the cohort 
population.   Subjects who are found to be ineligible, or who are discontinued or incomplete, will be 
classified as the non-cohort population.  The total number of subjects enrolled may not exceed 25 subjects, 
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except by joint agreement of the Investigator and Sponsor.
Eligibility Criteria: 
Subjects should meet all study Inclusion Criteria as outlined below:
1)
Healthy adult males or females 35 to 42 years of age (inclusive) with signed informed consent.  
2)
The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of 
DW for a minimum of 1 month prior to the study). 
3)
The subject’s optimal vertexed spherical equivalent distance correction must be between -6.00 and 
+4.00 D (inclusive). 
4)
$Q\F\OLQGHUSRZHUPXVWEH0.75D. 
5)
The subject must have visual acuity best correctable to 20/30 or better for each eye.
6)
The subject must read and sign the Informed Consent form.
7)
The subject must appear able and willing to adhere to the instructions set forth in this clinical 
protocol.
Subjects meeting any of the following Exclusion Criteria will not be eligible to participate in the study: 
1)
Currently pregnant or lactating,
2)
Any ocular or systemic allergies or diseases that may interfere with contact lens wear. 
3)
Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease 
(e.g., HIV) by self-report).
4)
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or 
any other abnormalities of the cornea which would contraindicate contact lens wear.
5)
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere 
with contact lens wear.
6)
Any ocular infection.
7)
Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, 
etc.).
8)
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
9)
Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended 
wear. 
10) Participation in any contact lens or lens care product clinical trial within 30 days prior to study 
enrollment. 
11) Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
Stopping Rules:  
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 Investigator before any further subjects are enrolled.
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2.4
DESCRIPTION OF TRIAL TREATMENTS
The study will be a bilateral, subject-masked, randomized 2x2 cross-over, non-dispensing pilot study 
involving three clinic visits.   Investigators who collect measurements for primary and secondary endpoints 
will also be masked to the identity of the study lenses.  The subjects will attend a first Enrolment / Fitting 
visit to initially obtain their informed consent and evaluate the potential participants suitability to take part 
in the investigation.  If they fulfill the investigation’s inclusion and exclusion criteria, they will be enrolled, 
fitted with the study contact lens type to ensure than a clinically acceptable fit is achieved and trained into 
the testing procedures.  At the completion of the visit the test and control contact lenses will be ordered.  
When the study contact lenses become available the subjects will then attend two test visits during which 
one of the study contact lens will be tested each time.  The order of testing the test or control contact lens 
will be randomized.  The participants will attend the visits not wearing contact lenses and not having worn 
contact lenses that day.
2.5
STATEMENT OF COMPLIANCE TO PROTOCOL, GCP, AND APPLICABLE 
REGULATORY GUIDELINES
This trial will be conducted in compliance with the protocol, the International Conference on 
Harmonization Good Clinical Practice E6 (ICH-GCP), the Declaration of Helsinki, and all applicable 
regulatory requirements.
2.6
DESCRIPTION OF POPULATION TO BE STUDIED, ENROLLMENT TARGETS, AND 
STUDY DURATION
The prospective subjects will all be subjects registered with the sites as potential study participants. They
will initially be contacted by telephone, the investigation will be explained in detail and if interested an 
Enrolment / Fitting / Measurement visit will be scheduled. The subjects fulfilling the criteria for inclusion 
and exhibiting none of the exclusion criteria will be invited in a random fashion to participate in the study 
until the test population is achieved.  Up to 25 subjects may be enrolled in order to achieve a cohort 
population of 20 subjects. The study is anticipated to last for approximately 4 months with each subject 
being involved for a period of up to 1 to 2 months, dependent upon the length of time that is required to 
manufacture their study lenses.
2.7
RELEVANT LITERATURE REFERENCES AND PRIOR DATA
See package insert (Appendix B).
3.1
DESCRIPTION OF OBJECTIVES AND PURPOSE
Johnson & Johnson Vision Care (JJVCI) are interested in evaluating the effects of incorporating a black 
annulus within a hydrogel contact lens, on functional visual performance. The black annulus is designed to 
mimic the performance of a similar design.  The research aims to determine whether this black annulus is 
likely to have any detrimental effect on vision for the wearer.   This pilot study will compare the central and 
peripheral visual performance, including functional assessment of vision, of a test contact lens 
incorporating a black annulus with that of a control clear contact lens.
The primary objective of the study will be to measure the binocular functional visual performance of the 
test and control contact lenses under distance day time conditions (250 cd/m2) for centrally presented high 
contrasts (HC) time controlled visual acuity (TCVA) targets.
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4.2
INCLUSION CRITERIA
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
1)
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT 
and receive a fully executed copy of the form.
2)
The subject must appear able and willing to adhere to the instructions set forth in this clinical 
protocol.
3)
The subject must be between 35 and 42 years of age (inclusive). 
4)
The subject’s vertex corrected spherical equivalent distance refraction must be in the range of -
6.00D to +4.00D in each eye.
5)
The subject’s refractive cylinder must be 'in each eye.
6)
The subject must have best corrected visual acuity of 20/30 or better in each eye.
7)
The subject must be an adapted soft contact lens wearer in both eyes (defined as a minimum of 
6 hours of DW for a minimum of 1 month prior to the study). 
8)
The subject must have normal eyes (i.e., no ocular medications or infections of any type).
4.3
EXCLUSION CRITERIA
Potential subjects who meet any of the following criteria will be excluded from participating in the study: 
1)
Currently pregnant or lactating (subjects who become pregnant during the study will be 
discontinued).
2)
Any ocular or systemic allergies or diseases that may interfere with contact lens wear.  
3)
Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive 
disease (e.g., HIV) by self-report.
4)
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or 
any other abnormalities of the cornea which would contraindicate contact lens wear.
5)
Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might 
interfere with contact lens wear.
6)
Any ocular infection.
7)
Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, 
etc.).
8)
Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
9)
Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as 
extended wear.
10) Participation in any contact lens or lens care product clinical trial within 30 days prior to study 
enrollment. 
11) Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
4.4 
STUDY DESIGN, TIME AND EVENT SCHEDULE, FLOWCHART
The study will be a bilateral, subject-masked, randomized, 2x2 cross-over, non-dispensing pilot study 
involving three clinic visits.  Investigators who collect measurements for primary and secondary endpoints 
will also be masked to the identity of the study lenses.  The study will have two treatments (Test and 
Control) in two periods (first and second) with two randomization groups (Test/Control or Control/Test).
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The participants will attend a first Enrolment / Fitting visit to initially obtain their informed consent and 
evaluate the potential participant’s suitability to take part in the investigation.  If they fulfill the 
investigation’s inclusion and exclusion criteria, they will be enrolled, fitted with the study contact lens type 
to ensure than a clinically acceptable fit is achieved and trained into the testing procedures.  This visit will 
last for approximately three hours. At the completion of the visit the test and control contact lenses will be 
ordered.  When the study contact lenses become available the participants will then attend two test visits 
during which one of the study contact lens types will be tested each time.  The order of testing of the test or 
control contact lens will be determined at random.  The participants will attend the visits not wearing 
contact lenses and not having worn contact lenses that day. Each measurement visit will last for 
approximately 4.5 hours.
The participants will not take part in any concomitant investigation of any type or take concomitant 
medications not allowed by the exclusion criteria.  
4.4.1
TIME AND EVENTS SCHEDULE
All study visits are required visits. There are no fixed time intervals between visits; however, it is 
anticipated that all subjects will complete both measurement visits within a period of no more than one 
month.
Visit 1 - Enrolment / Fitting Visit
The steps below will be followed:
x
Signing of the consent form
x
Participant demographics, medical and ocular history questions
x
Concomitant treatments questionnaire
x
Contact lens history
x
Ocular symptoms
x
Sphero-cylindrical refraction and BCVA
x
Spherical refraction
x
Ocular dominance measurement
x
Keratometry
x
Pupil measurement at 250, 50 & 2.5cd/m2
x
HVID
x
Biomicroscopy
x
Eligibility
x
Lens Information
x
Lens Damage
x
Lens Settling
x
Sphero-cylindrical refraction and VA
x
Lens fit assessment (including lens fit digital video recording)
x
Modification
x
Final contact lens prescription  
x
Familiarization with test measurements
x
Lens Removal
x
Biomicroscopy
x
Sphero-cylindrical refraction and BCVA
x
Continuance
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Visit 2 – First Measurement Visit
The routine below will be followed:
x
Concomitant treatments questionnaire
x
Ocular symptoms
x
Sphero-cylindrical refraction and BCVA
x
Biomicroscopy
x
Continuance
x
Lens Randomization
x
Lens Insertion
x
Lens Damage
x
Lens Settling
x
Spherical over- refraction and VA
x
Lens fit assessment (including lens fit digital video recording)
x
Visual field measurement, OD, OS, OU
x
Vision assessments (according to randomization scheme)
x
Lens Removal
x
Biomicroscopy
x
Sphero-cylindrical refraction and BCVA
x
Continuance
Visit 3 – Second Measurement Visit
The steps below will be followed:
x
Concomitant treatments questionnaire
x
Ocular symptoms
x
Sphero-cylindrical refraction and BCVA
x
Biomicroscopy
x
Continuance
x
Lens Randomization
x
Lens Insertion
x
Lens Damage
x
Lens Settling
x
Spherical over- refraction and VA
x
Lens fit assessment (including lens fit digital video recording)
x
Visual field measurement, OD, OS, OU
x
Vision assessments (according to randomization scheme)
x
Lens Removal
Final Evaluation
x
Biomicroscopy
x
Snellen VA measurement with spectacle refraction (Sphero-cylindrical)
x
Final Evaluation Form
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4.5 
RANDOMIZATION AND MASKING
The lenses will not be dispensed and will be worn in a bilateral and random fashion using a 2x2 cross-over 
design. Permuted block randomization will be used to minimize the potential for treatment imbalance. A 
block size of two (2) will be utilized. A computer-generated randomization scheme will be provided by the 
study biostatistician to randomly assign subjects to one of two possible lens wear sequences (Test/Control 
or Control/Test) in a 1:1 manner. The order of applied distance as well as luminance within distance (if 
applicable) during vision assessments will also be randomized for each subject within lens type. The same 
orders applied for the first lens type will be used for the second lens type.
The random scheme will be generated using the PROC PLAN procedure from SAS Software Version 9.4 
or higher (SAS Institute, Cary, NC).
The study site must follow the randomization scheme provided and complete the enrollment according to
the randomization list and not pre-select or assign subjects. The randomized assignment of subjects will
be performed at the beginning of Visit 2. The following must have occurred prior to randomization:
x
Informed consent has been obtained
x
Subject meets all the inclusion / exclusion criteria
x
Subject history and baseline information has been collected
This is a subject-masked study. Study participants will be masked with respect to the sequence of study 
lens wear to which they have been assigned. An unmasked investigator will insert and remove the study 
lenses so that the subject is not aware of the study lens type.  The identity of the study lenses will be
unmasked to the investigator who will record the lens fitting measurements. However, the identity of the 
study lenses will be masked to the investigator who will collect measurements for the study primary and 
secondary endpoints.
4.6 
WEAR AND REPLACEMENT SCHEDULES, INCLUDING FORM, PACKAGING AND 
LABELING
Wear Schedule: In addition to the trial fitting at the first visit, the study lenses will be worn for a period of 
approximately three to four hours while attending the study measurement visits.
Replacement Schedule: The study lenses will only be worn once and disposed of after use.
Test Article Packaging Description: Single vials.
Labeling: The study contact lenses are CE marked and marketed in the UK and will carry the approved CE 
marking.  
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9.
Ocular 
Dominance
The distance ocular dominance will be 
determined with the best distance correction in 
place using the +1.00 blur test. If the results are 
equivocal the sighting dominance test will be 
used to determine the dominant eye for the 
study.
Manual of 
Procedures
10.
Keratometry
Keratometry readings will be taken for each eye 
using an Autokeratometer. Steep and Flat K 
readings will be recorded in mm and axis.
Manual of 
Procedures
11.
Pupil size 
measurement 
The measurements will be carried out at three 
luminance: 250, 50 and 2.5 cd/m2
Manual of 
Procedures
12.
HVID 
measurement
Horizontal visible iris diameter will be recorded
in millimeters with one decimal place.
Manual of 
Procedures
13.
Biomicroscopy
Biomicroscopy will be performed OD and OS. 
Standard Slit Lamp Classification Scales will be 
used to grade the findings.  
For the limbal and conjunctival redness, 0.5 unit 
increments will be used in the grading.
Manual of 
Procedures 
14.
Eligibility
All responses to Inclusion Criteria questions 
must be answered “yes,” and all responses to 
Exclusion Criteria questions must be answered 
“no” for the subject to be considered eligible.
15.
Lens Information
The initial contact lenses will be selected based 
upon the fitting guide.  Place the lenses on the 
subject’s eyes.   
Appendix B
16.
Lens Damage 
Inspect the lenses on eye with the biomicroscope 
for damage and if damaged, record the damage 
and have the subject insert a new lens.  Save 
worn, damaged lenses in sterile saline in the 
labeled vials provided with the study materials 
and complete the quality product complaint 
form. 
17.
Lens Settling
Allow the lenses to settle for at least 15 minutes.
18.
Spherical Over- 
Refraction and 
Visual Acuity
A monocular distance spherical over-refraction 
will be performed.  The distance visual acuity to 
the nearest letter will be recorded OD, OS and 
OU.
Manual of 
Procedures
19.
Subjective Lens 
Fit Assessment 
Lens centration, primary gaze movement, 
upgaze movement and tightness (push-up test) 
will be evaluated and graded.
The subject should not proceed to wear the 
contact lenses if any of the following is 
observed:
x
presence of limbal exposure (appearance of 
clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
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x
Dryness
x
Lens Awareness
x
Grittiness/Foreign Body Sensation
x
Redness
x
Irritation/Discomfort
x
Cloudy/Blurry/Hazy
x
Variable Vision
x
Other
3.
Distance Sphero-
cylindrical 
Refraction and 
Entrance Visual 
Acuity
An optimal, binocular balanced distance sphero-
cylindrical refraction will be performed.  The 
distance visual acuity to the nearest letter will be 
recorded OD, OS and OU.
Manual of 
Procedures
4.
Biomicroscopy
Biomicroscopy will be performed OD and OS. 
Standard Slit Lamp Classification Scales will be 
used to grade the findings.  
For the limbal and conjunctival redness, 0.5 unit 
increments will be used in the grading.
Manual of 
Procedures
5.
Continuance
Indicate whether the visit needs to be 
rescheduled.
6.
Randomization
Study Lens Type will be selected based on the 
Randomization Scheme
7.
Study lens 
insertion
The initial study contact lenses will be selected 
based upon the randomization schedule.  Place 
the lenses on the subject eyes.   
8.
Lens Damage 
Inspect the lenses on eye with the biomicroscope 
for damage and if damaged, record the damage 
and have the subject insert a new lens.   Save 
worn, damaged lenses in sterile saline in the 
labeled vials provided with the study materials 
and complete the quality product complaint 
form. 
9.
Lens Settling
Allow the lenses to settle for at least 15 minutes.
10.
Spherical Over- 
Refraction and 
Visual Acuity
A monocular distance spherical over-refraction 
will be performed.  The distance visual acuity to 
the nearest letter will be recorded OD, OS and 
OU.
Manual of 
Procedures
11.
Subjective Lens 
Fit Assessment 
Lens centration, primary gaze movement, 
upgaze movement and tightness (push-up test) 
will be evaluated and graded.
The subject should not proceed to wear the 
contact lenses if any of the following is 
observed:
x
presence of limbal exposure (appearance of 
clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up).
If either lens is deemed unacceptable, the 
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Procedures 
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subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final Evaluation 
form.
12.
Visual Field 
Measurement
Esterman visual fields will be measured OD, OS 
and OU using a Humphrey perimeter.
Manual of 
Procedures
13.
Vision 
Assessments
Time Controlled Visual Acuity (TCVA)  
Measurements will be made at 4m using 2.5 and 
250 cd/m2 luminance, and at 67cm using 50
cd/m2 luminance.   The luminance requirements 
will be the same at the target and at the eye.  
Monocular and binocular visual performance 
will be measured for the following conditions: 
x
Distance 2.5 cd/m2
o
Central
o
5 degrees eccentricity
o
20 degrees eccentricity
x
Distance 250 cd/m2
o
Central
x
Intermediate 50 cd/m2
o
Central
o
5 degrees eccentricity
o
10 degrees eccentricity
The order of luminances tested will be 
randomized.
Subjects will undergo a driving simulation test 
and subsequently make a subjective assessment 
of their visual performance.
Subjects will play computer based reaction time 
games and subsequently make a subjective 
assessment of their visual performance.
Manual of 
Procedures
14.
Lens Removal 
The contact lenses are removed and discarded.
 
15.
Biomicroscopy
Biomicroscopy will be performed OD and OS. 
Standard Slit Lamp Classification Scales will be 
used to grade the findings.  
For the limbal and conjunctival redness, 0.5 unit 
increments will be used in the grading.
Manual of 
Procedures
16.
Distance Sphero-
cylindrical 
Refraction and 
Exit Visual 
Acuity
An optimal, binocular balanced distance sphero-
cylindrical refraction will be performed.  The 
distance visual acuity to the nearest letter will be 
recorded OD, OS and OU.
Manual of 
Procedures
17.
Continuance
Indicate whether the subject will continue to the 
next visit.  If not, proceed to Final Evaluation.
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11.
Subjective Lens 
Fit Assessment 
Lens centration, primary gaze movement, 
upgaze movement and tightness (push-up test) 
will be evaluated and graded.
The subject should not proceed to wear the 
contact lenses if any of the following is 
observed:
x
presence of limbal exposure (appearance of 
clear cornea) in any gaze
x
presence of edge lift
x
presence of unacceptable movement 
(excessive or insufficient) in all three
movement categories (primary gaze, 
upgaze, and push-up).
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Remove the lenses, perform a slit-lamp 
evaluation, and complete the Final Evaluation 
form.
Manual of 
Procedures 
12.
Visual Field 
Measurement
Esterman visual fields will be measured OD, OS 
and OU using a Humphrey perimeter.
Manual of 
Procedures
13.
Vision 
Assessments
Time Controlled Visual Acuity (TCVA)  
Measurements will be made at 4m using 2.5 and 
250 cd/m2 luminance, and at 67cm using 50 
cd/m2 luminance.  The luminance requirements 
will be the same at the target and at the eye.  
Monocular and binocular visual performance 
will be measured for the following conditions: 
x
Distance 2.5 cd/m2
o
Central
o
5 degrees eccentricity
o
20 degrees eccentricity
x
Distance 250 cd/m2
o
Central
x
Intermediate 50 cd/m2
o
Central
o
5 degrees eccentricity
o
10 degrees eccentricity
The order of luminances tested will be 
randomized.
Subjects will undergo a driving simulation test 
and subsequently make a subjective assessment 
of their visual performance.
Subjects will play computer based reaction time 
games and subsequently make a subjective 
assessment of their visual performance.
Manual of 
Procedures
14.
Lens Removal 
The contact lenses are removed and discarded.
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4.10 
PROCEDURES FOR MAINTAINING AND BREAKING RANDOMIZATION CODES
Subjects who have had their lens assignment unmasked are expected to return for all remaining scheduled 
evaluations. A replacement subject may be enrolled if a subject discontinues from the study prematurely 
(see section 5.1); the decision whether to enroll replacement subjects will be made by the joint agreement 
of the Investigator and Sponsor. 
When dispensing test articles, the following steps should be followed to maintain randomization codes :
1.
Investigator or designee (documented on the Delegation Log) will consult the randomization 
scheme to obtain the study test article assignment for that subject prior to dispensing.
2.
Investigator or designee will record the subject’s number on the appropriate line of the 
randomization scheme.
3.
Investigator or designee will pull the appropriate test articles from the study supply.  All test 
articles that were opened, whether dispensed or not, must be recorded on the Test Article 
Accountability Log in the “Dispensed” section.
There will be an un-masked investigator at the site, therefore no provision is required for breaking 
randomization codes.
4.11  
REPORTING 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.  A PQC is associated with any 
investigational product  (i.e. product manufactured or supplied specifically for a clinical trial). 
Complaint Handling
Once site personnel have become aware that a PQC has occurred, it shall then be recorded in the EDC 
system, which triggers 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, then 
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 shall complete the applicable sections of the Product 
Quality Complaint Form 
For each complaint, the following minimum information shall be recorded by the CRA/COM on the 
Product Quality Complaint Form 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor Awareness)
x
Who received the complaint
x
Study number
x
Investigational 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 or not 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.)
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 
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Clinical QA  will assign a unique number to the PQC. Complaint numbering is assigned as follows:
RDTC-XX-001, where RDTC = R&D Technical Complaint, XX = last two digits of the current year, 
001 = sequential numbering starting with 001.
5.1
WITHDRAWAL CRITERIA
A subject will be withdrawn from the study for any of the following reasons:
x Lost to follow-up
x Withdrawal of consent
x Death
x Discontinuation of study treatment as a result of the investigator’s clinical judgment that for safety 
reasons (e.g., adverse event) it is in the best interest of the subject to stop treatment.
x The subject becomes pregnant.
For discontinued subjects, the Investigator will:
x
Update the enrollment log to document reason for discontinuation
x
Complete the “last” Follow-up Visit form (scheduled or unscheduled)
x
Complete the Final Evaluation form, indicating the reason that the subject was discontinued from 
the study
x
Record the spherocylindrical refraction with best corrected distance visual acuity 
x
Collect used study lenses and test articles (worn or brought to the visit) from the subject and 
discard them
x
Collect all unused study lenses and test articles from the subject
Subjects becoming pregnant during the study will be discontinued.  Once discontinued, pregnant 
participants and their fetuses will not be monitored for study related purposes.  At the Investigators’ 
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.
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 as the final attempt.
6.1
PRESTUDY AND CONCOMITANT THERAPY
Concomitant medications will be documented during screening and during the study.
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6.2
MONITORING TREATMENT COMPLIANCE
Johnson & Johnson Vision Care, Inc. representatives or designees will monitor the study in a 
manner consistent with ICH GCP E6.  The study monitors will maintain close contact with 
the Principal Investigator and the Investigator’s designated staff.  The monitor’s 
responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol
x
Ensuring the rights and well being of subjects are protected
x
Ensuring that protocol deviations are documented with corrective action plans, as applicable
x
Ensuring that the site has sufficient test article and supplies
x
Clarifying questions regarding the study
x
Resolving study issues or problems that may arise
x
Reviewing the study records to ensure completeness and accuracy
x
Study and subject source document records reviewed will include:
x
The Information and Consent Form per 21CFR Parts 50 and 56 and the Data Protection Act
x
Source documentation including consenting, medical history, concomitant medications, and 
adverse event information as applicable.  The source document should be initialed and dated by 
the study investigator/s.
x
Investigational product shipping, dispensing, accountability, and return/destruction records
x
Study related Regulatory documents as per ICH E3 section 8
6.2.1
MONITORING PLAN
This section of the protocol constitutes the monitoring plan for this study:
At least two monitoring visits will be completed during the study. A combined interim
and closure visit may be conducted.
The following data will be reviewed:
1. Incl/Exc-Eligibility
2. Med History
3. Con Meds
4. Demographics
5. Test Article Accountability
6. Test Article Information
7. Primary End Points (PEP)
8. Secondary End Points
9. Protocol Deviations (PD)
10. AE’s
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11. Product Quality Complaints
12. Compliance
13. Symptoms
14. Comments
15. Intentionally Left Blank (ILB)
16. Unscheduled Visits (UV)
17. Final Evaluation
6.3
UNSCHEDULED VISITS
If, during the investigation, a subject experiences any investigational device-related difficulties and/or 
problems requiring an unscheduled visit to the clinic, the following information will be collected at a 
minimum:
x
Chief complaint prompting the visit.  If the reason is an adverse event, the applicable eCRF for the 
adverse event should be completed and source documentation completed as appropriate.
x
Date and time of the visit and all procedures completed at the unscheduled visit
x
Review of adverse event and concomitant medications
x
Documentation of any investigational product dispensed or collected from the subject.
x
Slit lamp findings (using the Slit Lamp Classification Scale)
If the Investigator withdraws a subject from the study, the final study visit case report forms must be 
completed indicating the reason(s) why the subject was withdrawn.  The subject enrollment log should be 
completed documenting the date and primary reason for withdrawal and the study CRA notified.
Any investigational device-related difficulties and/or problems that are ongoing at the time of the final 
study visit will be followed by the Investigator, within licensure, until they have returned to pre-treatment 
status, stabilized, or been satisfactorily explained.  If further treatment (i.e., beyond licensure) is required, 
the subject will be referred to the appropriate health care provider.
7.1
EFFICACY PARAMETERS
The primary efficacy parameters for this study will be measurements of binocular functional visual 
performance under distance day time conditions (250 cd/m2) for centrally presented high contrasts (HC) 
time controlled visual acuity (TCVA) targets.
The secondary efficacy parameters for this study will be measurements of binocular functional visual 
performance of the test and control contact lenses for the following conditions: 
i.
Distance night time conditions (2.5 cd/m2) for centrally presented HC TCVA targets;
ii.
Intermediate vision indoor conditions (50cd/m2) for centrally presented HC TCVA targets. 
Other efficacy parameters for this study will be measurements of:
i.
Monocular functional visual performance for centrally presented high contrast (HC) time 
controlled visual acuity (TCVA) targets.
a.
Distance day time conditions (250 cd/m2)
b.
Distance night time conditions (2.5 cd/m2)
c.
Intermediate vision indoor conditions (50cd/m2)
ii.
Distance monocular and binocular functional visual performance of the test and control contact 
lenses under night time conditions (2.5 cd/m2) for HC TCVA targets presented at 5° eccentricity;
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iii. Intermediate vision monocular and binocular functional visual performance of the test and control 
contact lenses under indoor conditions (50cd/m2) for HC TCVA targets presented at 5° 
eccentricity;
iv. Distance monocular and binocular functional visual performance of the test and control contact 
lenses under night time conditions (2.5 cd/m2) for decreasing contrast targets presented at 20° 
eccentricity;
v.
Intermediate vision monocular and binocular functional visual performance of the test and control 
contact lenses under indoor conditions (50cd/m2) for decreasing contrast targets presented at 20° 
eccentricity.
vi. Horizontal binocular visual field;
vii. Horizontal monocular visual field.
viii. Subjective rating of performance following driving simulation while wearing test and control 
contact lenses under night time condition (e.g. City Car Driving Simulator / PC game);
ix. Subjective rating of performance following PC based reaction time game while wearing test and 
control contact lenses.
7.2
METHODS FOR ASSESSING, RECORDING, AND ANALYZING EFFICACY
See detailed study procedures in section 4.7 regarding methods for assessing and recording efficacy.  
Statistical methods for analyzing efficacy data are provided in section 9.1 below.
8.1
SAFETY PARAMETERS
The following safety parameters will be monitored and evaluated:
• Ocular physiology characteristics
• Lens fitting characteristics
• Adverse events
• Ocular symptoms
• Snellen distance visual acuity
• Reasons for discontinuation
• Reasons for unplanned lens replacement
• Quality Complaints
Safety parameters will be tabulated using frequency distribution tables and descriptive statistics. Adverse 
events will be listed by subject/eye. There will be separate summary tables for adverse events and infiltrative 
adverse events. Statistical methods for analyzing safety data, if any, are provided in section 9. 
8.2
ADVERSE EVENTS
All adverse events will be will be recorded in the subject’s source document and documented in the 
appropriate section of the subject’s Case Report Form (CRF).
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 (see definition in Section 8.4).
x
Expectedness – i.e. if the event was unexpected or unanticipated in that it was not previously 
identified in nature, severity, or degree of incidence (see definition in Section 8.4).
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x
Causality or Relatedness – i.e. the relationship between the test article and the adverse event (not 
related; doubtful; possible; probable; very likely - see definition in Section 8.4).
x
Adverse Event Intensity or Classification – Adverse event intensity is used to assess the degree of 
intensity of the adverse event (mild, moderate, severe for all events). In addition adverse event 
Classification is used to assess the severity of ocular adverse events (AE not requiring treatment, 
non-significant or significant see definition in Section 8.4).
x
Outcome – Resolved, ongoing, not resolved, resolved with sequelae, fatal, resolving, and 
unknown.
x
Actions Taken – None, temporarily discontinued, permanently discontinued, other action taken.  
In addition, a written report will be submitted by the Principal Investigator to the IRB/IEC according to 
their requirements.  Such a report should comment whether or not the adverse event was considered to be 
related to the test article.
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 for review by the Medical Monitor.
Serious Adverse Events:
The Investigator will inform the sponsor of all serious 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 CRF. All subjects experiencing a serious adverse event must be followed up 
and all outcomes must be reported.
In the event of a serious adverse event, the investigator must:
x
Notify the Sponsor immediately
x
Obtain and maintain in the subject’s file all pertinent medical records, 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 investigational test article
x
Notify the IRB/IEC as required by the IRB/IEC 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 IRB/IEC 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 IRB/IEC and participating investigators within 10 working days after the Sponsor first receives 
notification of the effect.
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8.3
ADVERSE EVENT DEFINITIONS
Adverse Event (AE) – An AE is any untoward (unwanted) medical occurrence in a patient or clinical 
investigation subject administered a test article whether or not caused by the test article or treatment.  An 
AE can therefore be any unfavorable or unintended sign (including an abnormal finding), symptom, or 
disease temporally associated with the use of the test article whether or not related to the test article.
An AE includes any condition (including a pre-existing condition) that:  1) was not present prior to study 
treatment, but appeared or reappeared following initiation of study treatment; or 2) was present prior to 
study treatment, but worsened during study treatment.  This would include any condition resulting from 
concomitant illnesses, reactions to concomitant medications, or progression of disease states.  Pregnancy 
should be documented as an adverse event and should 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 (i.e., 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 investigational product 
resulting in a condition which requires medical or surgical intervention to preclude permanent 
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 Serious Adverse Events include:
x
Microbial Keratitis (MK)
x
Iritis
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 Significant Adverse Events include 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
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
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x
Non-contact 
lens 
related 
corneal 
events 
- 
e.g. 
EKC 
(Epidemic 
Keratoconjunctivitis)
x
Asymptomatic Corneal Scar
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 Non-Significant Adverse 
Events include the following:
x
Non-significant Infiltrative Event
x
Contact Lens Papillary Conjunctivitis
x
Superficial Punctate Keratitis
x
Conjunctivitis: Bacterial, Viral, Allergic
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) – A sub-set of AEs, and include only those adverse events that are cause by 
or related to the investigational device or study procedure.
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.
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.
x
Doubtful – 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
Possible – An adverse event that might be due to the use of the test article.  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
Probable – An adverse event that might be due to the use of the test article.  The relationship in 
time is suggestive (e.g. confirmed by de-challenge).  An alternative explanation is less likely, e.g. 
concomitant treatment or concomitant disease(s).
x
Very Likely – 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. 
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 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.
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x
Moderate – Event is bothersome, possible requiring additional therapy, and may interfere with the 
subject’s daily activities.
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy and interferes 
with the subject’s daily activities.
8.4
METHODS FOR ASSESSING, RECORDING, AND ANALYZING SAFETY
The recording and documenting of adverse events (ocular and non-ocular) begin when the subjects are 
exposed to the test article or study treatment.  Adverse events reported before the use of test article or start 
of study treatment should be recorded as medical history.  Untoward medical events reported after the 
subject’s exit from the study will be recorded as adverse events at the discretion of the Investigator.
All adverse events observed by the Investigator; reported by the subject spontaneously; or in response to 
direct questioning; will be recorded in the source document.  Such documentation will include a description 
of the adverse event, time of onset, duration of event, treatment regimen instituted, any referral to another 
health care provider (if needed), any new concomitant medications, outcome, ocular damage (if any), and 
likely etiology.  Best Corrected Visual Acuity (BCVA) should be recorded prior to the report of an adverse 
event (as part of the baseline evaluation), upon report of the subject’s report of the adverse event, and after 
the adverse event has resolved.  All adverse events will be followed in accordance with licensing 
requirements.
All adverse events will be documented in the appropriate section of the subject’s Case Report Form (CRF). 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure the events 
are categorized correctly.  Elements of categorization will include:
Seriousness (see definition in Section 8.3) 
Expectedness – i.e. if the event was unexpected or unanticipated in that it was not previously identified in 
nature, severity, or degree of incidence (see definition in Section 8.3) 
Causality or Relatedness – i.e. the relationship between the test article and the adverse event (not related; 
doubtful; possible; probable; very likely - see definition in Section 8.3) 
Adverse Event Intensity or Classification – Adverse event intensity is used to assess the degree of 
intensity of the adverse event (mild, moderate, severe for all  events).  In addition Adverse event 
Classification is used to assess the severity of ocular adverse events (AE not requiring treatment, non-
significant or significant see definition in Section 7.4).
Outcome – Fatal, not resolved, resolved, resolved with sequelae, resolving and unknown.  
Actions Taken – None, temporarily discontinued, permanently discontinued, Other action taken
Upon finding an adverse event, the Principal Investigator will document the condition on the follow-up 
visit worksheet source document and in the CRF’s using photos or drawings (where appropriate) that detail 
size, location, and depth.  He will also complete the Adverse Event Classification (AEC) Discovery form / 
eCRF.  In addition, if an infiltrate(s) is present, he will complete the Corneal Infiltrate Assessment Form / 
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, a source document note should be completed specifying the 
date of culture collection and laboratory utilized.  An eCRF documenting this should be completed in a 
comment or unscheduled visit.
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Complete description of all adverse events must be available in the source documents. All Adverse Events 
including local and systemic reactions not meeting the criteria for “serious adverse events” should be 
captured on the appropriate case report form or electronic data system.  Information to be recorded, based 
on above assessment criteria, includes date site notified, event description, date and time of onset, 
investigator assessment of severity, relationship to Study Agent(s)/Intervention(s), and time of 
resolution/stabilization of the event.  All adverse events occurring while on study must be documented 
appropriately regardless of relationship.  Define a timeframe for CRF completion and entry of the adverse 
event information into the database, as applicable.
Any medical condition that is present at the time that the subject is screened should be considered as 
baseline and not recorded as an AE.  However, if the condition deteriorates at any time during the study it 
should be recorded and reported as an AE. 
Changes in the severity of an AE should 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 
Study Agent(s)/Interventions should also be clearly documented.
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 a serious / significant adverse event, and 2 days from 
discovery for a non-significant adverse event.  In addition, a written report will be submitted by the 
Principal Investigator to the IRB/IEC according to their requirements (Section 12.3).  Such a report should 
comment whether or not the adverse event was considered to be related to the test article.
8.5
ADVERSE EVENTS FOLLOW-UP
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:
x
Adverse Event (Diagnosis not symptom)
x
Detailed drawings or photographs, when appropriate
x
Date and time of onset
x
Date and time of resolution
x
Adverse event intensity and classification, 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, the Investigator will complete the Corneal Infiltrate Assessment 
Form / eCRF.
Photographs or video recordings may be collected at the Investigator’s discretion for purposes of 
documenting adverse event findings.
Visual acuity (best corrected) should be recorded prior to the report of an adverse event (as part of the 
Baseline Evaluation), upon the subject’s report of the adverse event, and after the adverse event has 
resolved.  
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Subjects who present with an adverse events should 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 (i.e. beyond licensure) is required, the patient will be referred to the appropriate health 
care provider.  The Investigator should use his/her clinical judgment as to whether or not a subject (eye) 
reporting with an adverse event should 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 complete the Adverse Event Classification (AEC) Outcome form / eCRF. Any subjects with ongoing 
adverse events related to the test article 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.
9.1
STATISTICAL METHODS TO BE EMPLOYED
All data summaries and statistical analyses will be performed using either the SAS software Version 9.4 or 
higher (SAS Institute, Cary, NC) or SPSS software Version 23.0 or higher (IBM Corp, Armonk, NY). 
Description of Summary Tables
Summary tables (Descriptive statistics and/or frequency tables) will be provided for all baseline, efficacy 
and safety variables for each subject/eye 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 variables. 
Summaries will be presented by study lens type and will be performed separately by study population 
defined in section 9.7. Efficacy variables will be summarized descriptively on both the analysis and safety 
population. Safety variables will be summarized descriptively for the safety population. Unscheduled visits 
will be summarized separately if applicable. If the difference between the analysis and safety population is 
higher than 15%, a sensitivity analysis will be conducted on the safety population. 
Data summarization will be performed by OTG-i, with oversight by the JJVCI study responsible 
biostatistician.  
Raw data will be provided to OTG-i by JJVCI/Bioclinica in the Study Data Tabulation Model (SDTM) 
format in conformance to Clinical Data Interchange Standards Consortium (CDISC) standards. OTG-i will 
be responsible to create CDISC Analysis Data Model (ADaM) datasets as well as the display outputs 
including tables, listings and figures (TLFs) based on the CDISC ADaM datasets. For more details about 
CDISC, SDTM and ADaM, please refer to www.cdisc.org. 
OTG-i shall follow specifications of ADaM datasets and mock shells of TLFs provided by JJVCI.  Sample 
datasets, ADaM specifications, and mock shells of TLFs may be provided to OTG-i by JJVCI midway 
through the study if needed.
Description of Analysis Methods
Efficacy Analysis Set
The primary and secondary analysis will be performed on all randomized subjects who successfully
completed the study without any protocol deviations that the study responsible clinician documents as 
impacting the assessment of the hypotheses (i.e. analysis population). Justification of excluding subjects 
with protocol deviations in the analysis population set will be documented.
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Analysis Methods
The binocular central distance high contrast, high illumination (250 cd/m2) TCVA, the binocular central 
distance high contrast, low illumination (2.5 cd/m2) TCVA and the binocular central intermediate vision 
high contrast, medium illumination (50 cd/m2) TCVA will be analyzed together using a linear mixed 
model. The model will include the experimental design factors: sequence of lens wear, period, lens type, 
condition (determined jointly by distance, illumination and eccentricity) as well as lens type by condition 
interaction as fixed effects; and subject as a random effect. Other baseline characteristics known of 
importance such as age, gender and race may be included as fixed covariates when appropriate. The 
covariance between residual errors from the same subject and period at different conditions will be selected 
based on the finite-sample corrected Akaike’s Information Criterion (Keselman et al., 1998). Covariance 
structures considered may include:
x
Variance Component (VC)
x
Homogenous Compound Symmetry (CS),
x
Heterogeneous Compound Symmetry (CSH),
x
Heterogeneous Variance Component (UN(1)) 
x
Unstructured Covariance Structure (UN).
For UN(1) covariance structures, condition nested within subject and period will be included as an 
additional random effect. For the remaining structures only subject will be included as a random effect. The 
improved Kenward and Roger method (Kenward and Roger, 2009) using the KENWARDROGER2 option 
will be used for the calculation of the denominator degrees of freedom. Heterogeneous models between the 
study lenses may be considered when appropriate. The log-likelihood ratio test will be used to test for 
homogeneity of variances between lens types.
Primary Hypothesis Testing:
The null and alternative hypotheses for non-inferiority in the binocular central distance high contrast high 
illumination TCVA are as follows: H0: μ1- μ2  -0.5 v.s. Ha: μ1- μ2 > -0.5, where μ1 and μ2 are the 
population mean of binocular central distance high contrast high illumination TCVA for the Test lens and 
the Control lens, respectively. Comparisons between the Test lens and Control lens will be conducted using 
two-sided 95% confidence intervals constructed for least-square means (LSM) difference (Test - Control)
at central distance high contrast high illumination. Non-inferiority will be concluded if the lower limit of 
the LSM difference is greater than -0.5 VA units. 
Secondary Hypothesis Testing:
The null and alternative hypotheses for non-inferiority in each of the secondary endpoints are as follows: 
H0: μ1- μ2 -0.75 v.s. Ha: μ1- μ2 > -0.75, where μ1 and μ2 are the population mean of the corresponding 
endpoint for the Test lens and the Control lens, respectively. Comparisons between the Test lens and 
Control lens will be conducted using two-sided 95% confidence intervals constructed for least-square 
means (LSM) difference (Test - Control) at central distance high contrast low illumination and central 
intermediate vision high contrast medium illumination, respectively. Non-inferiority will be concluded if 
the lower limit of the LSM difference is greater than -0.75 VA units.
Bayesian analysis may be considered if the data is not normally distributed.
Further exploratory analysis can be undertaken if necessary at the discretion of the study responsible 
clinician.  
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9.2
NUMBER OF SUBJECTS BY SITE AND JUSTIFICATION FOR SAMPLE SIZE
A minimum of 20 subjects are targeted to complete the study as the cohort population.   Subjects who  are 
found to be ineligible, or who are discontinued or incomplete, will be classified as the non- cohort 
population.  The total number of subjects enrolled may not exceed 25 subjects, except by joint agreement of 
the Investigator and Sponsor.  Since this is a pilot study and all the hypotheses are exploratory in nature, the 
sample size was selected by the study responsible clinician and was not based on any empirical power 
calculation.
9.3 
LEVEL OF STATISTICAL SIGNIFICANCE
All planned analysis for this study will be conducted with an overall type I error rate of 5%. Since this 
study is exploratory in nature, no adjustment for multiple comparisons will be conducted.
9.4
CRITERIA FOR STUDY TERMINATION
In addition to the stopping rules defined in section 9.1, the occurrence of one or more Serious 
Unanticipated Adverse Device Effect (USADE), or any SAE where the relationship to study agent cannot 
be ruled out, may result in stopping further dispensing of investigational product.  In the event of a USADE 
or SAE, the Sponsor may unmask the treatment regimen for the subject(s) and may discuss this with the 
Investigator before any further subjects are enrolled.
The sponsor may determine when a study will be stopped.  The principal investigator always has the 
discretion to initiate stopping the study based on subject safety or if information indicates the study’s 
results may be compromised.
9.5
PROCEDURE FOR ACCOUNTING FOR MISSING, UNUSED, AND SPURIOUS DATA
Missing or spurious values will not be imputed. The count of missing values will be included in the 
summary tables and listings. 
9.6
PROCEDURE FOR REPORTING DEVIATIONS FROM STATISTICAL PLAN
The analysis will be conducted according to section 9.1.  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.
9.7
EVALUABLE SUBJECTS
Accountability (disposition) of all enrolled subjects will be presented in each of the following status 
subgroups.
1.
Completed: Randomized subjects who are eligible to participate in the study and have successfully 
completed all required visits including the final visit.
2.
Discontinued: Randomized subjects who are prematurely discontinued from the study due to (i) 
lost to follow-up, (ii) withdrawal of consent, (iii) death, (iv) unsuccessful dispensing (lack of 
efficacy or safety), (v) safety reasons at the discretion of the investigator, (vi) dissatisfactory of 
eligibility criteria (e.g., pregnancy), (vii) noncompliance of the study lens wear schedule.
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3.
Total Dispensed: Randomized subjects who administered the test article at least once (i.e. lens 
insertion occurred in at least one eye).
4.
Enrolled Not Dispensed: Subjects who were (i) enrolled in the study (provided informed consent) 
but failed to satisfy the eligibility criteria (inclusion/exclusion criteria), (ii) randomized but 
discontinued or drop out prior to administering the test article, or (iii) not randomized to treatment 
for any reason.
5.
Total enrolled (i.e. completed + discontinued + Enrolled not dispensed).
Subjects will be allocated to the following study populations. Safety variables will be summarized on the 
safety population whereas efficacy variables will be summarized on both the analysis and safety 
population.
1.
Safety Population: All subjects who are administered the test article and have at least one 
observation on any safety or/and efficacy variables.
2.
Analysis Population: All subjects who have successfully completed all required visits without any 
protocol deviations that the study responsible clinician documents as impacting the assessment of 
the hypotheses.
10.1
ELECTRONIC CASE REPORT FORM/DATA COLLECTION
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC system  
when possible. Designated study site personnel will enter study data into the electronic CRFs (eCRFs) 
using the EDC system. Data collected on equipment that is not possible to be captured in EDC will be 
formatted in conformance to Clinical Data Interchange Standards Consortium (CDISC) standards following 
JJVCI’s specification --i (refer to Section 9.1) for statistical analysis.
The CRFs will be reviewed for accuracy and completeness and signed by the investigator.  Unless 
otherwise stated, the eCRFs will be considered the source document. The sponsor or sponsor‘s 
representatives will be authorized to gain access to the source documentation for the purposes of 
monitoring and auditing the study. 
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 investigational 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 a non-editable format for all of the study data. The IPP should be retained 
in the study files as a certified copy of the source data for the study. 
The content and structure of the CRFs are compliant with ISO14155:2011 [3].
10.2
SOURCE DOCUMENTATION
At a minimum, source documentation should be available for the following to confirm data collected in the 
CRF: subject identification, eligibility, and study identification; study discussion, provision of and date of 
informed consent; visit dates; results of safety and efficacy parameters as required by the protocol; a record 
of all adverse events; follow-up of adverse events; concomitant medication; investigational product receipt 
/ dispensing / return records; study investigational product administration information; date of study 
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completion; reason for early discontinuation of investigational product or withdrawal from the study, if 
applicable.
The author of an entry in the source documents must be identifiable.  Adverse event notes should be 
reviewed and initialed by the Investigator.
At a minimum, the type and level of detail of source data available for a study subject should be consistent 
with that commonly recorded at the site as a basis for standard medical care.  Specific details required as 
source data for the study will be reviewed with the investigator before the study and will be described in the 
monitoring guidelines (or other equivalent documents).
10.3
ACCESS TO SOURCE DATA/DOCUMENTS
The Investigator(s) / Institution(s) will permit trial-related monitoring, audits, IRB/IEC review and 
regulatory inspection(s) by providing direct access to source data / documents.  Should the clinical site be 
contacted for an audit by an IRB/IEC or regulatory authority, JJVCI should be contacted and notified in 
writing within 24 hours.
10.4
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 JJVCI.  The Investigator may use this 
information for the purposes of the study only. It is understood by the Investigator that JJVCI will use 
information developed in this clinical study in connection with the development of an 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.
The Investigator may not submit for publication or presentation the results of this study without first 
receiving written authorization from JJVCI.  JJVCI agrees that, before it publishes any results of the study, 
it shall provide the Investigator with at least 30 days for review of the pre-publication manuscript prior to 
the submission of the manuscript to the publisher.
11.1
DATA QUALITY ASSURANCE
Steps to be taken to ensure the accuracy and reliability of data include the selection of qualified 
investigators and appropriate study sites and review of protocol procedures with the principal investigator.  
The principal investigator, in turn, must ensure that all sub-investigators and study staff are familiar with 
the protocol and all study-specific procedures and have appropriate knowledge of the study article.
Guidelines for case report form completion will be included in the eCRF.  The sponsor, Johnson & Johnson 
Vision Care, Inc. will review case report forms for accuracy and completeness remotely during the course 
of the study, during on-site 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 Johnson & Johnson Vision Care, Inc. may visit study sites to 
review data produced during the study and to access compliance with applicable regulations pertaining to 
the conduct of clinical trials.  The study sites will provide direct access to study-related source 
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data/documents and reports for the purpose of monitoring and auditing by Johnson & Johnson Vision Care, 
Inc. and for inspection by local and regulatory authorities.
12.1
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.  They 
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.
12.2
INVESTIGATOR RESPONSIBILITY
The Investigator is responsible for ensuring that the clinical study is performed in accordance with the 
protocol, Section 4 of the ICH E6 guidelines on Good Clinical Practice (GCP), 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 wellbeing of study subjects are protected, 
consistent with the principles of the Declaration of Helsinki 64th WMA General Assembly 2013 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), and applicable regulatory 
requirements.
12.3
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, if applicable
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, 
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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 recruiting materials approved by the Sponsor
x
Revisions to compensation for study-related injuries or payment to subjects for participation 
in the study, if applicable
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) 
x
Reports of adverse events that are serious, unanticipated, and associated with the 
investigational product, 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 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 be asked to 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 filed in the study Investigator binder and a 
copy provided to the CRO or Sponsor as applicable.
12.4
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 should be in accordance with principles that originated in the Declaration of Helsinki, 
current ICH and GCP guidelines, applicable regulatory requirements, and sponsor policy.
Before entry into the study, the Investigator or an authorized member of the investigational staff must 
explain to potential subject the aims, methods, reasonably anticipated benefits, and potential hazards of the 
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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. They will be informed that choosing not to 
participate will not affect the care the subject will receive.  Finally, they will be told that the Investigator 
will maintain a subject identification register for the purposes of long-term follow-up if needed and that 
their records may be accessed by health authorities and authorized sponsor staff without violating the 
confidentiality of the subject, to the extent permitted by the applicable law(s) or regulations. By signing the 
informed consent form the subject is authorizing such access, and agrees to be contacted after study 
completion, by health authorities and authorized sponsor staff, for the purpose of obtaining consent for 
additional safety evaluations if needed.
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.
In the event additional investigators / sites are added to the protocol, the informed consent will be modified 
to include the Investigator’s name, address, phone number and 24-hour emergency number. 
12.5
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 investigational staff (e.g., name, clinic 
address and phone number, curriculum vitae) is subject to compliance with the Data Protection Act of 1998 
and other applicable personal data protection and security laws and 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, 
Sponsors personnel and independent ethics committee.  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), independent ethics committee and regulatory organizations in the context of their investigation 
related activities that, as part of the investigation will have access to the CRFs and source documents.
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
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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. 
13.1
DATA HANDLING AND RECORD KEEPING
In compliance with the ICH/GCP guidelines, the Investigator / Institution will maintain all CRFs and all 
source documents that support the data collected from each subject, as well as all study documents as 
specified in ICH/GCP Section 8, Essential Documents for the Conduct of a Clinical Trial, 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.
Essential documents must be retained until at least 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 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 by an agreement with 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 should contact JJVCI Research 
and Development.
14.1
FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Investigator’s Research 
Agreement.  The Research Agreement will be signed by the Principal Investigator and a Johnson & 
Johnson Vision Care management representative prior to study initiation.
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Case Report Forms will be completed in real time according to the study procedures specified in the study 
protocol.  Case Report Forms should be completed and reviewed and signed as applicable by the 
Investigator within 3 days of visit completion.  Data queries must be addressed with complete responses 
within 3 days of generation.  Johnson & Johnson Vision Care reserves the right to withhold remuneration 
until these activities are addressed.
Johnson & Johnson Vision Care 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
15.1
PUBLICATION
This study will be registered on ClinicalTrials.gov. 
16.1
PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
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PRO SPECIFICATIO
1 Final  2016-05-03
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1
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PRO SPECIFICATIO
1 Final  2016-05-03
Protocol 5856                 Johnson & Johnson Vision Care, Inc.                  Confidential
2
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PRO SPECIFICATIO
1 Final  2016-05-03
Protocol 5856                 Johnson & Johnson Vision Care, Inc.                  Confidential
3
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PRO SPECIFICATIO
1 Final  2016-05-03
Protocol 5856                 Johnson & Johnson Vision Care, Inc.                  Confidential
4
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16.2
CLINICAL TECHNICAL PROCEDURES 
 
 
The following 
 are included in the Manual of Procedures: 
x
LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS 
x
  LENS FITTING CHARACTERISTICS 
x
 OCULAR SYMPTOMS 
x
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS 
x
  BIOMICROSCOPY SCALE 
x
  DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
16.3
PATIENT INSTRUCTION GUIDE (APPROVED PRODUCT) 
 
See package insert (Appendix B). 
16.4 
PACKAGE INSERT 
 
See Appendix B. 
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17.1
LIST OF ABBREVIATIONS
 
 
AE
Adverse Event/Adverse Experience
CFR
Code of Federal Regulations
CIB
Clinical Investigator’s Brochure
CRF
Case Report Form
CRO
Contract Research Organization
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act
IB
Investigator’s Brochure
ICF
Informed Consent Form
ICH
International Conference on Harmonization
IDE
Investigational Device Exemption
IEC
Independent Ethics Committee
IRB
Institutional Review Board
MedDRA ©
Medical Dictionary for Regulatory Activities
MOP
Manual of Procedures
NIH
National Institutes of Health
OHRP
Office for Human Research Protections
OHSR
Office for Human Subjects Research
PHI
Protected Health Information
PI
Principal Investigator
QA
Quality Assurance
QC
Quality Control
SAE
Serious Adverse Event/Serious Adverse Experience
SOP
Standard Operating Procedure
UADE  
            Unanticipated Adverse Device Effect
USADE
            Unanticipated Serious Adverse Device Effect
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APPENDIX A: SITE INSTRUCTIONS FOR TEST ARTICLE RECEIPT AND TEST ARTICLE 
ACCOUNTABILITY
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Part 1 – Overall Test Article Accountability 
y
Once the test article shipped sheet is completed for the shipment the investigational site must log the 
shipment into the lens depot in the EDC system. 
1. Log into the Study Database in BioClinica Express 5.4 
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*If Quantity shipped is different from Total Quantity Received, please notify your regional CRA immediately (a 
query will populate if this occurs to be resolved)  
y
At the end of the study you will need to return all unused test article 
y
At your close out visit your monitor will help you complete a Test Article Return Worksheet, documenting 
how much test article is being returned.   
y
Once the Test Article Return Worksheet is completed, you will need to enter the quantity of lenses being 
returned into the lens depot in the EDC system. 
6. Enter Total Quantity Returned after the study is completed and lens accountability has 
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y
# Lenses dispensed 
y
Date dispensed 
y
Dispenser initials 
y
Lens count 
 
y
The Lens Information eCRF is within the subject’s eCRF and is used to record individual lens information. 
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Once you click the Lot #, all other fields associated with the study are auto populated (e.g. Product Code,  
Sphere, Cylinder and Axis) – verify information is correct 
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x
Once “Yes” is selected and the form is saved an additional form will be generated to enter the 
replacement lens information. 
 
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APPENDIX B: LENS PACKAGE INSERT
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any adverse reaction arises. The patient should attend regular after-care appointments.
IMPORTANT PATIENT INFORMATION
PRECAUTIONS:
DO NOT exceed your recommended wearing time.
DO NOT use the lenses after the recommended replacement date.
DO NOT swim whilst wearing the lenses.
DO NOT sleep  whilst wearing the lenses unless advised to by your eye care professional.
DO NOT allow tap water or saliva to come into contact with your lenses as this increases your 
risk of infection.
DO NOT wear your lenses if your eyes are sore and/or red.
DO NOT store lenses in saline only, always use a contact lens solution.
DO NOT use lenses or solutions after their use by date.
DO NOT wear lenses if you are using eye drops unless advised to by your eye care professional. 
 YOU SHOULD wash and dry hands (with clean lint free tissue or towel) before handling, insert-
ing or removing the lens.
 YOU SHOULD rinse your lens case daily with saline or fresh contact lens solution and allow to 
air dry.
 YOU SHOULD replace your lens case on a regular basis.
 YOU SHOULD follow your eye care professional’s instructions.
 YOU SHOULD attend regular after-care appointments with your eye care professional. 
LENS CARE DIRECTIONS:
Correct care of your lenses is essential:
• Disinfect your lenses each time they are removed from your eyes to destroy harmful germs 
and to ensure safe and comfortable contact lens wear.
• A separate cleaning and rinsing step may be recommended by your eye care professional 
to remove contaminants from the lens surface. In addition, your lenses may require periodic 
enzymatic cleaning to remove protein. 
• Your eye care professional should recommend the lens care system most suitable for you.
• Ask your eye care professional before using any alternative lens care products.
• DO NOT alternate or mix lens care products from different systems. 
• DO NOT expose your lens(es) to hair or cosmetic sprays or excessive heat.
• Never expose contact lenses or your contact lens case to any non-sterile water as microbial 
contamination can occur which may lead to permanent eye damage, for example tap water.
• Never allow saliva to come in to contact with your lens.
If you have not worn your lenses for an extended period of time (several days or more) follow 
your contact lens care regimen to clean and disinfect the lens prior to insertion. 
LONG TERM STORAGE OF RGP LENSES:
If you are planning to store an RGP lens long term then it is best to store it dry. Disinfect and 
then wet the lens before use.
CARE FOR A STUCK (NON-MOVING) LENS:
If the lens sticks to the eye and stops moving, insert a recommended lubricating solution or 
rewetting solution directly into the eye and wait for the lens to begin moving before attempting 
to remove it. If the problems persist contact your eye care professional. 
Occasional dryness may be relieved by the use of lubricating drops which can be prescribed by 
your eye care professional.  
SCLERAL AND CORNEO SCLERAL CONTACT LENSES INSTRUCTIONS FOR USE 
PRACTITIONER INFORMATION:
Scleral and corneo scleral lenses are large diameter RGP lenses that extend beyond the cornea. 
Although supplied clean in CE marked wetting solution, if the lens does not wet well then clean 
with an alcohol based cleaner. 
MATERIAL:
• BOSTON XO
• OPTIMUM EXTRA
• HDS 100 (ICD 16.5)
INDICATIONS (USES):
Corneo Scleral & Scleral lenses are suitable for the optical correction of vision for myopia, hyper-
metropia, astigmatism, presbyopia and irregular corneas. ICD 16.5 is indicated for the optical 
correction of irregular corneas and for ocular surface disease.
CONTRAINDICATIONS:
DO NOT prescribe Corneo Scleral & Scleral lenses  in the presence of ocular infection, inflam-
mation or injury, any eye disease, severe dry eyes or corneal hypoaesthesia unless indicated. Or 
if there is any systemic condition that may affect the eye or cause heightened risk of allergy to 
contact lens or solution. Or if the patient is taking medication that may interfere with contact 
lens wear (e.g. preserved eye drops).
RECOMMENDED WEARING SCHEDULE: 
• Daily wear - less than 24 hours while awake
• Wearing time should be built up gradually before the maximum is achieved. 
REPLACEMENT SCHEDULE:
Corneo Scleral & Scleral lenses should be replaced on a yearly basis or more frequently as 
recommended by the eye care professional.  
WARNINGS:
In order to promote safe use it is essential that the patient follows the manufacturers recom-
mendations for care of contact lenses, use of care products and lens cases.
Patients should be warned that serious adverse reactions such as ulcers or keratitis can arise very 
quickly and are more likely to occur if the patient does not follow the manufacturers recom-
mendations for wearing times, replacement schedule, use of care products and lens cases.  The 
patient should not wear the lens whilst sleeping (unless indicated), showering or swimming.  
The eye care professional must ensure that the patient can remove their lenses before dispens-
ing them and should advise the patient to remove the lenses and contact them immediately if 
any adverse reaction arises. The patient should attend regular after-care appointments.
IMPORTANT PATIENT INFORMATION
PRECAUTIONS:
DO NOT exceed your recommended wearing time.
DO NOT use the lenses after the recommended replacement date.
DO NOT swim whilst wearing the lenses.
DO NOT sleep whilst wearing the lenses
DO NOT allow tap water or saliva to come into contact with your lenses.
DO NOT wear your lenses if your eyes are sore and/or red.
DO NOT store lenses in saline only, always use a contact lens solution.
DO NOT use lenses or solutions after their use by date.
DO NOT wear lenses if you are using eye drops unless advised to by your eye care professional. 
 YOU SHOULD wash and dry hands (with clean lint free tissue or towel) before handling, insert-
ing or removing the lens.
 YOU SHOULD rinse your lens case daily with saline or fresh contact lens solution and allow to 
air dry.
 YOU SHOULD replace your lens case on a regular basis.
 YOU SHOULD follow your eye care professional’s instructions.
 YOU SHOULD attend regular after-care appointments with your eye care professional.
LENS CARE DIRECTIONS:
Correct care of your lenses is essential:
• Disinfect your lenses each time they are removed from your eyes to destroy harmful germs 
and to ensure safe and comfortable contact lens wear.
• A separate cleaning and rinsing step may be recommended by your eye care professional 
to remove contaminants from the lens surface. In addition, your lenses may require periodic 
enzymatic cleaning to remove protein. 
• Your eye care professional should recommend the lens care system most suitable for you.
• Ask your eye care professional before using any alternative lens care products.
• DO NOT alternate or mix lens care products from different systems. 
• DO NOT expose your lens(es) to hair or cosmetic sprays or excessive heat.
• Never expose contact lenses to any non-sterile water as microbial contamination can occur 
GENERAL INFORMATION
POTENTIAL ADVERSE REACTIONS:
If you suffer from any of the following reactions associated with your contact lens wear, then 
discontinue lens wear and contact your eye care professional:
• Red eye
• Foreign body sensation (feeling of something in the eye)
• Sore or painful eye
• Sensitivity to light (photophobia)
• Burning, stinging or itchy eye
• Rainbows or haloes around lights
• Reduced sharpness of vision
• Increased eye secretions
• Severe or persistent dry eyes.
EMERGENCIES:
Sometimes eye infections can be very serious, if your eye is red, very sore and/or vision is 
reduced contact your eye professional or seek medical advice urgently.
If chemicals of any kind (household products, gardening solutions, laboratory chemicals, etc.) 
are splashed into your eyes or you come into contact with noxious vapours or hazardous 
environments. YOU SHOULD remove lenses and flush eyes immediately with saline (preferably) 
or tap water and immediately contact your eye care professional or seek medical advice.
RGP CONTACT LENSES INSTRUCTIONS FOR USE 
PRACTITIONER INFORMATION:
The enclosed rigid lens(es) have been supplied to a design and using a material specified by the 
practitioner ready for use, soaked in CE marked soaking/wetting solution. Please retain them in 
their sealed mailer until they are required for fitting. If the lens(es) have not been fitted within 28 
days, remove them from their mailer, clean and rinse the lens(es) and mailer and replenish the 
soaking solution. Repeat the procedure monthly until the lens(es) are used. Lenses should be 
discarded after the expiry date.
INDICATIONS (USES):
RGP or Rigid Gas Permeable lenses are suitable for the optical correction of vision for myopia, 
hypermetropia, presbyopia, astigmatism and irregular corneas.
CONTRAINDICATIONS:
DO NOT prescribe RGP lenses in the presence of ocular infection, inflammation or injury, 
any eye disease, severe dry eyes or corneal hypoaesthesia unless indicated. Or if there is any 
systemic condition that may affect the eye or cause heightened risk of allergy to contact lens 
or solution. Or if the patient is taking medication that may interfere with contact lens wear (e.g. 
preserved eye drops).
RECOMMENDED WEARING SCHEDULE: 
• Daily wear - less than 24 hours while awake
• Wearing time should be built up gradually before the maximum is achieved. 
REPLACEMENT SCHEDULE:
RGP lenses should be replaced on a yearly basis or more frequently as recommended by the eye 
care professional.  
WARNINGS:
In order to promote safe use it is essential that the patient follows the manufacturers recom-
mendations for care of contact lenses, use of care products and lens cases.
Patients should be warned that serious adverse reactions such as ulcers or keratitis can arise very 
quickly and are more likely to occur if the patient does not follow the manufacturers recom-
mendations for wearing times, replacement schedule, use of care products and lens cases.  The 
patient should not wear the lens whilst sleeping (unless indicated), showering or swimming.  
The eye care professional must ensure that the patient can remove heir lenses before dispens-
ing them and should advise the patient to remove the lenses and contact them immediately if 
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APPENDIX C:
 LIMBAL AND CONJUNCTIVAL (BULBAR) REDNESS
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APPENDIX D: 
 LENS FITTING CHARACTERISTICS
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APPENDIX E: 
 OCULAR SYMPTOMS
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APPENDIX F: 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS
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APPENDIX G: 
 BIOMICROSCOPY SCALE
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APPENDIX H: 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION
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