Clinical Evaluation of Investigational Multifocal Contact Lenses
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

 
 
 
Johnson & Johnson Vision Care 
7500 Centurion Parkway 
Jacksonville, FL 32256 
Protocol Number CR-5903 
Version 3.0 Amendment 2 
Date 01 March 2017 
Clinical Study Protocol 
Evaluation of a Novel Toric Multifocal 
Contact Lens in Hyperopic Presbyopes 
Distribution:  
 
 
 
Mr. Ron Clark  
 
 
 
 
 
 
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: 
Daily Disposables           Dispensing 
Etafilcon-A 
 
  Presbyopia 
Astigmatism                   Hyperopia  
Multifocal 
                         
CR-5903 Protocol v3.0
Page 1 of 168
CONFIDENTIAL

 
 
 
TABLE OF CONTENTS 
1.1 
PROTOCOL TITLE, NUMBER, DATE ...................................................................................................... 5 
1.2 
NAME AND ADDRESS OF SPONSOR .................................................................................................... 5 
1.3 
AUTHORIZED SIGNATURES ................................................................................................................. 5 
1.4 
MEDICAL MONITOR AND MEDICAL MONTIOR PLAN.......................................................................... 6 
1.5 
INVESTIGATOR(S) SIGNATURE PAGE ................................................................................................... 6 
1.6 
ESTIMATED REPORT DATE .................................................................................................................. 7 
1.7 
CHANGE HISTORY ............................................................................................................................... 7 
1.8   
PROTOCOL SYNOPSIS .......................................................................................................................... 7 
2.1           NAME AND DESCRIPTION OF INVESTIGATIONAL PRODUCTS .......................................................... 10 
2.2 
SUMMARY OF FINDINGS FROM NONCLINICAL STUDIES .................................................................. 11 
2.3 
SUMMARY OF KNOWN RISKS AND BENEFITS TO HUMAN SUBJECTS ............................................... 12 
2.4 
DESCRIPTION OF TRIAL TREATMENTS .............................................................................................. 12 
2.5 
STATEMENT OF COMPLIANCE TO PROTOCOL, GCP, AND APPLICABLE REGULATORY GUIDELINES . 12 
2.6 
DESCRIPTION OF POPULATION TO BE STUDIED, ENROLLMENT TARGETS, AND STUDY DURATION 12 
2.7 
RELEVANT LITERATURE REFERENCES AND PRIOR DATA ................................................................... 12 
3.1 
DESCRIPTION OF OBJECTIVES AND PURPOSE ................................................................................... 12 
4.1 
PRIMARY AND SECONDARY ENDPOINTS .......................................................................................... 12 
4.2 
INCLUSION CRITERIA ......................................................................................................................... 13 
4.3 
EXCLUSION CRITERIA ........................................................................................................................ 13 
4.4 
STUDY DESIGN, TIME AND EVENT SCHEDULE, FLOWCHART ............................................................ 14 
4.5 
RANDOMIZATION AND MASKING ..................................................................................................... 16 
4.6 
WEAR AND REPLACEMENT SCHEDULES, INCLUDING FORM, PACKAGING AND LABELING .............. 16 
4.7 
DETAILED STUDY PROCEDURES ........................................................................................................ 16 
4.7.1 
SEQUENCE OF EVENTS..............................................................................................................16 
4.8 
DISCONTINUATION CRITERIA ............................................................................................................ 33 
4.9 
ACCOUNTABILITY PROCEDURES FOR INVESTIGATIONAL PRODUCT AND CONTROL ........................ 34 
4.10 
PROCEDURES FOR MAINTAINING AND BREAKING RANDOMIZATION CODES .................................. 34 
4.11  
REPORTING PRODUCT QUALITY COMPLAINTS ................................................................................. 34 
5.1 
WITHDRAWAL CRITERIA ................................................................................................................... 35 
6.1 
PRESTUDY AND CONCOMITANT THERAPY ....................................................................................... 36 
6.2 
MONITORING TREATMENT COMPLIANCE ........................................................................................ 36 
6.3 
UNSCHEDULED VISITS ....................................................................................................................... 36 
7.1 
EFFICACY PARAMETERS .................................................................................................................... 37 
CR-5903 Protocol v3.0
Page 2 of 168
CONFIDENTIAL

 
 
 
7.2 
METHODS FOR ASSESSING, RECORDING, AND ANALYZING EFFICACY ............................................. 37 
8.1 
SAFETY PARAMETERS ........................................................................................................................ 37 
8.2 
ADVERSE EVENTS .............................................................................................................................. 37 
8.3          ADVERSE EVENT DEFINITIONS........................................................................................................... 38 
8.4 
METHODS FOR ASSESSING, RECORDING, AND ANALYZING SAFETY ................................................. 41 
8.5 
ADVERSE EVENTS FOLLOW-UP ......................................................................................................... 42 
9.1 
STATISTICAL METHODS TO BE EMPLOYED ....................................................................................... 43 
9.2 
NUMBER OF SUBJECTS BY SITE AND JUSTIFICATION FOR SAMPLE SIZE ........................................... 44 
9.3 
LEVEL OF STATISTICAL SIGNIFICANCE ............................................................................................... 44 
9.4 
CRITERIA FOR STUDY TERMINATION ................................................................................................ 44 
9.5 
PROCEDURE FOR ACCOUNTING FOR MISSING, UNUSED, AND SPURIOUS DATA ............................. 44 
9.6 
PROCEDURE FOR REPORTING DEVIATIONS FROM STATISTICAL PLAN ............................................. 45 
9.7 
EVALUABLE SUBJECTS ....................................................................................................................... 45 
10.1 
ELECTRONIC CASE REPORT FORM/DATA COLLECTION ..................................................................... 45 
10.2 
SOURCE DOCUMENTATION .............................................................................................................. 46 
10.3 
ACCESS TO SOURCE DATA/DOCUMENT ............................................................................................ 46 
10.4 
CONFIDENTIALITY OF INFORMATION ............................................................................................... 46 
11.1 
DATA QUALITY ASSURANCE .............................................................................................................. 47 
12.1 
STUDY-SPECIFIC DESIGN CONSIDERATIONS ..................................................................................... 47 
12.2 
INVESTIGATOR RESPONSIBILITY ........................................................................................................ 47 
12.3 
INDEPENDENT ETHICS COMMITTEE OR INSTITUTIONAL REVIEW BOARD (IEC/IRB) ......................... 47 
12.4 
INFORMED CONSENT ........................................................................................................................ 49 
12.5 
PRIVACY OF PERSONAL DATA ........................................................................................................... 49 
13.1 
DATA HANDLING AND RECORD KEEPING ......................................................................................... 50 
14.1 
FINANCIAL CONSIDERATIONS ........................................................................................................... 51 
15.1 
PUBLICATION .................................................................................................................................... 51 
16.1 
PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ........................................................... 52 
16.2 
CLINICAL TECHNICAL PROCEDURES (CTPS) ....................................................................................... 92 
16.3 
PATIENT INSTRUCTION GUIDE .......................................................................................................... 92 
16.4 
PACKAGE INSERT ............................................................................................................................... 92 
17.1 
LIST OF ABBREVIATIONS ................................................................................................................... 93 
APPENDIX A: TEST ARTICLE ACCOUNTABILITY IN THE EDC SYSTEM ............................................................... 94 
APPENDIX B: PRESBYOPIC SYMPTOMS ........................................................................................................... 99 
APPENDIX C: OCULAR DOMINANCE ..............................................................................................................100 
CR-5903 Protocol v3.0
Page 3 of 168
CONFIDENTIAL

 
 
 
APPENDIX D:  BINOCULAR OVER REFRACTION .............................................................................................101 
APPENDIX E: FITTING GUIDE .........................................................................................................................102 
APPENDIX F: 
 LIMBAL & CONJUCTIVAL (BULBAR) REDNESS ..........................................................104 
APPENDIX G: 
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING ........................................112 
APPENDIX H: 
 DETERMINATION OF NEAR ADD .............................................................................117 
APPENDIX I: 
 NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE .................................125 
APPENDIX J: 
 LENS FITTING CHARACTERISTICS ..............................................................................128 
APPENDIX K: 
 SUBJECT REPORTED OCULAR SYMPTOMS ...............................................................135 
APPENDIX L: 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS .....................137 
APPENDIX M: 
 BIOMICROSCOPY SCALE .........................................................................................144 
APPENDIX N: 
 KERATOMETRY ........................................................................................................150 
APPENDIX O: 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION ...............................................152 
APPENDIX P: 
 TORIC FIT EVALUATION ...........................................................................................157 
APPENDIX Q: 
 ETDRS DISTANCE VISUAL ACUITY MEASUREMENT PROCEDURE ............................161 
APPENDIX R: 
 MEASURING PUPIL DIAMETER WITH NEUROPTICS VIP-200 VARIABLE PUPILLOMETER
 ........................................................................................................................................................165 
 
 
 
 
 
 
 
 
 
 
 
 
 
CR-5903 Protocol v3.0
Page 4 of 168
CONFIDENTIAL

 
 
 
1.1 
PROTOCOL TITLE, NUMBER, DATE 
TITLE: Evaluation of a Novel Toric Multifocal Contact Lens in Hyperopic Presbyopes 
PROTOCOL NUMBER: CR-5903 
VERSION: 3.0 Amendment 2 
 
DATE: 01 March 2017  
1.2 
NAME AND ADDRESS OF SPONSOR 
Johnson & Johnson Vision Care 
7500 Centurion Parkway, Jacksonville, FL 32256 
1.3 
AUTHORIZED SIGNATURES 
 
 
 
 
Author: 
See Electronic Signature Report 
 
 
 
Name: Thomas R. Karkkainen, OD, MS, FAAO 
Title: Sr. Principal Research Optometrist 
 
DATE 
 
 
Biostatistician: 
See Electronic Signature Report 
 
 
 
Name: 
 
Title: Biostatistician III 
 
DATE 
 
 
Clinical Data Manager:      See Electronic Signature Report 
 
 
 
Name: 
 
Title: Clinical Project Manager-Data and Systems 
 
DATE 
 
 
 
Clinical Operations: 
See Electronic Signature Report 
 
 
 
Name: 
 
Title: Clinical Operations Manager 
 
 
DATE 
 
 
Management/Approver: See Electronic Signature Report 
 
 
 
Name: 
 
Title: Presbyopia Platform Sr. Manager 
 
 
DATE 
 
 
 
The signature below constitutes the approval of this protocol and the attachments, and provides the necessary 
assurances that this trial will be conducted according to all stipulations of the protocol, including all statements 
regarding confidentiality, and according to local legal and regulatory requirements and applicable U.S. federal 
regulations, ICH guidelines, and the Declaration of Helsinki. 
CR-5903 Protocol v3.0
Page 5 of 168
CONFIDENTIAL

 
 
 
1.4 
MEDICAL MONITOR AND MEDICAL MONTIOR PLAN 
NAME: Thomas R. Karkkainen, OD, MS, FAAO 
TITLE: Sr. Principal Research Optometrist 
ADDRESS: 7500 Centurion Parkway, Jacksonville, Florida 32256 
E-MAIL: TKarkkai@its.jnj.com 
 
 
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. 
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. 
CR-5903 Protocol v3.0
Page 6 of 168
CONFIDENTIAL

 
 
 
Eligibility Criteria:  
 
Potential subjects must satisfy all of the following Inclusion 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.
Healthy adult males or females that are at least 40 years of age and no more than 70 years of age. 
4.
The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over 
contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least 
one symptom on the “Presbyopic Symptoms Questionnaire”.(Appendix B)   
5.
The subject is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours 
of wear per day at least two days of the week for a minimum of 1 month prior to the study). 
6.
The subject’s distance spherical component of their refraction must be in the range  
+1.25D to +3.75D in each eye. 
7.
The subject’s refractive cylinder must be -1.00D to -1.50D in each eye. 
8.
The subject’s refractive cylinder axis must be 90° ± 30° or 180° ± 30° in each eye. 
9.
The subject’s ADD power must be in the range of +0.75D to +2.50D in each eye. 
10. The subject must have best corrected visual acuity of 20/20-3 or better in each eye. 
11. The subject must have a wearable pair of spectacles if required for their distance vision. 
 
Subjects meeting any of the following Exclusion Criteria will not be eligible to participate in the study:  
 
1.
Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens 
wear. 
2.
Pregnancy or lactation. 
3.
Currently diagnosed with diabetes.  
4.
Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV). 
5.
Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal 
abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would 
contraindicate contact lens wear. 
6.
Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent 
corneal erosions. 
7.
Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, lid 
procedures, cataract surgery, retinal surgery, etc.). 
8.
A history of amblyopia, strabismus or binocular vision abnormality. 
9.
Any ocular infection or inflammation. 
10. Any ocular abnormality that may interfere with contact lens wear.   
11. Use of any ocular medication, with the exception of rewetting drops. 
12. History of herpetic keratitis. 
13. Participation in any contact lens or lens care product clinical trial within 30 days prior to study 
enrollment. 
 
 
 
 
CR-5903 Protocol v3.0
Page 9 of 168
CONFIDENTIAL

 
 
 
Test Lens System Clinical Build Numbers 
Add 
70° Axis 
90° Axis 
110° Axis 
Low 
PRB 227 
PRB 229 
PRB 231 
Mid 
PRB 247 
PRB 249 
PRB 251 
High 
PRB 267 
PRB 269 
PRB 271 
 
 
  
 
 
 
       
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Test Lens System Clinical Build Numbers 
Add 
20° Axis 
160° Axis 
180° Axis 
Low 
PRB 222 
PRB 236 
PRB 220 
Mid 
PRB 242 
PRB 256 
PRB 240 
High 
PRB 262 
PRB 276 
PRB 260 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
*Over-label protocol (16CP1218-HIGH ADD, 16CP1219-MID ADD and 16CP1220-LOW ADD) 
Labels:  Below are examples of the investigational labels used for this study: 
 
2.2 
SUMMARY OF FINDINGS FROM NONCLINICAL STUDIES 
See Investigator Brochure 
CR-5903 Protocol v3.0
Page 11 of 168
CONFIDENTIAL

 
 
 
4.4 
STUDY DESIGN, TIME AND EVENT SCHEDULE, FLOWCHART 
The study is a bilateral, single masked, single-arm, 3-visit dispensing study.  Subjects will wear the study lens 
system for approximately 12-16 days.    
4.4.1 
TIME AND EVENT SCHEDULE 
 
Visit 1 (Day 0) 
Statement of Informed Consent 
Demographics 
Medical History/Concomitant Medications 
Current Contact Lens Brand/Modality/Type of Correction 
Contact Lens History 
Wear Time with Habitual Lenses 
Screening Eligibility 
Baseline PRO Questionnaire and CLDEQ-8 
Ocular Symptoms 
Distance and Near Entrance Visual Acuity 
Visual Performance 
Binocular Over-Refraction  
Lens Removal 
Pupillometry 
Keratometry 
Subjective Refraction and Distance Visual Acuity 
Add Determination 
Ocular Dominance 
Near Add Refinement 
Near Visual Acuity 
Biomicroscopy 
Baseline Eligibility 
Lens Selection 
Right Lens Insertion 
Lens Damage  
1 Minute Rotation Measurement 
3 Minute Rotation Measurement 
Left Lens Insertion 
Lens Damage  
1 Minute Rotation Measurement 
3 Minute Rotation Measurement 
15 Minute Settling Time 
Toric Fit Assessment 
Subjective Lens Fit Assessment 
Visual Satisfaction 
Study Lens Distance and Near Visual Acuity  
Distance Over-refraction and Distance Visual Acuity 
Modification (if required) 
PRO Post-Fit Questionnaire 
Manual Misrotation Base Nasal (Right Eye Only) 
Manual Misrotation Base Temporal (Right Eye Only) 
Manual Misrotation Base Nasal (Left Eye Only) 
Manual Misrotation Base Temporal (Left Eye Only) 
Distance and Near Exit Visual Acuity  
Dispensing Criteria 
CR-5903 Protocol v3.0
Page 14 of 168
CONFIDENTIAL

 
 
 
Patient Instructions 
Scheduling for Follow-up 6-8 days 
 
VISIT 2 (6-8 Days after Visit 1) 
Confirm Medical History 
Wear Time 
Compliance  
PRO Questionnaire  
Ocular Symptoms 
Subjective Acceptance  
Entrance Distance and Near Visual Acuity 
Toric Fit Assessment 
Subjective Lens Fit Assessment 
Distance Over-Refraction and Distance Visual Acuity 
Lens Optimization (if needed) 
Lens Selection (if needed) 
Lens Insertion (if needed) 
Lens Damage (if needed) 
1 Minute Rotation Measurement (if needed) 
3 Minute Rotation Measurement (if needed) 
15 Minute Settling Time (if needed) 
Toric Fit Assessment (if needed) 
Subjective Lens Fit Assessment (if needed) 
Visual Satisfaction (if needed) 
Study Lens Distance and Near Visual Acuity (if needed)  
Distance Over-Refraction and Distance Visual Acuity (if needed)  
Additional Optimization (if needed) 
Unworn Lens Collection (if lenses are optimized) 
Lens Removal 
Biomicroscopy 
Insertion of Study Lenses 
PRO Post-Fit Questionnaires 
Distance and Near Exit Visual Acuity 
Dispensing Criteria 
Patient Instructions 
Scheduling for Follow-up 6-8 day 
 
Visit 3 (6-8 days from Visit 2) 
Confirm Medical History 
Wear Time 
Compliance  
Unworn Lens Collection 
PRO Questionnaires and CLDEQ 8 
Ocular Symptoms 
Subjective Acceptance 
Distance and Near Entrance Visual Acuity  
Distance Over-refraction and Distance Visual Acuity  
Toric Fitting Assessment 
Subjective Lens Fit Assessment 
Visual Performance 
Questionnaires 
Lens Removal and Storage 
Biomicroscopy 
CR-5903 Protocol v3.0
Page 15 of 168
CONFIDENTIAL

 
 
 
Subject Interview (PRA only) 
Final Evaluation 
4.5 
RANDOMIZATION AND MASKING 
This study is single masked (subject masked), single-arm, dispensing clinical trial. Due to the nature of the study 
randomization is not required. 
 
This is a single masked study; investigators are not able to be masked due to the differences in the test articles 
(number of lenses) and fitting guide. Subjects will be masked to the identities of the study lenses. 
The lens assignment will be performed at the fitting visit following subject enrollment.  The following must occur 
prior to lens assignment: 
x
Informed consent must be obtained 
x
The subject must meet all of the inclusion / exclusion criteria 
x
The subject history and baseline information must be collected 
The following procedures will be followed: 
x
Subjects will not be aware of the identity of the study lenses.  
x
Investigators and technical personnel involved in the data collection will not be masked as to the identity 
of the study lenses. 
4.6 
WEAR AND REPLACEMENT SCHEDULES, INCLUDING FORM, PACKAGING AND LABELING 
Wear Schedule:  Daily Disposable 
Replacement Schedule: Daily 
Test Article Packaging Description:  Blister packs  
Labeling:  Investigational label for all study lenses 
4.7 
DETAILED STUDY PROCEDURES 
4.7.1 
SEQUENCE OF EVENTS  
Subjects must report to the initial visit wearing their habitual contact lenses, in order to accurately assess baseline 
PRO performance.  If the subject is not wearing their lenses they must be rescheduled. Subjects must also bring 
their readers if used over their contact lenses for reading to be worn when conducting the logMAR acuity at 
Baseline. If subjects do not bring their reading glasses (if required) they must be rescheduled.   
 
 
 
 
 
CR-5903 Protocol v3.0
Page 16 of 168
CONFIDENTIAL

 
 
 
3 
Distance and Near 
Entrance Visual Acuity 
Distance and near visual acuity will be measured for each 
eye with the subject’s habitual contact lenses in place. 
Standard examination room Snellen (or equivalent) charts 
will be used for distance vision.     
For near measures use the ETDRS 2000 Series Chart 1 or 
Chart 2.  
Note: The acuity will be recorded to the nearest letter OD, 
OS and OU.    
 
4 
Visual Performance 
Distance (3M) 
Intermediate 
(64cm) 
Near (40cm) 
 
 
 
(Subjects will  wear 
their Habitual Contact 
Lenses and readers 
for near if required) 
Visual performance will be recorded OD, OS and OU  for the 
following: 
Distance, Bright Illuminance 
ETDRS Charts 3M-HC#1, HC#2, HC#3 and LC#1, LC#2 and 
LC#3 
Near, Bright Illuminance 
Reduced Guillon-Poling charts 
High Contrast and Low Contrast Intermediate (64cm) and 
Near (40cm). 
Distance, Dim Illuminance (with Distance goggles) 
ETDRS Charts 3M-HC#4, HC#5, HC#6 
Near, Dim Illuminance (with Near goggles) 
Reduced Guillon-Poling charts 
High Contrast 
Intermediate (64cm) and Near (40cm). 
 
Note: 
The room illuminance must be between 7.3 and 7.9 EV. 
Distance, HC-1 Chart luminance Acceptable EV Range 
10.5-10.7. 
Guillon-Poling, Near Chart luminance Acceptable 
EV Range 10.8-11.1. 
Do not use the Mesopic filter for Dim luminance (Dim 
luminance will be simulated by using the goggles) 
 
 
 
5 
Binocular Distance 
Over- refraction and 
Distance Visual Acuity 
Perform a binocular over-refraction over the subject’s 
habitual contact lenses and record the OD and OS results 
and distance visual acuity. 
Appendix 
D 
6 
Lens Removal  
Have the subject remove their habitual lenses and store in 
an approved storage solution.   
 
7 
Pupillometry 
The pupil measurements will be performed OD and OS 
under bright illumination (7.3-7.9 EV) and dark illumination 
(ч0 EV) using a Neuroptic Pupillometer or similar 
instrument.   
The room illuminance will be measured for each condition 
using the Sekonic lightmeter or similar instrument.    
 
8 
Keratometry 
Keratometry will be performed OD and OS and the steep 
and flat dioptric power and corresponding meridians 
recorded. 
 
CR-5903 Protocol v3.0
Page 18 of 168
CONFIDENTIAL

 
 
 
6 
Toric Fit 
Evaluation 
After lens settling, record: 
ͻ 
The rotational position to the nearest degree 
ͻ 
Lens stability with blink 
ͻ 
Lens stability with eye versions 
ͻ 
Toric fit acceptable or unacceptable  
Toric lens fit will be unacceptable if lenses rotated more 
than 40 degrees, or lens stability is worse than 5 degrees 
movement with blink.  If toric fit is unacceptable, remove 
the lenses, perform biomicroscopy and proceed to final 
evaluation. 
 
7 
Lens Fit 
Assessment 
Lens fit will be assessed in primary gaze, upgaze & 
Josephson push up test. 
An unacceptable lens fit will be any one or more of the 
following: 
 
ͻ 
presence of limbal exposure (appearance of clear 
cornea) in any gaze 
ͻ   presence of edge lift 
ͻ 
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.  Perform a slit-lamp 
evaluation and complete the Final Evaluation 
 
8 
Determine Visual 
Satisfaction 
Determine if the subject’s vision is acceptable with the 
lenses. Allow the subject to look down a hallway or out of a 
window for distance vision assessments, and for them to 
read a book, magazine or similar for near vision. 
 
9 
Distance and Near 
Visual Acuity 
Distance and near Snellen visual acuity will be measured for 
each eye with the study contact lenses in place. For near 
measures use the ETDRS 2000 Series Chart 1 or 2. The acuity 
will be recorded to the nearest letter OD, OS and OU. 
 
10 
Over-refraction 
Perform a distance spherical over-refraction OD and OS 
using loose lenses outside of the phoropter under ambient 
room illumination.  The distance over- refraction may also be 
refined under binocular conditions. Record the results. The 
results of the distance over-refraction may also be checked 
for the impact on near vision under monocular and/or 
binocular conditions. 
 
CR-5903 Protocol v3.0
Page 21 of 168
CONFIDENTIAL

14 
Manual misrotation 
(base temporal, right 
lens only) 
The investigator will manually misrotate the right lens past 
45ȗ (base temporally) from the settled rotational position. 
As the lens begins to rotate back toward the correct 
position, the investigator will start a stop watch as soon as 
the lens is exactly 45 degrees misrotated from its earlier 
settled position. 
 
The investigator will then measure and record the lens 
rotation at 15 seconds, 30 seconds, 1 minute, 2 minutes 
and 3 minutes following the start of the stop watch. 
 
15 
Manual misrotation 
(base nasal, left lens 
only) 
The investigator will manually misrotate the left lens past 
45ȗ (base nasally) from the settled rotational position.  As 
the lens begins to rotate back toward the correct position, 
the investigator will start a stop watch as soon as the lens is
exactly 45 degrees misrotated from its earlier settled 
position. 
The investigator will then measure and record the lens 
rotation at 15 seconds, 30 seconds, 1 minute, 2 minutes 
and 3 minutes following the start of the stop watch. 
 
16 
Manual misrotation 
(base temporal, left 
lens only) 
The investigator will manually misrotate the left lens past 
45ȗ (base temporally) from the settled rotational position. 
As the lens begins to rotate back toward the correct 
position, the investigator will start a stop watch as soon as 
the lens is exactly 45 degrees misrotated from its earlier 
settled position. 
 
The investigator will then measure and record the lens 
rotation at 15 seconds, 30 seconds, 1 minute, 2 minutes 
and 3 minutes following the start of the stop watch. 
 
CR-5903 Protocol v3.0
Page 23 of 168
CONFIDENTIAL

 
 
 
9 
Lens Fit Assessment 
 
Evaluate and grade lens centration, primary gaze 
movement, upgaze movement and tightness (push-up 
test). 
An unacceptable lens fit will be any one or more of the 
following: 
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.  Perform a slit-lamp 
evaluation and complete the Final Evaluation.   
 
10 
Distance Over-
refraction and 
Distance Visual 
Acuity 
Perform a distance spherical over-refraction OD and OS 
using loose lenses outside of the phoropter under 
ambient room illumination.  The distance over-refraction 
may also be refined under binocular conditions.  Record 
the results and distance visual acuity OD and OS.  The 
results of the distance over-refraction may also be 
checked for the impact on near vision under monocular 
and/or binocular conditions.  
 
11 
Determination of 
Lens Optimization 
If the subjects vision is unacceptable for at least one 
distance or the Investigator determines that the visual 
acuity or over-refraction are not acceptable then a lens 
modification must be made.   
Up to two attempts at changes are permitted if necessary, 
in order to achieve an acceptable distance and near 
binocular performance for the subject. 
Follow the fitting guide allowing for at least 15 minutes of 
settling time between lens changes. 
Appendix E      
(Fitting Guide) 
 
 
 
 
 
 
 
 
 
 
 
 
 
CR-5903 Protocol v3.0
Page 26 of 168
CONFIDENTIAL

 
 
 
6 
Toric Fit Evaluation 
 
After lens settling, record: 
 
x
The rotational position to the nearest degree 
x
Lens stability with blink 
x
Lens stability with eye versions 
x
Toric fit acceptable or unacceptable 
Toric lens fit will be unacceptable if lenses rotated more 
than 40 degrees, or lens stability is worse than 5 degrees 
movement with blink.  If toric fit is unacceptable, remove 
the lenses, perform biomicroscopy and proceed to final 
evaluation. 
 
7 
Lens Fit Assessment 
Evaluate and grade lens centration, primary gaze 
movement, upgaze movement and tightness (push-up 
test). 
An unacceptable lens fit will be any one or more of the 
following: 
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.  Perform a slit-lamp 
evaluation and complete the Final Evaluation.   
 
8 
Determine Visual 
Satisfaction 
Determine if the subject’s vision is acceptable with the 
lenses.  Allow the subject to look down a hallway or out of 
a window for distance vision assessments, and for them 
to read a book, magazine or similar for near vision.   
 
9 
Distance and Near 
Visual Acuity 
Distance and near Snellen visual acuity will be measured 
for each eye with the study contact lenses in place. For 
near measures use the ETDRS 2000 Series Chart 1 or 
Chart 2.    
Note: The acuity will be recorded to the nearest letter 
OD, OS and OU. 
 
10 
Over-refraction 
Perform a distance spherical over-refraction OD and OS 
using loose lenses outside of the phoropter under 
ambient room illumination.  The distance over-refraction 
may also be refined under binocular conditions.  Record 
the results.  The results of the distance over-refraction 
may also be checked for the impact on near vision under 
monocular and/or binocular conditions.    
 
CR-5903 Protocol v3.0
Page 28 of 168
CONFIDENTIAL

 
 
 
11 
Additional 
Optimization  
(if needed) 
Repeat steps 1-10 if an additional optimization is needed.   
Note: Two total attempts at optimization are permitted. 
Appendix E 
(Fitting Guide) 
 
12 
Collection of unworn 
lenses 
Collect unworn lenses returned by the subject when lens 
power has been optimized  
If lens power was not changed allow the subject to use the 
unworn lenses dispensed at Visit 1 and dispense enough 
lenses of the same power to last the subject until their 
next visit.  
 
13 
Lens Removal 
The optimized study lenses will be removed and 
discarded. 
If the lenses were not modified also remove and discard 
the lenses.   
 
14 
Biomicroscopy 
Perform biomicroscopy OD and OS. Slit Lamp 
Classification Scales will be used to grade the findings.  
For the conjunctival redness 
) 0.5 unit 
increments will be used in the grading.  
Corneal Staining Assessment (
 will be graded in 
1.0 increments. 
  
 
 
 
15 
Insertion of Study 
Lenses 
Provide the subject with a new set of lenses that match 
the distance and ADD power of the lenses that were 
discarded in step 13 above. 
 
Note: For lens accountability in EDC, add this new set of 
lenses to the total number dispensed on the Dispensing 
form. 
 
16 
 
PRO  Questionnaires 
 
The subject will complete the PRO post-fit questionnaire.   
 
Note: Subject’s Must respond to the Questionnaire in 
the KIOSK using their User Name and Password. 
Section 16.1 
 
 
 
 
 
 
 
 
CR-5903 Protocol v3.0
Page 29 of 168
CONFIDENTIAL

 
 
 
10 
Toric Fitting 
Assessment 
Record the toric fit of the study lenses: 
 
x
The rotational position to the nearest degree 
x
Lens stability with blink 
x
Lens stability with eye versions 
x
Toric fit acceptable or unacceptable 
 
Toric lens fit will be unacceptable if lenses rotated more 
than 40 degrees, or lens stability is worse than 5 degrees 
movement with blink. 
 
11 
Lens Fit 
Assessment: 
Evaluate and grade lens centration, primary gaze 
movement, upgaze movement and tightness (push-up test).
 
An unacceptable lens fit will be any one or more of the 
following: 
 
x
Presence of limbal exposure (appearance of 
clear cornea) 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). 
 
12 
Visual Performance 
Distance (3M) 
Intermediate (64cm) 
Near (40cm) 
Visual performance will be recorded OD, OS, and OU  for 
the following: 
Distance, Bright Illuminance 
ETDRS Charts 3M-HC#1, HC#2, HC#3 and LC#1, LC#2 and 
LC#3 
Near, Bright Illuminance 
Reduced Guillon-Poling charts High Contrast and Low 
Contrast Intermediate (64cm) and Near (40cm). 
 
Distance, Dim Illuminance (with Distance goggles) 
ETDRS Charts 3M-HC#4, HC#5, HC#6 
Near, Dim Illuminance (with Near goggles) 
Reduced Guillon-Poling charts 
High Contrast 
Intermediate (64cm) and Near (40cm). 
 
Note: 
The room illuminance must be between 7.3 and 7.9 EV. 
Distance, HC-1 Chart luminance Acceptable EV Range 
10.5-10.7. 
Guillon-Poling, Near Chart luminance Acceptable 
EV Range 10.8-11.1. 
Do not use the Mesopic filter for Dim luminance (Dim 
luminance will be simulated by using the goggles) 
 
 
 
CR-5903 Protocol v3.0
Page 32 of 168
CONFIDENTIAL

 
 
 
4.9 
ACCOUNTABILITY PROCEDURES FOR INVESTIGATIONAL PRODUCT AND CONTROL 
Johnson & Johnson Vision Care, Inc. will provide the Investigator with sufficient quantities of study articles and 
supplies to complete the investigation.  The Investigator is asked to retain all lens shipment documentation for the 
test article accountability records. The Investigator may provide the subject additional lenses in the event a lens is 
damaged or lost between visits.   
Test articles must be kept in a locked storage cabinet, accessible only to those assigned by the Investigator for 
dispensing.  All investigational products must be accounted.  This includes 1) what was dispensed for the subject to 
wear out of the office or issued for the subject to replace appropriately between visits, 2) what was returned to 
the Investigator unused, and 3) the number and reason for unplanned replacements.  The Investigator may 
delegate this activity to an authorized study site staff member on the Delegation Log.   
The Investigator will collect all unused test articles from the subjects at the end of the subject’s participation.  
Following final reconciliation of test articles, the Investigator will package and return all unused study articles to 
JJVC. 
Reference APPENDIX A: TEST ARTICLE ACCOUNTABILITY IN THE EDC SYSTEM for additional instructions.  
4.10 
PROCEDURES FOR MAINTAINING AND BREAKING RANDOMIZATION CODES 
The study lenses will be labeled using lens codes. It is not possible to mask the subjects as to the prescription type 
(i.e. astigmatism, spherical, multifocal) however the partial masking will occur as the subjects will not be informed 
of the identity of the test lens.  The study lens mask shall not be broken unless information concerning the lens 
type is necessary for the urgent medical treatment of a subject.  The Sponsor should be notified before the mask is 
broken. 
As the study is a single ARM study there is no randomization.   
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 
  
 
 
CR-5903 Protocol v3.0
Page 34 of 168
CONFIDENTIAL

 
 
 
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 
 
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 return to 
JJVC 
x
Collect all unused study lenses and test articles from the subject and return to JJVC 
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 
CR-5903 Protocol v3.0
Page 35 of 168
CONFIDENTIAL

 
 
 
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.  Disallowed medications for 
this study include: use of medications that contraindicate contact lens wear.  Concomitant therapies that are 
disallowed include: therapies in which contact lens wear is contraindicated.   
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 wellbeing 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 HIPAA documents 
x
Source documentation including consenting and HIPAA process, 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 
Monitoring for this study will be specified in the monitoring plan which will be provided separately. 
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 
CR-5903 Protocol v3.0
Page 36 of 168
CONFIDENTIAL

 
 
 
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 efficacy parameter in this study is subjective assessment of quality of vision after wearing the optimized study 
lenses for 12 to 16 days. 
7.2 
METHODS FOR ASSESSING, RECORDING, AND ANALYZING EFFICACY 
See detailed study procedures section 4.5 and statistics section 9. 
8.1 
SAFETY PARAMETERS 
The following safety parameters will be monitored and evaluated: 
x
Ocular physiology characteristics 
x
Lens fitting characteristics 
x
Adverse events 
x
Ocular symptoms 
x
Snellen distance visual acuity 
x
Reasons for discontinuation 
x
Reasons for unplanned lens replacement 
x
Product 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 
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. 
 
 
CR-5903 Protocol v3.0
Page 37 of 168
CONFIDENTIAL

 
 
 
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. 
When medically necessary, the investigator may break the randomization code to determine the identity of the 
treatment that the subject received.  The Sponsor and study monitor should be notified prior to unmasking the 
test articles. 
In the event of a serious 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. 
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 
 
. 
CR-5903 Protocol v3.0
Page 38 of 168
CONFIDENTIAL

 
 
 
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 
x
Non-contact lens related corneal events - e.g. EKC (Epidemic Keratoconjunctivitis) 
x
Asymptomatic Corneal Scar 
 
 
 
CR-5903 Protocol v3.0
Page 39 of 168
CONFIDENTIAL

 
 
 
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.  
 
 
 
CR-5903 Protocol v3.0
Page 40 of 168
CONFIDENTIAL

 
 
 
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. 
x
Moderate – Event is bothersome, possible requiring additional therapy, and may interfere with the 
subject’s daily activities. 
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy and interferes with 
the subject’s daily activities. 
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 
CR-5903 Protocol v3.0
Page 41 of 168
CONFIDENTIAL

 
 
 
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. 
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 1212.3).  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. 
CR-5903 Protocol v3.0
Page 42 of 168
CONFIDENTIAL

 
 
 
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.   
Subjects who present with 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 the SAS software Version 9.4 (SAS Institute, 
Cary, NC). Throughout the analysis of data, the results for each subject/eye will be used when available for 
summarization and statistical analysis.  Unscheduled visits will be summarized separately and will be excluded 
from the statistical analysis. 
Summary tables (Descriptive statistics and/or frequency tables) will be provided for all baseline variables, efficacy 
variables and safety variables as appropriate.  Continuous variables will be summarized with descriptive statistics 
(n, mean, standard deviation (SD), median, minimum and maximum). Frequency count and percentage of subjects 
or eyes within each category will be provided for categorical data. 
 
Summaries will be presented by study lens type and will be performed separately by completion status (Completed 
or Non Completed). All analyses will be conducted on all subjects who completed the study (see section 9.7).   
 
Primary Endpoint: 
Overall quality of vision scores will be analyzed using a linear mixed model. The model will include the 
experimental design factors: time point (baseline/follow-up) as fixed effects. Other baseline characteristics known 
of importance such as age, gender, and/or add power will be included as fixed covariates when appropriate.  Site 
will be included as random covariates when appropriate. The covariance between residual errors from the same 
subject across time points will be selected based on the finite-sample corrected Akaike’s Information Criterion 
(Keselman et al. 1998). Covariance structures considered may include: Homogenous compound symmetry (CS) and 
Unstructured covariance structure (UN). The structure that returns the lowest Akaike Information Criteria 
Corrected (AICC) will be selected as the structure that best fit the data.  
Comparisons between the time points will be carried out using 95% confidence intervals constructed of least-
square means (LSM) differences (follow-up minus baseline) from the linear mixed model. The non-inferiority of the 
CR-5903 Protocol v3.0
Page 43 of 168
CONFIDENTIAL

 
 
 
test lens relative to the control will be concluded if the lower confidence limit of LSM difference is above the non-
inferiority margin -5. The superiority will be established if the lower confidence limit is above 0. 
In all models, the Kenward and Roger method (Kenward and Roger, 1997) will be used for the calculation of the 
denominator of degrees of freedom.  
9.2 
NUMBER OF SUBJECTS BY SITE AND JUSTIFICATION FOR SAMPLE SIZE 
Approximately 60 eligible subjects will be enrolled and approximately 48 subjects are targeted to complete the 
study. Data from historical study CR 5758 and CR 5765 were used as the bench mark for sample size calculation 
because it tested the same population with the same study design and test article. 
Using the POWER procedure in SAS 9.4, below is the summary of sample size required based on the different 
assumptions of the true difference. Each study hypothesis is tested with at least 90% of statistical power and 2-
sided type I error of 0.05.  
Several scenarios were listed in the table below to allow variations in the upcoming clinical trial: 
Difference (FU-Baseline) 
Standard Deviation 
# of subjects needed 
Power 
2 
19 
65 
0.9 
3 
19 
50 
0.9 
4 
19 
40 
0.9 
 9.3 
LEVEL OF STATISTICAL SIGNIFICANCE 
All planned analysis for this study will be conducted with an overall type I error rate of 5%. 
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. If the percent of dropout is higher than 15% a sensitivity analysis will be conducted on all subjects who 
successfully tried at least one study lens.  
CR-5903 Protocol v3.0
Page 44 of 168
CONFIDENTIAL

 
 
 
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 
Subjects will be allocated to one of the three mutually exclusive groups: 
1.
Enrolled, Not Assigned: Subjects were considered to be Enrolled Not Eligible if they are (i) enrolled to the 
study (i.e. provided informed consent) but failed to satisfy the eligibility criteria (i.e. inclusion/exclusion 
criteria) or (ii) are not assigned to treatment for any reason. 
2.
Assigned, Not Completed: Subject are considered to have not completed the study from the study if they (i) 
were discontinued because of one the reasons described in section 5.1 or (ii) have successfully completed all 
required visits with a protocol deviation that the study responsible clinician documents as impacting the 
assessment of the hypotheses 
3.
Assigned, Completed: Subject are considered to have completed the study if (i) they are eligible, (ii) not 
discontinued (iii)  have successfully completed all required visits without a protocol deviation 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 to the 
specification of the JJVC database manager and sent to JJVC for analysis.  Data generated from post hoc 
measurements (e.g. Compositional characteristics of contact lens lipid uptake, Measured tear film protective 
capability, Measured contact lens surface dehydration rate) will be collected on specific Microsoft Office Excel 
format worksheets at the clinical site and at the completion of the analysis transferred to JJVC biostatistician for 
data analysis in such format. 
External Data Source: Not Applicable or, if External Data is collected outside of EDC, please enter vendor contact 
information in this section of the protocol and type of external data collected.  
Vendor Name: NA 
Vendor Address: NA 
Vendor Contact: NA 
Phone: NA 
Email: NA 
Type of Data collected:  NA 
 
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 
CR-5903 Protocol v3.0
Page 45 of 168
CONFIDENTIAL

 
 
 
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 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/DOCUMENT 
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, JJVC 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 JJVC.  The Investigator may use this information 
for the purposes of the study only. It is understood by the Investigator that JJVC will use information developed in 
this clinical study in connection with the development of the investigational product and therefore may disclose it 
as required to other clinical investigators and to regulatory agencies. In order to allow the use of the information 
derived from this clinical study, the Investigator understands that he/she has an obligation to provide complete 
test results and all data developed during this study to the Sponsor. 
The Investigator may not submit for publication or presentation the results of this study without first receiving 
written authorization from JJVC.  JJVC 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. 
CR-5903 Protocol v3.0
Page 46 of 168
CONFIDENTIAL

 
 
 
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 provided and reviewed with study personnel before the start of 
the study.  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 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 well-being 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 
CR-5903 Protocol v3.0
Page 47 of 168
CONFIDENTIAL

 
 
 
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, 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  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. 
CR-5903 Protocol v3.0
Page 48 of 168
CONFIDENTIAL

 
 
 
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 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. 
CR-5903 Protocol v3.0
Page 49 of 168
CONFIDENTIAL

 
 
 
The collection and processing of personal data from subjects enrolled in this study will be limited to those data 
that are necessary to investigate the efficacy, safety, quality, and utility of the investigational product(s) used in 
this study. 
 
These data must be collected and processed with adequate precautions to ensure confidentiality and compliance 
with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
 
x
processed fairly and lawfully 
x
collected for specified, explicit, and legitimate purposes and not further processed in a way incompatible 
with these purposes 
x
adequate, relevant, and not excessive in relation to said purposes 
x
accurate and, where necessary, kept current 
Explicit consent for the processing of personal data will be obtained from the participating subject before 
collection of data. Such consent should also address the transfer of the data to other entities and to other 
countries. 
 
The subject has the right to request through the Investigator access to his personal data and the right to request 
rectification of any data that are not correct or complete. Reasonable steps should be taken to respond to such a 
request, taking into consideration the nature of the request, the conditions of the study, and the applicable laws 
and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against unauthorized disclosures 
or access, accidental or unlawful destruction, or accidental loss or alteration must be put in place. Sponsor 
personnel whose responsibilities require access to personal data agree to keep the identity of study subjects 
confidential 
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. 
CR-5903 Protocol v3.0
Page 50 of 168
CONFIDENTIAL

 
 
 
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 JJVC 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. 
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 Clinical Trials.gov. 
 
 
 
 
 
 
 
 
 
 
 
CR-5903 Protocol v3.0
Page 51 of 168
CONFIDENTIAL

 
 
 
16.1 
PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
CR-5903 Protocol v3.0
Page 52 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
1
CR-5903 Protocol v3.0
Page 53 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
2
CR-5903 Protocol v3.0
Page 54 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
3
CR-5903 Protocol v3.0
Page 55 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
4
CR-5903 Protocol v3.0
Page 56 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
5
CR-5903 Protocol v3.0
Page 57 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
6
CR-5903 Protocol v3.0
Page 58 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
7
CR-5903 Protocol v3.0
Page 59 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
8
CR-5903 Protocol v3.0
Page 60 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
9
CR-5903 Protocol v3.0
Page 61 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
10
CR-5903 Protocol v3.0
Page 62 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
11
CR-5903 Protocol v3.0
Page 63 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
12
CR-5903 Protocol v3.0
Page 64 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
13
CR-5903 Protocol v3.0
Page 65 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
14
CR-5903 Protocol v3.0
Page 66 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
15
CR-5903 Protocol v3.0
Page 67 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
16
CR-5903 Protocol v3.0
Page 68 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
17
CR-5903 Protocol v3.0
Page 69 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
18
CR-5903 Protocol v3.0
Page 70 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
19
CR-5903 Protocol v3.0
Page 71 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
20
CR-5903 Protocol v3.0
Page 72 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
21
CR-5903 Protocol v3.0
Page 73 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
22
CR-5903 Protocol v3.0
Page 74 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
23
CR-5903 Protocol v3.0
Page 75 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
24
CR-5903 Protocol v3.0
Page 76 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
25
CR-5903 Protocol v3.0
Page 77 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
26
CR-5903 Protocol v3.0
Page 78 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
27
CR-5903 Protocol v3.0
Page 79 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
28
CR-5903 Protocol v3.0
Page 80 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
29
CR-5903 Protocol v3.0
Page 81 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
30
CR-5903 Protocol v3.0
Page 82 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
31
CR-5903 Protocol v3.0
Page 83 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
32
CR-5903 Protocol v3.0
Page 84 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
33
CR-5903 Protocol v3.0
Page 85 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
34
CR-5903 Protocol v3.0
Page 86 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
35
CR-5903 Protocol v3.0
Page 87 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
36
CR-5903 Protocol v3.0
Page 88 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
37
CR-5903 Protocol v3.0
Page 89 of 168
CONFIDENTIAL

PRO SPECIFICATION Version 1 Final  2016-09-08
Protocol 5903                 Johnson & Johnson Vision Care, Inc.                  Confidential
38
CR-5903 Protocol v3.0
Page 90 of 168
CONFIDENTIAL

CR-5903 Subject Interview Questions (PRA site only) 
 
1. What are some of the challenges you face with your current vision correct solutions, 
such as glasses or contact lenses? 
2. How did the new lens you tried as part of this clinical study compare to your current 
vision correction solutions? 
3. What did you like most about this study lens? 
4. Describe a moment when you felt this study lens performed well. 
5. How did the study lens feel on your eye?  
6. How would this study lens change the vision correction solutions you use today? 
7. If you were to buy this study lens, what impact do you think it would have on your 
contact lens use? 
8. Do you have any final remarks about this contact lens that you would like ACUVUE to 
know? 
 
CR-5903 Protocol v3.0
Page 91 of 168
CONFIDENTIAL

 
 
 
16.2 
CLINICAL TECHNICAL PROCEDURES (CTPS)  
x
 LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS (APPENDIX F) 
x
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING (APPENDIX G) 
x
 DETERMINATION OF NEAR ADD (APPENDIX H) 
x
 NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE (APPENDIX I) 
x
  LENS FITTING CHARACTERISTICS (APPENDIX J) 
x
 SUBJECT REPORTED OCULAR SYMPTOMS (APPENDIX K) 
x
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS (APPENDIX L) 
x
 BIOMICROSCOPY SCALE (APPENDIX M) 
x
 KERATOMETRY PROCEDURE (APPENDIX N) 
x
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION (APPENDIX O) 
x
 TORIC FIT EVALUATION (APPENDIX P) 
x
 ETDRS DISTANCE VISUAL ACUITY MEASURMENT PROCEDURE (APPENDIX Q) 
x
 MEASURING PUPIL DIAMETER WITH NEUROPTICS VIP-200 VARIABLE PUPILLOMETER (APPENDIX R) 
16.3 
PATIENT INSTRUCTION GUIDE  
 
A Patient Instruction Guide will be provided separately. 
16.4 
PACKAGE INSERT 
Not Applicable 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CR-5903 Protocol v3.0
Page 92 of 168
CONFIDENTIAL

 
 
 
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 
 
 
 
 
 
 
 
 
 
 
CR-5903 Protocol v3.0
Page 93 of 168
CONFIDENTIAL

 
 
 
APPENDIX A: TEST ARTICLE ACCOUNTABILITY IN THE EDC SYSTEM 
Test Article Accountability in the BioClinica Express EDC 5.4 System 
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. 
CR-5903 Protocol v3.0
Page 94 of 168
CONFIDENTIAL

 
 
 
4. Click on to open each form to receive the lenses. 
*Lenses MUST be received before the First Subject is seen. 
*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. 
 
 
 
 
 
 
 
 
CR-5903 Protocol v3.0
Page 95 of 168
CONFIDENTIAL

 
 
 
6. Enter Total Quantity Returned after the study is completed and lens accountability has been completed on 
paper. 
 
CR-5903 Protocol v3.0
Page 96 of 168
CONFIDENTIAL

 
 
 
y
The Lot Number field is an Auto Fill field – start to type in the Lot # and the system will complete the field
 
 
 
 
 
 
 
 
 
 
CR-5903 Protocol v3.0
Page 97 of 168
CONFIDENTIAL

 
 
 
y
If additional lenses are needed, click “Yes” on the eCRF for the “Are additional lenses needed to proceed 
with fit?” question. (Note: this is not for modification of lens power) 
CR-5903 Protocol v3.0
Page 98 of 168
CONFIDENTIAL

 
 
 
APPENDIX B: PRESBYOPIC SYMPTOMS 
 
Presbyopic Symptoms Questionnaire 
 
1.
Do you notice that you often have to hold things farther away so that you could read them? 
 
2.
Do you notice that you often have difficulty focusing on near objects (i.e., experiencing blurry vision 
when looking at things close-up)? 
 
3.
Do you often have headaches or eyestrains, or feel fatigued, when read or conduct other near 
activities? 
 
4.
Do you often have difficulty reading small or fine prints, such as phone books, medicine bottles or 
package labels, etc.? 
 
5.
Do you often have difficulty reading under dim or low light? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CR-5903 Protocol v3.0
Page 99 of 168
CONFIDENTIAL

 
 
 
APPENDIX C: OCULAR DOMINANCE 
 
CR-5903 Protocol v3.0
Page 100 of 168
CONFIDENTIAL

 
 
 
APPENDIX D:  BINOCULAR OVER REFRACTION 
 
CR-5903 Protocol v3.0
Page 101 of 168
CONFIDENTIAL

 
 
 
APPENDIX E: FITTING GUIDE  
 
 
 
 
5903 Protocol v3.0
Page 102 of 168
CONFIDENTIAL

 
 
 
 
 
 
 
 
 
 
 
 
 
5903 Protocol v3.0
Page 103 of 168
CONFIDENTIAL

 
 
 
APPENDIX F: 
 LIMBAL & CONJUCTIVAL (BULBAR) REDNESS 
 
5903 Protocol v3.0
Page 104 of 168
CONFIDENTIAL

 
Page 3 of 7 
 
Attachment A
Efron Grading Scale for Limbal Redness (0.5 unit increments) 
5903 Protocol v3.0
Page 107 of 168
CONFIDENTIAL

 
Page 4 of 7 
 
Attachment B
Efron Grading Scale for Limbal Redness (1.0 unit increments) 
5903 Protocol v3.0
Page 108 of 168
CONFIDENTIAL

 
Page 5 of 7 
 
Attachment C
Efron Grading Scale for Bulbar Redness (0.5 unit increments) 
5903 Protocol v3.0
Page 109 of 168
CONFIDENTIAL

 
Page 6 of 7 
 
Attachment D
Efron Grading Scale for Bulbar Redness (1.0 unit increments) 
5903 Protocol v3.0
Page 110 of 168
CONFIDENTIAL

 
Page 7 of 7 
 
Attachment E
5903 Protocol v3.0
Page 111 of 168
CONFIDENTIAL

 
 
 
APPENDIX G: 
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING 
 
5903 Protocol v3.0
Page 112 of 168
CONFIDENTIAL

 
 
 
APPENDIX H: 
 DETERMINATION OF NEAR ADD 
 
5903 Protocol v3.0
Page 117 of 168
CONFIDENTIAL

 
 
 
APPENDIX I: 
 NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 
 
5903 Protocol v3.0
Page 125 of 168
CONFIDENTIAL

 
 
 
APPENDIX J: 
 LENS FITTING CHARACTERISTICS 
 
5903 Protocol v3.0
Page 128 of 168
CONFIDENTIAL

Page 4 of 6 
 
 
 
 
 
5903 Protocol v3.0
Page 132 of 168
CONFIDENTIAL

Page 5 of 6 
 
5903 Protocol v3.0
Page 133 of 168
CONFIDENTIAL

Page 6 of 6 
 
 
 
 
 
 
5903 Protocol v3.0
Page 134 of 168
CONFIDENTIAL

 
 
 
APPENDIX K: 
 SUBJECT REPORTED OCULAR SYMPTOMS 
 
5903 Protocol v3.0
Page 135 of 168
CONFIDENTIAL

 
 
 
APPENDIX L: 
DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS 
 
5903 Protocol v3.0
Page 137 of 168
CONFIDENTIAL

 
 
 
APPENDIX M: 
 BIOMICROSCOPY SCALE 
 
5903 Protocol v3.0
Page 144 of 168
CONFIDENTIAL

 
 
 
APPENDIX N: 
 KERATOMETRY  
 
5903 Protocol v3.0
Page 150 of 168
CONFIDENTIAL

 
 
 
APPENDIX O: 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION                                    
 
5903 Protocol v3.0
Page 152 of 168
CONFIDENTIAL

 
 
 
 APPENDIX P: 
 TORIC FIT EVALUATION 
 
5903 Protocol v3.0
Page 157 of 168
CONFIDENTIAL

 
Page 3 of 3 
 
5903 Protocol v3.0
Page 160 of 168
CONFIDENTIAL

 
 
 
APPENDIX Q
 ETDRS DISTANCE VISUAL ACUITY MEASUREMENT PROCEDURE 
 
5903 Protocol v3.0
Page 161 of 168
CONFIDENTIAL

 
 
 
APPENDIX R: 
 MEASURING PUPIL DIAMETER WITH NEUROPTICS VIP-200 VARIABLE PUPILLOMETER 
 
5903 Protocol v3.0
Page 165 of 168
CONFIDENTIAL

Page 2 of 3 
 
5903 Protocol v3.0
Page 167 of 168
CONFIDENTIAL