The Effects of Contact Lenses With Experimental Dye on Visual Function
Phase: NA
Conditions: Ametropia
Sponsor: Johnson & Johnson Vision Care, Inc.

Johnson & Johnson Vision Care, Inc. 
Clinical Study Protocol 
The effects of contact lenses with experimental dye on visual function 
Protocol CR-6100 
Version: 2.0, Amendment 1.0  
Date: 07 June 2018 
Investigational Products:  senofilcon A with new UV-blocker 
Key Words:  senofilcon A-based contact lens with new UV-blocker, ACUVUE OASYS, 
senofilcon A, daily disposable, non-dispensing. 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines: 
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements. 
Confidentiality Statement: 
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care, Inc.  The 
information may not be disclosed to others except to the extent necessary to obtain Institutional 
Review Board/Independent Ethics Committee approval and informed consent, or as required 
by International, Federal and State Laws, as applicable. Persons to whom this information is 
disclosed must be informed that this information is privileged and confidential and that it 
should not be further disclosed without the written permission of Johnson & Johnson Vision 
Care, Inc.  Any supplemental information that may be added to this document is also 
confidential and proprietary to Johnson & Johnson Vision Care, Inc. and must be kept in 
confidence in the same manner as the contents of this document. 
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TABLE OF CONTENTS  
PROTOCOL TITLE, NUMBER, VERSION ........................................................................... 6 
SPONSOR NAME AND ADDRESS ....................................................................................... 6 
MEDICAL MONITOR ............................................................................................................. 6 
AUTHORIZED SIGNATURES ............................................................................................... 7 
CHANGE HISTORY................................................................................................................ 8 
SYNOPSIS ................................................................................................................................ 9 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 14 
1.
INTRODUCTION AND BACKGROUND ................................................................... 15
1.1. 
Name and Descriptions of Investigational Products ................................................ 17 
1.2. 
Intended Use of Investigational Products................................................................. 17 
1.3. 
Summary of Findings from Nonclinical Studies ...................................................... 17 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ................................... 17 
1.4.1. 
Relevant Literature References and Prior Clinical Data Relevant to Previous 
Utilized Measures: Disability Glare, Discomfort Glare, Photostress Recovery, and 
Chromatic Contrast ......................................................................................................... 17 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical 
Study 18 
1.5.1. 
Relevant Literature References and Prior Clinical Data Relevant to New 
Proposed Measures: Halos, Starbursts, Two-Point Thresholds ...................................... 19 
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 20
2.1. 
Objectives ................................................................................................................. 20 
2.2. 
Endpoints .................................................................................................................. 20 
2.3. 
Hypotheses ............................................................................................................... 21 
3.
TARGETED STUDY POPULATION ........................................................................... 22
3.1. 
General Characteristics ............................................................................................ 22 
3.2. 
Inclusion Criteria ...................................................................................................... 23 
3.3. 
Exclusion Criteria ..................................................................................................... 23 
3.4. 
Enrollment Strategy.................................................................................................. 24 
4.
STUDY DESIGN AND RATIONALE .......................................................................... 24
4.1. 
Description of Study Design .................................................................................... 24 
4.2. 
Study Design Rationale ............................................................................................ 24 
4.3. 
Enrollment Target and Study Duration .................................................................... 25 
5.
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 25
5.1. 
Test Article Allocation ............................................................................................. 25 
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5.2. 
Masking .................................................................................................................... 26 
5.3. 
Procedures for Maintaining and Breaking the Masking........................................... 26 
6. 
STUDY INTERVENTION ............................................................................................. 27 
6.1. 
Identity of Test Articles............................................................................................ 27 
6.2. 
Ancillary Supplies/Products ..................................................................................... 27 
6.3. 
Administration of Test Articles ................................................................................ 27 
6.4. 
Packaging and Labeling ........................................................................................... 28 
6.5. 
Storage Conditions ................................................................................................... 28 
6.6. 
Collection and Storage of Samples .......................................................................... 28 
6.7. 
Accountability of Test Articles ................................................................................ 28 
7. 
STUDY EVALUATIONS .............................................................................................. 29 
7.1. 
Time and Event Schedule ......................................................................................... 29 
7.2. 
Detailed Study Procedures ....................................................................................... 30 
VISIT 1 ........................................................................................................................... 30 
VISIT 2 ........................................................................................................................... 47 
FINAL EVALUATION .................................................................................................. 50 
7.3. 
Unscheduled Visits ................................................................................................... 50 
7.4. 
Laboratory Procedures ............................................................................................. 51 
8. 
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 52 
8.1. 
Completion Criteria .................................................................................................. 52 
8.2. 
Withdrawal/Discontinuation from the Study ........................................................... 52 
9. 
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 52 
10. 
DEVIATIONS FROM THE PROTOCOL .................................................................. 53 
11. 
STUDY TERMINATION ........................................................................................... 53 
12. 
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 53 
13. 
ADVERSE EVENTS ................................................................................................... 55 
13.1. 
Definitions and Classifications ............................................................................. 55 
13.2. 
Assessing Adverse Events .................................................................................... 57 
13.2.1. 
Causality Assessment .................................................................................... 57 
13.2.2. 
Severity Assessment ...................................................................................... 57 
13.3. 
Documentation and Follow-Up of Adverse Events .............................................. 58 
13.4. 
Reporting Adverse Events .................................................................................... 59 
13.4.1. 
Reporting Adverse Events to Sponsor .......................................................... 59 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
 
60 
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13.5. 
Event of Special Interest ....................................................................................... 60 
13.6. 
Reporting of Pregnancy ........................................................................................ 60 
14. 
STATISTICAL METHODS ........................................................................................ 61 
14.1. 
General Considerations ......................................................................................... 61 
14.2. 
Sample Size Justification ...................................................................................... 61 
14.3. 
Analysis Populations ............................................................................................ 61 
14.4. 
Level of Statistical Significance ........................................................................... 61 
14.5. 
Primary Analysis .................................................................................................. 62 
14.6. 
Secondary Analysis .............................................................................................. 62 
14.7. 
Other Exploratory Analyses ................................................................................. 64 
14.8. 
Interim Analysis ................................................................................................... 64 
14.9. 
Procedure for Handling Missing Data and Drop-Outs ......................................... 64 
14.10. 
Procedure for Reporting Deviations from Statistical Plan ................................... 64 
15. 
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 64 
15.1. 
Electronic Case Report Form/Data Collection ..................................................... 64 
15.2. 
Subject Record ...................................................................................................... 65 
16. 
DATA MANAGEMENT............................................................................................. 65 
16.1. 
Access to Source Data/Document ........................................................................ 65 
16.2. 
Confidentiality of Information.............................................................................. 66 
16.3. 
Data Quality Assurance ........................................................................................ 66 
17. 
MONITORING ............................................................................................................ 66 
18. 
ETHICAL AND REGULATORY ASPECTS ............................................................ 67 
18.1. 
Study-Specific Design Considerations ................................................................. 67 
18.2. 
Investigator Responsibility ................................................................................... 67 
18.3. 
Independent Ethics Committee or Institutional Review Board (IEC/IRB) .......... 67 
18.4. 
Informed Consent ................................................................................................. 68 
18.5. 
Privacy of Personal Data ...................................................................................... 69 
19. 
STUDY RECORD RETENTION................................................................................ 70 
20. 
FINANCIAL CONSIDERATIONS ............................................................................ 70 
21. 
PUBLICATION ........................................................................................................... 71 
22. 
REFERENCES ............................................................................................................ 71 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) ..... 73 
APPENDIX B: PATIENT INSTRUCTION GUIDE ............................................................. 78 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ......................................... 79 
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APPENDIX D: 
 ...................................... 82 
 Lens Fitting Characteristics .................................................................................. 83 
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS ......................... 90 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL REFRACTIONS
................................................................................................................................................. 92 
 BIOMICROSCOPY SCALE ............................................................................... 99 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION ........................ 105 
 PATIENT REPORTED OUTCOMES .............................................................. 110 
APPENDIX E: DETERMINATION OF EYE DOMINANCY ........................................... 112 
APPENDIX F: IRIS COLOR ............................................................................................... 113 
APPENDIX G: SPECTRUM OF THE UV ACTUATOR ................................................... 115 
APPENDIX H: STARBURST AND HALO IMAGES ....................................................... 116 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 117 
 
TABLE OF CONTENTS 
Figure 1: Study Flowchart ...................................................................................................... 13 
Figure 2: Schematic of the 2-channel Maxwellian optical system used for our dependent 
measures. ................................................................................................................................. 36 
Figure 3: Actual Testing System............................................................................................. 37 
Figure 4: The xenon (dark line) compared to noon day sun light (red line).  The line in red is 
taken from the NASA solar spectrum measured at the earth’s surface 13 and adjusted along the 
ordinate with respect to the xenon source that will be used in this study. .............................. 38 
Figure 5: Schematic of the dysphotopsia-measuring device................................................... 42 
Figure 6: Protototype of testing system for two-point spread functions ................................. 43 
Figure 7: Prototype of Testing System for halos and starbursts ............................................. 44 
 
TABLE OF CONTENTS 
Table 1: Test Articles .............................................................................................................. 27 
Table 2: Ancillary Supplies .................................................................................................... 27 
Table 3: Time and Events ....................................................................................................... 29 
 
 
 
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SYNOPSIS  
Protocol Title 
The effects of contact lenses with experimental dye on visual 
function 
Sponsor 
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256 
Clinical Phase 
Development phase 3 
Trial Registration 
This study will be registered on ClinicalTrials.gov. 
Test Article(s) 
Investigational Products:  senofilcon A-based contact lens 
with new UV blocker. 
Control Products:  ACUVUE OASYS 
Wear and Replacement 
Schedules 
Wear Schedule:  daily wear 
Replacement Schedule:  daily 
Objectives  
The objective of this study is to objectively measure potential 
benefits of the new UV blocker.  
Study Endpoints 
Primary endpoint(s): two-point light thresholds, halo and 
starbursts geometry. 
Secondary endpoint(s): photostress recovery (PR) time, glare 
discomfort threshold (GDc), glare disability threshold (GDs), 
heterochromatic contrast. 
Other observations: on-eye light transmission, ocular 
physiology, subjective response. 
Study Design 
This is a single-site, two-visit, contralateral, non-dispensing, 
randomized, controlled and subject-masked study. At Visit 1 
subjects will be randomly assigned to wear one of two lens 
wear sequences (left: Test, right: Control or left: Control, 
right: Test) and will undergo Psychometric Testing A.   
At Visit 2, there are two levels of randomization, first subjects 
will be assigned randomly to 1 of 2 lens wear sequences (left: 
Test, right: Control or left: Control, right: Test) and subjects 
will then be randomized to the order of the Test lens activation 
(activated/inactivated or inactivated/activated) and will then 
undergo Psychometric Testing B. 
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1: Study Flowchart). 
Sample Size 
Approximately 66 eligible subjects will be enrolled and 
randomized into the study. Approximately 60 subjects are 
targeted to complete the study. Of these, approximately 40 
will be in the 18-39 age range, and approximately 20 in the 
40-65 age range.   
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Study Duration 
There are two study visits that will last approximately 2-3 
hours each.  At least 24 hours must separate the end of Visit 1 
and the beginning of Visit 2.  Once enrolled, all subjects are 
expected to complete both visits within 28 days.  The study 
enrollment period will be approximately 6 weeks. 
Anticipated Study 
Population 
All subjects will be habitual wearers of spherical soft 
silicone hydrogel contact lenses that can be fit with the lens 
powers available for this study.  Healthy male and female 
volunteers of any race and ethnicity will be recruited that are 
≥18 and ≤39 years of age (∼2/3 of the total sample) and are 
≥40 and ≤65 years of age (∼1/3 of the total sample). 
Eligibility Criteria 
(Inclusion) 
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. Appear able and willing to adhere to the instructions set 
forth in this clinical protocol 
3. Between 18 and 65 (inclusive) years of age at the time of 
screening. 
4. Be a current spherical soft silicone hydrogel contact lens 
wearer in both eyes with a minimum of 6 hours/day and 5 
days/week wear time over the last 30 days by self-report. 
 
Inclusion Criteria after Baseline 
5. The subject’s vertex-corrected spherical equivalent 
distance refraction must be in the range of -1.00 through -
4.50 D in each eye. 
6. The subject has a best corrected visual acuity of 20/25 or 
better in each eye. 
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Eligibility Criteria 
(Exclusion) 
Potential subjects who meet any of the following criteria will 
be excluded from participating in the study:  
1. Currently pregnant or breastfeeding. 
2. Any ocular or systemic allergies or diseases that may 
interfere with contact lens wear.   
3. Any autoimmune disease or use of medication, which may 
interfere with contact lens wear.   Habitual medications 
used by successful soft contact lens wearers are considered 
acceptable. 
4. Entropion, ectropion, extrusions, chalazia, recurrent styes, 
glaucoma, history of recurrent corneal erosions, or 
aphakia. 
5. Any previous, or planned, ocular or interocular surgery 
(e.g., radial keratotomy, PRK, LASIK, etc.). 
6. Any corneal distortion resulting from previous hard or 
rigid gas permeable contact lens wear. 
7. Multifocal, toric or extended wear contact lens correction. 
8. Participation in any contact lens or lens care product 
clinical trial within 14 days prior to study enrollment. 
9. History of binocular vision abnormality or strabismus. 
10. Any infectious disease (e.g., hepatitis, tuberculosis) or 
contagious immunosuppressive diseases (e.g., HIV) by 
self-report. 
11. Employee or immediate family member of an employee of 
clinical site (e.g., Investigator, Coordinator, Technician). 
 
Exclusion Criteria after Baseline 
12. Any ocular infection. 
13. Any grade 3 or greater slit lamp findings (e.g., edema, 
corneal neovascularization, corneal staining, tarsal 
abnormalities, conjunctival injection) on the FDA 
classification scale, any previous history or signs of a 
contact lens-related corneal inflammatory event (e.g., past 
peripheral ulcer or round peripheral scar), or any other 
ocular abnormality that may contraindicate contact lens 
wear. 
Disallowed 
Medications/Interventions  
Use of any prescription or over-the-counter (OTC) 
medications that may affect contact lens wear from 24 hours 
prior to receiving the study product through the study period 
of 2 visits.  Habitual medications taken by successful soft 
contact lens wearers are considered acceptable. 
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Measurements and 
Procedures 
The new UV-blocker has the potential to provide visual 
benefits that go beyond the correction of ametropia.  This 
study will objectively measure these benefits using an optical 
bench set-up. 
Microbiology or Other 
Laboratory Testing 
None 
Study Termination 
The occurrence of one or more Unanticipated Adverse 
Device Effect (UADE), or any SAE where relationship to 
study agent cannot be ruled out, will result in stopping 
further dispensing investigational product.  In the event of a 
UADE or SAE, the Sponsor Medical Monitor may unmask 
the treatment regimen of subject(s) and may discuss this with 
the Principal Investigator before any further subjects are 
enrolled. 
Ancillary Supplies/ Study-
Specific Materials 
EyeCept preservative-free eyedrops, optical bench set-up. 
Principal Investigator(s) 
and Study 
Institution(s)/Site(s) 
A full list of Principal Investigators, clinical sites, and 
institutions is kept separately from the Study Protocol and is 
included in the study Trial Master File.   
 
 
 
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COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS 
ADD  
 
Plus Power Required For Near Use 
ADE  
 
Adverse Device Effect 
AE 
 
 
Adverse Event/Adverse Experience 
BCVA  
 
Best Corrected Visual Acuity 
BSCVA 
 
Best Spectacle Corrected Visual Acuity 
CFR 
 
 
Code of Federal Regulations 
CIE 
 
 
Corneal Infiltrative Event 
CLUE  
 
Contact Lens User Experience 
COAS  
 
Complete Ophthalmic Analysis System 
COM  
 
Clinical Operations Manager 
CRA  
 
Clinical Research Associate 
CRF 
 
 
Case Report Form 
CRO  
 
Contract Research Organization 
CT 
 
 
Center Thickness 
 
 
 
 
D 
 
 
Diopter 
DMC  
 
Data Monitoring Committee 
eCRF  
 
Electronic Case Report Form 
EDC  
 
Electronic Data Capture 
ETDRS 
 
Early Treatment Diabetic Retinopathy Study 
FDA  
 
Food and Drug Administration 
GCP  
 
Good Clinical Practice 
HIPAA 
 
Health Insurance Portability and Accountability Act 
HEV  
 
High Energy Visible 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICH 
 
 
International Council on Harmonisation 
IDE 
 
 
Investigational Device Exemption 
IEC 
 
 
Independent Ethics Committee 
IRB 
 
 
Institutional Review Board 
ISO 
 
 
International Organization for Standardization 
ITT 
 
 
Intent-to-Treat 
JJVC  
 
Johnson & Johnson Vision Care, Inc. 
LC 
 
 
Limbus Center 
LogMAR 
 
Logarithm of Minimal Angle of Resolution 
MedDRA© 
 
Medical Dictionary for Regulatory Activities 
MOP  
 
Manual of Procedures 
MPMVA 
 
Maximum Plus to Maximum Visual Acuity 
NIH 
 
 
National Institutes of Health 
OD 
 
 
Right Eye 
OHRP  
 
Office for Human Research Protections 
OHSR  
 
Office for Human Subjects Research 
OS 
 
 
Left Eye 
OU 
 
 
Both Eyes 
PD 
 
 
Protocol Deviation 
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PHI 
 
 
Protected Health Information 
PI 
 
 
Principal Investigator 
PIG 
 
 
Patient Instruction Guide 
PQC  
 
Product Quality Complaint 
PRO  
 
Patient Reported Outcome 
QA 
 
 
Quality Assurance 
QC 
 
 
Quality Control 
SAE 
 
 
Serious Adverse Event/Serious Adverse Experience 
SAP 
 
 
Statistical Analysis Plan 
SAS 
 
 
Statistical Analysis System 
SD 
 
 
Standard Deviation 
SKU  
 
Stock Keeping Unit 
SOP 
 
 
Standard Operating Procedure 
UADE  
 
Unanticipated Adverse Device Effect 
USADE 
 
Unanticipated Serious Adverse Device Effect 
UV 
 
 
Ultraviolet 
VA 
 
 
Visual Acuity 
1. INTRODUCTION AND BACKGROUND 
Photochromic spectacle lenses have been tested for their ability to improve visual functions 
under intense light conditions.5  In that study, 75 subjects were tested in a subject-masked 
cross-over design (a transparent spectacle lens was compared to a partially activated 
photochromic).  Subjects wearing the photochromic lenses (a variety of types were used) 
showed significant improvements in photostress recovery, glare disability, and glare 
discomfort.  Recently, a similar effect was found for photochromic contact lenses 
(unpublished) using a contralateral design.  Compared to a clear contact in one eye (the 
OASYS), a photochromic contact 
 demonstrated improved photostress recovery, 
glare disability and discomfort (and chromatic contrast, an effect not seen as strongly in the 
parallel photochromic spectacle study).  Although compelling as a first study, two major 
questions remain. 
 
Question 1:  Are the deleterious effects of light scatter continuous?  Glare disability specifically 
refers to visual function under intense light circumstances.  Light enters the eye, is scattered 
by the anterior media (or even surface characteristics of the cornea such as excess lacrimal 
fluid or even contact lenses), and this scatter interferes with visual function (e.g., by veiling an 
image).   Since this scattering, however, is caused by static features of the eye (ranging from 
the optical quality of a contact lens to in homogeneities within the cornea or lens), it is also 
present under low light conditions.  Stated differently, scattering is no more excessive in 
intense light, it is just more aversive.  Scattering under low-moderate light conditions may not 
be as bothersome but it is much more pervasive:  to wit, it degrades our vision under all lighting 
conditions.  
 
One very convenient way of measuring the visual effects of low-level light scatter is based on 
the two-point-light spread technique .6  Two small points of light are used (simulated sunlight 
is the best to use for ecological validity).  The light can either start as one point (subjects then 
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determine the minimum distance needed to see two points) or two points (the subjects indicate 
when only one point is perceived).  The intensity of the points can be varied from very high to 
low.  As the point spread function of the eye is increased, the distance between when the points 
are deemed distinct is also proportionally increased.    
 
Question 2:  What aspects of glare are improved by filtering?  Glare disability is measured by 
exposing subjects to a bright source of light and then measuring how this light interferes with 
some form of visual discrimination (either the glare source can be varied or the intensity of the 
target).  In this scenario, one is simply testing how bright light interferes with some aspect of 
visual function (such as contrast discrimination).  It does not, however, measure how the glare 
light itself is scattered.   For example, light can scatter uniformly causing a homogenous veil 
(similar to a ganzfeld).7  It can also spread in what appears like spokes or starbursts (this 
sometimes referred to as positive dysphotopsia and is caused by high-order aberrations).  These 
appear to be particularly pernicious when individuals have gone through laser correction of 
myopia and cataract surgery (dysphotopsia is the number one problem following successful 
cataract surgery, around 51% of patients).  They also, however, accompany a plethora of other 
conditions including dry eye, astigmatism, epiphora, mild-traumatic brain injury, epicanthic 
eye structure, increased lens density (particularly glycemic), etc.  Ritschel et al. (2009) 
described these autonomous glare phenomenon  
 
“In general the effects of glare can be divided into bloom, a general loss of contrast in the 
surroundings of the retinal image of the light-source (veil), and flare which comprises the 
ciliary corona (the sharp needles) and the lenticular halo surrounding the light.”8 
 
In the previous study, we measured the first aspect of glare (the veil or bloom).  In this study, 
we would like to measure the latter two, the halo and spokes.   
 
Practical implications: 
Visual disturbance in the form of halos and starbursts is common; when the issues become 
clinical, they are often referred to as dysphotopsia.  Dysphotopsia, for instance, is common in 
patients who have had LASIK surgery to correct vision.  In fact, it has been argued that these 
complications are why LASIK has dropped by more than 50 percent, from 1.5 million 
procedures a year in 2007 to 604K in 2015 (e.g., see lasikcomplications.com).  Dysphotopsia 
is also common in patients who are progressing from early, pre-cataractous vision toward 
severe (operable) cataract (about half of the population over 70 years).  Dysphotopsia is 
particularly evident during night time driving and is one of the major reasons why older adult 
patients stop driving at night. It is also a major reason for displanting IOLs that were implanted 
to correct cataracts.   
 
It is not simply older patients, however, who have these issues.  To demonstrate this 
(unpublished data), we measured halos and visual starbursts in a sample of young subjects (17-
22 years of age).   The size of the central halo for these young subjects varied by a factor of six 
(range = 3-13 cm).  Their peripheral spokes varied by nearly a factor of three (6-15).  Hence, 
even in these young healthy and largely homogeneous subjects the range (and aversive ness) 
was very large.  This is why a number of spectacle lenses (even contact lenses, see 
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http://blog.uniqso.com/contact-lenses-help-reduce-halos-glare/) are specifically marketed for 
their ability to reduce halos and starbursts. 
 
This study will have one Control lens (ACUVUE OASYS), and one Test lens (Investigational).  
However, the one Test lens will be evaluated under two separate lighting conditions making 
three study articles altogether. 
1.1. Name and Descriptions of Investigational Products  
This study will evaluate the Test lens vs. the Control lens.  The Test lens is senofilcon A with 
a new UV blocker, while the Control lens is senofilcon A without the new UV blocker (i.e., 
ACUVUE OASYS).  Further details about the test articles are found in Section 6 of this 
protocol. 
1.2. Intended Use of Investigational Products 
The intended use of the investigative product in this study is for correcting myopia and for the 
attenuation of bright lights.  The study articles will be worn contralaterally in a daily wear, 
daily disposable modality for approximately 2 hours on both days of the study. The study 
articles will not be dispensed. 
1.3. Summary of Findings from Nonclinical Studies 
All previous pre-clinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans.  For the most comprehensive nonclinical information regarding the 
senofilcon A-based contact lens with new UV blocker, refer to the latest version of the 
Investigator’s Brochure 
1.4. Summary of Known Risks and Benefits to Human Subjects 
In addition to the correction of their myopia, subjects are likely to experience a reduction of 
bright lights. 
 
For the most comprehensive risk and benefit information regarding the senofilcon A-based 
contact lens with new UV blocker, refer to the latest version of the Investigator’s Brochure. 
1.4.1. Relevant Literature References and Prior Clinical Data Relevant to Previous 
Utilized Measures: Disability Glare, Discomfort Glare, Photostress Recovery, 
and Chromatic Contrast 
• Colombo, L., Melardi, E., Ferri, P., Montesano, G., Attaalla, S. S., Patelli, F., ... & Rossetti, 
L. (2017). Visual function improvement using photocromic and selective blue-violet light 
filtering spectacle lenses in patients affected by retinal diseases. BMC ophthalmology, 
17(1), 149. 
• Huang, W. J., Yang, Y., & Luo, M. R. (2017). Discomfort glare caused by white LEDs 
having different spectral power distributions. Lighting Research & Technology, 
1477153517704996. 
• Lee, H. S., Kim, J. Y., Subramaniyam, M., Park, S., & Min, S. N. (2017). Evaluation of 
quantitative glare technique based on the analysis of bio-signals. Ergonomics, 60(10), 
1376-1383. 
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•
Longley, C., & Whitaker, D. (2016). Google Glass Glare: disability glare produced by a
head‐mounted visual display. Ophthalmic and physiological optics, 36(2), 167-173.
•
Mahjoob, M., Heydarian, S., & Koochi, S. (2016). Effect of yellow filter on visual acuity
and contrast sensitivity under glare condition among different age groups. International
ophthalmology, 36(4), 509-514.
•
Mehri, A., Farhang Dehghan, S., Hajizadeh, R., Zakerian, S. A., Mohammadi, H., &
Abbasi, M. (2017). Survey of discomfort glare from the headlamps of cars widely used in
Iran. Traffic injury prevention, (just-accepted).
•
Pierson, C., Bodart, M., Cauwerts, C., & Wienold, J. (2017). Discomfort glare from
daylighting: study of factors influencing discomfort glare perception and validation of a
universal discomfort glare index. In VELUX Daylight Symposium.
•
Pierson, C., Wienold, J., & Bodart, M. (2017). Discomfort glare from daylighting:
influence of culture on discomfort glare perception. In CIE 2017 Midterm Meeting.
•
Ritschel, T., Ihrke, M., Frisvad, J. R., Coppens, J., Myszkowski, K., & Seidel, H. P. (2009).
Temporal Glare: Real‐Time Dynamic Simulation of the Scattering in the Human Eye. In
Computer Graphics Forum 28, 2, 183-192.
•
Rodriguez, R. G., Yamín Garretón, J. A., & Pattini, A. E. (2016). Glare and cognitive
performance in screen work in the presence of sunlight. Lighting Research & Technology,
48(2), 221-238.
•
Rosli, S. A., Aladin, A. Z., Muhamad, N., & Chen, A. H. (2016). Comparison of visibility
threshold on different chromatic contrast objects. Social and Management Research
Journal, 13(1), 106-115.
•
Sewall, A. A. S., Borzendowski, S. A. W., Tyrrell, R. A., Stephens, B. R., & Rosopa, P. J.
(2016). Observers’ Judgments of the Effects of Glare on Their Visual Acuity for High and
Low Contrast Stimuli. Perception, 45(7), 755-767.
•
Siah, W. F., O’Brien, C., & Loughman, J. J. (2017). Macular pigment is associated with
glare-affected visual function and central visual field loss in glaucoma. British Journal of
Ophthalmology, bjophthalmol-2017.
•
Stringham, J. M., O’Brien, K. J., & Stringham, N. T. (2016). Macular carotenoid
supplementation improves disability glare performance and dynamics of photostress
recovery. Eye and Vision, 3(1), 30.
•
Wahl, S., Fornoff, L., Ochakovski, G. A., & Ohlendorf, A. (2017). Disability glare in soft
multifocal contact lenses. Contact Lens and Anterior Eye.
See also the Investigator’s Brochure.9 
1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
 evaluated the same study lenses as the current study on a similar optical bench set 
up.  In that study, the Test and Control lenses were subjected to a 395 nm light source that 
would normally be present in the outdoor environment on a sunny day.  The Test lens 
performed better than the Control lens in this simulated environment.10  However, previous 
studies 
 have shown an indoor benefit of the Test lens over the Control lens and 
this remains unexplained - particularly since indoor light is typically absent of any significant 
395 nm light.11  It is important to understand whether the same optical bench metrics 
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(photostress recovery, discomfort glare, disability glare, and heterochromatic contrast) can 
help explain the indoor benefit. 
 
The same previous studies that have shown an indoor benefit with the Test lens have shown a 
benefit with daytime and nighttime driving.  Subjects typically report that their vision is better 
and they have less issues with bright lights.  The mechanism behind this remains unexplained.  
The current study will investigate this area by evaluating the magnitude of dysphotopsia with 
the Test and Control lens under simulated daytime and nighttime wavelengths. 
1.5.1. Relevant Literature References and Prior Clinical Data Relevant to New 
Proposed Measures: Halos, Starbursts, Two-Point Thresholds 
• Artal, Pablo, and Rafael Navarro (1992). Simultaneous measurement of two-point-spread 
functions at different locations across the human fovea. Applied optics 31.19: 3646-3656. 
• Aujla, M., Wolffsohn, J. S., & Sheppard, A. L. (2015). Halo size and subjective complaints 
of dysphotopsia in a normal population. Investigative Ophthalmology & Visual Science, 
56(7), 4314-4314. 
• Babizhayev, M. A., Minasyan, H., & Richer, S. P. (2009). Cataract halos: a driving hazard 
in aging populations. Implication of the Halometer DG test for assessment of intraocular 
light scatter. Applied ergonomics, 40(3), 545-553. 
• Brown, S. M. (2004). Measuring starbursts. Journal of Cataract & Refractive Surgery, 
30(12), 2646-2647. 
• Davison, J. A. (2000). Positive and negative dysphotopsia in patients with acrylic 
intraocular lenses. Journal of Cataract & Refractive Surgery, 26(9), 1346-1355. 
• De Boer, J. B. (1967). Visual perception in road traffic and the field of vision of the 
motorist. In Public Lighting (pp. 11-96). 
• Finney, D. J. (1971). Probit analysis (3rd ed.). Cambridge: University Press. 
• Gowrisankaran, S., Sheedy, J. E., & Hayes, J. R. (2007). Eyelid squint response to 
asthenopia-inducing conditions.  Optometry and Vision Science, 84, 611-19.  
• Hammond, B. R. (2012). The visual effects of intraocular filters. Scientifica, 2012. 
doi:10.6064/2012/424965 
• Hammond, B. R., Bernstein, B., & Dong, J. (2009). The effect of the AcrySof Natural lens 
on glare disability and photostress. American Journal of Ophthalmology, 148(2), pp. 272-
276. 
• Hammond, B. R., Renzi, L. M., Sachak, S., & Brint, S. F. (2010). Contralateral comparison 
of blue-filtering and non-blue-filtering intraocular lenses: glare disability, heterochromatic 
contrast, and photostress recovery. Clinical Ophthalmology, 4, pp. 1465-1473. 
• Kenward, M. G., & Roger, J. H. (1997). Small sample inference for fixed effects from 
restricted maximum likelihood. Biometrics, 53(3), pp. 983-997. 
• Mecherikunnel, A. T., & Richmond, J. C. (1980). Spectral distribution of solar radiation. 
Technical Memorandum 82021, NASA, Goddard Space Flight Center, Greenbelt, 
Maryland. 
• Nahar, N. K., Sheedy, J. E., Hayes, J., & Tai, Y. C. (2007). Objective measurements of 
lower-level visual stress. Optometry and Vision Science, 84(7), 620-629. 
• Renzi, L. and Hammond, B.R.  (2016). The effects of photochromic lenses on visual 
performance.  Clinical and Experimental Optometry, 1-7. 
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• Ritschel, T., Ihrke, M., Frisvad, J. R., Coppens, J., Myszkowski, K., & Seidel, H. P. (2009, 
April). Temporal Glare: Real‐Time Dynamic Simulation of the Scattering in the Human 
Eye. In Computer Graphics Forum (Vol. 28, No. 2, pp. 183-192). Blackwell Publishing 
Ltd. 
• Sayre, R. M., Cole, C., Billhimer, W., Stanfield, J., & Ley, R. D. (1990). Spectral 
comparison of solar simulators and sunlight. Photodermatol Photoimmunol Photomed, 7, 
pp. 159-165. 
• Sheedy, J. E., Truong, S. D., & Hayes, J. R. (2003). What are the visual benefits of eyelid 
squinting?. Optometry and vision science, 80(11), 740-744. 
• Stringham, J. M., Fuld, K., & Wenzel, A. J. (2003). Action spectrum for 
photophobia. JOSA A, 20(10), 1852-1858. 
• Valverde, J. A., & Gonza, R. (2003). Simple device for quantifying the influence of halos 
after lasik surgery. Journal of biomedical optics, 8(4), 663-667. 
• Westheimer, G. (1975). Visual acuity and hyperacuity. Investigative Ophthalmology, 
14(8), pp. 570-572. 
2. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1. Objectives  
Primary Objective(s) 
The primary objective of this study is to investigate the daytime and nighttime driving benefit 
seen with previous studies.  It will determine whether the Test lens can demonstrate an 
objective benefit in the absence and presence of a UV/HEV light source over the Control lens.  
The size of dysphotopsia (halos, starburst, scattering) will be measured. 
 
Secondary Objective(s) 
The secondary objective of this study is to investigate the indoor benefit seen with previous 
studies.  It will determine whether the investigational lens can demonstrate an objective benefit 
in the absence of a UV/HEV light source over the Control lens.  Psychophysical measures such 
a photostress recovery, disability glare, discomfort glare, and chromatic contrast will be used. 
 
Exploratory Objective(s) 
The on-eye light transmission will be measured on a sampling of subjects by measuring 
absolute sensitivity to test lights with activated and inactivated lenses.  Slit lamp findings and 
subjective ratings will be monitored. 
2.2. Endpoints  
There is one Control lens and one Test lens in this study.  However, the Test lens is evaluated 
with and without an added UV/HEV light source.  The testing conditions and endpoints are 
summarized here with detail provided. 
 
 
 
 
 
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2. Haloes 
a. The Test lens (in the absence of an additional UV/HEV light source) will be 
statistically lower than the Control lens with respect to halos. This is measured 
using the halometer instrument. 
b. The Test lens (in the presence of an additional UV/HEV light source) will be 
statistically lower than the Control lens with respect to halos. This is measured 
using the halometer instrument. 
 
3. Starbursts 
a. The Test lens (in the absence of an additional UV/HEV light source) will be 
statistically lower than the Control lens with respect starbursts as measured 
using the halometer instrument.  
b. The Test lens (in the presence of an additional UV/HEV light source) will be 
statistically lower than the Control lens with respect starbursts as measured 
using the halometer instrument.  
 
Secondary Hypotheses (each is considered independent) 
1. The Test lens (in the absence of an additional UV/HEV light source) will be statistically 
lower than the Control lens with respect to photostress recovery time (seconds) as 
measured using the optical bench instrument.  
2. The Test lens (in the absence of an additional UV/HEV light source) will be statistically 
higher than the Control lens with respect to disability glare threshold as measured using 
the optical bench instrument. 
3. The Test lens (in the absence of an additional UV/HEV light source) will be statistically 
lower than the Control lens with respect to discomfort glare (eyelid squinting) as 
measured using the optical bench instrument. 
4. The Test lens (in the absence of an additional UV/HEV light source) will be statistically 
higher than the Control lens with respect to chromatic contrast threshold than as 
measured using the optical bench instrument. 
 
Other Hypotheses 
1. In vivo light transmission will be collected on a sampling of subjects for informational 
purposes only.  Slit lamp findings and subjective ratings will be described descriptively. 
3. TARGETED STUDY POPULATION 
3.1. General Characteristics  
Male and female volunteers of any nationality that satisfy the inclusion and exclusion criteria. 
 
 
 
 
 
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3.2. Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
  
Inclusion Criteria after Screening 
  
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form. 
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol 
3. Between 18 and 65 (inclusive) years of age at the time of screening. 
4. Be a current spherical soft silicone hydrogel contact lens wearer in both eyes with a 
minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-
report. 
 
Inclusion Criteria after Baseline 
 
5. The subject’s vertex-corrected spherical equivalent distance refraction must be in the 
range of -1.00 through -4.50 D in each eye. 
6. The subject has a best corrected visual acuity of 20/25 or better in each eye. 
3.3. Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study:  
 
Exclusion Criteria after Screening: 
 
1. Currently pregnant or breastfeeding. 
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.   
3. Any autoimmune disease or use of medication, which may interfere with contact lens 
wear.   Habitual medications used by successful soft contact lens wearers are 
considered acceptable. 
4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of 
recurrent corneal erosions, or aphakia. 
5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, 
LASIK, etc.). 
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens 
wear. 
7. Multifocal, toric or extended wear contact lens correction. 
8. Participation in any contact lens or lens care product clinical trial within 14 days prior 
to study enrollment. 
9. History of binocular vision abnormality or strabismus. 
10. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive 
diseases (e.g., HIV) by self-report. 
11. Employee or immediate family member of an employee of clinical site (e.g., 
Investigator, Coordinator, Technician). 
 
 
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Exclusion Criteria after Baseline 
 
12. Any ocular infection. 
13. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, 
corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification 
scale, any previous history or signs of a contact lens-related corneal inflammatory event 
(e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality 
that may contraindicate contact lens wear. 
3.4. Enrollment Strategy 
Study subjects will be recruited from the Institution/clinical site’s subject database and/or 
utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved 
materials.  
4. STUDY DESIGN AND RATIONALE 
4.1. Description of Study Design 
The study is a single-site, controlled, randomized, subject-masked, non-dispensing, 
contralateral design.  The study begins with an initial visit (Visit 1 - Day 0), if a subject is 
found to meet all eligibility criteria, then they will be randomized to one of two lens wear 
sequences (Left: Test, Right: Control or Left: Control, Right: Test); otherwise a subject will 
be deemed ineligible for this study.   
 
If a subject is found eligible and was ‘dispensed’ study lenses at the initial visit, then one 
additional visit will occur.  Visit 2 will occur no sooner than 24 hours after Visit 1 and no later 
than 28 days after visit 1.  Each visit will last approximately 2-3 hours each. Unscheduled visits 
may occur during the course of the study.  
4.2. Study Design Rationale 
This study will be executed using a contralateral design. There are several benefits to this 
choice of design. First, we intend to relate performance with the investigational lens in its 
activated and inactivated states to baseline light sensitivity.  A contralateral design will allow 
us to compare performance with both activation states within the same individual, ostensibly 
with the same baseline light sensitivity.  Second, other subject factors that can influence visual 
performance, such as iris color and absorption of test lights via macular pigment, are better 
controlled using this design. Third, in psychophysical testing, which is the gold standard for 
many of the visual functions being tested, participants make judgments about some event 
threshold, such as when an image disappears or how large or bothersome or intense a visual 
event appears.  Participants may have different criteria for threshold events that are internally 
consistent within subjects but can vary between subjects. A contralateral design allows the 
investigational lens to be compared within subjects, with consistent criteria for threshold 
events. Given the fact that sufficient time will be taken between measures, in some cases 24 
hours or more, carryover effects are unlikely. 
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4.3. Enrollment Target and Study Duration 
Approximately 66 subjects will be enrolled to complete approximately 60 at a single site.  The 
point of study enrollment is the execution and completion of the signed Informed Consent 
document.  Subjects will be stratified into one of two age groups using a 2:1 allocation ratio: 
 
• 40 subjects ±3 in age group 18-39 
• 20 subjects ±3 in age group 40-65 
 
There are two study visits that will last approximately 2-3 hours each.  At least 24 hours must 
separate the end of Visit 1 and the beginning of Visit 2.  Once enrolled, all subjects are expected 
to complete both visits within 28 days.  The study enrollment period will be approximately 6 
weeks. 
5. TEST ARTICLE ALLOCATION AND MASKING 
5.1. Test Article Allocation  
Use of the test articles will be randomized using a randomization scheme supplied by the study 
biostatistician. 
 
This is a single-site, two-visit, contralateral, subject-masked, non-dispensing and randomized 
study.  The study lenses will be worn in a contralateral and random fashion.  At visit 1, a block 
size of (2) sequences will be used to randomly assign subjects to one of two lens wear 
sequences (Left: Test, Right: Control or Left: Control, Right: Test).  
 
At visit 2, there are two levels of randomization, a block size of (2) sequences will be used to 
randomly assign subjects to one of two lens wear sequences (Left: Test, Right: Control or Left: 
Control, Right: Test).  Once subjects are randomized to a lens wear sequence, subjects will 
then be randomized to the order of Test lens activation (activated/inactivated or 
inactivated/activated).  
 
The random scheme for each visit will be generated by site using the PROC PLAN procedure 
from SAS Software Version 9.4 or higher (SAS Institute, Cary, NC).  
 
The study site must follow the randomization scheme provided and complete enrollment 
according to the randomization list and not pre-select or assign subjects. The randomized 
assignment of subjects will be performed at the first visit prior to the first fitting. The following 
must have occurred prior to randomization: 
 
• Informed consent has been obtained 
• Subject meets all the inclusion / exclusion criteria 
• Subject history and baseline information has been collected 
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5.2. Masking 
This is a subject-masked study.  Masking will be used to reduce potential bias.  Subjects will 
be unaware of the identity of the investigational product. Investigators and clinical site 
personnel involved in the data collection will not be masked as to the identity of the 
investigational product.  Although the subjects will not be aware of which study lens is going 
on which eye, the dynamic nature of the test lens during the assessments may give the identity.   
 
Under normal circumstances, the mask should not be broken until all subjects have completed 
the study and the database is finalized. Otherwise, the mask should be broken only if specific 
emergency treatment/course of action would be dictated by knowing the treatment status of the 
subject. In such cases, the Investigator may, in an emergency, contact the medical monitor.  In 
the event the mask is broken, the Sponsor must be informed as soon as possible. The date, 
time, and reason for the unmasking must be documented in the subject record. The Investigator 
is also advised not to reveal the study treatment assignment to the clinical site or Sponsor 
personnel.  
 
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations.  Subjects who are discontinued will be replaced. 
5.3. Procedures for Maintaining and Breaking the Masking 
The identity of the study lenses will be masked to the subjects by over labeling the blister pack 
of the study lens. The label will contain the study number, lot number, sphere power, expiration 
date and the randomization codes S and N.   
 
The test articles mask shall not be broken unless information concerning the lens type is 
necessary for the urgent medical treatment of a subject.  The Sponsor must be notified before 
the mask is broken. 
 
When dispensing test articles, the following steps should be followed to maintain 
randomization codes: 
1. Investigator or designee (documented on the Delegation Log) will consult the lens 
fitting schedule/randomization scheme to obtain the test article assignment for that 
subject prior to dispensing 
2. Investigator or designee will record the subject’s number on the appropriate line of the 
randomization scheme 
3. Investigator or designee will pull the appropriate test articles from the study supply.  
All test articles that are opened, whether dispensed (placed/fit on eye or dispensed 
outside the clinical site) or not, must be recorded on the Test Article Accountability 
Log in the “Dispensed” section 
 
Subjects who have had their treatment assignment unmasked are expected to return for all 
remaining scheduled evaluations.  Subjects who are discontinued may be replaced. 
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6.4. Packaging and Labeling 
The test articles will be packaged in blisters as the primary packaging.  The test article will be 
over-labeled to mask the subject to the identity of the lens. The test articles will be in 
investigational cartons sealed with a tamper evident seal, commercial cartons, or in plastic bags 
as the secondary packaging form. The sample study label is shown below: 
6.5. Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions and stored out of direct sunlight or other source of UV/HEV 
radiation. 
6.6. Collection and Storage of Samples 
When possible, any lens or test article associated with an Adverse Events and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return back to JJVC. 
6.7. Accountability of Test Articles 
JJVC 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.  
 
Test article must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log.  All test articles must be accounted.  This includes: 
 
1. What was dispensed for the subject for trial fitting, to wear out of the office, or issued 
for the subject to replace appropriately between visits  
2. What was returned to the Investigator unused 
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Figure 4: The xenon (dark line) compared to noon day sun light (red line).  The line 
in red is taken from the NASA solar spectrum measured at the earth’s surface 13 and 
adjusted along the ordinate with respect to the xenon source that will be used in this 
study.   
 
 
 
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8. SUBJECTS COMPLETION/WITHDRAWAL  
8.1. Completion Criteria 
Subjects are considered to have completed the study if they have completed all scheduled 
visits.  
8.2. Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons: 
• Subject death during the study period 
• Subject withdrawal of consent 
• Subject not compliant to protocol (e.g. Subject more than 2 days out of visit window). 
• Subject lost to follow-up  
• Subject no longer meets eligibility criteria (e.g. the subject becomes pregnant) 
• Subject develops significant or serious adverse events causing discontinuation of study 
lens wear (subjects missing more than 2 days of missed lens wear within a period 1 of 
week should be discontinued)  
• Subjects who have experienced a Corneal Infiltrative Event (CIE) 
• Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment) 
• Subject missed any scheduled study visits  
• Subject not compliant with study lens wear schedule  
• Subject not successfully dispensed due to lack of efficacy and safety including poor 
vision, poor comfort or unacceptable fit 
For discontinued subjects, the Investigator will: 
• Complete the current visit (scheduled or unscheduled) 
• Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study 
• Record the spherocylindrical refraction with best corrected distance visual acuity  
• Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in Section 7.2. Collect all unused test article(s) from the 
subject.  
 
Investigator will discuss with sponsor before enrolling any additional subjects if a subject 
discontinues from the study prematurely.  
 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal.  The measures taken to 
follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt.  
9. PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications for this study include: See section 3.3   
Concomitant therapies that are disallowed include: See section 3.3 
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10. DEVIATIONS FROM THE PROTOCOL 
Investigator will notify study sponsor upon identification of a protocol deviation. Major 
protocol deviations must be reported to the sponsor within 24 hours after discovery of the 
protocol deviation.  The Investigator will report deviations per IRB/IEC requirements.  All 
deviations will be tracked and corrective actions implemented as appropriate.  
 
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB.  
11. STUDY TERMINATION 
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article.  In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled. 
 
The Sponsor will determine when a study will be stopped.  The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised. 
 
JJVC reserves the right to terminate the study at any time for any reason.  Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined.  The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.  
 
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events.  If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated, as soon as possible. 
 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.   
 
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
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• Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO)” 
• Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site 
• Lens replacements that occur due to drops/fall-outs 
• Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the subject 
 
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.   
 
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:  
• Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness) 
• Who received the complaint 
• Study number 
• Clinical site information (contact name, site ID, telephone number) 
• Lot number(s) 
• Unique Subject Identifier(s) 
• Indication of who first observed complaint (site personnel or subject) 
• OD/OS indication, along with whether the lens was inserted 
• Any related AE number if applicable 
• Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.) 
• Eye Care Provider objective (slit lamp) findings if applicable 
• Confirmation of product availability for return (and tracking information, if available), 
or rationale if product is not available for return 
 
 
 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE).  If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.   
 
In some cases, a PQC form may be generated in EDC by the site in error.  In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented. 
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13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users 
or other persons, whether or not related to the investigational medical device.  
Note 1 to entry: This definition includes events related to the investigational medical device 
or the comparator. 
Note 2 to entry: This definition includes events related to the procedures involved. 
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices.” 1 
 
An AE includes any condition (including a pre-existing condition) that: 
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study  
2. Was present prior to the study, but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states  
3. Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event 
 
Serious Adverse Event (SAE) – An SAE is any untoward medical occurrence that: 
• Results in death 
• Is life threatening 
• Requires in-patient hospitalization or prolongation of existing hospitalization 
• Results in persistent or significant disability/incapacity (e.g., a sight threatening event, 
a significant persistent or permanent change, impairment, damage, or disruption to the 
subject’s body) 
• Is a congenital anomaly/birth defect 
• Requires intervention to prevent permanent damage (the use of the test article resulting 
in a condition which requires medical or surgical intervention to preclude permanent 
impairment of the body structure or a body function).  Important medical events that 
may not result in death, be life-threatening, or require hospitalization may be 
considered an SAE when, based upon appropriate medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in the above definition 
 
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to: 
• Microbial Keratitis (MK) 
• Iritis (including cells in the anterior chamber) 
• Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater 
• Central Corneal Opacity 
• Central Corneal Neovascularization 
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• Uveitis 
• Endophthalmitis 
• Hypopyon 
• Hyphemia 
• Penetration of Bowman’s Membrane 
• Persistent Epithelial Defect 
• Limbal cell Damage leading to Conjunctivalization 
 
Significant Adverse Events – Those events that are usually symptomatic and warrant 
discontinuation (temporary or permanent) of the test article (excluding Serious Adverse 
Events).   
 
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following: 
• Contact Lens Induced Peripheral Ulcer (CLPU) 
• Significant Infiltrative Events (SIE) 
• Superior Epithelial Arcuate Lesions (SEALs) 
• Any Temporary Loss of > 2 Lines of BSCVA 
• Other grade 3 or higher corneal findings, such as abrasions or edema 
• Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
• Asymptomatic Corneal Scar 
• Any corneal event which necessitates temporary lens discontinuation > 2 weeks 
 
Non-Significant Adverse Events – Those conditions that are usually asymptomatic and 
usually do not warrant discontinuation (temporary or permanent) of the test article.  However, 
the Investigator may choose to treat as a precautionary measure.   
 
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following: 
• Non-significant Infiltrative Event (NSIE) 
• Contact Lens Papillary Conjunctivitis (CLPC) 
• Superficial Punctate Keratitis (SPK) 
• Conjunctivitis: Bacterial, Viral, Allergic 
• Blepharitis 
• Meibomianitis 
• Contact Dermatitis 
• Localized Allergic Reactions 
• Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks 
 
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device. 
Note 1 to entry: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device. 
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Note 2 to entry: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.” 1 
 
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the test article, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure or protocol, or any other 
unanticipated serious problem associated with the test article that relates to the rights, safety 
and welfare of subjects. 
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly.  Elements of categorization will include: 
• Seriousness/Classifications (see definition in Section 13.1) 
• Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related; unlikely related; possibly 
related; related - see definition in Section 13.2.1) 
• Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild; moderate; severe for all events - see definition in 
Section 0)   
• Outcome – not recovered or not resolved; recovering or resolving; recovered or 
resolved with sequelae; recovered or resolved; death related to adverse event; unknown 
• Actions Taken – none; temporarily discontinued; permanently discontinued; other 
13.2.1. Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations: 
• Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures 
• Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely 
• Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive.  The relationship in time is 
reasonable.  Therefore, the causal relationship cannot be excluded 
• Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s).  The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge 
13.2.2. Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the subject.  The assessment of 
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severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
• Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities 
• Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities 
• Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities 
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begins when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator. 
 
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.   
 
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.   
 
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements.  
Such documentation will include the following: 
• Adverse event (diagnosis not symptom) 
• Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.)  
• Date the clinical site was notified  
• Date and time of onset 
• Date and time of resolution 
• Adverse event classification, severity, and relationship to test articles, as applicable 
• Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements 
• Any referral to another health care provider if needed 
• Outcome, ocular damage (if any) 
• Likely etiology 
• Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event 
 
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In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF.  Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature.  If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded.  
 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed.  Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented. 
 
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved.  If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider.  The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study.  If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation.  The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up. 
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event.  In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (Section 13.4.2).  The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events 
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
hours following discovery of the event.  The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported. 
 
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received.  The Sponsor and study monitor should 
be notified prior to unmasking the test articles. 
 
In the event of a serious/significant adverse event, the Investigator must: 
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• Notify the Sponsor immediately 
• Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject 
• Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article 
• Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations 
 
Unanticipated (Serious) Adverse Device Effect (UADE) 
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect.  This report is in addition to the 
immediate notification mentioned above. 
 
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect. 
 
Non-Serious Adverse Events 
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities. 
 
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines.  
13.5. Event of Special Interest 
None 
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event.  Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes.  At the Investigator’s discretion, the 
study participant may be followed by the Investigator through delivery. However, this data will 
not be collected as part of the clinical study database.  Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use.  Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus. 
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14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical Analysis will be undertaken by the sponsor or under the authority of the sponsor. A 
general description of the statistical methods to be implemented in this clinical trial is outlined 
below.  
 
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. 
14.2. Sample Size Justification 
The plan is to enroll a maximum of 66 subjects with a minimum target of 60 subjects to 
complete. The sample size was chosen by the study responsible clinician and was not based on 
any empirical power calculation. Furthermore, a power calculation cannot be provided for any 
of the primary endpoints because no historical data is available. This data from this study will 
be utilized in the sample size calculations for any additional follow-up studies.  
14.3. Analysis Populations 
Safety Population: 
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded. 
 
Per-Protocol Population:  
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population). Justification of excluding subjects with protocol deviations in the 
per-protocol population set will be documented in a memo to file. 
 
Intent-to-Treat (ITT) Population: 
All randomized subjects regardless of actual treatment and subsequent withdrawal from study 
or deviation from protocol. At least one observation should be recorded. 
14.4. Level of Statistical Significance 
Each primary and secondary hypothesis will be tested individually using a type I error rate of 
5%.  
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14.5. Primary Analysis  
Light Scattering (Two-point Light Spread Function) 
This is defined as the minimum distance (mm) that two points of light are completely distinct. 
This threshold will be analyzed by a linear mixed model. Sequence of lens wear, lens type, age 
group, dominant eye and the interaction between lens type and age group will be included in 
the model as fixed effects. An appropriate covariance structure will be used to model the 
residual errors between measurements between eyes within a subject. The variance-covariance 
structure will be selected based on the finite-sample corrected Akaike’s Information Criterion 
Corrected (AICC). The structure that returns the lowest AICC will be deemed the most 
appropriate structure. Covariance structures under consideration include:  
 
• Unstructured (UN)  
• Compound Symmetry (CS) 
• Heterogeneous Compound Symmetry (CSH)  
 
Heterogeneous covariance structures across lens type may be considered if necessary. The 
Kenward and Roger method (Kenward and Roger, 1997)15 will be used for the denominator 
degrees of freedom. 
 
Comparisons between lenses (Test inactivated vs Control and Test activated vs Control) will 
be carried out using 2-sided 95% confidence intervals constructed for the least-square mean 
(LSM) difference (Test – Control). Statistically significantly lower differences of the Test lens 
relative to the Control lens will be concluded if the upper limit of the 95% confidence interval 
is below 0. If the interaction between lens type and age is significant then comparisons between 
lenses will be made within age group.  
 
Starburst  
Starbursts will be quantified by the diameter of the light’s lateral spread. A calibrated custom-
made micrometer (two sides with reverse threading) will be used to spread two posts out from 
a central mid-point). Those posts can then be used to define the outer boundaries of the 
starburst image (i.e. the diameter). The diameter of the light’s lateral spread will be analyzed 
and tested in the same manner as described for light scattering above. 
  
Halos 
Halos will be quantified by the diameter (mm) of outer edges of the halo image and is measured 
using the same micrometer as for starbursts and light scattering. The diameter will be analyzed 
using the same model as described for light scattering.  
14.6. Secondary Analysis  
Photostress Recovery Time (Seconds)  
Photostress recovery time (PSRT) will be evaluated by exposing subjects to an intense light 
source (10-deg circular broad-band white at ~4.5 log Tds) and will be quantified as the time 
necessary to regain site of the grating after exposure.  
 
PSRT will be analyzed using a linear mixed model. Sequence of lens wear, lens type, age group 
dominant eye and all the interaction between lens type and age group will be included as fixed 
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effects. An appropriate covariance structure will be used to model the residual errors between 
measurements between eyes within a subject. The variance-covariance structure will be 
selected based on the finite-sample corrected Akaike’s Information Criterion Corrected 
(AICC). The structure that returns the lowest AICC will be deemed the most appropriate 
structure. Covariance structures under consideration include:  
 
• Unstructured (UN)  
• Compound Symmetry (CS) 
• Heterogeneous Compound Symmetry (CSH)  
 
Heterogeneous covariance structures across lens type may be considered if necessary. The 
Kenward and Roger method (Kenward and Roger, 1997)15 will be used for the denominator 
degrees of freedom. 
 
Comparisons between lenses will be carried out using 2-sided 95% confidence intervals 
constructed for the least-square mean (LSM) difference (Test – Control). Statistically 
significantly lower differences of the Test lens relative to the Control lens will be concluded if 
the upper limit of the 95% confidence interval is below 0. If the interaction between lens type 
and age is significant then comparisons between lenses will be made within age group.  
 
Disability Glare Threshold (Change in log relative energy level) 
Glare disability threshold (GDT) (change in log relative energy level) will be evaluated by 
exposing subjects to various intensity of a white-light annulus (10-geg diameter) and will be 
quantified by the log relative energy level necessary to obscure a central target.  
 
GDT will be analyzed and tested in the same manner as described for PSRT.  
 
Discomfort Glare (change in palpebral fissure height (mm)) 
Glare discomfort (GD) will be evaluated by squint response of the extraocular muscles and by 
a subjective questionnaire regarding the patients’ comfort. Squint response will be captured by 
using a high-resolution camera for each subject eye. The resultant videos will then be analyzed 
as still frames. Squint response will be quantified as the calculated ratio of the height of the 
palpebral fissure under normal light conditions compared to maximal squint produced during 
the Photostress exposure.  GD will be analyzed in the same manner as described for PSRT. 
 
Comparisons between lenses will be carried out using 2-sided 95% confidence intervals 
constructed for the least-square mean (LSM) difference (Test – Control). Statistically 
significantly higher differences of the Test lens relative to the Control lens will be concluded 
if the lower limit of the 95% confidence interval is above 0. If the interaction between lens 
type and age is significant then comparisons between lenses will be made within age group.  
 
Heterochromatic Contrast Threshold (HCT) 
Heterochromatic contrast thresholds will be evaluated using a variable wavelength central 
target presented on a short-wave (460nm) sky-light background and will be quantified by the 
amount of light absorbed by the macular.  
 
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HCT will be analyzed and tested in the same manner as GD.  
14.7. Other Exploratory Analyses  
In vivo light transmission and slit lamp findings will be descriptively summarized for each lens 
type.  
14.8. Interim Analysis 
There will not be an interim analysis conducted on this study.  
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings.  
 
Subject dropout is expected to be one of the main reasons of missing data in this clinical trial. 
Past clinical trials don’t provide the evidence that subject dropout is systematic or not-at-
random. To evaluate the impact of missing data, sensitivity analysis will be conducted using 
multiple imputation methods if the proportion of subject dropout is greater than the 15%. The 
SAS/STAT procedures PROC MI and PROC MIANALYZE will be utilized with a parametric 
regression method used to make at least 10 imputations. 
14.10. Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections.  There are no 
known reasons for which it is planned to deviate from these analysis methods.  If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change. 
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC 
system (Bioclinica). An authorized data originator will enter study data into the eCRFs using 
the EDC system. Data collected on equipment that is not captured in EDC will be formatted to 
the specification of the JJVC database manager and sent to JJVC for analysis. 
The follow data testing/measurements will be calculated and entered into the EDC at the study 
site.  
• Light Scattering 
• Starburst 
• Halos 
• Photostress Recovery Time 
• Disability Glare Threshold 
• Discomfort Glare 
• Heterochromatic Contrast Threshold 
 
 
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The clinical data will be recorded on dedicated eCRFs specifically designed to match the study 
procedures for each visit.  Once completed, the eCRFs will be reviewed for accuracy and 
completeness and signed by the Investigator.  The sponsor or sponsor’s representatives will be 
authorized to gain access to the subject recordation for the purposes of monitoring and auditing 
the study.  
 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study.  
 
The content and structure of the eCRFs are compliant with ISO14155:2011. 1 
15.2. Subject Record 
At a minimum, subject record should be available for the following:  
• subject identification 
• eligibility 
• 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 
• medical history and concomitant medication 
• test article receipt/dispensing/return records 
• date of study completion 
• reason for early discontinuation of test article or withdrawal from the study, if 
applicable 
 
The subject record is the eCRF or an external record.  The author of an entry in the subject 
record must be identifiable.  The first point of entry is considered to be the source record. 
 
Adverse event notes must be reviewed and initialed by the Investigator. 
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents.  Should the 
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clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
16.2. Confidentiality of Information 
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC.  The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator.  The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study.  The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management.  Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate. 
 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials.  The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
17. MONITORING 
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel.  The monitor’s responsibilities will include: 
• Ensuring that the investigation is being conducted according to the protocol, any 
subsequent amendments, and regulatory requirements are maintained 
• Ensuring the rights and wellbeing of subjects are protected 
• Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel 
• Ensuring that protocol deviations are documented with corrective action plans, as 
applicable 
• Ensuring that the clinical site has sufficient test article and supplies 
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• Clarifying questions regarding the study 
• Resolving study issues or problems that may arise 
• Reviewing of study records and source documentation verification in accordance with 
the monitoring plan 
18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation.  Subjects will be told that their consent to participate in the study is voluntary 
and may be withdrawn at any time with no reason given and without penalty or loss of benefits 
to which they would otherwise be entitled.  Only subjects who are fully able to understand the 
risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled. 
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements.  GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible.  The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements. 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
• Final protocol and, if applicable, amendments 
• Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects) 
• Investigator’s Brochure (or equivalent information) and amendments 
• Sponsor-approved subject recruitment materials 
• Information on compensation for study-related injuries or payment to subjects for 
participation in the study 
• Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB) 
• Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects 
• Any other documents that the IEC/IRB requests to fulfill its obligation 
 
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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: 
• Protocol amendments 
• Revision(s) to informed consent form and any other written materials to be provided to 
subjects 
• If applicable, new or revised subject recruitment materials approved by the Sponsor 
• Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study 
• Investigator’s Brochure amendments or new edition(s) 
• Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB) 
• Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements 
• New information that may adversely affect the safety of the subjects or the conduct of 
the study 
• Major protocol deviations as required by the IEC/IRB 
• Report of deaths of subjects under the Investigator's care 
• Notification if a new Investigator is responsible for the study at the clinical site 
• Any other requirements of the IEC/IRB 
 
For protocol amendments that increase subject risk, the amendment and applicable informed 
consent form revisions must be submitted promptly to the IEC/IRB for review and approval 
before implementation of the change(s). 
 
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing. 
 
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion.  Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable. 
18.4. Informed Consent 
Each subject must give written consent according to local requirements after the nature of the 
study has been fully explained. The consent form must be signed before performance of any 
study-related activity. The consent form that is used must be approved by both the Sponsor 
and by the reviewing IEC/IRB. The informed consent is in accordance with principles that 
originated in the Declaration of Helsinki,3 current ICH2 and ISO 141551 guidelines,  applicable 
regulatory requirements, and Sponsor Policy. 
 
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Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any 
time.  
 
The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject. 
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA)19 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, Sponsor’s personnel and IEC/IRB.  No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records. 
 
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study. 
 
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations. 
The Sponsor ensures that the personal data will be: 
• processed fairly and lawfully 
• collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes 
• adequate, relevant, and not excessive in relation to said purposes 
• 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. 
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The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential. 
19. STUDY RECORD RETENTION 
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents. 
 
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained. 
 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports. 
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC. 
20. FINANCIAL CONSIDERATIONS 
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement.  The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation. 
 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as: 
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16. 
Stringham, J.M., K.J. O’Brien, and N.T. Stringham, Macular carotenoid 
supplementation improves disability glare performance and dynamics of photostress 
recovery. Eye and Vision, 2016. 3(1). 
17. 
Nahar, N.K., et al., Objective Measurements of Lower-Level Visual Stress. Optometry 
and Vision Science, 2007. 84(7): p. 620-629. 
18. 
Gowrisankaran, S., J.E. Sheedy, and J.R. Hayes, Eyelid Squint Response to 
Asthenopia-Inducing Conditions. Optometry and Vision Science, 2007. 84(7): p. 611-
619. 
19. 
Health Information Portability and Accountability Act (HIPAA). In 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html (Ed.). 
 
 
 
 
 
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
 
 
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PRO SPECIFICATIO
1 Final  2018-03-22
Protocol 6100                 Johnson & Johnson Vision Care, Inc.                  Confidential
1
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PRO SPECIFICATIO
1 Final  2018-03-22
Protocol 6100                 Johnson & Johnson Vision Care, Inc.                  Confidential
2
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PRO SPECIFICATION Version 1 Final  2018-03-22
Protocol 6100                 Johnson & Johnson Vision Care, Inc.                  Confidential
3
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PRO SPECIFICATIO
1 Final  2018-03-22
Protocol 6100                 Johnson & Johnson Vision Care, Inc.                  Confidential
4
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
The Patient Instruction Guide will be provided separately.   
 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
•
Acuvue OASYS Brand Contact Lenses
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APPENDIX D: 
 
 
Lens Fitting Characteristics 
 
Subject Reported Ocular Symptoms/Problems 
 
Determination of Distance Spherocylindrical Refractions 
 
Biomicroscopy Scale 
 
Distance and Near Visual Acuity Evaluation 
 
Patient Reported Outcomes 
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 LENS FITTING CHARACTERISTICS 
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Page 4 of 6 
 
 
 
 
 
 
 
 
 
 
 
 
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 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
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 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS  
 
 
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 BIOMICROSCOPY SCALE 
 
 
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 DISTANCE AND NEAR VISUAL ACUITY EVALUATION  
 
 
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 PATIENT REPORTED OUTCOMES 
 
 
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APPENDIX E: DETERMINATION OF EYE DOMINANCY 
 
+1.00 D LENS TEST 
 
Step 
Procedure 
1 
Place the subjects best sphero-cylindrical distance refraction in a trial frame 
2 
Have the subject view a BVA line of letters 
3 
With both eyes open alternate a +1.00 D trial lens between the right and left 
eye and ask the subject to indicate over which eye does the lens cause the 
line of letters to appear more blurred.  The eye that the greatest blur is 
reported is the distance dominant eye.  If the subject indicates that the 
amount of blur is about the same between the two eyes then record as 
neither eye dominant. 
 
 
SIGHTING OCULAR DOMINANCE 
 
Step 
Procedure 
1 
Ask the subject to extend both arms out and use his/her hands to form a 
triangle.  The subject will be asked to keep both eyes open, and look 
through the triangle at a small object on the wall (e.g., a light switch or 
doorknob). 
2 
Occlude the subject's left eye, then right eye.  While alternating the occluder 
from the subject's eyes, ask the subject when they see the object. 
 
A. If the subject sees the object when the left eye is covered, the subject 
is right eye dominant. 
B. If the subject sees the object when the right eye is covered, the 
subject is left eye dominant. 
C. If the subject sees the object with both eyes, the opening between 
the hands may be too large.  Therefore, ask the subject to make a 
smaller opening and repeat the procedure 
 
 
 
 
 
 
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APPENDIX F: IRIS COLOR  
 
 
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APPENDIX G: SPECTRUM OF THE UV ACTUATOR 
 
 
Irradiance 
-10
0
10
20
30
40
50
60
70
0
100
200
300
400
500
600
700
800
Wavelength 
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APPENDIX H: STARBURST AND HALO IMAGES  
 
 
 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6100 The effects of contact lenses with experimental dye on 
visual function 
Version and Date: v2.0 07 June 2018 
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that all 
clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and GCP 
guidelines regarding clinical trials during and after study completion. 
I will assure that no deviation from, or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. 
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere 
to all ICH2 regulations and GCP guidelines regarding clinical trials during and after study 
completion. 
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training.  
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments. 
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization. 
Principal 
Investigator: 
Signature 
Date 
Name and Professional Position (Printed) 
Institution/Site: 
Institution/Site Name 
Institution/Site Address 
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