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

 
Johnson & Johnson Vision Care, Inc.
Clinical Study Protocol
Handling Evaluation of Multifocal Toric Contact Lenses
Protocol CR-5935
Version: 3.0 Amendment 2
Date: 31-MAY-2017
Investigational Products: JJVC Investigational etafilcon A Multifocal Toric Contact Lens
Key Words: Presbyopia, Astigmatism, Multifocal, Etafilcon A, Daily Wear, Non-Dispensing
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, the International Conference on 
Harmonization Good Clinical Practice E6 (ICH-GCP), ISO 14155, the Declaration of 
Helsinki, 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 
Figure 1: Study Flowchart ..............................................................................................12 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS ...............13 
INTRODUCTION AND BACKGROUND ......................................................................15 
1.1. 
Name and Descriptions of Investigational Products ............................................15 
1.2. 
Intended Use of Investigational Products.............................................................15 
1.3. 
Summary of Findings from Nonclinical Studies..................................................15 
1.4. 
Summary of Known Risks and Benefits to Human Subjects...............................15 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study.......................................................................................................15 
1. STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................16 
1.1. 
Objectives.............................................................................................................16 
1.2. 
Endpoints..............................................................................................................16 
1.3. 
Hypotheses ...........................................................................................................17 
2. TARGETED STUDY POPULATION........................................................................17 
2.1. 
General Characteristics.........................................................................................17 
2.2. 
Inclusion Criteria..................................................................................................17 
2.3. 
Exclusion Criteria.................................................................................................18 
2.4. 
Enrollment Strategy..............................................................................................18 
3. STUDY DESIGN AND RATIONALE.......................................................................18 
3.1. 
Description of Study Design ................................................................................18 
3.2. 
Study Design Rationale........................................................................................18 
3.3. 
Enrollment Target and Study Duration ................................................................19 
4. TEST ARTICLE ALLOCATION AND MASKING..................................................19 
4.1. 
Test Article Allocation .........................................................................................19 
4.2. 
Masking................................................................................................................19 
4.3. 
Procedures for Maintaining and Breaking Randomization Codes .......................20 
5. STUDY INTERVENTION..........................................................................................20 
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5.1. 
Identity of Test Articles........................................................................................20 
Table 1: Test Articles......................................................................................................20 
5.2. 
Ancillary Supplies/Products.................................................................................23 
Table 2: Ancillary Supplies ............................................................................................23 
5.3. 
Administration of Test Articles............................................................................23 
5.4. 
Packaging and Labeling .......................................................................................23 
5.5. 
Storage Conditions ...............................................................................................23 
5.6. 
Collection and Storage of Samples ......................................................................23 
5.7. 
Accountability of Test Articles ............................................................................24 
6. STUDY EVALUATIONS...........................................................................................24 
6.1. 
Time and Event Schedule.....................................................................................24 
Table 3: Time and Events ...............................................................................................24 
6.2. 
Detailed Study Procedures ...................................................................................26 
VISIT 1...................................................................................................................... 26 
VISIT 2...................................................................................................................... 34 
FINAL EVALUATION ............................................................................................ 44 
7.3 
Unscheduled Visits...............................................................................................44 
7.4
Laboratory Procedures.........................................................................................45 
7. SUBJECTS COMPLETION/WITHDRAWAL...........................................................46 
7.1. 
Completion Criteria..............................................................................................46 
7.2. 
Withdrawal/Discontinuation from the Study .......................................................46 
8. PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ..............47 
9. DEVIATIONS FROM THE PROTOCOL..................................................................47 
10. STUDY TERMINATION ...........................................................................................47 
11. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS..............48 
12. ADVERSE EVENTS...................................................................................................49 
12.1. Definitions and Classifications.............................................................................49 
12.2. Assessing Adverse Events....................................................................................51 
13.2.1 Causality Assessment.................................................................................... 51 
13.2.2 Severity Assessment...................................................................................... 52 
12.3. Documentation and Follow-Up of Adverse Events .............................................52 
12.4. Reporting Adverse Events....................................................................................53 
13.4.1 Reporting Adverse Events to Sponsor........................................................... 54 
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13.4.2 Reporting Adverse Events to the Responsible IEC/IRB and Health 
Authorities................................................................................................................. 54 
12.5. Event of Special Interest.......................................................................................55 
12.6. Reporting of Pregnancy........................................................................................55 
13. STATISTICAL METHODS........................................................................................55 
13.1. General Considerations ........................................................................................55 
13.2. Sample Size Justification......................................................................................55 
13.3. Analysis Populations ............................................................................................56 
13.4. Level of Statistical Significance...........................................................................56 
13.5. Primary Analysis ..................................................................................................56 
13.6. Secondary Analysis ..............................................................................................57 
13.7. Other Exploratory Analyses .................................................................................57 
13.8. Interim Analysis ...................................................................................................57 
13.9. Procedure for Handling Missing Data and Drop-Outs.........................................57 
13.10. Procedure for Reporting Deviations from Statistical Plan ...................................57 
14. DATA HANDLING AND RECORD KEEPING/ARCHIVING................................57 
14.1. Electronic Case Report Form/Data Collection.....................................................57 
14.2. Subject Record .....................................................................................................58 
15. DATA MANAGEMENT.............................................................................................58 
15.1. Access to Source Data/Document ........................................................................58 
15.2. Confidentiality of Information .............................................................................59 
15.3. Data Quality Assurance........................................................................................59 
16. MONITORING............................................................................................................59 
17. ETHICAL AND REGULATORY ASPECTS ............................................................60 
17.1. Study-Specific Design Considerations.................................................................60 
17.2. Investigator Responsibility...................................................................................60 
17.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)..........60 
17.4. Informed Consent.................................................................................................61 
17.5. Privacy of Personal Data ......................................................................................62 
18. STUDY RECORD RETENTION................................................................................63 
19. FINANCIAL CONSIDERATIONS ............................................................................63 
20. PUBLICATION...........................................................................................................64 
21. REFERENCES ............................................................................................................64 
APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)65 
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APPENDIX B: PATIENT INSTRUCTION GUIDE ........................................................73 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)....................................88 
APPENDIX D: PRESBYOPIC SYMPTOMS QUESTIONNAIRE .................................88 
APPENDIX E: CLINICAL TECHNICAL PROCEDURES 
..................................88 
 LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS ...............................89 
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING...............97 
 DETERMINATION OF NEAR ADD ..........................................................102 
 LENS FITTING CHARACTERISTICS.......................................................110 
 SUBJECT REPORTED OCULAR SYMPTOMS........................................117 
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS ..............................................................................................................119 
 BIOMICROSCOPY SCALE ........................................................................126 
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION...................132 
 TORIC FIT EVALUATION.........................................................................137 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ...................141 
LISTING OF TABLES  
Table 1: Test Articles.........................................................................................................20
Table 2: Ancillary Supplies ...............................................................................................23
Table 3: Time and Events ..................................................................................................24
LISTING OF FIGURES 
Figure 1: Study Flowchart .................................................................................................12 
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PROTOCOL TITLE, NUMBER, VERSION  
Title: Handling Evaluation of Multifocal Toric Contact Lenses
Protocol Number: CR-5935
Version: 3.0 Amendment 1
Date: 31-MAY-2017
SPONSOR NAME AND ADDRESS 
Johnson & Johnson Vision Care, Inc. (JJVC)
7500 Centurion Parkway, 
Jacksonville, FL 32256
MEDICAL MONITOR 
Name:  Thomas R. Karkkainen, OD, MS, FAAO
Title: Sr. Principal Research Optometrist
Address: 7500 Centurion Parkway, Jacksonville, Florida 32256
Email: TKarkkai@its.jnj.com
The Medical Monitor must be notified by the clinical institution/site by e-mail, fax, or 
telephone within 24 hours of learning of a Serious Adverse Event. The Medical Monitor 
may be contacted during business hours for adverse event questions.  General study related 
questions should be directed towards your assigned clinical research associate.
The Medical Monitoring Plan is maintained as a separate document and included in the Trial 
Master File.
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AUTHORIZED SIGNATURES 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and according 
to local legal and regulatory requirements and applicable U.S. federal regulations, ICH 
guidelines, ISO 14155 and the Declaration of Helsinki.
Author
See Electronic Signature Report
Thomas R. Karkkainen
Sr. Principal Research Optometrist
DATE
Clinical Operations 
Manager
See Electronic Signature Report
DATE
Biostatistician
See Electronic Signature Report
DATE
Data Management 
See Electronic Signature Report
DATE
Reviewer
See Electronic Signature Report
Fellow Review Not Required
DATE
Approver
See Electronic Signature Report
DATE
 
 
 
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VCT-0007 (5) 
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SYNOPSIS  
Protocol Title
Handling Evaluation of Multifocal Toric Contact Lenses
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Development phase, Phase 1
Trial Registration
This study will be registered on ClinicalTrials.gov.
Test Article(s)
Investigational Products: JJVC Investigational Multifocal Toric 
Contact Lens manufactured in etafilcon A material in varying
thicknesses.
Wear and Replacement 
Schedules
Wear Schedule: The lenses will be used on a daily wear basis and 
just worn while in the clinic.
Replacement Schedule: There is no planned replacement as the 
study is non-dispensing. 
Objectives 
This study is an initial evaluation of subject responses to the 
handling of a JJVC Investigational etafilcon A Toric Multifocal 
Contact Lenses in varying thicknesses.
Study Endpoints
Primary endpoint: Subjective responses for handling using the 
CLUE questionnaire.
The secondary endpoint will be lens fitting.
Study Design
This is a double-masked, bilateral, randomized, non-dispensing 
clinical trial. The subjects will wear each pair of lenses for 
approximately 15 minutes with a 15-minute wash-out between 
each pair. A total of 2 pairs of lenses will be fit at the first visit 
and 3 at the second visit. Lens Stability and Lens fit will be 
assessed for each pair. See the flow chart at the end of the 
synopsis table for the schematic of the study visits and procedures 
of main observations.
Sample Size
A total of approximately 100 eligible subjects will be enrolled with 
80 targeted to complete.
Study Duration
The study will last approximately 4 weeks.
Anticipated Study 
Population
Healthy male and female volunteers who are presbyopic astigmats 
who have myopia and are adapted contact lens wearers currently 
wearing contact lenses in both eyes.
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Eligibility Criteria
Potential subjects must satisfy all of the following criteria to be 
enrolled in the study
1. The subject must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and receive a 
fully executed copy of the form
2. The subject must appear able and willing to adhere to the 
instructions set forth in this clinical protocol
3. The subject must be between 40 and 70 years of age.
4. The subject’s distance refraction must be in the range 
of -1.50 to -4.50
5. The subject’s refractive cylinder must be -1.00 to -1.50 D in 
each eye
6. The subject’s ADD power must be in the range of +0.75 D to 
+2.50 D in each eye
7. The subject must have best corrected visual acuity of 20/20-3
or better in each eye.
8. Subjects must own a wearable pair of spectacles if required 
for their distance vision.
9. The subject must be an adapted soft contact lens wearer in 
both eyes (ie, worn lenses a minimum of 2 days per week for 
at least 8 hours per wear day, for 1 month or more duration)
10. The subject must already be wearing a presbyopic contact 
lens correction (eg, reading spectacles over contact lenses, 
multifocal or monovision contact lenses, etc) or if not 
respond positively to at least one symptom on the 
“Presbyopic Symptoms Questionnaire”. 
Potential subjects who meet any of the following criteria will be 
excluded from participating in the study:
1. Ocular or systemic allergies or disease, or use of medication 
which might interfere with contact lens wear
2. Pregnancy or lactation
3. Currently diagnosed with diabetes
4. Infectious diseases (eg, hepatitis, tuberculosis) or an 
immune-suppressive disease (eg, HIV).
5. Clinically significant (Grade 3 or 4) corneal edema, corneal 
vascularization, corneal staining, tarsal abnormalities or 
bulbar injection, or any other corneal or ocular abnormalities 
which would contraindicate contact lens wear
6. Entropion, ectropion, extrusions, chalazia, recurrent styes, 
dry eye, glaucoma, history of recurrent corneal erosions
7. Any previous, or planned, ocular or intraocular surgery (eg,
radial keratotomy, PRK, LASIK, lid procedures, cataract 
surgery, retinal surgery, etc)
8. A history of amblyopia, strabismus or binocular vision 
abnormality
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9. Any ocular infection or inflammation
10. Any ocular abnormality that may interfere with contact lens 
wear
11. Use of any ocular medication, with the exception of 
rewetting drops
12. History of herpetic keratitis
13. Participation in any contact lens or lens care product clinical 
trial within 30 days prior to study enrollment
14. Employee of clinical site (eg, Investigator, Coordinator, 
Technician).
Disallowed 
Medications/Interventions
Use of any prescription or over-the-counter (OTC) medications 
that may affect contact lens wear.  
Measurements and 
Procedures
Subjective responses for handling using the CLUE 
questionnaire. 
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
Eye-Cept® Rewetting drops.
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
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
IB
Investigator’s Brochure
ICF
Informed Consent Form
ICH
International Conference on Harmonization
IDE
Investigational Device Exemption
IEC
Independent Ethics Committee
IRB
Institutional Review Board
ISO
International Organization for Standardization
ITT
Intent-to-Treat
JJVC
Johnson & Johnson Vision Care, Inc.
LC
Limbus Center
LogMAR
Logarithm of Minimal Angle of Resolution
MedDRA©
Medical Dictionary for Regulatory Activities
MOP
Manual of Procedures
NIH
National Institutes of Health
OD
Right Eye
OHRP
Office for Human Research Protections
OHSR
Office for Human Subjects Research
OS
Left Eye
OU
Both Eyes
PD
Protocol Deviation
PHI
Protected Health Information
PI
Principal Investigator
PIG
Patient Instruction Guide
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PQC
Product Quality Complaint
PRO
Patient Reported Outcome
QA
Quality Assurance
QC
Quality Control
SAE
Serious Adverse Event/Serious Adverse Experience
SAP
Statistical Analysis Plan
SAS
Statistical Analysis System
SD
Standard Deviation
SOP
Standard Operating Procedure
UADE
Unanticipated Adverse Device Effect
USADE
Unanticipated Serious Adverse Device Effect
VA
Visual Acuity
HIV
Human immunodeficiency virus
PRK
Photorefractive keratectomy
LASIK
Laser-assisted in situ keratomileusis
IRT
Item Response Theory
CIE
Corneal infiltrative Event
ILB
Intentionally Left Blank
CLPU
Contact Lens Induced Peripheral
SIE
Significant Infiltrative Events
SEALs
Superior Epithelial Arcuate Lesions
BSCVA
Best Spectacle-Corrected Visual Acuity
EKC
Epidemic Keratoconjunctivitis
MK
Microbial Keratitis
CLPC
Contact Lens Papillary Conjunctivitis
CS
Homogenous compound symmetry
UN
Unstructured covariance structure
AICC
Akaike Information Criteria Corrected
LSM
Least-square means
NSIE
Non-significant Infiltrative Event
SPK
Superficial Punctate Keratitis
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1.
INTRODUCTION AND BACKGROUND 
Johnson & Johnson Vision Care (JJVC) has recently launched a multifocal contact lens, 
1-Day ACUVUE Moist Multifocal.  The lens is indicated to correct ≤-0.75 D of refractive 
cylinder.  A significant number of presbyopic eyes have greater than -0.75 D of cylinder.  
With this in mind, JJVC has a toric multifocal lens development program to attempt to fill 
this need. The purpose of the current study is to evaluate the impact peripheral thickness has 
on the handling characteristics of the toric multifocal lens.  
1.1. Name and Descriptions of Investigational Products  
Investigational Products:  Etafilcon A Toric Multifocal Contact Lens
1.2. Intended Use of Investigational Products 
The toric lens product is indicated to correct presbyopic eyes that have between -1.00 
and -1.50 D of refractive cylinder.
1.3. Summary of Findings from Nonclinical Studies 
All previous preclinical findings were deemed satisfactory prior to proceeding with clinical 
trials on humans. 
For the most comprehensive nonclinical information regarding the 
etafilcon-A Toric Multifocal Contact Lens refer to the latest version of the CR-5935
Investigational Brochure.
1.4. Summary of Known Risks and Benefits to Human Subjects 
The Investigational Toric Multifocal contact lenses are designed as a continuous asphere with 
toric correction providing for the correction of refractive ametropia and presbyopia.  The 
lenses have the same stabilization as the marketed 1-DAY ACUVUE® MOIST® for 
Astigmatism lenses.  The material is a hydrogel material, etafilcon-A, which is in the 
Group 4, high water, ionic polymer family and is used in the 1-DAY ACUVUE® MOIST®
brand of products.  
The intent of this product is as a daily disposable contact lens that the subject wears while 
awake.  This lens is not intended for reusable or extended wear.  This evaluation is for daily 
disposable modality only.  Anticipated risks and adverse reactions with this lens are similar 
to other soft daily wear contact lenses used to correct presbyopia.  A listing of examples of 
adverse reactions is found in the Section 13 of this protocol.  The Investigator should follow 
normal clinical guidelines in regard to examination and care of subjects who participate in 
this trial. For the most comprehensive clinical information regarding etafilcon A Toric 
Multifocal Contact Lens refer to the latest version of the etafilcon A Toric Multifocal Contact 
Lens Investigator Brochure. 
1.5. Relevant Literature References and Prior Clinical Data Relevant to Proposed Clinical Study 
A PubMed search using the terms “contact lens handling and thickness” revealed one 
relevant article to this study.  Harris, et. al.1 studied the impact lens center thickness had on 
performance.  They evaluated two groups of lenses having conventional thicknesses 
(0.14-0.16 mm) and a third group that were thin (0.04-0.06 mm) that the thin lens group 
performed less favorably with the main reason for failure being comfort due to poor 
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centration and arcuate staining and they also noted that lens handling was a major problem 
for the thinner lenses.  
Lenses that have the same nominal design as the Control lenses used in this study have been 
evaluated in a number of other clinical studies 
.  In addition to these studies the same lens design is being 
evaluated in 
 which is ongoing at the time of the writing of this protocol.  Details 
with regards to these studies can be found in the latest version of the Investigator Brochure.
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1. Objectives  
This study is an initial evaluation of subject responses to the handling of JJVC 
Investigational etafilcon A Toric Multifocal Contact Lenses in varying thicknesses.
Primary Objective
The primary objective is to evaluate the handling of a toric multifocal lens of various 
peripheral thicknesses. 
Secondary Objective
Lens fitting characteristics on the eye will be evaluated.
Exploratory Objective
Subjective comfort scores will also be evaluated.
2.2. Endpoints  
To evaluate the handling performance of contact lenses in myopic subjects who are habitual 
soft contact lens wearers. The primary endpoint will be the subjective handling responses. 
Primary Endpoint
The primary endpoint is overall lens handling assessed using the Contact Lens User 
Evaluation questionnaire (CLUE™). CLUE is a validated Patient Reported Outcome (PRO) 
questionnaire developed to measure general and throughout the day comfort/vision, as well 
as symptoms of discomfort/poor vision, lens handling and packaging. Derived CLUE scores 
using Item Response Theory (IRT) follow a normal distribution with a population average 
score of 60 (SD 20), where higher scores indicate a more favorable/positive response.  A 5 
point increase in an average CLUE score translates into 10% shift in the distribution of 
scores for population of soft contact lens wearers.  
Secondary Endpoint
Lens fitting.
Other Observation
Subjective Comfort.
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2.3. Hypotheses 
Primary Hypotheses
1. Test lens #1 (30 microns thicker) handling scores will be non-inferior to the Control 
lens after approximately 15 minutes of wear.  A non-inferiority margin of -5 CLUE 
points will be used.
2. Test lens #2 (16 microns thinner) handling scores will be non-inferior to the Control
lens after approximately 15 minutes of wear. A non-inferiority margin of -5 CLUE 
points will be used.
If both primary hypotheses are met, the following two secondary hypotheses will be tested.
Secondary Hypotheses
1. Test lens #3 (22 microns thinner) handling scores will be non-inferior to the Control
lens after approximately 15 minutes of wear. A non-inferiority margin of -5 CLUE 
points will be used.
2. Test lens #4 (28 microns thinner) handling scores will be non-inferior to the Control
lens after approximately 15 minutes of wear. A non-inferiority margin of -5 CLUE 
points will be used.
Other Hypotheses
Not Applicable.
3.
TARGETED STUDY POPULATION 
3.1. General Characteristics  
Healthy male and female volunteers who are presbyopic astigmats who have myopia and are 
adapted contact lens wearers currently wearing contact lenses in both eyes.
3.2. Inclusion Criteria 
Potential subjects must satisfy all of the following criteria to be enrolled in the study: 
1. The subject must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form
2. The subject must appear able and willing to adhere to the instructions set forth in this 
clinical protocol
3. The subject must be between 40 and 70 years of age.
4. The subject’s distance refraction must be in the range of -1.50 D to -4.50 D.
5. The subject’s refractive cylinder must be -1.00 to -1.50 D in each eye
6. The subject’s ADD power must be in the range of +0.75 D to +2.50 D in each eye
7. The subject must have best corrected visual acuity of 20/20-3 or better in each eye
8. Subjects must own a wearable pair of spectacles if required for their distance vision
9. The subject must be an adapted soft contact lens wearer in both eyes (ie, worn lenses 
a minimum of 2 days per week for at least 8 hours per wear day, for 1 month or more 
duration)
10. The subject must already be wearing a presbyopic contact lens correction (eg, reading 
spectacles over contact lenses, multifocal or monovision contact lenses, etc) or if not 
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respond positively to at least one symptom on the “Presbyopic Symptoms 
Questionnaire”. 
3.3. Exclusion Criteria 
Potential subjects who meet any of the following criteria will be excluded from participating 
in the study: 
1. Ocular or systemic allergies or disease, or use of medication which might interfere 
with contact lens wear
2. Pregnancy or lactation
3. Currently diagnosed with diabetes
4. Infectious diseases (eg, hepatitis, tuberculosis) or an immune-suppressive disease (eg,
HIV)
5. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal 
staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular 
abnormalities which would contraindicate contact lens wear
6. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history 
of recurrent corneal erosions
7. Any previous, or planned, ocular or intraocular surgery (eg,radial keratotomy, PRK,         
LASIK, lid procedures, cataract surgery, retinal surgery, etc
8. A history of amblyopia, strabismus or binocular vision abnormality
9. Any ocular infection or inflammation
10. Any ocular abnormality that may interfere with contact lens wear
11. Use of any ocular medication, with the exception of rewetting drops
12. History of herpetic keratitis
13. Participation in any contact lens or lens care product clinical trial within 30 days prior 
to study enrollment
14. Employee of clinical site (eg, Investigator, Coordinator, Technician).
3.4. Enrollment Strategy 
Study subjects will be recruited from the potentially eligible subjects identified in the clinical 
site’s subject database.
4.
STUDY DESIGN AND RATIONALE 
4.1. Description of Study Design 
This is a double-masked, bilateral, randomized, non-dispensing clinical trial. The subjects 
will wear each pair of lenses for approximately 15 minutes with a 15 minute wash-out 
between each pair. A total of 2 pairs of lenses will be fit at the first visit and 3 at the second 
visit. Lens stability and lens fit will be assessed for each pair. See the flow chart at the end of 
the synopsis table for the schematic of the study visits and procedures.
4.2. Study Design Rationale 
As handling of lenses is subjective measure related to a subject’s experience the primary 
measurement tool selected for the study was a validated PRO questionnaire (CLUE) that can 
be used to quantify that experience.  A crossover design was chosen to help to control for 
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confounding variables between subjects that may influence the primary outcome.  In order to 
help control for potential carry over effects a washout period is being employed between lens
trials and the study will also be randomized.  As the lenses have no unique identifiers the 
subjects as well as the examiners will be masked in an attempt to reduce bias.  
4.3. Enrollment Target and Study Duration 
Approximately 100 subjects will be enrolled in the study with 80 targeted to complete the 
cohort.  All subjects will have at least -1.00 D to -1.50 D of refractive cylinder in both eyes.  
The study will take place at several clinical sites and have two study visits per subject.
5.
TEST ARTICLE ALLOCATION AND MASKING 
5.1. Test Article Allocation  
The study lenses will be worn in a bilateral and random fashion using a 5x5 crossover 
Williams design with 5 lens types and 5 periods. Two lens types will be fit at the first visit 
and three lens types will be fit at the second visit. Using a computer-generated randomization 
scheme provided by the study biostatistician, each subject will randomly be assigned to 1 of 
10 unique sequences of the 5 lens types.  Randomization will be stratified by site.
Permuted block randomization will be used to avoid bias in the assignment of subjects to 
treatment, and to enhance the validity of statistical comparisons across treatment groups. 
Each block will contain 10 different lens trial sequences.   
The order of lens wear will be based on the randomization scheme assigned to the study site.  
The study site will follow the randomization scheme provided and will complete enrollment 
according to the randomization list and will not pre-select or assign subjects. 
The following must have occurred prior to randomization:
x
Informed consent has been obtained
x
Subject met all the inclusion / exclusion criteria
x
Subject history and baseline information has been collected
5.2. Masking 
This is a double-masked study with the Subjects and Investigators being masked. Subjects 
will be unaware of the identity of the investigational product. Investigators and clinical site 
personnel involved in the data collection will be masked as to the identity of the 
investigational product.
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 
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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 will be discontinued from the 
study.  Subjects who are discontinued may be replaced.
5.3. Procedures for Maintaining and Breaking Randomization Codes 
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
6.
STUDY INTERVENTION 
6.1. Identity of Test Articles  
The following contact lenses will be used in this study:
Table 1: Test Articles
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Oxygen 
Permeability (Dk)
28%
28%
28%
28%
28%
Modality in Current 
Study 
Daily Wear
Daily Wear
Daily Wear
Daily Wear
Daily Wear
Replacement 
Frequency
Daily Disposable
Daily Disposable
Daily Disposable
Daily Disposable
Daily Disposable
Packaging Form
(vial, blister, etc)
Blister
Blister
Blister
Blister
Blister
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the nearest degree.
At one (1) minute after insertion: Record:
1.   The   rotational   position   to   the nearest 
degree
At three (3) minutes after insertion: Record:
1. The rotational position to the nearest 
degree
1.20
Lens Settling 
Allow the study lenses to settle for a 
minimum of 15 minutes.
1.21
Toric Fit
Evaluation
After lens settling, record:
x
The rotational position to the nearest 
degree
x
Lens stability with blink
x
Lens stability with eye versions
x
Toric fit acceptable or unacceptable 
Toric lens fit will be unacceptable if lenses 
rotated more than 40 degrees, or lens 
stability is worse than 10 degrees movement 
with blink.  If toric fit is unacceptable, remove 
the lenses, perform biomicroscopy and 
proceed to final evaluation.
Note: If unacceptable fit save the lenses and 
store in saline in glass vials labeled 
appropriately.
1.22
Subjective Lens Fit 
Assessment
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics.
An unacceptable fit is deemed by one of the 
following criteria: 
x
limbal exposure at primary gaze or 
with extreme eye movement;
x
edge lift;
x
excessive movement in primary and 
up gaze; or 
x
insufficient movement in all three of 
the following conditions: primary 
gaze, up gaze, and Josephson push up.
If either lens is deemed unacceptable, the 
subject   will   be   discontinued   from   the 
study.  Perform a slit-lamp evaluation and 
complete the Final Evaluation.
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Note: If unacceptable fit save the lenses and 
store in saline in glass vials labeled 
appropriately.
1.23
Post-Fit 
Questionnaire
The subject will respond to the PRO Post-Fit 
Questionnaire.
1.24
Lens Removal
The Subject will remove the study lenses and 
store in saline in glass vials labeled 
appropriately.
1.25
Removal Questions
The subject will respond to the removal 
questions.
1.26
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
1.27
15 Minute Wash-out
Subjects will complete a wash-out period for 
at least 15 minutes. Subjects can wear their 
glasses during this period.
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the nearest degree.
At one (1) minute after insertion: Record:
1.   The   rotational   position   to   the nearest 
degree
At three (3) minutes after insertion: Record:
1. The rotational position to the nearest 
degree
1.33
Lens Settling 
Allow the study lenses to settle for a 
minimum of 15 minutes.
1.34
Toric Fit
Evaluation
After lens settling, record:
x
The rotational position to the nearest 
degree
x
Lens stability with blink
x
Lens stability with eye versions
x
Toric fit acceptable or unacceptable 
Toric lens fit will be unacceptable if lenses 
rotated more than 40 degrees, or lens stability 
is worse than 10 degrees movement with
blink.  If toric fit is unacceptable, remove the 
lenses, perform biomicroscopy and proceed to 
final evaluation.
Note: If unacceptable fit save the lenses and 
store in saline in glass vials labeled 
appropriately.
1.35
Subjective Lens Fit 
Assessment
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics.
An unacceptable fit is deemed by one of the 
following criteria: 
x
limbal exposure at primary gaze or 
with extreme eye movement;
x
edge lift;
x
excessive movement in primary and 
up gaze; or 
x
insufficient movement in all three of 
the following conditions: primary
gaze, up gaze, and Josephson push up.
If either lens is deemed unacceptable, the 
subject   will   be   discontinued   from   the 
study.  Perform a slit-lamp evaluation and 
complete the Final Evaluation.
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Note: If unacceptable fit save the lenses and 
store in saline in glass vials labeled 
appropriately.
1.36
Post-Fit 
Questionnaire
The subject will respond to the PRO Post-Fit 
Questionnaire
1.37
Lens Removal
Subjects will remove the study lenses and 
store in saline in glass vials labeled 
appropriately.
1.38
Removal Questions
The subject will respond to the Removal 
Questions.
1.39
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
1.40
Biomicroscopy
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility.  
For the conjunctival redness 
 0.5 
unit increments will be used in the grading. 
Corneal Staining Assessment 
will be graded in 1.0 increments.
If any of these slit lamp findings are Grade 3 
or higher, the subject will be discontinued. If 
discontinued a final examination must be 
completed.
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled. 
1.41
Exit VA
Record subjects’ distance visual acuity, OD, 
OS and OU to the nearest letter with their 
habitual correction in place.
1.42
Instructions
Schedule the subject to return in 7±1 Day for 
Visit 2
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At one (1) minute after insertion: Record:
1. The rotational position to the nearest 
degree
At three (3) minutes after insertion: Record:
1. The rotational position to the nearest 
degree
2.12
Lens Settling 
Allow the study lenses to settle for a 
minimum of 15 minutes.
2.13
Toric Fit
Evaluation
After lens settling, record:
x
The rotational position to the nearest 
degree
x
Lens stability with blink
x
Lens stability with eye versions
x
Toric fit acceptable or unacceptable 
Toric lens fit will be unacceptable if lenses 
rotated more than 40 degrees, or lens stability 
is worse than 10 degrees movement with 
blink. If toric fit is unacceptable, remove the 
lenses, perform biomicroscopy and proceed to 
final evaluation.
Note: If unacceptable fit save the lenses and 
store in saline in glass vials labeled 
appropriately.
2.14
Subjective Lens Fit 
Assessment
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics.
An unacceptable fit is deemed by one of the 
following criteria: 
x
limbal exposure at primary gaze or 
with extreme eye movement;
x
edge lift;
x
excessive movement in primary and 
up gaze; or 
x
insufficient movement in all three of 
the following conditions: primary 
gaze, up gaze, and Josephson push up.
If either lens is deemed unacceptable, the 
subject   will   be   discontinued   from   the 
study.  Perform a slit-lamp evaluation and 
complete the Final Evaluation.
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Note: If unacceptable fit save the lenses and 
store in saline in glass vials labeled 
appropriately.
2.15
Post-Fit 
Questionnaire
The subject will respond to the PRO Post-Fit 
Questionnaire
2.16
Lens Removal
Subjects will remove the study lenses and 
store in saline in glass vials labeled 
appropriately.
2.17
Removal Questions
The subject will respond to the Removal 
Questions.
2.18
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
2.19
15 Minute Wash-out
Subjects will complete a wash-out period for 
at least 15 minutes.
Subjects can wear their glasses during this 
period.
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At one (1) minute after insertion: Record:
1. The rotational position to the nearest degree
At three (3) minutes after insertion: Record:
1. The rotational position to the nearest degree
2.25
Lens Settling 
Allow the study lenses to settle for a minimum 
of 15 minutes.
2.26
Toric Fit
Evaluation
After lens settling, record:
•
The rotational position to the nearest 
degree
•
Lens stability with blink
•
Lens stability with eye versions
•
Toric fit acceptable or unacceptable
Toric lens fit will be unacceptable if lenses 
rotated more than 40 degrees, or lens stability 
is worse than 10 degrees movement with blink.  
If toric fit is unacceptable, remove the lenses, 
perform biomicroscopy and proceed to final 
evaluation.
Note: If unacceptable fit save the lenses and 
store in saline in glass vials labeled 
appropriately.
2.27
Subjective Lens Fit 
Assessment
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics.
An unacceptable fit is deemed by one of the 
following criteria: 
x
limbal exposure at primary gaze or 
with extreme eye movement;
x
edge lift;
x
excessive movement in primary and up 
gaze; or 
x
insufficient movement in all three of 
the following conditions: primary
gaze, up gaze, and Josephson push up.
If either lens is deemed unacceptable, the 
subject will be discontinued from the study.  
Perform a slit-lamp evaluation and complete 
the Final Evaluation.
Note: If unacceptable fit save the lenses and 
store in saline in glass vials labeled 
appropriately.
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2.28
Post-Fit 
Questionnaire
The subject will respond to the PRO Post-Fit 
Questionnaire
2.29
Lens Removal
Subjects will remove the study lenses and 
store in saline in glass vials labeled 
appropriately.
2.30
Removal Questions
The subject will respond to the Removal 
Questions.
2.31
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
2.32
15 Minute Wash-out
Subjects will complete a wash-out period for 
at least 15 minutes.
Subjects can wear their glasses during this 
period.
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Record base nasal or base temporal rotation to 
the nearest degree.
At one (1) minute after insertion: Record:
1.   The   rotational   position   to   the nearest 
degree
At three (3) minutes after insertion: Record:
1. The rotational position to the nearest 
degree
2.38
Lens Settling 
Allow the study lenses to settle for a 
minimum of 15 minutes.
2.39
Toric Fit
Evaluation
After lens settling, record:
•
The rotational position to the nearest 
degree
•
Lens stability with blink
•
Lens stability with eye versions
•
Toric fit acceptable or unacceptable
Toric lens fit will be unacceptable if lenses 
rotated more than 40 degrees, or lens stability 
is worse than 10 degrees movement with 
blink.  If toric fit is unacceptable, remove the 
lenses, perform biomicroscopy and proceed to 
final evaluation.
Note: If unacceptable fit save the lenses and 
store in saline in glass vials labeled 
appropriately.
2.40
Subjective Lens Fit 
Assessment
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics.
An unacceptable fit is deemed by one of the 
following criteria: 
x
limbal exposure at primary gaze or 
with extreme eye movement;
x
edge lift;
x
excessive movement in primary and 
up gaze; or 
x
insufficient movement in all three of 
the following conditions: primary 
gaze, up gaze, and Josephson push up.
If either lens is deemed unacceptable, the 
subject will be  discontinued from the study.  
Perform a slit-lamp evaluation and complete 
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the Final Evaluation.
Note: If unacceptable fit save the lenses and 
store in saline in glass vials labeled 
appropriately.
2.41
Post-Fit 
Questionnaire
The subject will respond to the PRO Post-Fit 
Questionnaire
2.42
Lens Removal
Subjects will remove the study lenses and 
store in saline in glass vials labeled 
appropriately.
2.43
Removal Questions
The subject will respond to the Removal 
Questions.
2.44
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
2.45
Biomicroscopy
FDA Slit Lamp Classification Scale will be 
used to grade the findings and determine 
eligibility.  
For the conjunctival redness 
 0.5 
unit increments will be used in the grading. 
Corneal Staining Assessment 
will be graded in 1.0 increments.
If any of these slit lamp findings are Grade 3 
or higher, the subject will be discontinued. If 
discontinued a final examination must be 
completed.
If the clearance of the fluorescein needs to be 
expedited, preservative-free rewetting drops 
or saline may be instilled. 
 
 
 
 
 
 
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8.
SUBJECTS COMPLETION/WITHDRAWAL  
8.1. Completion Criteria 
Subjects are considered to have completed the study if they:
•
provided informed consent; 
•
they are eligible;
•
have not withdrawn/discontinued for any reason described in Section 8.2;
•
Complete all study visits
8.2. Withdrawal/Discontinuation from the Study 
A subject will be withdrawn from the study for any of the following reasons:
x
Subject death during the study period
x
Subject withdrawal of consent
x
Subject not compliant to protocol 
x
Subject lost to follow-up
x
Subject no longer meets eligibility criteria (eg, the subject becomes pregnant)
x
Subject develops significant or serious adverse events causing discontinuation of 
study lens wear
x
Subjects who have experienced a Corneal infiltrative Event (CIE)
x
Investigator’s clinical judgment regarding the subject safety reasons (that it is in the 
best interest of the subject to stop treatment)
x
Subject not compliant with study lens wear schedule
x
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:
x
Complete the current visit (scheduled or unscheduled)
x
Complete the Final Evaluation, indicating the reason that the subject was 
discontinued from the study
x
Record the spherocylindrical refraction with best corrected distance visual acuity 
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in Section 7.2
x
Collect all unused test article(s) from the subject
An additional subject may be enrolled if a subject discontinues from the study prematurely.
In cases where a subject is lost to follow-up, every possible effort must be made to contact 
the subject and determine the reason for discontinuation/withdrawal.  The measures taken to 
follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt. 
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9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications for this study include: Any ocular medications with the exception of 
rewetting drops.  
Concomitant therapies that are disallowed include: Any therapies that may contraindicate 
lens wear.
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 
If more than 2 subjects in the investigational soft contact lens group develop serious expected 
(eg, definite or probable MK) or unexpected device related adverse events, the study will be 
suspended. Upon review and consultation with IRB, DMC, and JJVC safety review 
committee, the study may be terminated. 
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article.  In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled.
The Sponsor will determine when a study will be stopped.  The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason.  Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined.  The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is 
determined that it would be unwise to continue at the clinical site.   
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JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events.  If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated, as soon as possible.
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial 
use.  
Potential complaints may come from a variety of sources including but not limited to 
subjects, clinical research associates (CRA), clinical operations managers (COM), medical 
monitors, and site personnel, etc. The following are not considered product quality 
complaints:
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO)”.
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site.
x
Lens replacements that occur due to drops/fall-outs.
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (ie, tears, rips, etc), only in situations where 
there is no deficiency alleged by the subject.
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in 
use is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include:
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness)
x
Who received the complaint
x
Study number
x
Clinical site information (contact name, site ID, telephone number)
x
Lot number(s)
x
Unique Subject Identifier(s)
x
Indication of who first observed complaint (site personnel or subject)
x
OD/OS indication, along with whether or not the lens was inserted
x
Any related AE number if applicable
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x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc)
x
Eye Care Provider objective (slit lamp) findings if applicable
x
Confirmation of product availability for return (and tracking information, if 
available), or rationale if product is not available for return (
for test article return instructions)
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE).  If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, 
these procedures also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error.  In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must 
be documented.
13. ADVERSE EVENTS 
13.1. Definitions and Classifications 
Adverse Event (AE) – An AE is any untoward (unwanted) medical occurrence in a patient 
or clinical investigation subject administered a test article, study treatment or study procedure 
whether or not caused by the test article, study treatment or procedure.  An AE can therefore 
be any unfavorable or unintended sign (including an abnormal finding), symptom, or disease 
temporally associated with the use of the test article, study treatment, or study procedure
whether or not related to the test article, study treatment, or study procedure.
An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study , but appeared or reappeared following initiation of 
the study 
2. Was present prior to the study, but worsened during the study. This would include 
any condition resulting from concomitant illnesses, reactions to concomitant 
medications, or progression of disease states 
3. Pregnancy must be documented as an adverse event and must be reported to the 
clinical monitor and to the Sponsor immediately upon learning of the event
Serious Adverse Event (SAE) – An SAE is any untoward medical occurrence that:
x
Results in death
x
Is life threatening
x
Requires in-patient hospitalization or prolongation of existing hospitalization
x
Results in persistent or significant disability/incapacity (eg, a sight threatening event, 
a significant persistent or permanent change, impairment, damage, or disruption to the 
subject’s body)
x
Is a congenital anomaly/birth defect, or
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x
Requires intervention to prevent permanent damage (the use of the test article
resulting in a condition which requires medical or surgical intervention to preclude 
permanent impairment of the body structure or a body function).  Important medical 
events that may not result in death, be life-threatening, or require hospitalization may 
be considered an SAE when, based upon appropriate medical judgment, they may 
jeopardize the patient or subject and may require medical or surgical intervention to 
prevent one of the outcomes listed in the above definition.
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity 
lines or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis
x
Hypopyon
x
Hyphemia
x
Penetration of Bowman’s Membrane
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – Those events that are usually symptomatic and warrant 
discontinuation (temporary or permanent) of the test article (excluding Serious Adverse 
Events).  
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following:
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of > 2 Lines of BSCVA
x
Other Grade 3 or higher corneal findings, such as abrasions or edema
x
Non-contact lens related corneal events - eg, Epidemic Keratoconjunctivitis (EKC)
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation > 2 weeks
Non-Significant Adverse Events – Those conditions that are usually asymptomatic and 
usually do not warrant discontinuation (temporary or permanent) of the test article.
However, the Investigator may choose to treat as a precautionary measure.  
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events 
include, but not limited to the following:
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x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event,
which necessitates temporary lens discontinuation < 2 weeks
Adverse Device Effect (ADE) – A sub-set of AEs, and include only those adverse events 
that are cause by or related to the investigational device.
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the test article,
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure or protocol, or any other 
unanticipated serious problem associated with the test article that relates to the rights, safety 
and welfare of subjects.
13.2. Assessing Adverse Events 
In conjunction with the medical monitor, the Investigator will evaluate adverse events to 
ensure the events are categorized correctly.  Elements of categorization will include:
x
Seriousness/Classifications (see definition in Section 13.1)
x
Causality or Relatedness – ie, the relationship between the test article, study treatment 
or study procedures and the adverse event (not related; doubtful; possible; probable; 
very likely - see definition in Section 13.2.1)
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild; moderate; severe for all events - see definition in 
Section 13.2.2).
x
Outcome – Not Recovered or Not Resolved; Recovering or Resolving; Recovered or 
Resolved with Sequelae; Recovered or Resolved; Death Related to Adverse Event;
Unknown
x
Actions Taken – None; temporarily discontinued; permanently discontinued; other 
action taken
13.2.1
Causality Assessment 
Causality Assessment – A determination of the relationship between an adverse event and 
the test article, study treatment, or study procedure. The test article, study treatment or study 
procedure relationship for each adverse event shall be determined by the Investigator using 
these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures.
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x
Doubtful – An adverse event for which an alternative explanation is more likely, eg,
concomitant treatment, concomitant disease(s), or the relationship of time suggests 
that a causal relationship is unlikely.
x
Possible – 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, eg, concomitant 
treatment, concomitant disease(s), is inconclusive.  The relationship in time is 
reasonable.  Therefore, the causal relationship cannot be excluded.
x
Probable – An adverse event that might be due to the use of the test article. The 
relationship in time is suggestive (eg, confirmed by de-challenge).  An alternative 
explanation is less likely, eg, concomitant treatment or concomitant disease(s).
x
Very Likely – An adverse event that is listed as a possible adverse effect (device) or 
adverse reaction (drug) and cannot be reasonably explained by an alternative 
explanation, eg, concomitant treatment of concomitant disease(s). The relationship in 
time is very suggestive, eg, it is confirmed by de-challenge and re-challenge. 
13.2.2
Severity Assessment 
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse 
event as determined by the Investigator or reported to him/her by the subject.  The 
assessment of severity is made irrespective of test article, study treatment or study procedure 
relationship or seriousness of the event and should be evaluated according to the following 
scale:
x
Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begins when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the 
study it will be recorded and reported as an AE. Untoward medical events reported after the 
subject’s exit from the study will be recorded as adverse events at the discretion of the 
Investigator.
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data 
system. All adverse events occurring while the subject is enrolled in the study must be 
documented appropriately regardless of relationship.  
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It is the Investigator’s responsibility to maintain documentation of each reported adverse 
event. All adverse events will be followed in accordance with applicable licensing 
requirements.  Such documentation will include the following:
x
Adverse event (diagnosis not symptom)
x
Drawings or photographs (where appropriate) that detail the finding (eg, size, 
location, and depth, etc) 
x
Date the clinical site was notified 
x
Date and time of onset
x
Date and time of resolution
x
Adverse event classification, severity, and relationship to test articles, as applicable
x
Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements
x
Any referral to another health care provider if needed
x
Outcome, ocular damage (if any)
x
Likely etiology
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event
In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate 
Assessment /eCRF.  Where necessary, a culture of the corneal lesion will be collected to 
determine if the infection is microbial in nature.  If cultures are collected, the date of culture 
collection and laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed.  Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved.  If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider.  The Investigator will use his/her clinical 
judgment as to whether or not 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.
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 
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according to their requirements (Section 13.4.2).  The report will comment whether or not 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:
x
Notify the Sponsor immediately
x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no 
later than 24 hours after the Investigator first learns of the effect.  This report is in addition to 
the immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect.
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery.
13.4.2
Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set 
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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 
Not Applicable.
13.6. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the course of the study will be 
discontinued after the event is recorded as an Adverse Event.  Once discontinued, pregnant 
participants and their fetuses will not be monitored for study related purposes.
At the 
Investigator’s discretion, the study participant may be followed by the Investigator through 
delivery. However, this data will not be collected as part of the clinical study database.  
Pregnant participants are not discontinued from contact lens or solution related studies for 
safety concerns, but due to general concerns relating to pregnancy and contact lens use.  
Specifically, pregnant women are discontinued due to fluctuations in refractive error and/or 
visual acuity that occur secondary to systemic hormonal changes, and not due to unforeseen 
health risks to the mother or fetus.
14. STATISTICAL METHODS 
14.1. General Considerations 
All data summaries and statistical analyses will be performed using the SAS software 
Version 9.4 (SAS Institute, Cary, NC). Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis.  
Unscheduled visits will be summarized separately and will be excluded from the statistical 
analysis.
Summary tables (Descriptive statistics and/or frequency tables) will be provided for all 
baseline variables, efficacy variables and safety variables as appropriate.  Continuous 
variables will be summarized with descriptive statistics (n, mean, standard deviation [SD], 
median, minimum and maximum). Frequency count and percentage of subjects or eyes 
within each category will be provided for categorical data.
Summaries will be presented by study lens type and will be performed separately by 
completion status. All analyses will be conducted on per-protocol population (see Section 
14.3).
14.2. Sample Size Justification 
232 cohort subjects from 
were used as historical 
input for the sample size calculation. The lenses used in the above single arm studies had the 
same optical design as the lenses used in this trial. The standard deviation of CLUE handling 
from visit 2 and 3 was the input for calculating the sample size.
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The true difference between the Test lens and the Control lens was assumed to be 0 and -1
points to make 2 different scenarios. It is reasonable to further assume the handling scores 
from different lenses are correlated since the only difference in the lenses is the thickness 
profile (correlation is assumed to be 0.6 and 0.7).
Below is the summary of sample size required to test the primary hypotheses at alpha = 0.05 
and power at least 0.8
Mean Diff Correlation Actual Power Sample Size
0
0.6
0.802
116
0
0.7
0.801
87
-1
0.6
0.801
180
-1
0.7
0.800
135
14.3. Analysis Populations 
Safety Population:
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded.
Per-Protocol Population: 
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population). Justification of excluding subjects with protocol deviations in the 
per-protocol population set will be documented in a memo to file.
Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from 
study or deviation from protocol. At least one observation should be recorded.
14.4. Level of Statistical Significance 
All planned analysis for this study will be conducted with an overall type I error rate of 5%. 
14.5. Primary Analysis  
Primary efficacy analysis:
The CLUE handling score will be analyzed using a linear mixed model. The model will 
include the experimental design factors: sequence of lens wear, lens wearing period and lens 
type as fixed effects. Site and subject nested in site will be included as random effects. Age 
and gender will be included as fixed covariates when appropriate. The covariance between 
residual errors from the same subject across lens wearing periods will be selected based on 
the finite-sample corrected Akaike’s Information Criterion (Keselman et al. 19982).
Covariance structures considered may include: Homogenous compound symmetry (CS) and 
Unstructured covariance structure (UN). The structure that returns the lowest Akaike 
Information Criteria Corrected (AICC) will be selected as the structure that best fit the data. 
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Comparisons between each Test lens and Control lens will be carried out using 95% 
confidence intervals constructed of least-square means (LSM) differences (Test minus 
Control) from the linear mixed models. Non-inferiority will be concluded if the lower 
confidence limit is greater than -5 points.
In all models, the Kenward and Roger method (Kenward and Roger, 1997) will be used for 
the calculation of the denominator of degrees of freedom.
14.6. Secondary Analysis  
Secondary efficacy analysis:
The secondary analysis will be conducted using the same method as the primary analysis. 
14.7. Other Exploratory Analyses  
Not Applicable.
14.8. Interim Analysis 
Not Applicable.
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 5 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 
Bioclinica Express version 5.5 EDC system). 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. 
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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.
15.2. Subject Record 
At a minimum, subject record should be available for the following:
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable.  The first point of entry is considered to be the source record.
Adverse event notes must be reviewed and initialed by the Investigator.
16. DATA MANAGEMENT 
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents.  Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours.
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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:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent amendments, and regulatory requirements are maintained
x
Ensuring the rights and wellbeing of subjects are protected
x
Ensuring adequate resources, including facilities, laboratories, equipment, and  
qualified clinical site personnel
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable
x
Ensuring that the clinical site has sufficient test article and supplies
x
Clarifying questions regarding the study
x
Resolving study issues or problems that may arise
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x
Reviewing of study records and source documentation verification in accordance with
the monitoring plan
18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, 
during the study, subjects will be given any new information that may affect their decision to 
continue participation.  Subjects will be told that their consent to participate in the study is 
voluntary and may be withdrawn at any time with no reason given and without penalty or 
loss of benefits to which they would otherwise be entitled.  Only subjects who are fully able 
to understand the risks, benefits, and potential adverse events of the study, and provide their 
consent voluntarily will be enrolled.
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), and applicable regulatory requirements.  GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 2013 and that the clinical study data are credible.  The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP), and applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable):
x
Final protocol and, if applicable, amendments
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects)
x
Investigator’s Brochure (or equivalent information) and amendments
x
Sponsor-approved subject recruitment materials
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless 
not required, as documented by IEC/IRB)
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects
x
Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after IEC/IRB has given full approval of the final 
protocol, amendments (if any), the informed consent form, applicable recruiting materials, 
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and subject compensation programs, and the Sponsor has received a copy of this approval. 
This approval letter must be dated and must clearly identify the documents being approved.
During the study the Investigator (or Sponsor when applicable) will send the following 
documents to the IEC/IRB for their review and approval, where appropriate:
x
Protocol amendments
x
Revision(s) to informed consent form and any other written materials to be provided 
to subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure amendments or new edition(s)
x
Summaries of the status of the study (at least annually or at intervals stipulated in 
guidelines of the IEC/IRB)
x
Reports of adverse events that are serious, unanticipated, and associated with the test 
articles, according to the IRB’s requirements
x
New information that may adversely affect the safety of the subjects or the conduct of 
the study
x
Major protocol deviations as required by the IEC/IRB
x
Report of deaths of subjects under the Investigator's care
x
Notification if a new Investigator is responsible for the study at the clinical site
x
Any other requirements of the IEC/IRB
For protocol amendments that increase subject risk, the amendment and applicable informed 
consent form revisions must be submitted promptly to the IEC/IRB for review and approval 
before implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing.
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion.  Documentation of this notification must be retained at the 
clinical site and a copy provided to the CRO or Sponsor as applicable.
18.4. Informed Consent 
Each subject must give written consent according to local requirements after the nature of the 
study has been fully explained. The consent form must be signed before performance of any 
study-related activity. The consent form that is used must be approved by both the Sponsor 
and by the reviewing IEC/IRB. The informed consent is in accordance with principles that 
originated in the Declaration of Helsinki, current ICH and GCP guidelines, applicable 
regulatory requirements, and Sponsor policy.
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential subject the aims, methods, reasonably anticipated 
benefits, and potential hazards of the study, and any discomfort it may entail. Subjects will be 
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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 (eg, name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Data Protection Act of 1998 and other applicable personal data 
protection and security laws and regulations.  Appropriate measures will be employed to 
safeguard these data, to maintain the confidentiality of the person’s related health and 
medical information, to properly inform the concerned persons about the collection and 
processing of their personal data, to grant them reasonable access to their personal data and 
to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as 
confidential. All personal data gathered in this trial will be treated in strictest confidence by 
Investigators, monitors, Sponsor’s personnel and IEC/IRB.  No data will be disclosed to any 
third party without the express permission of the subject concerned, with the exception of 
Sponsor personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of 
their investigation related activities that, as part of the investigation will have access to the 
CRFs and subject records.
The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility 
of the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure 
confidentiality and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes
x
adequate, relevant, and not excessive in relation to said purposes
x
accurate and, where necessary, kept current
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and 
the right to request rectification of any data that are not correct or complete. Reasonable steps 
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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, 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/GCP Section 8, Essential Documents for the Conduct of 
a Clinical Trial, and all study documents as specified by the applicable regulatory 
requirement(s). The Investigator/Institution will take measures to prevent accidental or 
premature destruction of these documents.
Essential documents must be retained until at least 2 years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or 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 Investigator’s 
Research Agreement.  The Research Agreement will be signed by the Principal Investigator 
and a JJVC management representative prior to study initiation.
Case Report Forms will be completed in real time according to the study procedures 
specified in the study protocol.  Case Report Forms should be completed and reviewed and 
signed as applicable by the Investigator within 3 days of visit completion.  Data queries must 
be addressed with complete responses within 3 days of generation.  JJVC reserves the right to 
withhold remuneration until these activities are addressed.
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JJVC reserves the right to withhold remuneration for costs associated with protocol 
violations such as:
x
Continuing an ineligible subject in the study
x
Scheduling a study visit outside the subject’s acceptable visit range
21. PUBLICATION 
This study will be registered on ClinicalTrials.gov. 
22. REFERENCES 
1. Harris MG, Sarver MD and Polse KA.  Patient response to thin hydrogel contact 
lenses. J Am Optom Assoc. 1977 Mar;(48)3:295-299.
2. Keselman HJA, J.; Kowalchuk, R. K.; and Wolfinger, R. D. A Comparison of Two 
Approaches for Selecting Covariance Structures in the Analysis of Repeated 
Measures. 
Communications 
in 
Statistics—Simulation 
and 
Computation. 
1998(27):591–604.
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
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PATIENTINSTRUCTIONGUIDE

DailyDisposableWear
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Soft(hydrophilic)ContactLenses
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StudyCRͲ5935
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TABLEOFCONTENTS
TABLEOFCONTENTS...............................................................................................................................................2
INTRODUCTION.......................................................................................................................................................3
SYMBOLSKEY..........................................................................................................................................................4
GLOSSARYOFCOMMONLYUSEDTERMS...............................................................................................................5
POTENTIALBENEFITS..............................................................................................................................................5
REASONSYOUSHOULDNOTWEARTHESTUDYLENSES........................................................................................6
POSSIBLERISKSORDISCOMFORTSRELATEDTOTHESTUDY..................................................................................7
PRECAUTIONS..........................................................................................................................................................8
LENSHANDLINGANDINSERTION...........................................................................................................................9
Step1:GettingStarted.......................................................................................................................................9
Step2:OpeningthePackaging...........................................................................................................................9
Step3:PlacingtheLensontheEye..................................................................................................................10
LENSWEARING......................................................................................................................................................11
REMOVINGYOURLENSES.....................................................................................................................................12
EMERGENCIES.......................................................................................................................................................12
NOTES....................................................................................................................................................................13
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INTRODUCTION
AboutThisBooklet:
Theinformationandinstructionscontainedinthisbookletapplyonlytoyourstudycontactlenses.
Foryoureyehealth,itisimportantthatyourcontactlensesbewornonlyasdirectedbyyourStudy
Investigator.YourStudyInvestigatorshouldbekeptfullyawareofyourmedicalhistoryandwill
developatotalprogramofcarebasedonthestudyandyourspecificneeds.Heorshewillreview
withyouallinstructionsforlenshandling,includinghowtosafelyandeasilyopenthepackaging.You
willalsobetaughthowtoproperlyinsertandremovelenses.Thisbookletwillreinforcethose
instructions.

Ifyouhaveanyquestions,alwaysaskyourStudyInvestigator.

A“GlossaryofCommonlyUsedTerms”isincludedforyourreference.Thiscontainsdefinitionsof
medicalandtechnicalterminologyusedinthisbooklet.Inaddition,a“SymbolsKey”providesan
explanationofsymbolsthatmayappearonthelenspackaging.
AboutYourLensesandContactLensWear:
Yourcontactlensesaremadefromawaterloving(hydrophilic)materialthathastheabilitytoabsorb
water,makingthelensessoftandflexible.Thelensesaretintedtoimprovevisibilityforhandlingand
mayalsocontainanultraviolet(UV)radiationabsorbingingredienttoblockUVradiation.

Youshouldalwayshaveglassesoryourowncontactlensesavailable.
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REASONSYOUSHOULDNOTWEARTHESTUDYLENSES
(PARTICIPATIONCRITERIA)
x
Youhaveabnormalitiesofthecorneathatcouldbecomeproblemsforyouifyouwearcontact
lenses.Theseabnormalitiesinclude:
o
Cornealedema(swellingofthecorneaorclearcoveringoftheeye)
o
Cornealvascularization(smallbloodvesselsgrowingintothecornea)
o
Cornealstaining(defectonthecornealsurface)
o
Cornealdistortion(irregularsurfaceoftheeye)
o
BulbarInjection(rednessofthewhiteoftheeye)
x
Youhaveeyelidabnormalities(suchasbumpsontheinsideoftheuppereyelid)thatmight
interferewithcontactlenswear
x
Youhaveentropion(eyelidturnsinward),ectropion(eyelidturnsoutward),extrusion(eyelid
thrustingoutofthesocket),chalazia(bumpontheeyelid),recurrentstye,dryeye,glaucoma,
orhistoryofcornealerosions
x
Anypreviousorplannedeyesurgeries(forexampleradialkeratometry,PRK,LASIK,lid
procedures,cataractsurgery,retinalsurgery)
x
Youhaveahistoryofabinocularvisionabnormality,strabismus(crossedeyes)oramblyopia
(lazyeye)
x
Anyothercornealorocularabnormalitythatwouldnotallowyoutowearcontacts
x
Youhaveanyactiveeyeinfectionorinflammation(suchasconjunctivitisor“pinkeye”)
x
Youhaveeyeorgeneralbodyallergies(likeseasonalallergies)thatmayinterferewithcontact
lenswear
x
Youusemedicationthatmayinterferewithcontactlenswear
x
Useofanyocularmedication,exceptforrewettingdrops
x
Youareawomanwhoiscurrentlypregnantorisbreastfeeding
x
Youcurrentlyhavediabetes
x
Haveahistoryofherpetickeratitis
x
Youhaveanyinfectiousdisease,(forexample,tuberculosis,hepatitis)orimmuneͲsuppressive
disease(forexample,HIV)
x
Youhaveparticipatedinanycontactlensstudyorlenscareproductstudyinthepast30days
priortostartingthisstudy
x
Youareanemployeeoftheclinicalsite(forexample,Investigator,Coordinator,Technician)

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POSSIBLERISKSORDISCOMFORTSRELATEDTOTHESTUDY
WhatYouShouldKnowAboutContactLensWearandThisStudy:
Thefollowingproblemsmayalsooccurwhenwearingcontactlenses:
x
Burning,stinging,and/oritchingoftheeyes
x
Afeelinglikethereissomethingintheeye(foreignbody,scratchedarea)
x
Reducedvisionortemporarylossofvisionduetoperipheralinfiltrates(whitebloodcells),
peripheralcornealulcers(inflammationofthecornea),and/orcornealerosion(defectsinthe
cornealsurface)
x
Localorgeneralizededema(swelling)
x
Cornealneovascularization(smallbloodvesselsgrowingintothecornea)
x
Cornealstaining(defectinthecornealsurface)
x
Redness
x
Tarsalabnormalities(bumpsontheinsideuppereyelid)
x
Iritis(internalinflammationoftheeye)
x
Conjunctivitis(infectionorinflammationofthewhitepartoftheeyeorundertheeyelids)
x
Excessivewatering,unusualeyesecretions,orrednessoftheeye
x
Poorvisualacuity
x
Blurredvision
x
Rainbowsorhalosaroundobjects
x
Sensitivitytolight
Youshouldtellthestudydoctororstudystaffaboutanyeyediscomfort,visionchanges,orothereye
problemsyoumayexperienceduringorafterwearingthestudycontactlenses.Youshouldcontinue
toseeyourregulareyecarepractitionerroutinelyasdirected.
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PRECAUTIONS
Foryoureyehealth,itisimportanttocarefullyfollowthehandling,insertion,removalandwearing
instructionsinthisbookletaswellasthoseprescribedbyyourStudyInvestigator(see“LensHandling
&Insertion”and“LensWearing”sections).
GeneralPrecautions:
x
AlwayscontactyourStudyInvestigatorbeforeusinganymedicineinyoureyes.
x
Beawarethatcertainmedications,suchasantihistamines,decongestants,diuretics,
musclerelaxants,tranquilizersandthoseformotionsicknessmaycausedrynessofthe
eye,increasedlensawareness(feelingofthelensintheeye)orblurredvision.Always
informyourStudyInvestigatorifyouexperienceanyproblemswithyourlenseswhile
takingsuchmedications.Dependingonyoursymptoms,yourStudyInvestigatormay
recommendrewettingdropsthatareavailableforusewithsoftcontactlensesormay
recommendthatyoustopwearingcontactlenseswhileyouareusingthesemedications.
x
Beawarethatifyouuseoralcontraceptives(birthcontrolpills),youcoulddevelop
changesinvisionorcomfortwhenwearingcontactlenses.
x
Aswithanycontactlens,followͲupvisitsarenecessarytoassurethecontinuinghealthof
youreyes.AskyourStudyInvestigatorabouttherecommendedfollowͲupschedule.
WhoShouldKnowThatYouareWearingContactLenses:
x
Informallofyourdoctors(HealthCareProfessionals)aboutbeingacontactlenswearer.
x
Alwaysinformyouremployerofbeingacontactlenswearer.Somejobsmayrequireuse
equipmentormayrequirethatyounotwearcontactlenses.

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LENSHANDLINGANDINSERTION
Foryoureyehealth,itisimportanttocarefullyfollowthehandling,insertion,removalandwearing
instructionsinthisbookletaswellasthoseprescribedbyyourStudyInvestigator.Ifyouwillnotor
cannotalwaysfollowtherecommendedcareprocedures,youshouldnotattempttowearcontact
lenses.
Step1:GettingStarted
Itisessentialthatyoulearnandusegoodhygieneinthecareandhandlingofyourstudylenses.
Cleanlinessisthefirstandmostimportantaspectofpropercontactlenscare.Inparticular,your
handsshouldbeclean,dry,andfreeofanysoaps,lotions,orcreamsbeforeyouhandleyourlenses.
Beforeyoustart:
x
Alwayswashyourhandsthoroughlywithamildsoap,rinsecompletelyanddrywithalintͲ
freetowelbeforetouchingyourlenses.
DONOTtouchyourcontactlenseswithyourfingersorhandsiftheyarenotcompletely
clean,becausetinylensscratchesmayoccur,causingunclearvisionand/orinjurytoyour
eye.
x
Youshouldavoidtheuseofsoapscontainingcoldcream,lotion,oroilycosmeticsbefore
handlingyourlenses.Thesesubstancesmaycomeintocontactwiththelensesand
interferewithsuccessfulwearing.
DONOTgetcosmetics,lotions,soaps,creams,deodorantsorspraysinyoureyesoron
yourlenses.
Startoffcorrectlybygettingintothehabitofalwaysusingproperhygienesothattheybecome
automatic.
Step2:OpeningthePackaging
Multipack
Eachmultipackcontainsindividuallypackagedlenses.Eachlenscomesinitsownlenspackage
designedspecificallytokeepitsterile.
LensPackage
Toopenanindividuallenspackage,followthesesimplesteps:
DONOTuseifthesterileblisterpackageisopenedordamaged.
1. Shakethelenspackageandchecktoseethatthelensisfloatinginthesolution.
2. Peelbackthefoilclosuretorevealthelens.BystabilizingthelenspackageonthetableͲ
top,youwillminimizethepossibilityofasuddensplash.
3. Placeafingeronthelensandslidethelensupthesideofthebowlofthelenspackage
untilitisfreeofthecontainer.
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NEVERusetweezersorothertoolstoremoveyourlensesfromthelenscontainerunless
specificallyindicatedforthatuse.
Occasionally,alensmaysticktotheinsidesurfaceofthefoilwhenopened,ortotheplasticpackage
itself.Thiswillnotaffectthesterilityofthelens.Itisstillperfectlysafetouse.Carefullyremoveand
inspectthelensfollowingthehandlinginstructions.
LensHandlingTips
x
Handleyourlenseswithyourfingertips,andbecarefultoavoidcontactwithfingernails.It
ishelpfultokeepyourfingernailsshortandsmooth.
DONOTtouchthelenswithyourfingernails.
x
DevelopthehabitofalwaysworkingwiththesamelensfirsttoavoidmixͲups.
x
Afteryouhaveremovedthelensfromthepackaging,examineittobesurethatitismoist,
clean,andfreeofanynicksortears.Ifthelensappearsdamaged,DONOTuseit.The
StudyInvestigatorwillreplacethelens.
ALWAYShandlelensescarefullyandavoiddroppingthem.
Step3:PlacingtheLensontheEye
Remember,alwaysstartwiththesameeye.
Onceyouhaveopenedthelenspackage,removedandexaminedthelens,followthesestepstoinsert
thelenstoyoureye:
1. BESURETHELENSISNOTINSIDEͲOUTbyfollowingeitherofthefollowingprocedures:
x
Placethelensonthetipofyourindexfingerandcheckitsprofile.Thelensshould
assumeanatural,curved,bowlͲlikeshape.Ifthelensedgestendtopointoutward,the
lensisinsideout.Anothermethodistogentlysqueezethelensbetweenthethumb
andforefinger.Theedgesshouldturninward.Ifthelensisinsideout,theedgeswill
turnslightlyoutward.
2. Withthelensonyourindexfinger,useyourotherhandtoholdyouruppereyelidsoyou
won’tblink.
3. Pulldownyourlowereyelidwiththeotherfingersofyour“inserting”hand.
4. Lookupattheceilingandgentlyplacethelensonthelowerpartofyoureye.
5. Slowlyreleaseyoureyelidandcloseyoureyeforamoment.
6. Blinkseveraltimestocenterthelens.
7. Usethesametechniquewheninsertingthelensforyourothereye.
Thereareothermethodsoflensplacement.Iftheabovemethodisdifficultforyou,askyourStudy
Investigatorforanalternatemethod.
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LENSWEARING
Whilewearingyourlenses,rememberthefollowingimportantprecautions:
HazardousConditions
x
Ifyouuseaerosol(spray)products,suchashairspray,whilewearinglenses,keepyoureyes
closeduntilthesprayhassettled.
x
Avoidallharmfulorirritatingvaporsandfumeswhilewearinglenses.
Lubricating/RewettingSolutions
x
YourStudyInvestigatormayrecommendalubricating/rewettingsolutionforyouruse.These
solutionscanbeusedtowet(lubricate)yourlenseswhileyouarewearingthem.
x
Donotusesalivaoranythingotherthantherecommendedsolutionsforlubricatingor
rewettingyourlenses.Donotputlensesinyourmouth.
x
Neverrinseyourlensesinwaterfromthetap.Therearetworeasonsforthis:
1. Tapwatercontainsmanyimpuritiesthatcancontaminateordamageyourlensesandmay
leadtoeyeinfectionorinjury.
2. Youmightloseyourlensdownthedrain.
Sticking(NonͲMoving)Lens
x
Foryoureyehealth,itisimportantthelensmovesfreelyonyoureye.
x
Ifthelenssticks(stopsmoving)onyoureye,applyafewdropsoftherecommendedrewetting
solution.Waituntilthelensbeginstomovefreelyontheeyebeforeremovingit.IfnonͲ
movementofthelenscontinues,youshouldimmediatelyconsultyourStudyInvestigator.
SharingLenses
x
Neverallowanyoneelsetowearyourlenses.Sharinglensesgreatlyincreasesthechanceof
eyeinfections.
AdheringtothePrescribedWearingSchedule
x
NeverwearyourlensesbeyondtheamountoftimerecommendedbyyourStudyInvestigator.
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REMOVINGYOURLENSES
CAUTION:Alwaysbesurethelensisonthecornea(inthecenterofyoureye)beforeattemptingto
removeit.Determinethisbycoveringtheothereye.Ifvisionisblurred,thelensiseitheronthewhite
partoftheeyeoritisnotontheeyeatall.Tolocatethelens,inspecttheupperareaoftheeyeby
lookingdownintoamirrorwhilepullingtheupperlidup.Theninspectthelowerareabypullingthe
lowerliddown.
Alwaysremovethesamelensfirst.
1. Wash,rinseanddryyourhandsthoroughly.
2. Therearetworecommendedmethodsoflensremoval:thePinchMethodandtheForefinger
andThumbMethod.YoushouldfollowthemethodthatisrecommendedbyyourStudy
Investigator.
PinchMethod:
Step1.Lookup,slidethelenstothelowerpartoftheeyeusingtheforefinger.
Step2.Gentlypinchthelensbetweenthethumbandforefinger.
Step3.Removethelens.

ForefingerandThumbMethod:
Step1.Placeyourhandoratowelunderyoureyetocatchthelens.
Step2.Placeyourforefingeronthecenteroftheupperlidandyourthumbonthecenterof
thelowerlid.
Step3.Pressinandforceablink.Thelensshouldfallontoyourhandorthetowel.

Note:Thelensmaycomeout,butremainontheeyelid,fingerorthumb.

3. Removetheotherlensbyfollowingthesameprocedure.
Alwayshaveglassesoryourowncontactlensesavailable.
Note:Ifthesemethodsofremovingyourlensaredifficultforyou,askyourStudyInvestigatorforan
alternatemethod.

EMERGENCIES
Ifchemicalsofanykind(householdproducts,gardeningsolutions,laboratorychemicals,etc.)are
splashedintoyoureyes:FLUSHEYESIMMEDIATELYWITHTAPWATERANDIMMEDIATELYCONTACT
YOURSTUDYINVESTIGATORORVISITAHOSPITALEMERGENCYROOMRIGHTAWAY.

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NOTES
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SponsoredBy:
Johnson&JohnsonVisionCare,Inc.
7500CenturionParkway
Jacksonville,FL32256
USA
Tel:1Ͳ800Ͳ843Ͳ2020
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©JohnsonandJohnsonVisionCareCompanies2017
Revisiondate05/2017
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
Not Applicable for Investigational Products
APPENDIX D: PRESBYOPIC SYMPTOMS QUESTIONNAIRE 
Presbyopic Symptoms Questionnaire
1. Do you notice that you often have to hold things farther away so that you could read 
them?
2. Do you notice that you often have difficulty focusing on near objects (ie, 
experiencing blurry vision when looking at things close-up)?
3. Do you often have headaches or eyestrains, or feel fatigued, when read or conduct 
other near activities?
4. Do you often have difficulty reading small or fine prints, such as phone books, 
medicine bottles or package labels, etc?
5. Do you often have difficulty reading under dim or low light?
APPENDIX E: 
 
 
x
 LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS 
x
 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING 
x
DETERMINATION OF NEAR ADD
x
  LENS FITTING CHARACTERISTICS 
x
 SUBJECT REPORTED OCULAR SYMPTOMS 
x
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS 
x
 BIOMICROSCOPY SCALE 
x
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION
x
 TORIC FIT EVALUATION
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 LIMBAL & CONJUNCTIVAL (BULBAR) REDNESS 
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 EXPANDED SODIUM FLUORESCEIN CORNEAL STAINING  
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 DETERMINATION OF NEAR ADD 
 
 
 
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 LENS FITTING CHARACTERISTICS  
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 SUBJECT REPORTED OCULAR SYMPTOMS  
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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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 TORIC FIT EVALUATION  
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: Handling Evaluation of Multifocal Toric Contact Lenses 
Version and Date: v3.0, 31-May-2017
I have read and understand the protocol specified above and agree on its content.  
I agree to conduct this study according to GCP and ICH guidelines, the Declaration of 
Helsinki, ISO 14155, United States (US) Code of Federal Regulations (CFR), 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 ICH 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 ICH 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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