Characterizing Successful Myopic Multifocal Contact Lens Wearers
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

Johnson & Johnson Vision Care, Inc.
Clinical Study Protocol 
Characterizing Successful Myopic Multifocal Contact Lens 
Wearers 
Protocol CR-5945   
Version: 9.0 Amendment 8
Date: 20 December 2019
Investigational Products: etafilcon A Daily Disposable Multifocal Contact Lens
Key Words: Daily Disposable Multifocal contact lens, successful lens wear, habitual contact 
lens, soft contact lens, distance vision, intermediate vision, near vision, contact lens drop out 
Statement of Compliance to protocol, GCP and applicable regulatory guidelines:
This trial will be conducted in compliance with the protocol, ISO 14155,1 the International 
Conference on Harmonization Good Clinical Practice E6 (ICH-GCP),2 the Declaration of 
Helsinki,3 and all applicable regulatory requirements. 
Confidentiality Statement:
This document contains confidential information, which should not be copied, referred to, 
released or published without written approval from Johnson & Johnson Vision Care.  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.  Any supplemental information that may be added to this document is also confidential 
and proprietary to Johnson & Johnson Vision Care 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........................................................................... 7 
SPONSOR NAME AND ADDRESS....................................................................................... 7 
MEDICAL MONITOR............................................................................................................. 7 
AUTHORIZED SIGNATURES............................................................................................... 8 
CHANGE HISTORY.............................................................................................................. 10 
SYNOPSIS .............................................................................................................................. 13 
COMMONLY USED ABBREVIATIONS AND DEFINITIONS OF TERMS .................... 24 
1.
INTRODUCTION AND BACKGROUND ................................................................... 26
1.1. 
Name and Descriptions of Investigational Products .................................................26 
1.2. 
Intended Use of Investigational Products ..................................................................26 
1.3. 
Summary of Findings from Nonclinical Studies .......................................................26 
1.4. 
Summary of Known Risks and Benefits to Human Subjects ....................................26 
1.5. 
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study.......................................................................................................................26 
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES ...................................... 26
2.1. 
Objectives ..................................................................................................................26 
2.2. 
Endpoints ...................................................................................................................27 
2.3. 
Hypotheses ................................................................................................................28 
3.
TARGETED STUDY POPULATION ........................................................................... 28
3.1. 
General Characteristics .............................................................................................28 
3.2. 
Inclusion Criteria .......................................................................................................28 
3.3. 
Exclusion Criteria ......................................................................................................29 
3.4. 
Enrollment Strategy ...................................................................................................30 
4.
STUDY DESIGN AND RATIONALE .......................................................................... 30
4.1. 
Description of Study Design .....................................................................................30 
4.2. 
Study Design Rationale .............................................................................................30 
4.3. 
Enrollment Target and Study Duration .....................................................................31 
5.
TEST ARTICLE ALLOCATION AND MASKING ..................................................... 31
5.1. 
Test Article Allocation ..............................................................................................31 
5.2. 
Masking .....................................................................................................................31 
5.3. 
Procedures for Maintaining and Breaking the Masking ............................................31 
6.
STUDY INTERVENTION ............................................................................................. 32
6.1. 
Identity of Test Articles .............................................................................................32 
6.2. 
Ancillary Supplies/Products ......................................................................................32 
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6.3. 
Administration of Test Articles .................................................................................32 
6.4. 
Packaging and Labeling ............................................................................................33 
6.5. 
Storage Conditions ....................................................................................................33 
6.6. 
Collection and Storage of Samples ...........................................................................33 
6.7. 
Accountability of Test Articles .................................................................................33 
7.
STUDY EVALUATIONS .............................................................................................. 34
7.1. 
Time and Event Schedule ..........................................................................................34 
7.1.1. 
Additional screening visits .............................................................................34 
7.2. 
Detailed Study Procedures ........................................................................................34 
VISIT 1 
39 
VISIT 2 
42 
VISIT 3 
47 
VISIT 4 
51 
VISIT 5 
55 
VISIT 6 
58 
Final Evaluation ...............................................................................................................60 
7.3. 
Unscheduled Visits ....................................................................................................61 
7.4. 
Laboratory Procedures ..............................................................................................64 
8.
SUBJECTS COMPLETION/WITHDRAWAL.............................................................. 64
8.1. 
Completion Criteria ...................................................................................................64 
8.2. 
Withdrawal/Discontinuation from the Study ............................................................64 
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION ................. 65
10.
DEVIATIONS FROM THE PROTOCOL .................................................................. 66
11.
STUDY TERMINATION ........................................................................................... 66
12.
PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS .............. 66
13.
ADVERSE EVENTS ................................................................................................... 68
13.1. Definitions and Classifications ..................................................................................68 
13.2. Assessing Adverse Events .........................................................................................70 
13.2.1. 
Causality Assessment .....................................................................................70 
13.2.2. 
Severity Assessment .......................................................................................70 
13.3. Documentation and Follow-Up of Adverse Events ..................................................71 
13.4. Reporting Adverse Events .........................................................................................72 
13.4.1. 
Reporting Adverse Events to Sponsor ...........................................................72 
13.4.2. 
Reporting Adverse Events to the Responsible IEC/IRB and Health 
Authorities........................................................................................................................73 
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13.4.3. 
Event of Special Interest ................................................................................73 
13.5. Reporting of Pregnancy .............................................................................................73 
14.
STATISTICAL METHODS ........................................................................................ 74
14.1. General Considerations .............................................................................................74 
14.2. Sample Size Justification ..........................................................................................74 
14.3. Analysis Populations .................................................................................................74 
14.4. Level of Statistical Significance ................................................................................75 
14.5. Primary Analysis .......................................................................................................75 
14.6. Secondary Analysis ...................................................................................................75 
14.7. Other Exploratory Analyses ......................................................................................75 
14.8. Interim Analysis ........................................................................................................75 
14.9. Procedure for Handling Missing Data and Drop-Outs ..............................................75 
14.10. Procedure for Reporting Deviations from Statistical Plan ........................................76 
15.
DATA HANDLING AND RECORD KEEPING/ARCHIVING ................................ 76
15.1. Electronic Case Report Form/Data Collection ..........................................................76 
15.2. Subject Record ..........................................................................................................77 
16.
DATA MANAGEMENT............................................................................................. 77
16.1. Access to Source Data/Document .............................................................................77 
16.2. Confidentiality of Information ..................................................................................77 
16.3. Data Quality Assurance .............................................................................................78 
17.
MONITORING ............................................................................................................ 78
18.
ETHICAL AND REGULATORY ASPECTS ............................................................. 78
18.1. Study-Specific Design Considerations ......................................................................78 
18.2. Investigator Responsibility ........................................................................................79 
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) ...............79 
18.4. Informed Consent ......................................................................................................80 
18.5. Privacy of Personal Data ...........................................................................................80 
19.
STUDY RECORD RETENTION ................................................................................ 82
20.
FINANCIAL CONSIDERATIONS ............................................................................ 82
21.
PUBLICATION ........................................................................................................... 83
22.
REFERENCES ............................................................................................................ 83
APPENDIX 
A 
: 
PATIENT 
REPORTED 
OUTCOMES 
(STUDY 
QUESTIONNAIRES) AND QUEST/QUANT QUESTIONNAIRES : ................................. 84 
APPENDIX B: PATIENT INSTRUCTION GUIDE ........................................................... 126 
APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) ....................................... 127 
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APPENDIX D: PRESBYOPIC SYMPTOMS QUESTIONNAIRE .................................... 156 
APPENDIX E: OCULAR DOMINANCE ........................................................................... 157 
APPENDIX F: TEST LENS FITTING GUIDE ................................................................... 158 
APPENDIX G: NON-INVASIVE TEAR BREAK-UP TIME (NITBUT) .......................... 160 
APPENDIX H: LOGMAR VISUAL ACUITY .................................................................... 161 
APPENDIX I: RANDOT STEREOPSIS.............................................................................. 162 
APPENDIX J: UNILATERAL COVER TEST .................................................................... 163 
APPENDIX K: FIXATION DISPARITY ............................................................................ 164 
APPENDIX L: DISTANCE CONTRAST THRESHOLD................................................... 165 
APPENDIX M: BLUR TOLERANCE TESTING ............................................................... 166 
APPENDIX N: PERSONALITY TEST (BIG 5) ................................................................. 168 
APPENDIX O: PRE-FIT INTERVIEW ............................................................................... 169 
APPENDIX P: POST-FIT INTERVIEW ............................................................................. 170 
APPENDIX Q: MEASUREMENT OF LENS CENTRATION WITH MEDMONT 
TOPOGRAPHER ................................................................................................................. 171 
APPENDIX R:
 ................................................ 173 
 DETERMINATION OF NEAR ADD ................................................................ 174 
 LENS FITTING CHARACTERISTICS ............................................................. 182 
SUBJECT REPORTED OCULAR SYMPTOMS .............................................. 189 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS ................................................................................................................... 191 
BIOMICROSCOPY SCALE .............................................................................. 198 
KERATOMETRY PROCEDURE ...................................................................... 204 
MEASUREMENT OF COAS WAVEFRONT ABBERATIONS...................... 206 
LENS INSERTION AND REMOVAL .............................................................. 214 
WAM-5500 ON-AXIS AUTO REFRACTION MEASUREMENT .................. 217 
Work-aid: Measuring Pupil Diameter with NeurOptics VIP-300 Variable 
Pupillometer .......................................................................................................................... 221 
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE ........................ 225 
TABLE OF CONTENTS 
Figure 1: Study Flowchart ...................................................................................................... 23 
TABLE OF CONTENTS
Table 1: Test Article ............................................................................................................... 32 
Table 2: Ancillary Supplies .................................................................................................... 32 
Table 3: Time and Events ....................................................................................................... 34 
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Table 4: Study procedures by visit.......................................................................................... 35 
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SYNOPSIS 
Protocol Title
Characterizing Successful Myopic Multifocal Contact Lens 
Wearers
Sponsor
JJVC, 7500 Centurion Parkway, Jacksonville, FL  32256
Clinical Phase
Development phase, Phase 0
Trial Registration
This study will be registered on ClinicalTrials.gov by the 
sponsor.
Ethics approvals
Ethics approval will be sought by CORE through a 
University of Waterloo ethics committee.
Regulatory approval
The contact lens is approved for sale in Canada.
Test Article(s)
Investigational Products: Etafilcon A Multifocal Contact 
Lens
Control Products: None
Wear and Replacement 
Schedules
Wear Schedule: Daily wear
Replacement Schedule: Daily Disposable
Objectives 
Primary Objectives: To determine if the QUEST 
questionnaire, collected at baseline, are significantly 
correlated with subject groups that are classified as being 
‘likely to be successful’ and/or ‘likely to be unsuccessful’ 
after wearing an investigational multifocal (ML) contact lens
(CL).
Secondary Objectives: To determine if certain physical 
ocular related data is significantly correlated with subject 
groups that are classified as being ‘likely to be successful’, 
‘likely to be unsuccessful’ after wearing an investigational
multifocal contact lens. 
Likely to be Successful Group definition: 
x
Completed study, AND ... 
x
Investigator would recommend the study CLs, AND ... 
x
The subject’s response on the MRD “overall quality of 
vision” and “overall comfort” questions as good, very 
good, or excellent.
Likely to be Unsuccessful Group definition:
x
Not meeting the definition of successful.
Study Endpoints
Primary endpoint(s) :
x
Quest questionnaire classification
x
Likelihood to be a successful lens wearer
Secondary endpoint(s):
x
Auto-refraction & keratometry (Autorefractor)
x
Refraction including reading addition (Phoropter) 
x
LogMAR acuity (using VA charts): monocular & 
binocular; distance, near (0.4 m), intermediate (1 m) 
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x
Fixation Disparity (with refraction): distance, & near 
(40 cm)
x
Blur tolerance (with refraction): binocular, 1-meter 
distance only
x
Stereo-acuity: near (40 cm) 
x
Contrast threshold: OD, OS, and OU distance only
x
Pupil size: Photopic; OD & OS, distance, intermediate 
(1 m) & near (40 cm)
x
Pupil size: Scotopic; OD & OS, distance, intermediate 
(1 m) & near (40 cm)
x
Non-invasive tear break-up time: OD & OS (Placido disc)
x
Objective accommodation with distance refraction (WAM 
5500: 4 m, 1 m, and 40 cm target) OD & OS
x
Spherical aberration: COAS, over 2 seconds after blink, 
OD & OS @ distance target
x
Coma 
x
Other higher order aberrations  
x
Medmont Lens centration OD and OS
Study Design
This is a prospective, single-arm, and bilateral dispensing 
study.  
There will a total of 6 visits:
Visit 1 (Screening and Baseline-day 0 ): consent, eligibility 
confirmation, pre-fit interview, and evaluation assessments
Visit 2 (Baseline & dispensing-Day 0): personality test, 
evaluation assessments, study lens fitting, CL insertion and 
removal training (non-CL wearers, up to 1 additional training 
appointments are permitted), subjective responses to CL 
performance, dispensing of CL  
Visit 3 (1-week follow-up, lens power optimization-Day 7±3 
from Visit 2): CL power optimization, lens fit assessment, 
evaluation assessments
Visit 4 (2-week follow-up- Day 7±3 from Visit 3): lens fit 
assessment, evaluation assessments, subjective responses to 
CL performance 
Visit 5 (6-week follow-up Day 28±6 from Visit 2-): lens fit 
assessment, evaluation assessments, subjective responses to 
CL performance 
Visit 6 (12-week follow-up Day 42±6 from Visit 2-): Post-fit 
interview, lens fit assessment, evaluation assessments, 
subjective responses to CL performance 
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Study exit: Investigator recommendation, if applicable (study 
CLs suitable/not suitable to prescribe, plus investigator 
reasons where not suitable is indicated), exit procedures. 
See the flow chart at the end of the synopsis table for the 
schematic of the study visits and procedures of main 
observations (Figure 1).
Sample Size
The target is to dispense lenses to 50 presbyopic Subjects
who had no experience with soft multifocal contact lens wear 
for >2 years; total sample size 50. Enrollment is potentially 
likely to be up to approximately 75 to account for screen 
failures.
Study Duration
The study is anticipated to have a duration of approximately 
9 months in total, with enrollment lasting approximately 
6 months.
Anticipated Study 
Population 
All eligible Subjects will have no experience with soft 
multifocal contact lenses (MF CLs) for >2 years. The study 
population includes previous MF CL wearers, single vision 
CL wearers and subjects who are neophyte to CL wear; 
The target is to include myopes only, with a maximum 
reading addition of +1.75 DS. 
There are no sex or race requirements.
All subjects need to be in the presbyopic age group ie, 
 years old and with a minimum add of +0.75 D.
Current MF CL wearers and current monovision wearers are 
not eligible. 
Eligibility Criteria
Potential Subjects must satisfy all of the following criteria to 
participate in the study:
1. The participant must read, understand, and sign the 
STATEMENT OF INFORMED CONSENT and receive a 
fully executed copy of the form.  
2. Appear able and willing to adhere to the instructions set 
forth in this clinical protocol. 
3. Is at least 40 years of age (inclusive) at the time of 
screening and has full legal capacity to volunteer. 
4. Had a self-reported eye examination in the last two years.
5. The subject must either already be wearing a presbyopic
correction (e.g., reading spectacles over contact lenses, or 
multifocal spectacles, etc.) or respond positively to at least 
one 
symptom 
on 
the 
“Presbyopic 
Symptoms 
Questionnaire”. 
6. Can achieve best corrected distance monocular visual 
acuity of at least +0.20 logMAR and binocular visual 
acuity of at least +0.10 logMAR with refraction.
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7. +DYHDUHIUDFWLYHF\OLQGHURI' in each eye.
8. Has corrected best sphere equivalent distance refraction in 
the range of -0.50 to -6.00 DS in each eye (vertex corrected 
if greater than -4.00 D).
9. Have a reading ADD power in the range of +0.75 D to 
+1.75 D (inclusive) in each eye. 
10. Have a wearable pair of spectacles if applicable (at the 
discretion of the investigator) to wear when they cannot 
wear the study lenses
Potential Subjects who meet any of the following criteria 
will be excluded from participating in the study: 
1. Participation in any contact lens or lens care clinical trial 
within 1 week prior to study enrollment. 
2. Employee or immediate family member of an employee of 
the Centre for Ocular Research & Education listed on the 
study Delegation Log (e.g., Investigator, Coordinator, 
Technician). 
3. Is currently pregnant or lactating, by self-report, or 
planning a pregnancy at the time of enrollment.  
4. Has any known active ocular disease and/or allergies, 
ocular infections or other abnormalities that are known to 
interfere with contact lens wear (at the discretion of the 
investigator). This may include, but not be limited to 
entropion, ectropion, extrusions, chalazia, recurrent styes, 
glaucoma, history of recurrent corneal erosions, or corneal 
distortion. 
5. Is using any topical ocular medications other than 
lubricating eye drops. 
6. Known to have any infectious disease (e.g., hepatitis, 
tuberculosis) or a contagious immunosuppressive disease.
7. Have any systemic disease, autoimmune disease, or use of 
medication, which may interfere with contact lens wear (at 
the discretion of the investigator). This may include, but 
not be limited to, hyperthyroidism, recurrent herpes 
simplex/zoster, Sjogren’s syndromes, xerophthalmia, acne 
rosacea, Stevens-Johnson syndromes.
8. Had a diagnosis of a condition known to affect ocular 
prescription or ocular surface or tear film e.g., rheumatoid 
arthritis, diabetes. 
9. Had a change within the previous 3 months to the dosage 
of a systemic medication known to affect ocular 
prescription or ocular surface or tear film (e.g., steroids) 
that in the opinion of the investigator may affect a study 
outcome variable.
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10. Has undergone cataract or refractive error surgery (e.g., 
radial keratotomy, PRK, LASIK, etc.), or has any planned 
(during the study) major surgery (e.g. hip replacement), or 
any planned ocular surgery (e.g. cataract or refractive error 
surgery).  
11. Is a current rigid contact lens wearer, or is wearing contact 
lenses on extended wear basis, or has a history of extended 
wear in the past 6 months. 
12. Has worn soft MF CLs in the past 2 years or is a habitual 
wearer of monovision CLs. 
13. Has a constant unilateral strabismus at both far and near 
distances, or Has anisometropia >2 D between both eyes, 
or has amblyopia. 
14. Has a known sensitivity to the diagnostic pharmaceuticals
to be used in the study (Refresh Plus® rewetting drop 
solution, or Sodium Fluorescein.
15. Has any Grade 3.0 or greater slit lamp findings (e.g., 
edema, corneal neovascularization, corneal staining, tarsal 
abnormalities, 
conjunctival 
injection) 
on 
the 
Biomicroscopy classification scale, any previous history 
or signs of a contact lens-related corneal inflammatory 
event (e.g., past peripheral ulcer or round peripheral scar), 
or any other ocular abnormality that may contraindicate 
contact lens wear (at the discretion of the investigator).
Disallowed 
Medications/Interventions 
Any medications (Rx or OTC, systemic or topical) that may 
interfere with contact lens wear (at the discretion of the 
investigator).
No ocular topical medications (e.g. Restasis, Xiidra, ocular 
steroids) except lubricating eye drops.  
Measurements and 
Procedures 
Visit 1 (Screening, Baseline):
Subjects will attend wearing their habitual contact lenses or 
if not a contact lens wearer then spectacles (if applicable), 
they also need to bring any distance / reading spectacles, 
package of their CLs, lens care solution, and 
rewetting/lubrication eye drops to the appointment. 
Consent procedures 
Demographics, health and medication, habitual correction 
type, CL wearing history.
Subjective responses to CL performance (CLUE 
questionnaire).  If habitual contact lens wearers.
CL experience and expectations (Quest-Quant questionnaire)
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Interview (pre-fit) to identify: Subjects’ success criteria; 
reasons for success/failure; visual demands eg. laptop, shift 
work, night driving etc.
logMAR acuity with habitual contact lenses/spectacles (if 
applicable): monocular & binocular; distance 
Auto-refraction & keratometry
Refraction including reading addition 
logMAR acuity (with refraction): monocular & binocular; 
distance, near (0.4 m), intermediate (1 m)
Ocular dominance 
Unilateral cover test: distance & near (40 cm) 
Stereo-acuity with refraction: near (40 cm) 
Fixation Disparity: distance& near (40 cm) 
Contrast threshold: OD, OS, and OU distance only
Non-invasive tear break-up time: OD & OS
Objective accommodation with distance refraction (WAM 
5500: 4 m, 1 m, and 40 cm target) OD & OS
Spherical aberration over bare eye: COAS, 2 secs after blink, 
OD & OS @ distance target
Coma over bare eye
Other higher order aberrations over bare eye 
logMAR acuity with habitual spectacles (if applicable):
monocular & binocular; distance
Visit 2 (Baseline, Treatment 1):
Subjects will attend wearing their habitual spectacles (if 
applicable) 
Personality test: BIG5
logMAR acuity with refraction: monocular & binocular; 
distance
Blur tolerance with refraction: binocular, 1 m distance only
Pupil size: Photopic; OD & OS, distance, intermediate (1 m) 
& near (40 cm) 
Pupil size: Scotopic; OD & OS, distance, intermediate (1 m) 
& near (40 cm) 
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Slit Lamp Biomicroscopy
Study CL fitting
Training for CL insertion & removal and lens care (non-CL 
wearers, up to 1 additional separate training visit within a 
maximum of 2 weeks from Visit 2 is permitted)
Post-fit Market Research (MRD) questionnaire 
Study CL dispense  
Lens fit assessment
logMAR acuity: monocular & binocular; distance, near (0.4 
m), intermediate (1 m)
Visit 3 Follow-up 1(1-week), lens optimization:
Subjects will attend wearing study CLs 
logMAR acuity with CLs: monocular & binocular; distance 
& near (40 cm) only
Pupil size: Photopic with CLs; OD & OS, distance, 
intermediate (1 m) & near (40 cm) 
Pupil size: Scotopic with CLs; OD & OS, distance, 
intermediate (1 m) & near (40 cm) 
Slit Lamp Biomicroscopy
Study CL fitting (CL power optimization)
logMAR acuity with CLs: monocular & binocular; distance 
& near (40 cm) only 
Post-fit questionnaire (MRD)
Contrast threshold: OD, OS, and OU distance only
Stereo-acuity with study CLs: near (0.4 m) 
Pre-lens non-invasive tear break-up time: OD & OS
Objective accommodation with CLs (WAM 5500: 4 m, 1 m, 
and 40 cm target) OD & OS
Spherical aberration over CLs: COAS, 2 secs after blink, OD 
& OS @ distance target
Coma over CLs
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Other higher order aberrations over CLs
Imaging for lens centration using Medmont Topographer, 
over CLs: OD, OS
Exit logMAR acuity with CLs: monocular & binocular; 
distance
Visit 4 Follow-up 2 (2-week) 
Subjects will attend wearing study CLs 
Subjective responses to CL performance (CLUE 
questionnaire).  
logMAR acuity with CLs: monocular & binocular; distance, 
intermediate (1 m) & near (40 cm)
Contrast threshold: OD, OS, and OU distance only
Stereo-acuity with study CLs: near (0.4 m)
Lens fit assessment
Pre-lens non-invasive tear break-up time: OD & OS
Objective accommodation with CLs (WAM 5500: 4 m, 1 m, 
and 40 cm target) OD & OS 
Spherical aberration over CLS: COAS, 2 secs after blink, 
OD & OS @ distance target
Coma over CLs
Other higher order aberrations over CLs 
Slit Lamp Biomicroscopy
Exit logMAR acuity with CLs: monocular & binocular; 
distance
Visit 5 Follow-up 3 (6-week):
Subjects will attend wearing study CLs 
Subjective responses to CL performance (CLUE 
questionnaire) 
logMAR acuity with CLs: monocular & binocular; distance, 
intermediate (1 m) & near (40 cm)
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Lens fit assessment
Slit Lamp Biomicroscopy
Exit logMAR acuity with CLs: monocular & binocular; 
distance
Visit 6 Follow-up 4 (12-week):
Interview (post-fit)
Subjective responses to CL performance (CLUE 
questionnaire, market research questionnaire)
logMAR acuity with CLs: monocular & binocular; distance, 
intermediate (1 m) & near (40 cm)
Contrast threshold: OD, OS, and OU distance only 
Stereo-acuity with study CLs: near (0.4 cm) 
Lens fit assessment
Objective accommodation with CLs (WAM 5500: 4 m, 1 m, 
and 40 cm target) OD & OS 
Spherical aberration over CLs: COAS, 2 secs after blink, OD 
& OS @ distance target
Coma over CLs
Other higher order aberrations over CLs 
Slit Lamp Biomicroscopy
Investigator RecommendationInvestigator recommendation, 
if applicable (study CLs suitable/not suitable to prescribe,
plus investigator reasons where not suitable is indicated)
Exit Slit Lamp Biomicroscopy  
Exit logMAR acuity with refraction: monocular & binocular; 
distance.
Final Evaluation
Biomicroscopy (if subject is discontinued and 
Biomicroscopy was not completed in the Visit) 
PRO (CLUE and MRD) contact lens questionnaires (if 
subject discontinued).
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 
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UADE or SAE, the Sponsor Medical Monitor may unmask
(if applicable) the treatment regimen of participant(s) and 
may discuss this with the Principal Investigator before any 
further Subjects are enrolled.
Ancillary Supplies/ Study-
Specific Materials
No lens care solution will be used in this study. The lenses 
will be worn on a daily disposable modality.
Principal Investigator(s) 
and Study 
Institution(s)/Site(s)
Prof. Lyndon Jones
Centre for Ocular Research and Education, University of 
Waterloo, CANADA
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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 
CI 
 
 
Confidence Interval 
CL 
 
 
Contact lens 
CLUE  
 
Contact Lens User Experience
COAS  
 
Complete Ophthalmic Analysis System
COM  
 
Clinical Operations Manager
CORE  
 
Centre for Ocular Research and Education
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
HCVA  
 
High Contrast Visual Acuity
HIPAA 
 
Health Insurance Portability and Accountability Act 
HIV 
 
 
Human Immunodeficiency Virus 
IB 
 
 
Investigator’s Brochure 
ICF 
 
 
Informed Consent Form 
ICL 
 
 
Informed Consent letter 
ICH 
 
 
International Council 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
MF 
 
 
Multifocal
MF CLs 
 
Multifocal Contact Lenses
MOP  
 
Manual of Procedures 
NIH 
 
 
National Institutes of Health
NITBUT 
 
Non Invasive Tear Break Up Time 
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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
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
UW 
 
 
University of Waterloo
VA 
 
 
Visual Acuity
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1.
INTRODUCTION AND BACKGROUND
Despite the growing number of presbyopes by aging, only a small fraction of presbyopic 
patients can be categorized as successful habitual soft multifocal (MF) contact lens (CL) 
wearers. Some habitual spectacle/single vision contact lens wearers in the presbyopic age 
group may have tried soft MF CLs in the past and dropped out from MF CL wear for various 
reasons. This single-arm study was designed to investigate the possible underlying reasons for 
achieving success or dropping out from soft MF CL wear.
1.1.
Name and Descriptions of Investigational Products 
This study will test a etafilcon Multifocal CL. Further details about the test article is found in 
Section 6 of this protocol. No control products will be used in this study. 
1.2.
Intended Use of Investigational Products
The intended use of the investigative product is for correcting presbyopia. During the study, 
the test article will be worn bilaterally in daily wear, daily  disposable modality for at least 6 
hours per day every day for approximately 12 weeks.  
1.3.
Summary of Findings from Nonclinical Studies
N/A
1.4.
Summary of Known Risks and Benefits to Human Subjects
x
This is a minimal risk study because of the use of an approved and previously marketed 
contact lens (1-Day Acuvue Moist brand Multifocal) and standard optometric assessments. 
x
Participants may not benefit directly in this study, other than having an opportunity to wear 
a marketed multifocal contact lens, at no cost to them. Information from this study may 
help the study sponsor to come up with new soft multifocal contact lens designs to help 
others in the future.  
See package insert for additional information.  
1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study
N/A.
2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES
2.1.
Objectives 
Primary Objective(s): 
To determine if the QUEST questionnaire, collected at baseline, are significantly correlated 
with subject groups that are classified as being ‘likely to be successful’ and/or ‘likely to be 
unsuccessful’ after wearing an investigational multifocal contact lens.  
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Secondary Objective(s):  
To determine if certain physical ocular related data is significantly correlated with subject 
groups that are classified as being ‘likely to be successful’, ‘likely to be unsuccessful’ after 
wearing an investigational multifocal contact lens.
Likely to be Successful Group definition: 
x
Completed study, AND ... 
x
Investigator would recommend the study CLs, AND ... 
x
The subjects’ response on the MRD “overall quality of vision” and “overall comfort” 
questions as good, very good, or excellent.
Likely to be Unsuccessful Group definition:
x
Not meeting the definition of successful. 
Exploratory Objective(s):  
BIG 5 Personality Assessment 
2.2.
Endpoints 
Primary Endpoints 
x
Likelihood to be a successful lens wearer * 
x
Quest questionnaire classification
Secondary Endpoints
x
Auto-refraction & keratometry (Autorefractor)
x
Refraction including reading addition (Phoropter) 
x
LogMAR acuity (using VA charts): monocular & binocular; distance, near (0.4 m), 
intermediate (1 m) 
x
Fixation Disparity (with refraction): distance, & near (40 cm)
x
Blur tolerance (with refraction): binocular, 1-meter distance only 
x
Stereo-acuity: near (40 cm) 
x
Contrast threshold: OD. OS, and OU distance only
x
Pupil size: Photopic; OD & OS, distance, intermediate (1 m) & near (40 cm) 
x
Pupil size: Scotopic; OD & OS, distance, intermediate (1 m) & near (40 cm)
x
Non-invasive tear break-up time: OD & OS (Placido disc)
x
Objective accommodation with distance refraction (WAM 5500: 4 m, 1 m, and 40 cm 
target) OD & OS
x
Spherical aberration: COAS, 2 secs after blink, OD & OS @ distance target
x
Coma 
x
Other higher order aberrations  
x
Lens centration OD & OS: Medmont 
Exploratory Endpoint(s):
x
BIG 5 Personality Assessment 
x
CLUE and Market Research Questionnaires
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*Likely to be Successful Group definition: 
x
Completed all required study visits, AND ... 
x
Investigator would recommend the study CLs, AND ... 
x
The subjects’ response on the MRD “overall quality of vision” and “overall comfort” 
questions as good, very good or excellent. 
Likely to be Unsuccessful Group definition:
x
Not meeting the definition of successful. 
2.3.
Hypotheses
Primary Hypothesis 
x
At least 75% of the subjects who are classified by Quest questionnaire as being
“discontented and driven” will be in the “likely to be successful” group. The Quest 
questionnaire will be collected at baseline.
Secondary Hypothesis
x
At least one of the secondary endpoints will be significantly correlated with the success 
classification of the subjects after adjusting for age, sex and ADD power.  
3.
TARGETED STUDY POPULATION
3.1.
General Characteristics 
There are no sex or race requirements for potential study Subjects. 
All Subjects need to be in the presbyopic age group i.e. 40 years or older and with a minimum 
add of +0.75 D. All eligible Subjects will have no experience with soft multifocal lenses (MF 
CLs) for >2 years. The study population includes previous MF CL wearers, Single vision CL 
wearers and Subjects who are neophyte to CL wear. Current MF CL wearers and current 
monovision wearers are not eligible.
The study will include myopes only, with reading ADDs from +0.75 up to and including 
+1.75 DS.
3.2.
Inclusion Criteria
Potential Subjects must satisfy all of the following criteria to be enrolled in the study:
1. The participant must read, understand, and sign the STATEMENT OF INFORMED 
CONSENT and receive a fully executed copy of the form.  
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol. 
3. Is at least 40 years of age (inclusive) at the time of screening and has full legal capacity to 
volunteer. 
4. Had a self-reported eye examination in the last two years.
5. The subject must either already be wearing a presbyopic correction (e.g., reading spectacles 
over contact lenses, or multifocal spectacles, etc.) or respond positively to at least one 
symptom on the “Presbyopic Symptoms Questionnaire”. 
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6. Can achieve best corrected distance monocular visual acuity of at least +0.20 logMAR and 
binocular visual acuity of at least +0.10 logMAR with refraction. 
7. Have a refractLYHF\OLQGHURI' in each eye.
8. Has corrected best sphere equivalent distance refraction in the range -0.50 D of -6.00 D in 
each eye (vertex corrected if greater than -4.00D). 
9. Have a reading ADD power in the range of +0.75 D to +1.75 D (inclusive) in each eye.
10. Have a wearable pair of spectacles (at the discretion of the investigator) to wear when they 
cannot wear the study lenses. 
3.3.
Exclusion Criteria
Potential Subjects who meet any of the following criteria will be excluded from participating 
in the study:  
1. Participation in any contact lens or lens care clinical trial within 1 week prior to study 
enrollment. 
2. Employee or immediate family member of an employee of the Centre for Ocular Research 
& Education listed on the study Delegation Log (e.g., Investigator, Coordinator, 
Technician).
3. Is currently pregnant or lactating, by self-report, or planning a pregnancy at the time of
enrollment.  
4.
Has any known active ocular disease and/or allergies, ocular infections or other 
abnormalities that are known to interfere with contact lens wear (at the discretion of the 
investigator). This may include, but not be limited to entropion, ectropion, extrusions, 
chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or corneal 
distortion. 
5. Is using any topical ocular medications other than lubricating eye drops. 
6. Known to have any infectious disease (e.g., hepatitis, tuberculosis) or a contagious 
immunosuppressive disease. 
7. Have any systemic disease, autoimmune disease, or use of medication, which may interfere 
with contact lens wear (at the discretion of the investigator).  This may include, but not be 
limited to, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren’s syndromes, 
xerophthalmia, acne rosacea, Stevens-Johnson syndromes.
8. Had a diagnosis of a condition known to affect ocular prescription or ocular surface or tear 
film e.g., rheumatoid arthritis, diabetes. 
9. Had a change within the previous 3 months to the dosage of a systemic medication known 
to affect ocular prescription or ocular surface or tear film (e.g., steroids) that in the opinion 
of the investigator may affect a study outcome variable. 
10. Has undergone cataract or refractive error surgery (e.g., radial keratotomy, PRK, LASIK, 
etc.), or has any planned (during the study) major surgery (e.g., hip replacement), or any 
planned ocular surgery (e.g., cataract or refractive error surgery).
11. Is a current rigid contact lens wearer, or is wearing contact lenses on extended wear basis, 
or has a history of extended wear in the past 6 months. 
12. Has worn soft MF CLs in the past 2 years or is a habitual wearer of monovision CLs. 
13. Has a constant unilateral strabismus at both far and near distances, or has anisometropia 
>2 D between both eyes, or has amblyopia. 
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14. Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study (Refresh 
Plus®rewetting drop solution, or Sodium Fluorescein). 
15. Has any Grade 3.0 or greater slit lamp findings (e.g., edema, corneal neovascularization, 
corneal staining, tarsal abnormalities, conjunctival injection) on the biomicroscopy
classification scale, any previous history or signs of a contact lens-related corneal 
inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular 
abnormality that may contraindicate contact lens wear (at the discretion of the investigator).
3.4.
Enrollment Strategy
All Subjects QHHGWREHLQWKHSUHVE\RSLFDJHJURXSLH years old and with a minimum add 
of +0.75 D. There are no sex or race requirements.
All eligible Subjects will have no experience with soft multifocal lenses (MF CLs) for >2 years. 
The study population includes previous MF CL wearers, Single vision CL wearers and 
Subjects who are neophyte to CL wear. Current MF CL wearers and current monovision 
wearers are not eligible.
The study will include myopes only, with reading ADDs from +0.75 up to and including 
+1.75 DS. 
4.
STUDY DESIGN AND RATIONALE
4.1.
Description of Study Design
This will be a prospective, single group, single-arm, and bilateral dispensing study. There will 
be no randomization and no masking in this non-controlled single-arm study. There also will 
be no wash out period. Subjects will be assigned to a single study lens type to be worn 
bilaterally in daily wear, and daily disposable modality, for at least 6 hours per day every day 
for approximately 12 weeks. 
There will 6 visits in this study: 
Visit 1: screening and baseline; eligibility confirmation, Quest questionnaire, pre-fit interview 
Visit 2: baseline; personality test, study lens fitting
Visit 3: 1-week; CL power optimization
Visit 4: 2-week assessments with study CLs
Visit 5: 6-week assessments with study CLs
Visit 6: 12-week assessments with study CLs, post-fit interview
4.2.
Study Design Rationale
This study was designed based on its exploratory nature. The single-arm design is used to 
explore differences in personality and qualitative interview variations as well as differences in 
refraction and anatomical measurements between successful and unsuccessful Subjects with
study soft multifocal lenses. 
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4.3.
Enrollment Target and Study Duration
x
Up to approximately 75 Subjects will be screened, with a target of dispensing product 
to up to 50 subjects who may complete the study. Subjects will be recruited using 
CORE records and advertising approved by the University of Waterloo (UW) Office 
of Research Ethics (ORE).
x
Point of enrollment in this study will be execution of informed consent. 
x
There will be a total of 6 study visits including the study screening visit during which 
consent, eligibility confirmation, interview and evaluation assessments will be 
conducted. 
x
The study will last approximately 9 months and include a 6 month enrollment period. 
x
This will be a single site study. Study visits will be conducted at Centre for Ocular 
Research & Education (CORE), University of Waterloo, Ontario.
5.
TEST ARTICLE ALLOCATION AND MASKING
5.1.
Test Article Allocation 
There will be no randomization in this single arm study as there will be no controls, and only 
one test article is used.
5.2.
Masking
Not applicable. There will be no masking in this study. 
Subjects who are discontinued will not be replaced.
5.3.
Procedures for Maintaining and Breaking the Masking
Not applicable. There will be no masking in this study. 
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adequate supply of test articles to complete the study. Lost or damaged test articles may be 
replaced at the discretion of the Investigator and/or the Sponsor.
6.4.
Packaging and Labeling
The test articles will be packaged in blisters as the primary packaging. 
The test articles will be in labeled cartons based upon their lens power. The sample label is 
shown below:  
6.5.
Storage Conditions 
Test articles will be maintained at ambient temperatures at the clinical site. Test articles must 
be kept under secure conditions. 
6.6.
Collection and Storage of Samples 
When possible, any lens or test article associated with an Adverse Events and/or a Product 
Quality Complaint must be retained and stored in a glass vial with moderate solution pending 
directions from the sponsor for potential return back to JJVC. 
6.7.
Accountability of Test Articles
JJVC will provide the Investigator with sufficient quantities of study articles and supplies to 
complete the investigation.  The Investigator is asked to retain all lens shipment documentation 
for the test article accountability records. 
Test article must be kept in a locked storage cabinet, accessible only to those assigned by the 
Investigator for dispensing. The Investigator may delegate this activity to authorized study site 
personnel listed on the Site Delegation Log.  All test articles must be accounted.  This includes:
1. What was dispensed for the participant for trial fitting, to wear out of the office, or 
issued for the participant to replace appropriately between visits 
2. What was returned to the Investigator unused 
3. The number and reason for unplanned replacements. 
The Investigator will collect all unused test articles from the Subjects at the end of the 
participant’s participation, when possible. Subject returned unused test articles must be 
separated from the clinical study inventory of un-dispensed test articles and must be labeled 
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OS, distance, 
intermediate (1 m) 
& near (40 cm),
with refraction
Pupil size 
Photopic; OD & 
OS, distance, 
intermediate (1 m) 
& near (40 cm) 
Pupil size: 
Scotopic; OD & 
OS, distance, 
intermediate (1 m) 
& near (40 cm)
with CLs
X
Auto-refraction & 
keratometry
X
Subjective Sphero-
Cylindrical 
Refraction
X
X
Reading addition
X
logMAR acuity: 
monocular & 
binocular; distance, 
near (0.4 m), 
intermediate (1 m),
with refraction
X
logMAR acuity: 
monocular & 
binocular; distance 
& near (0.4 m) 
only,  
with CLs
X
X
logMAR acuity: 
monocular & 
binocular; distance 
& near (0.4 m) 
only,  
with over-
refraction
X
X
logMAR acuity: 
monocular & 
binocular; distance, 
near (0.4 m), 
intermediate (1 m),
with CLs
X
X
X
Ocular dominance
X
Unilateral cover 
test: distance & 
near (40 cm)
X
Stereo-acuity: near 
(40 cm), with near 
refraction
X
Stereo-acuity: near 
(40 cm), with CLs
X
X
X
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Fixation Disparity
with refraction
X
Contrast threshold: 
OD, OS and OU
distance only,
with refraction
X
Contrast threshold: 
OD, OS and OU
distance only,
with CLs
X
X
X
Non-invasive tear 
break-up time: OD 
& OS,
over bare eye
X
Pre-lens Non-
invasive tear 
break-up time: OD 
& OS,
over CLs
X
X
Slit Lamp 
Biomicroscopy,
X
X
X
X
X
X
X (if 
required)
Objective 
accommodation 
(WAM 5500: 4 m, 
1 m, and 40 cm 
target) OD & OS,
with distance 
refraction
X
Objective 
accommodation 
(WAM 5500: 4 m, 
1 m, and 40 cm 
target) OD & OS,
with CLs
X
X
X
Spherical 
aberration: COAS, 
over 2 secs after 
blink, OD & OS @ 
distance target
Coma Other higher 
order aberrations,  
over bare eye
X
Spherical 
aberration: COAS, 
over 2 secs after 
blink, OD & OS @ 
distance target
Coma Other higher 
order aberrations, 
over CLS
X
X
X
Baseline imaging 
for lens centration 
OD & OS: 
Medmont,
over bare eye
X
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Imaging for lens 
centration OD & 
OS: Medmont,
over CLs
X
Exit distance VA 
with spectacles/
refraction
X
X
Exit distance VA 
with CLs
X
X
X
X
Lens Selection
X
X (if 
modified)
Lens Insertion & 
Settling
X
X (if 
modified)
Lens Power 
Modification (if 
applicable)
X
X
Subject Reported 
Ocular Symptoms
X
X
X
X
X
Subjective 
responses to CL 
performance
(CLUE)
X
X
X
X
X
Subjective 
responses to CL 
performance 
(market research)
X
X
Lens Fit 
Assessment
X
X
X
X
X
Training for CL 
insertion & 
removal and lens 
care (non-CL 
wearers)
X
Study CL dispense 
X
X
X
X
Dispense Patient 
Instruction Guide
X
Lens wear 
Compliance
X
X
X
X
Study Completion
X
Investigator 
recommendation, if 
applicable (study 
CLs suitable/not
suitable to 
prescribe, plus 
investigator 
reasons where not 
suitable is 
indicated)
X
Final Evaluation 
X
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2.21. Continuance 
(Neophytes and/ or 
lapsed wearers)
The investigator will confirm the participant is able 
to insert/remove study CLs independently and 
willing to follow lens handling and care 
instructions.
Note: If the subject is unable to insert and remove 
the contact lenses independently the subject may 
return for one additional visit to repeat the I/R 
training and be dispensed lenses if training is 
successful.  If the subject needs additional training 
they will not be dispensed any lenses at this visit 
and will have exit visual exit visual acuity as 
described in step 2.22 below measured with their 
habitual spectacles.  They will have a separate I/R 
training visit within two weeks and at the visit VA 
will be measured at distance OD, OS and OU with 
their habitual spectacles, biomicroscopy will be 
performed prior to I/R training and if the subject is 
successful a lens fit assessment will be performed 
and steps 2.22 through 2.27 below will be repeated.  
If unsuccessful the subject will be discontinued, 
and the final evaluation completed.
2.22. Exit Visual Acuity
Record the distance exit visual acuity, to the 
nearest letter, with the contact lenses (OD, OS, 
OU).  
Note that the distance visual acuity must be at 
least 0.18 logMAR OU for the lenses to be 
dispensed and the participant must indicate that 
their vision is acceptable with the lenses.  If the 
participant does not obtain an acceptable visual 
response (subjective or objective) remove the 
lenses, complete the slit-lamp exam and Final 
Evaluation.    
2.23. Dispensing Criteria
For the participant to continue in the study, they 
must meet all three of the following criteria:
x
Distance Binocular Visual acuity is 0.18 or 
better 
x
The lens fit is acceptable OD and OS
x
Investigator approval.  
If the Investigator does not approve the dispensing 
of the study lens, then the study is terminated for 
that participant.
2.24. Lenses 
Subjects will be dispensed enough lenses to last 
them until their next visit. Additional “spare” 
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lenses may be dispensed to the subject based on 
the Investigators discretion.  
Subjects are permitted to use Refresh Plus® CL 
rewetting drops with the study lenses. Use of any 
other artificial tears/lubricating eye drops is not 
permitted with study CLs.
2.25. Patient Instructions
Instruct the Subject the following:
x
The lenses will be worn on a daily wear daily 
disposable basis. 
x
Enough lenses will be dispensed to the subject 
to wear for the required number of days until 
their follow-up visit   Additional “spare” 
lenses may be dispensed to the subject based 
on the Investigators discretion.     
x
Instruct the subject to bring back all unworn 
study lenses.  If determined necessary by the 
Investigator Refresh Plus® sterile non-
preserved rewetting drops may be dispensed to 
be used as needed for dryness.
x
Subjects will be instructed to wear lenses for a 
minimum of 6 hours a day every day during 
the study. 
x
Subjects will be instructed to wear their 
glasses (if applicable) when not wearing the 
study lenses.
x
A patient instruction booklet will be provided. 
Note: In the event a lens is lost or damaged, if no 
spare lenses are available, the subject will return 
to the investigator site for replacement.  As much 
as reasonably possible, a damaged lens should be 
returned to the investigational site and then 
returned to the Sponsor.  If lens damage is 
present, complete the Product Quality Complaint 
Form. The lens will be stored in labeled vial with 
sterile saline and returned to the Sponsor.
2.26. Wearing Schedule
The test lenses will be worn on a daily wear, daily 
disposable basis.  
Note: Instruct the Neophytes / Lapsed wearer 
subjects to follow this wear schedule for wearing 
the study lenses:
Dispensing day: 6 hours of wear
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x
Participant not compliant to protocol (not compliant with or not able to follow study 
procedures, or study procedures/interviews /assessments could not be conducted)
x
Participant lost to follow-up  
x
Participant no longer meets eligibility criteria (e.g. the participant becomes pregnant)
x
Participant develops significant or serious adverse event during the study visit (e.g. a 
heart attack)
x
Subjects presenting with a Corneal Infiltrative Event (CIE), or an eye infection
x
Subject develops significant or serious adverse events causing discontinuation of 
study lens wear (missing more than half of the required days of lens wear in-between 
visits will lead to discontinuation, e.g. wearing the lens for only 1 day instead of the 
minimum of 4 days between visits 2 and 3) 
x
Investigator’s clinical judgment regarding the participant safety reasons (that it is in 
the best interest of the participant to stop the study visit) 
x
Participant missed two consecutive study visits 
x
Participant not compliant with study lens wear schedule 
x
Participant 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
not complete the scheduled visit procedures
x
Complete the Final Evaluation, indicating the reason that the participant was 
discontinued from the study 
x
Record the spherocylindrical refraction with best corrected distance visual acuity if 
applicable (i.e. if this was already measured during the same day) otherwise perform a 
spherocylindrical refraction and record the exit distance visual acuity. 
x
Collect used test article(s) (worn or brought to the visit) from the participant and discard 
them, unless otherwise stated in Section 7.2
x
Collect all unused test article(s) from the participant
An additional participant may be enrolled if a participant discontinues from the study 
prematurely. 
In cases where a participant is lost to follow-up, every possible effort must be made to contact 
the participant and determine the reason for discontinuation/withdrawal.  The measures taken 
to follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt.  
9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION
Concomitant medications will be documented during screening and updated during the study.  
Disallowed medications for this study include: Any topical ocular medications except 
lubricating eye drops.   
Concomitant therapies that are disallowed include: A change within the previous 3 months to 
the dosage of a systemic medication known to affect prescription or ocular surface or tear film 
(eg. steroids).
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10. DEVIATIONS FROM THE PROTOCOL
Investigator will notify study sponsor upon identification of a protocol deviation. Major 
protocol deviations must be reported to the sponsor within 24 hours after discovery of the 
protocol deviation.  The Investigator will report deviations per IRB/IEC requirements.  All 
deviations will be tracked, and corrective actions implemented as appropriate.  
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial participant, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB.  
11. STUDY TERMINATION
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article.  In the event of a USADE or SAE, the Sponsor may unmask 
(if applicable) the treatment regimen for the participant(s) and will discuss this with the 
Investigator before any further Subjects are enrolled.
The Sponsor will determine when a study will be stopped.  The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason.  Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined.  The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.   
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events.  If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated, as soon as possible. 
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements. 
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to Subjects,
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints: 
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x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO)” 
x
Clinical test articles that are stored improperly or damaged after receipt at the 
investigational site
x
Lens replacements that occur due to drops/fall-outs
x
Damage deemed by clinicians or clinical staff to be caused by handling by the user, 
and not indicative of a quality deficiency (i.e. tears, rips, etc.), only in situations where 
there is no deficiency alleged by the participant
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 participant) 
x
OD/OS indication, along with whether the lens was inserted 
x
Any related AE number if applicable 
x
Detailed complaint description (scheduled/unscheduled visit, wear time, symptoms, 
resolution of symptoms, etc.) 
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 
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE).  If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.   
In some cases, a PQC form may be generated in EDC by the site in error.  In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented. 
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13. ADVERSE EVENTS
13.1. Definitions and Classifications
Adverse Event (AE) – An AE is “any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal laboratory findings) in Subjects, users 
or other persons, whether or not related to the investigational medical device.  
Note 1 to entry: This definition includes events related to the investigational medical device 
or the comparator.
Note 2 to entry: This definition includes events related to the procedures involved. 
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices.”1
An AE includes any condition (including a pre-existing condition) that:
1. Was not present prior to the study, but appeared or reappeared following initiation of 
the study  
2. Was present prior to the study but worsened during the study. This would include any 
condition resulting from concomitant illnesses, reactions to concomitant medications, 
or progression of disease states 
3. Pregnancy must be documented as an adverse event and must be reported to the clinical 
monitor and to the Sponsor immediately upon learning of the event 
Serious Adverse Event (SAE) – An SAE is any untoward medical occurrence that: 
x
Results in death
x
Is life threatening
x
Requires in-patient hospitalization or prolongation of existing hospitalization
Results in persistent or significant disability/incapacity (e.g., a sight threatening event, a 
significant persistent or permanent change, impairment, damage, or disruption to the 
participant’s body)
x
Is a congenital anomaly/birth defect
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 participant 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 (BSCVA) equivalent to 2 
acuity lines or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
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x
Uveitis
x
Endophthalmitis 
x
Hypopyon 
x
Hyphemia 
x
Penetration of Bowman’s Membrane 
x
Persistent Epithelial Defect
x
Limbal cell Damage leading to Conjunctivalization 
Significant Adverse Events – Those events that are usually symptomatic and warrant 
discontinuation (temporary or permanent) of the test article (excluding Serious Adverse 
Events).   
Diagnoses and conditions that are considered Ocular Significant Adverse Events include, but 
not limited to the following: 
x
Contact Lens Induced Peripheral Ulcer (CLPU)
x
Significant Infiltrative Events (SIE)
x
Superior Epithelial Arcuate Lesions (SEALs)
x
Any Temporary Loss of >2 Lines of BSCVA 
x
Other grade 3 or higher corneal findings, such as abrasions or edema 
x
Non-contact lens related corneal events - e.g. Epidemic Keratoconjunctivitis (EKC) 
x
Asymptomatic Corneal Scar
x
Any corneal event which necessitates temporary lens discontinuation >2 weeks
Non-Significant Adverse Events – Those conditions that are usually asymptomatic and 
usually do not warrant discontinuation (temporary or permanent) of the test article.  However, 
the Investigator may choose to treat as a precautionary measure.  
Diagnoses and conditions that are considered Ocular Non-Significant Adverse Events include, 
but not limited to the following: 
x
Non-significant Infiltrative Event (NSIE)
x
Contact Lens Papillary Conjunctivitis (CLPC)
x
Superficial Punctate Keratitis (SPK)
x
Conjunctivitis: Bacterial, Viral, Allergic
x
Blepharitis
x
Meibomianitis
x
Contact Dermatitis
x
Localized Allergic Reactions
x
Any corneal event not explicitly defined as serious or significant adverse event, which 
necessitates temporary lens discontinuation < 2 weeks
Adverse Device Effect (ADE) – An ADE is an “adverse event related to the use of an 
investigational medical device.
Note 1 to entry: This definition includes adverse events resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device. 
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Note 2 to entry: This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device.”1
Unanticipated Adverse Device Effect (UADE) – Any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, the test article, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, Investigator’s Brochure or protocol, or any other 
unanticipated serious problem associated with the test article that relates to the rights, safety 
and welfare of Subjects. 
13.2. Assessing Adverse Events
In conjunction with the medical monitor, the Investigator will evaluate adverse events to ensure 
the events are categorized correctly.  Elements of categorization will include:
x
Seriousness/Classifications (see definition in Section 13.1) 
x
Causality or Relatedness – i.e. the relationship between the test article, study treatment 
or study procedures and the adverse event (not related; unlikely related; possibly 
related; related - see definition in Section 13.2.1) 
x
Adverse Event Severity – Adverse event severity is used to assess the degree of 
intensity of the adverse event (mild; moderate; severe for all events - see definition in 
Section 13.2.2)
x
Outcome – not recovered or not resolved; recovering or resolving; recovered or 
resolved with sequelae; recovered or resolved; death related to adverse event; unknown
x
Actions Taken – none; temporarily discontinued; permanently discontinued; other 
13.2.1. Causality Assessment
Causality Assessment – A determination of the relationship between an adverse event and the 
test article. The test article relationship for each adverse event should be determined by the 
investigator using these explanations:
x
Not Related- An adverse event that is not related to the use of the test article, study 
treatment or study procedures 
x
Unlikely Related – An adverse event for which an alternative explanation is more 
likely, e.g. concomitant treatment, concomitant disease(s), or the relationship of time 
suggests that a causal relationship is not likely
x
Possibly Related – An adverse event that might be due to the use of the test article, or 
to the study treatment or study procedures. An alternative explanation, e.g. concomitant 
treatment, concomitant disease(s), is inconclusive.  The relationship in time is 
reasonable.  Therefore, the causal relationship cannot be excluded 
x
Related – An adverse event that is listed as a possible adverse effect (device) or adverse 
reaction (drug) and cannot be reasonably explained by an alternative explanation, e.g. 
concomitant treatment of concomitant disease(s).  The relationship in time is very 
suggestive, e.g. it is confirmed by de-challenge and re-challenge 
13.2.2. Severity Assessment
Severity Assessment – A qualitative assessment of the degree of intensity of an adverse event 
as determined by the Investigator or reported to him/her by the participant.  The assessment of 
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severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale: 
x
Mild – Event is noticeable to the participant, but is easily tolerated and does not 
interfere with the participant’s daily activities
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the participant’s daily activities
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the participant’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 
participant’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 
participant record and in the eCRFs. He/she will complete the Adverse Event /eCRF.  
Complete descriptions of all adverse events must be available in the participant 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 participant is enrolled in the study must be documented 
appropriately regardless of relationship.   
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements.  
Such documentation will include the following: 
x
Adverse event (diagnosis not symptom) 
x
Drawings or photographs (where appropriate) that detail the finding (e.g., size, 
location, and depth, etc.)  
x
Date the clinical site was notified 
x
Date and time of onset
x
Date and time of resolution
x
Adverse event classification, severity, and relationship to test articles, as applicable
x
Treatment regimen instituted, including concomitant medications prescribed, in 
accordance with applicable licensing requirements
x
Any referral to another health care provider if needed
x
Outcome, ocular damage (if any) 
x
Likely etiology 
x
Best corrected visual acuity at the discovery of the event and upon conclusion of the 
event 
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In addition, if an infiltrate(s) is present, he/she will complete the Corneal Infiltrate Assessment 
eCRF.  Where necessary, a culture of the corneal lesion will be collected to determine if the 
infection is microbial in nature.  If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed.  Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved.  If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider.  The Investigator will use his/her clinical 
judgment as to whether a participant reporting with an adverse event will continue in the study.  
If a participant is discontinued from the study, it will be the responsibility of the Investigator 
to record the reason for discontinuation.  The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any Subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up.
13.4. Reporting Adverse Events 
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event.  In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (Section 13.4.2).  The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures. 
13.4.1. Reporting Adverse Events to Sponsor
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
hours following discovery of the event.  The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
Subjects experiencing a serious/significant adverse event must be followed up and all 
outcomes must be reported. 
When medically necessary, the Investigator may break the randomization code (if applicable) 
to determine the identity of the treatment that the participant received.  The Sponsor and study 
monitor should be notified prior to unmasking (if applicable) the test articles.
In the event of a serious/significant adverse event, the Investigator must:
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x
Notify the Sponsor immediately 
x
Obtain and maintain in the participant’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
participant
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations 
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect.  This report is in addition to the 
immediate notification mentioned above. 
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect.
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery. 
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set forth 
by their Approving IEC/IRB. Each clinical site will refer to and follow any guidelines set forth 
by their local governing Health Authorities. 
The Sponsor will report applicable Adverse Events to the local health authorities according the 
written guidelines, including reporting timelines.  
13.4.3. Event of Special Interest
Not applicable - No events of special interest are expected for this study.
13.5. Reporting of Pregnancy
Subjects reporting pregnancy (by self-report) during the study screening section of this study 
will be discontinued as a screen failure. Subjects reporting pregnancy (by self-report) during 
the study will be discontinued after the event is recorded as an Adverse Event.  Once 
discontinued, pregnant Subjects and their fetuses will not be monitored for study related 
purposes. Pregnant Subjects are not discontinued from contact lens or solution related studies 
for safety concerns, but due to general concerns relating to pregnancy and contact lens use.  
Specifically, pregnant women are discontinued due to fluctuations in refractive error and/or
visual acuity that occur secondary to systemic hormonal changes, and not due to unforeseen 
health risks to the mother or fetus.
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14. STATISTICAL METHODS
14.1. General Considerations
Statistical Analysis will be undertaken by the sponsor. A general description of the statistical 
methods to be implemented in this clinical trial is outlined below. 
All data summaries and statistical analyses will be performed using the SAS software Version 
9.4 or higher (SAS Institute, Cary, NC). Throughout the analysis of data, the results for each 
subject/eye will be used when available for summarization and statistical analysis.  
Unscheduled visits will be summarized separately and will be excluded from the statistical 
analysis.
Summary tables (descriptive statistics and/or frequency tables) will be provided for all baseline 
variables, efficacy variables and safety variables as appropriate.  Continuous variables will be 
summarized with descriptive statistics (n, mean, standard deviation [SD], median, minimum 
and maximum). Frequency count and percentage of subjects or eyes within each category will 
be provided for categorical data. 
14.2. Sample Size Justification
This is an exploratory study to generate initial data for assessing a computational vision model. 
As such, the sample size was not determined based on any power analysis with regard to the 
primary endpoint. The collected data will be used to design future studies, if necessary. 
The planned sample size (75 to enroll and 50 to complete) was selected to enroll different 
categories of myopic presbyopes including previous MF CL wearers, Single vision CL wearers 
and Subjects who are neophyte to CL wear. Efforts will be made to enroll subjects in all three 
categories without specific targets to be achieved. 
All analysis will be conducted on the per-protocol population defined in section 14.3. 
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 Subjects regardless of actual treatment and subsequent withdrawal from study or deviation 
from protocol. At least one observation should be recorded. 
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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  
Likelihood to be a successful lens wearer vs. Quest questionnaire classification
The successful lens wear will be converted to a binary response the same as in the previous 
analysis. The proportion of response (“1”) will be analyzed using a generalized linear mixed 
model with a binary distribution and logit link function for all questions. Each model will 
include the experimental design factors: Quest questionnaire classification as the fixed effect; 
and subject as the random effect. Other baseline characteristics known to be important such as 
age, sex, and/or add power will be included as fixed covariates when appropriate.  
The proportion of successful lens wear for the subjects classified as being “discontented and 
driven” will be calculated with 95% CI for least square mean. If the lower limit of the CI is 
greater than 75%, the statistical superiority will be concluded.
14.6. Secondary Analysis 
Likelihood to be a successful lens wearer vs. physical ocular related measurements
The secondary analysis will be conducted using the same method as descried in Section 14.5 
regarding CLUE vision score at baseline. In the model the CLUE vision score at baseline will 
be replaced by the secondary endpoints (defined in Section 2.2) one at a time to determine 
the significance level of each physical ocular related measurement. If the measurement is 
taken by eye, average value of the left and right eye will be used.  
Kenward and Roger6 method will be used for the calculation of the denominator of degrees of 
freedom. 
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. 
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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 participant 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 participant 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 the 
Bioclinica 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. 
Data generated from interviews will be saved as audio files and any subsequent collation and 
tabulation of the interview notes will be organized in both Word and Excel files. 
Where applicable, data print-outs from instruments will be marked with study and participant
identifiers and retained in the participant record. If the print-out ink/paper are not stable, they 
will be photocopied, and the photocopy will also be retained in the participant record.  
External Date Sources for this study include: Not Applicable 
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 participant recordation for the purposes of monitoring and 
auditing the study. 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study.  
The content and structure of the eCRFs are compliant with ISO14155:2011.1
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15.2. Subject Record
At a minimum, participant record should be available for the following:  
x
participant 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 participant record is the eCRF or an external record.  The author of an entry in the 
participant record must be identifiable.  The first point of entry is considered to be the source 
record. 
Adverse event notes must be reviewed and initialed by the Investigator. 
16. DATA MANAGEMENT
16.1. Access to Source Data/Document 
The Investigator/Institution will permit trial-related monitoring, audits, IEC/IRB review and 
regulatory inspection(s) by providing direct access to source data/documents.  Should the 
clinical site be contacted for an audit by an IEC/IRB or regulatory authority, JJVC must be 
contacted and notified in writing within 24 hours. 
16.2. Confidentiality of Information
Information concerning the investigational product and patent application processes, scientific 
data or other pertinent information is confidential and remains the property of JJVC.  The 
Investigator may use this information for the purposes of the study only. It is understood by 
the Investigator that JJVC will use information developed in this clinical study in connection 
with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor. 
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16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, including the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator.  The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article. 
Training on case report form completion will be provided to clinical site personnel before the 
start of the study.  The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management.  Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate. 
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials.  The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities. 
17. MONITORING
The study monitors will maintain close contact with the Principal Investigator and the 
Investigator’s designated clinical site personnel.  The monitor’s responsibilities will include:
x
Ensuring that the investigation is being conducted according to the protocol, any 
subsequent amendments, and regulatory requirements are maintained 
x
Ensuring the rights and wellbeing of Subjects are protected
x
Ensuring adequate resources, including facilities, laboratories, equipment, and 
qualified clinical site personnel
x
Ensuring that protocol deviations are documented with corrective action plans, as 
applicable 
x
Ensuring that the clinical site has sufficient test article and supplies
x
Clarifying questions regarding the study
x
Resolving study issues or problems that may arise 
x
Reviewing of study records and source documentation verification in accordance with 
the monitoring plan 
18. ETHICAL AND REGULATORY ASPECTS
18.1. Study-Specific Design Considerations
Potential Subjects will be fully informed of the risks and requirements of the study and, during 
the study, Subjects will be given any new information that may affect their decision to continue 
participation.  Subjects will be told that their consent to participate in the study is voluntary 
and may be withdrawn at any time with no reason given and without penalty or loss of benefits 
to which they would otherwise be entitled.  Only Subjects who are fully able to understand the 
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risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled.
18.2. Investigator Responsibility
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements.  GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human Subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study Subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible.  The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical 
Practice (GCP),2 and applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB)
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable): 
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 participant recruitment materials
x
Information on compensation for study-related injuries or payment to Subjects for 
participation in the study
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB) 
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for Subjects 
x
Any other documents that the IEC/IRB requests to fulfill its obligation
This study will be undertaken only after IEC/IRB has given full approval of the final protocol, 
amendments (if any), the informed consent form, applicable recruiting materials, and 
participant 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 participant 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) 
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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 participant 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 participant must give written consent according to local requirements after the nature of 
the study has been fully explained. The consent form must be signed before performance of 
any study-related activity. The consent form that is used must be approved by both the Sponsor 
and by the reviewing IEC/IRB. The informed consent is in accordance with principles that 
originated in the Declaration of Helsinki,3 current ICH2 and ISO 141551 guidelines, applicable 
regulatory requirements, and Sponsor Policy. 
Before entry into the study, the Investigator or an authorized member of the clinical site 
personnel must explain to potential participant the aims, methods, reasonably anticipated 
benefits, and potential hazards of the study, and any discomfort it may entail. Subjects will be 
informed that their participation is voluntary and that they may withdraw consent to participate 
at any time.  
The participant 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 participant's dated signature. After having 
obtained the consent, a copy of the informed consent form must be given to the participant. 
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 
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personnel (e.g., name, clinic address and phone number, curriculum vitae) is participant to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States5 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 participant 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 participant 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 
participant before collection of data. Such consent should also address the transfer of the data 
to other entities and to other countries. 
The participant has the right to request through the Investigator access to his personal data and 
the right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations. 
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study Subjects confidential. 
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19. STUDY RECORD RETENTION
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all participant records that support the data collected from each participant, as well 
as all study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained for a minimum of 25 years, and at least two (2) years 
after the last approval of a marketing application in an ICH region and until there are no 
pending or contemplated marketing applications in an ICH region or until at least two (2) years 
have elapsed since the formal discontinuation of clinical development of the investigational 
product. These documents will be retained for a longer period if required by the applicable 
regulatory requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to 
inform the Investigator/Institution as to when these documents no longer need to be retained. 
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
accept the responsibility. The Sponsor must be notified in writing of the name and address of 
the new custodian. Under no circumstance shall the Investigator relocate or dispose of any 
study documents before having obtained written approval from the Sponsor. 
If it becomes necessary for the Sponsor or the appropriate regulatory authority to review any 
documentation relating to this study, the Investigator must permit access to such reports. 
If the Investigator has a question regarding retention of study records, he/she should contact 
JJVC.
20. FINANCIAL CONSIDERATIONS
Remuneration for study services and expenses will be set forth in detail in the Clinical Research 
Agreement.  The Research Agreement will be signed by the Principal Investigator and a JJVC 
management representative prior to study initiation. 
JJVC reserves the right to withhold remuneration for costs associated with protocol violations 
such as:
x
Continuing an ineligible participant in the study 
x
Scheduling a study visit outside the participant’s acceptable visit range
JJVC reserves the right to withhold final remuneration until all study related activities have 
been completed, such as: 
x
Query resolution 
x
Case Report Form signature 
x
Completion of any follow-up action items 
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21. PUBLICATION
This study will be registered on ClinicalTrials.gov by the sponsor.  
22. REFERENCES
1. ISO 14155:2011: Clinical Investigation of Medical Devices for Human Subjects — 
Good Clinical Practice. Available at: https://www.iso.org/standard/45557.html  
2. International Conference on Harmonization Good Clinical Practice E6 (ICH-GCP). 
Available at: http://www.ich.org/products/guidelines/efficacy/article/efficacy-
guidelines.html  
3. Declaration of Helsinki - Ethical principles for Medical Research Involving Human 
Subjects. Available at: https://www.wma.net/policies-post/wma-declaration-of-
helsinki-ethical-principles-for-medical-research-involving-human-Subjects/  
4. United States (US) Code of Federal Regulations (CFR). Available at: 
https://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR  
5. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html  
6. Kenward MG and Roger JH. Small Sample Inference for Fixed Effects from Restricted 
Maximum Likelihood. Biometrics. 1997; 53:983–997. 
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APPENDIX A : PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES)
AND QUEST/QUANT QUESTIONNAIRES :
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1
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2
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3
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5
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6
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7
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8
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10
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11
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12
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14
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15
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16
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18
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19
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
Will be provided separately
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT)
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T h e l e n s e s ar e ti nt e d bl u e u si n g R e a cti v e Bl u e D y e # 4 t o m a k e t h e l e n s e s m or e 
vi si bl e f or h a n dli n g. A b e n z otri a z ol e U V a b s or bi n g m o n o m er i s u s e d t o bl o c k U V 
r a di ati o n. 
L e n s Pr o p erti e s:
T h e p h y si c al/ o pti c al pr o p erti e s of t h e l e n s ar e:
• S p e ciﬁ c Gr a vit y ( c al c ul at e d):  
0. 9 8 – 1. 1 2
• R efr a cti v e I n d e x:  
1. 4 0
• Li g ht Tr a n s mitt a n c e: 
8 5 % mi ni m u m
• S urf a c e C h ar a ct er: 
H y dr o p hili c
• W at er C o nt e nt: 
5 8 %
• O x y g e n P er m e a bilit y ( D/ k):
V A L U E  
M E T H O D
2 1. 4 x 1 0 1 1 (c m2/sec)
( ml O2/ ml x m m Hg) @ 3 5° C  
Fatt (boundary corrected, edge corrected)
2 8. 0 x 1 0 1 1 (c m2/sec)
( ml O2/ ml x m m Hg) @ 3 5° C
Fatt (boundary corrected, non-edge corrected)
L e n s P ar a m et er s R a n g e s:
• Di a m et er ( DI A): 
1 2. 0 m m t o 1 5. 0 m m
• C e nt er T hi c k n e s s: 
Vari e s wit h p o w er
• B a s e C ur v e ( B C): 
7. 8 5 m m t o 1 0. 0 0 m m
• S p h eri c al P o w er ( D): 
- 2 0. 0 0 D t o + 2 0. 0 0 D
• C yli n d er P o w er ( C Y L): 
- 0. 2 5 D t o - 1 0. 0 0 D
• A xi s ( A XI S): 
2. 5° t o 1 8 0°
• A D D P o w er s :
+ 0. 2 5 D t o + 4. 0 0 D
A V AI L A B L E L E N S P A R A M E T E R S
1- D A Y A C U V U E ®  M OI S T Br a n d C o nt a ct L e n s e s ar e h e mi s p h eri c al s h ell s of t h e 
f oll o wi n g di m e n si o n s:
Di a m et er ( DI A):
1 4. 2 m m
C e nt er T hi c k n e s s:
0. 0 8 4 m m t o 0. 2 3 0 m m ( v ari e s wit h p o w er)
3
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 3 0 of 2 2 5
J J V C C O N FI D E N TI A L

B a s e C ur v e ( B C):
8. 5 m m, 9. 0 m m
P o w er s ( D):
- 0. 5 0 D t o - 6. 0 0 D (i n 0. 2 5 D i n cr e m e nt s)
- 6. 5 0 D t o - 1 2. 0 0 D (i n 0. 5 0 D i n cr e m e nt s)
+ 0. 5 0 D t o + 6. 0 0 D (i n 0. 2 5 D i n cr e m e nt s)
1- D A Y A C U V U E ®  M OI S T Br a n d C o nt a ct L e n s e s f or A S TI G M A TI S M ar e h e mit ori c 
s h ell s of t h e f oll o wi n g di m e n si o n s:
Di a m et er ( DI A):
1 4. 5 m m
C e nt er T hi c k n e s s:
0. 0 9 0 m m t o 0. 1 8 9 m m ( v ari e s wit h p o w er)
B a s e C ur v e ( B C):
8. 5 m m
P o w er s ( D):
+ 0. 0 0 t o - 6. 0 0 D (i n 0. 2 5 D i n cr e m e nt s)
C yli n d er s ( C Y L): - 0. 7 5 D, - 1. 2 5 D, - 1. 7 5 D, - 2. 2 5 D*
A xi s ( A XI S): 1 0° t o 1 8 0° i n 1 0° i n cr e m e nt s
*- 2. 2 5 D c yli n d er i s a v ail a bl e i n 1 0°, 2 0°, 7 0°, 8 0°, 9 0°, 
1 0 0°, 1 1 0°, 1 6 0°, 1 7 0°, 1 8 0° a x e s o nl y
- 6. 5 0 D t o - 9. 0 0 D (i n 0. 5 0 D i n cr e m e nt s)
C yli n d er s ( C Y L): - 0. 7 5 D, - 1. 2 5 D, - 1. 7 5 D, - 2. 2 5 D*
A xi s ( A XI S): 1 0°, 2 0°, 6 0°, 7 0°, 8 0°, 9 0°, 1 0 0°, 1 1 0°, 
1 2 0°, 1 6 0°, 1 7 0°, 1 8 0°
*- 2. 2 5 D c yli n d er i s a v ail a bl e i n 2 0°, 9 0°, 1 6 0°, 1 8 0° 
a x e s o nl y
+ 0. 2 5 D t o + 4. 0 0 D (i n 0. 2 5 D i n cr e m e nt s)
C yli n d er s ( C Y L): - 0. 7 5 D, - 1. 2 5 D, - 1. 7 5 D
A xi s ( A XI S): 1 0°, 2 0°, 7 0°, 8 0°, 9 0°, 1 0 0°, 1 1 0°, 1 6 0°, 
1 7 0°, 1 8 0°
1- D A Y A C U V U E ®  M OI S T Br a n d M U L TI F O C A L C o nt a ct L e n s e s ar e h e mi s p h eri c al 
s h ell s of t h e f oll o wi n g di m e n si o n s:
Di a m et er ( DI A):
1 4. 3 m m
C e nt er T hi c k n e s s:
0. 0 8 4 m m t o 0. 2 0 7 m m ( v ari e s wit h p o w er)
B a s e C ur v e ( B C):
8. 4 m m
P o w er s ( D):
+ 6. 0 0 D t o - 9. 0 0 D (i n 0. 2 5 D i n cr e m e nt s)
N e ar A D D P o w er s 
( M A X A D D):
L o w N e ar A D D ( L O W): + 1. 2 5 D
M e di u m N e ar A D D ( MI D): + 1. 7 5 D
Hi g h N e ar A D D ( H G H): + 2. 5 0 D
4
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 3 1 of 2 2 5
J J V C C O N FI D E N TI A L

1- D A Y A C U V U E ®  M OI S T Br a n d C o nt a ct L e n s e s ( et aﬁ l c o n A) Vi si bilit y Ti nt e d wit h 
U V Bl o c k er v s. 2 4 yr. ol d h u m a n c or n e a a n d 2 5 yr. ol d h u m a n cr y st alli n e l e n s. 
*The data are representative measure ments taken through the central 3- 5 m m portion for the 
thinnest marketed lens (- 3. 0 0 D lens, 0. 0 8 4 m m center thickness).
1 L er m a n, S., R a di a nt E n er g y a n d t h e E y e, M a c Mill a n, N e w Y or k, 1 9 8 0, p. 5 8, ﬁ g ur e 2- 2 1
2 W a xl er, M., Hit c hi n s, V. M., O pti c al R a di ati o n a n d Vi s u al H e a t h, C R C Pr e s s, B o c a R at o n, Fl ori d a, 
1 9 8 6, p. 1 9, ﬁ g ur e 5
W A R NI N G: U V a b s or bi n g c o nt a ct l e n s e s ar e N O T s u b stit ut e s f or 
pr ot e cti v e U V a b s or bi n g e y e w e ar, s u c h a s U V a b s or bi n g g o g gl e s 
or s u n gl a s s e s b e c a u s e t h e y d o n ot c o m pl et el y c o v er t h e e y e a n d 
s urr o u n di n g ar e a. T h e p ati e nt s h o ul d c o nti n u e t o u s e U V a b s or bi n g 
e y e w e ar a s dir e ct e d.
A C TI O N S
I n it s h y dr at e d st at e, t h e c o nt a ct l e n s, w h e n pl a c e d o n t h e c or n e a, a ct s a s a 
r efr a cti n g m e di u m t o f o c u s li g ht r a y s o n t h e r eti n a.
T h e U V Bl o c ki n g f or t h e s e l e n s e s a v er a g e s 9 7 % i n t h e U V B r a n g e of 2 8 0 n m t o 
3 1 5 n m a n d 8 2 % i n t h e U V A r a n g e of 3 1 6 n m t o 3 8 0 n m f or t h e e ntir e p o w er 
r a n g e.
T R A N S MI T T A N C E C U R V E S
1- D AY A C U V UE ®  M OI ST
Brand Contact Lenses*
24 Y R. OL D H U M A N 
C O R NE A 1
25 Y R. OL D H U M A N
C R Y STALLI NE LE N S 2
5
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 3 2 of 2 2 5
J J V C C O N FI D E N TI A L

N O T E: L o n g-t er m e x p o s ur e t o U V r a di ati o n i s o n e of t h e ri s k f a ct or s 
a s s o ci at e d wit h c at ar a ct s. E x p o s ur e i s b a s e d o n a n u m b er of f a ct or s 
s u c h a s e n vir o n m e nt al c o n diti o n s ( altit u d e, g e o gr a p h y, cl o u d c o v er) a n d 
p er s o n al f a ct or s ( e xt e nt a n d n at ur e of o ut d o or a cti viti e s). U V- Bl o c ki n g 
c o nt a ct l e n s e s h el p pr o vi d e pr ot e cti o n a g ai n st h ar mf ul U V r a di ati o n. 
H o w e v er, cli ni c al st u di e s h a v e n ot b e e n d o n e t o d e m o n str at e t h at 
w e ari n g U V- Bl o c ki n g c o nt a ct l e n s e s r e d u c e s t h e ri s k of d e v el o pi n g 
c at ar a ct s or ot h er e y e di s or d er s. T h e E y e C ar e Pr of e s si o n al s h o ul d b e 
c o n s ult e d f or m or e i nf or m ati o n.
I N DI C A TI O N S ( U S E S)
1- D A Y A C U V U E ®  M OI S T Br a n d C o nt a ct L e n s e s ar e i n di c at e d f or d ail y 
di s p o s a bl e w e ar f or t h e o pti c al c orr e cti o n of r efr a cti v e a m etr o pi a ( m y o pi a a n d 
h y p er o pi a) i n p h a ki c or a p h a ki c p er s o n s wit h n o n- di s e a s e d e y e s w h o m a y h a v e 
1. 0 0 D or l e s s of a sti g m ati s m.
1- D A Y A C U V U E ®  M OI S T Br a n d C o nt a ct L e n s e s f or A S TI G M A TI S M ar e i n di c at e d 
f or d ail y di s p o s a bl e w e ar f or t h e o pti c al c orr e cti o n of r efr a cti v e a m etr o pi a ( m y o pi a 
a n d h y p er o pi a) i n p h a ki c or a p h a ki c p er s o n s wit h n o n- di s e a s e d e y e s w h o m a y 
h a v e 0. 5 0 D t o 3. 0 0 D of a sti g m ati s m.
1- D A Y A C U V U E ®  M OI S T Br a n d M U L TI F O C A L C o nt a ct L e n s e s ar e i n di c at e d 
f or d ail y di s p o s a bl e w e ar f or t h e o pti c al c orr e cti o n of di st a n c e a n d n e ar vi si o n i n 
pr e s b y o pi c p h a ki c or a p h a ki c p er s o n s wit h n o n- di s e a s e d e y e s w h o m a y h a v e 
4. 0 0 D of A D D p o w er or l e s s a n d 0. 7 5 D or l e s s of a sti g m ati s m.
T h e l e n s e s c o nt ai n a U V Bl o c k er t o h el p pr ot e ct a g ai n st tr a n s mi s si o n of h ar mf ul 
U V r a di ati o n t o t h e c or n e a a n d i nt o t h e e y e.
W h e n pr e s cri b e d f or d ail y di s p o s a bl e u s e, n o cl e a ni n g or di si nf e cti o n i s r e q uir e d. 
L e n s e s s h o ul d b e di s c ar d e d u p o n r e m o v al.
C O N T R AI N DI C A TI O N S ( R E A S O N S N O T T O U S E) 
D O N O T U S E t h e s e l e n s e s w h e n a n y of t h e f oll o wi n g c o n diti o n s e xi st:
•  A c ut e or s u b a c ut e i nﬂ a m m ati o n or i nf e cti o n of t h e a nt eri or c h a m b er of 
t h e e y e.
•  A n y e y e di s e a s e, i nj ur y, or a b n or m alit y t h at aff e ct s t h e c or n e a, 
c o nj u n cti v a, or e y eli d s.
•  S e v er e i n s ufﬁ ci e n c y of l a cri m al s e cr eti o n ( dr y e y e).
•  C or n e al h y p o e st h e si a (r e d u c e d c or n e al s e n siti vit y).
6
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 3 3 of 2 2 5
J J V C C O N FI D E N TI A L

•  A n y s y st e mi c di s e a s e t h at m a y aff e ct t h e e y e or b e e x a g g er at e d b y 
w e ari n g c o nt a ct l e n s e s.
•  All er gi c r e a cti o n s of o c ul ar s urf a c e s or a d n e x a t h at m a y b e i n d u c e d or 
e x a g g er at e d b y w e ari n g c o nt a ct l e n s e s or u s e of c o nt a ct l e n s s ol uti o n s.
•  O c ul ar irrit ati o n d u e t o all er gi c r e a cti o n s w hi c h m a y b e c a u s e d b y u s e 
of c o nt a ct l e n s s ol uti o n s (i. e., r e w etti n g dr o p s) t h at c o nt ai n c h e mi c al s or 
pr e s er v ati v e s ( s u c h a s m er c ur y, T hi m er o s al, et c.) t o w hi c h s o m e p e o pl e 
m a y d e v el o p a n all er gi c r e s p o n s e.
•  A n y a cti v e c or n e al i nf e cti o n ( b a ct eri al, f u n g al, pr ot o z o al, or vir al).
•  If e y e s b e c o m e r e d or irrit at e d.
W A R NI N G S
P ati e nt s s h o ul d b e a d vi s e d of t h e f oll o wi n g w ar ni n g s p ert ai ni n g t o 
c o nt a ct l e n s w e ar:
E Y E P R O B L E M S, I N C L U DI N G C O R N E A L U L C E R S, C A N D E V E L O P 
R A PI D L Y A N D L E A D T O L O S S O F VI SI O N. I F T H E P A TI E N T 
E X P E RI E N C E S:
•  E y e  Di s c o mf ort,
•  E x c e s si v e  T e ari n g,
•  Vi si o n  C h a n g e s,
•  L o s s of Vi si o n,
•  E y e R e d n e s s, or
•  Ot h er E y e Pr o bl e m s,
T H E P A TI E N T S H O U L D B E I N S T R U C T E D T O I M M E DI A T E L Y 
R E M O V E T H E L E N S E S A N D P R O M P T L Y C O N T A C T T H E E Y E C A R E 
P R O F E S SI O N A L.
•  W h e n pr e s cri b e d f or d ail y w e ar, p ati e nt s s h o ul d b e i n str u ct e d n ot t o w e ar 
t h eir l e n s e s w hil e sl e e pi n g. Cli ni c al st u di e s h a v e s h o w n t h at w h e n l e n s e s 
ar e w or n o v er ni g ht, t h e ri s k of ul c er ati v e k er atiti s i s gr e at er t h a n a m o n g 
t h o s e w h o d o n ot w e ar t h e m o v er ni g ht.3
•  St u di e s h a v e s h o w n t h at c o nt a ct l e n s w e ar er s w h o ar e s m o k er s h a v e a 
hi g h er i n ci d e n c e of a d v er s e r e a cti o n s t h a n n o n s m o k er s.
•  Pr o bl e m s wit h c o nt a ct l e n s e s or l e n s c ar e pr o d u ct s c o ul d r e s ult i n 
s eri o u s i nj ur y t o t h e e y e. P ati e nt s s h o ul d b e c a uti o n e d t h at pr o p er u s e 
a n d c ar e of c o nt a ct l e n s e s a n d l e n s c ar e pr o d u ct s ar e e s s e nti al f or t h e 
s af e u s e of t h e s e pr o d u ct s.
7
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 3 4 of 2 2 5
J J V C C O N FI D E N TI A L

•  T h e o v er all ri s k of ul c er ati v e k er atiti s m a y b e r e d u c e d b y c ar ef ull y 
f oll o wi n g dir e cti o n s f or l e n s c ar e.
3 N e w E n gl a n d J o ur n al of M e di ci n e, S e pt e m b er 2 1, 1 9 8 9; 3 2 1 ( 1 2), p p. 7 7 3- 7 8 3
S p e ci ﬁ c I n str u cti o n s f or U s e a n d W ar ni n g s:
•  W at er  A cti vit y
I n str u cti o n f or U s e
D o n ot e x p o s e c o nt a ct l e n s e s t o w at er w hil e w e ari n g t h e m.
W A R NI N G:
W at er c a n h ar b or mi cr o or g a ni s m s t h at c a n l e a d t o s e v er e i nf e cti o n, 
vi si o n l o s s, or bli n d n e s s. If l e n s e s h a v e b e e n s u b m er s e d i n w at er w h e n 
p arti ci p ati n g i n w at er s p ort s or s wi m mi n g i n p o ol s, h ot t u b s, l a k e s, or 
o c e a n s, t h e p ati e nt s h o ul d b e i n str u ct e d t o di s c ar d t h e m a n d r e pl a c e 
t h e m wit h a n e w p air. T h e E y e C ar e Pr of e s si o n al s h o ul d b e c o n s ult e d f or 
r e c o m m e n d ati o n s r e g ar di n g w e ari n g l e n s e s d uri n g a n y a cti vit y i n v ol vi n g 
w at er.
P R E C A U TI O N S
S p e ci al Pr e c a uti o n s f or E y e C ar e Pr of e s si o n al s:
•  D u e t o t h e s m all n u m b er of p ati e nt s e nr oll e d i n cli ni c al i n v e sti g ati o n of 
l e n s e s, all r efr a cti v e p o w er s, d e si g n c o nﬁ g ur ati o n s, or l e n s p ar a m et er s 
a v ail a bl e i n t h e l e n s m at eri al ar e n ot e v al u at e d i n si g niﬁ c a nt n u m b er s. 
C o n s e q u e ntl y, w h e n s el e cti n g a n a p pr o pri at e l e n s d e si g n a n d 
p ar a m et er s, t h e E y e C ar e Pr of e s si o n al s h o ul d c o n si d er all c h ar a ct eri sti c s 
of t h e l e n s t h at c a n aff e ct l e n s p erf or m a n c e a n d o c ul ar h e alt h, i n cl u di n g 
o x y g e n p er m e a bilit y, w ett a bilit y, c e ntr al a n d p eri p h er al t hi c k n e s s, a n d 
o pti c z o n e di a m et er.
T h e p ot e nti al i m p a ct of t h e s e f a ct or s o n t h e p ati e nt’s o c ul ar h e alt h 
s h o ul d b e c ar ef ull y w ei g h e d a g ai n st t h e p ati e nt’s n e e d f or r efr a cti v e 
c orr e cti o n; t h er ef or e, t h e c o nti n ui n g o c ul ar h e alt h of t h e p ati e nt a n d l e n s 
p erf or m a n c e o n t h e e y e s h o ul d b e c ar ef ull y m o nit or e d b y t h e pr e s cri bi n g 
E y e C ar e Pr of e s si o n al.
•  P ati e nt s w h o w e ar t h e s e l e n s e s t o c orr e ct pr e s b y o pi a u si n g m o n o vi si o n 
( or m o diﬁ e d m o n o vi si o n u si n g 1- D A Y A C U V U E®  M OI S T Br a n d 
M U L TI F O C A L) m a y n ot a c hi e v e t h e b e st c orr e ct e d vi s u al a c uit y f or eit h er 
f ar or n e ar vi si o n. Vi s u al r e q uir e m e nt s v ar y wit h t h e i n di vi d u al a n d s h o ul d 
b e c o n si d er e d w h e n s el e cti n g t h e m o st a p pr o pri at e t y p e of l e n s f or e a c h 
p ati e nt.
8
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 3 5 of 2 2 5
J J V C C O N FI D E N TI A L

•  Fl u or e s c ei n, a y ell o w d y e, s h o ul d n ot b e u s e d w hil e t h e l e n s e s ar e o n 
t h e e y e s. T h e l e n s e s a b s or b t hi s d y e a n d b e c o m e di s c ol or e d. W h e n e v er 
ﬂ u or e s c ei n i s u s e d i n e y e s, t h e e y e s s h o ul d b e ﬂ u s h e d wit h a st eril e 
s ali n e s ol uti o n t h at i s r e c o m m e n d e d f or i n- e y e u s e.
•  E y e C ar e Pr of e s si o n al s s h o ul d i n str u ct t h e p ati e nt t o r e m o v e l e n s e s 
i m m e di at el y if t h e e y e s b e c o m e r e d or irrit at e d. 
E y e C ar e Pr of e s si o n al s s h o ul d c ar ef ull y i n str u ct p ati e nt s a b o ut t h e 
f oll o wi n g c ar e r e gi m e n a n d s af et y pr e c a uti o n s.
H a n dli n g Pr e c a uti o n s:
•  B ef or e l e a vi n g t h e E y e C ar e Pr of e s si o n al’s ofﬁ c e, t h e p ati e nt s h o ul d 
b e a bl e t o pr o m ptl y r e m o v e t h e l e n s e s or s h o ul d h a v e s o m e o n e el s e 
a v ail a bl e w h o c a n r e m o v e t h e l e n s e s f or hi m or h er.
•  D O N O T u s e if t h e st eril e bli st er p a c k a g e i s o p e n e d or d a m a g e d.
•  Al w a y s w a s h a n d ri n s e h a n d s b ef or e h a n dli n g l e n s e s. D o n ot g et 
c o s m eti c s, l oti o n s, s o a p s, cr e a m s, d e o d or a nt s, or s pr a y s i n t h e e y e s or 
o n t h e l e n s e s. It i s b e st t o p ut o n l e n s e s b ef or e p utti n g o n m a k e u p.
•  D O N O T t o u c h c o nt a ct l e n s e s wit h t h e ﬁ n g er s or h a n d s if t h e h a n d s ar e 
n ot fr e e of f or ei g n m at eri al s, a s mi cr o s c o pi c s cr at c h e s of t h e l e n s e s m a y 
o c c ur, c a u si n g di st ort e d vi si o n a n d/ or i nj ur y t o t h e e y e.
•  C ar ef ull y f oll o w t h e h a n dli n g, i n s erti o n, r e m o v al, a n d w e ari n g i n str u cti o n s 
i n t h e P ati e nt I n str u cti o n G ui d e f or t h e s e l e n s e s a n d t h o s e pr e s cri b e d b y 
t h e E y e C ar e Pr of e s si o n al.
•  Al w a y s h a n dl e l e n s e s c ar ef ull y a n d a v oi d dr o p pi n g t h e m.
•  N e v er u s e t w e e z er s or ot h er t o ol s t o r e m o v e l e n s e s fr o m t h e l e n s 
c o nt ai n er. Sli d e t h e l e n s u p t h e si d e of t h e b o wl u ntil it i s fr e e of t h e 
c o nt ai n er.
•  D o n ot t o u c h t h e l e n s wit h ﬁ n g er n ail s.
L e n s W e ari n g Pr e c a uti o n s:
•  If t h e l e n s sti c k s ( st o p s m o vi n g) o n t h e e y e, f oll o w t h e r e c o m m e n d e d 
dir e cti o n s i n “ C ar e f or Sti c ki n g ( N o n- M o vi n g) L e n s e s.” T h e l e n s s h o ul d 
m o v e fr e el y o n t h e e y e f or t h e c o nti n u e d h e alt h of t h e e y e. If n o n-
m o v e m e nt of t h e l e n s c o nti n u e s, t h e p ati e nt s h o ul d b e i n str u ct e d t o 
i m m e di at el y c o n s ult hi s or h er E y e C ar e Pr of e s si o n al.
•  N e v er w e ar l e n s e s b e y o n d t h e p eri o d r e c o m m e n d e d b y t h e E y e C ar e 
Pr of e s si o n al.
9
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 3 6 of 2 2 5
J J V C C O N FI D E N TI A L

•  T h e p ati e nt s h o ul d b e a d vi s e d t o n e v er all o w a n y o n e el s e t o w e ar t h eir 
l e n s e s. T h e y h a v e b e e n pr e s cri b e d t o ﬁ t t h eir e y e s a n d t o c orr e ct t h eir 
vi si o n t o t h e d e gr e e n e c e s s ar y. S h ari n g l e n s e s gr e atl y i n cr e a s e s t h e 
c h a n c e of e y e i nf e cti o n s.
•  If a er o s ol pr o d u ct s, s u c h a s h air s pr a y, ar e u s e d w hil e w e ari n g l e n s e s, 
e x er ci s e c a uti o n a n d k e e p e y e s cl o s e d u ntil t h e s pr a y h a s s ettl e d.
•  Av oi d all h ar mf ul or irrit ati n g v a p or s a n d f u m e s w hil e w e ari n g l e n s e s.
L e n s C ar e Pr e c a uti o n s:
•  T h e p ati e nt s h o ul d b e i nf or m e d t h at n o cl e a ni n g or di si nf e cti o n i s n e e d e d 
w h e n l e n s e s ar e w or n f or d ail y di s p o s a bl e w e ar. P ati e nt s s h o ul d al w a y s 
di s p o s e of l e n s e s w h e n r e m o v e d a n d h a v e s p ar e l e n s e s or s p e ct a cl e s 
a v ail a bl e.
Ot h er T o pi c s t o Di s c u s s wit h P ati e nt s:
•  Al w a y s c o nt a ct t h e E y e C ar e Pr of e s si o n al b ef or e u si n g a n y m e di ci n e i n 
t h e e y e s.
•  C ert ai n m e di c ati o n s, s u c h a s a nti hi st a mi n e s, d e c o n g e st a nt s, di ur eti c s, 
m u s cl e r el a x a nt s, tr a n q uili z er s, a n d t h o s e f or m oti o n si c k n e s s m a y c a u s e 
dr y n e s s of t h e e y e, i n cr e a s e d l e n s a w ar e n e s s, or bl urr e d vi si o n. S h o ul d 
s u c h c o n diti o n s e xi st, pr o p er r e m e di al m e a s ur e s s h o ul d b e pr e s cri b e d. 
•  Or al c o ntr a c e pti v e u s er s c o ul d d e v el o p vi s u al c h a n g e s or c h a n g e s i n 
l e n s t ol er a n c e w h e n u si n g c o nt a ct l e n s e s. P ati e nt s s h o ul d b e c a uti o n e d 
a c c or di n gl y.
•  A s wit h a n y c o nt a ct l e n s, f oll o w- u p vi sit s ar e n e c e s s ar y t o a s s ur e t h e 
c o nti n ui n g h e alt h of t h e p ati e nt’s e y e s. T h e p ati e nt s h o ul d b e i n str u ct e d 
a s t o a r e c o m m e n d e d f oll o w- u p s c h e d ul e.
W h o S h o ul d K n o w T h at t h e P ati e nt i s W e ari n g C o nt a ct L e n s e s ?
•  P ati e nt s s h o ul d i nf or m all d o ct or s ( H e alt h C ar e Pr of e s si o n al s) a b o ut 
b ei n g a c o nt a ct l e n s w e ar er.
•  P ati e nt s s h o ul d al w a y s i nf or m t h eir e m pl o y er of b ei n g a c o nt a ct l e n s 
w e ar er. S o m e j o b s m a y r e q uir e u s e of e y e pr ot e cti o n e q ui p m e nt or m a y 
r e q uir e t h at t h e p ati e nt n ot w e ar c o nt a ct l e n s e s.
1 0
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 3 7 of 2 2 5
J J V C C O N FI D E N TI A L

A D V E R S E R E A C TI O N S
T h e p ati e nt s h o ul d b e i nf or m e d t h at t h e f oll o wi n g pr o bl e m s m a y o c c ur 
w h e n w e ari n g c o nt a ct l e n s e s:
•  T h e e y e m a y b ur n, sti n g, a n d/ or it c h.
•  T h er e m a y b e l e s s c o mf ort t h a n w h e n t h e l e n s w a s ﬁ r st pl a c e d o n t h e 
e y e.
•  T h er e m a y b e a f e eli n g of s o m et hi n g i n t h e e y e (f or ei g n b o d y, s cr at c h e d 
ar e a).
•  T h er e m a y b e t h e p ot e nti al f or s o m e t e m p or ar y i m p air m e nt d u e t o 
p eri p h er al i nﬁ ltr at e s, p eri p h er al c or n e al ul c er s, or c or n e al er o si o n. T h er e 
m a y b e t h e p ot e nti al f or ot h er p h y si ol o gi c al o b s er v ati o n s, s u c h a s l o c al 
or g e n er ali z e d e d e m a, c or n e al n e o v a s c ul ari z ati o n, c or n e al st ai ni n g, 
i nj e cti o n, t ar s al a b n or m aliti e s, iriti s, a n d c o nj u n cti viti s, s o m e of w hi c h ar e 
cli ni c all y a c c e pt a bl e i n l o w a m o u nt s.
•  T h er e m a y b e e x c e s si v e w at eri n g, u n u s u al e y e s e cr eti o n s, or r e d n e s s 
of t h e e y e.
•  P o or vi s u al a c uit y, bl urr e d vi si o n, r ai n b o w s or h al o s ar o u n d o bj e ct s, 
p h ot o p h o bi a, or dr y e y e s m a y al s o o c c ur if t h e l e n s e s ar e w or n 
c o nti n u o u sl y or f or t o o l o n g a ti m e.
T h e p ati e nt s h o ul d b e i n str u ct e d t o c o n d u ct a si m pl e 3- p art s elf- e x a mi n ati o n at 
l e a st o n c e a d a y. T h e y s h o ul d a s k t h e m s el v e s:
•  H o w d o t h e l e n s e s f e el o n m y e y e s ?
•  H o w d o m y e y e s l o o k ?
•  H a v e I n oti c e d a c h a n g e i n m y vi si o n ? 
If t h e p ati e nt r e p ort s a n y pr o bl e m s, h e or s h e s h o ul d b e i n str u ct e d t o 
I M M E DI A T E L Y R E M O V E T H E L E N S. If t h e pr o bl e m or di s c o mf ort st o p s, t h e 
p ati e nt s h o ul d di s c ar d t h e l e n s a n d pl a c e a n e w fr e s h l e n s o n t h e e y e.
If aft er i n s erti n g t h e n e w l e n s, t h e pr o bl e m c o nti n u e s, t h e p ati e nt s h o ul d b e 
dir e ct e d t o I M M E DI A T E L Y R E M O V E T H E L E N S A N D C O N T A C T HI S O R H E R 
E Y E C A R E P R O F E S SI O N A L.
T h e p ati e nt s h o ul d b e a d vi s e d t h at w h e n a n y of t h e a b o v e s y m pt o m s o c c ur, 
a s eri o u s c o n diti o n s u c h a s i nf e cti o n, c or n e al ul c er, n e o v a s c ul ari z ati o n, or iriti s 
m a y b e pr e s e nt. H e or s h e s h o ul d b e i n str u ct e d t o s e e k i m m e di at e pr of e s si o n al 
i d e ntiﬁ c ati o n of t h e pr o bl e m a n d pr o m pt tr e at m e nt t o a v oi d s eri o u s e y e d a m a g e.
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G E N E R A L FI T TI N G G UI D E LI N E S
A.  P ati e nt  S el e cti o n
P ati e nt s s el e ct e d t o w e ar t h e s e l e n s e s s h o ul d b e c h o s e n b a s e d o n: 
• 
M oti v ati o n t o w e ar l e n s e s 
• 
A bilit y t o f oll o w i n str u cti o n s r e g ar di n g l e n s w e ar
• 
G e n er al h e alt h 
• 
A bilit y t o a d e q u at el y h a n dl e a n d c ar e f or t h e l e n s e s 
• 
A bilit y t o u n d er st a n d t h e ri s k s a n d b e n eﬁ t s of l e n s w e ar
P ati e nt s w h o d o n ot m e et t h e a b o v e crit eri a s h o ul d n ot b e pr o vi d e d wit h c o nt a ct 
l e n s e s. 
B.  Pr e- ﬁ tti n g E x a mi n ati o n
I niti al e v al u ati o n of t h e p ati e nt s h o ul d b e gi n wit h a t h or o u g h c a s e hi st or y 
t o d et er mi n e if t h er e ar e a n y c o ntr ai n di c ati o n s t o c o nt a ct l e n s w e ar. D uri n g 
t h e c a s e hi st or y, t h e p ati e nt’s vi s u al n e e d s a n d e x p e ct ati o n s s h o ul d b e 
d et er mi n e d a s w ell a s a n a s s e s s m e nt of t h eir o v er all o c ul ar, p h y si c al, a n d 
m e nt al h e alt h. 
Pr e c e di n g t h e i niti al s el e cti o n of tri al c o nt a ct l e n s e s, a c o m pr e h e n si v e o c ul ar 
e v al u ati o n s h o ul d b e p erf or m e d t h at i n cl u d e s, b ut i s n ot li mit e d t o, t h e 
m e a s ur e m e nt of di st a n c e a n d n e ar vi s u al a c uit y, di st a n c e a n d n e ar r efr a cti v e 
pr e s cri pti o n (i n cl u di n g d et er mi ni n g t h e pr ef err e d r e a di n g di st a n c e f or 
pr e s b y o p e s), k er at o m etr y, a n d bi o mi cr o s c o pi c e v al u ati o n. 
B a s e d o n t hi s e v al u ati o n, if it i s d et er mi n e d t h at t h e p ati e nt i s eli gi bl e t o w e ar 
t h e s e l e n s e s, t h e E y e C ar e Pr of e s si o n al s h o ul d pr o c e e d t o t h e l e n s ﬁ tti n g 
i n str u cti o n s a s o utli n e d b el o w. 
C.  I niti al P o w er D et er mi n ati o n
A s p e ct a cl e r efr a cti o n s h o ul d b e p erf or m e d t o e st a bli s h t h e p ati e nt’s b a s eli n e 
r efr a cti v e st at u s a n d t o g ui d e i n t h e s el e cti o n of t h e a p pr o pri at e l e n s p o w er. 
R e m e m b er t o c o m p e n s at e f or v ert e x di st a n c e if t h e r efr a cti o n i s gr e at er t h a n 
± 4. 0 0 D.
D.  B a s e C ur v e S el e cti o n ( Tri al L e n s Fitti n g)
T h e f oll o wi n g tri al l e n s e s s h o ul d b e s el e ct e d f or p ati e nt s r e g ar dl e s s of 
k er at o m etr y r e a di n g s. H o w e v er, c or n e al c ur v at ur e m e a s ur e m e nt s s h o ul d b e 
p erf or m e d t o e st a bli s h t h e p ati e nt’s b a s eli n e o c ul ar st at u s. 
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• 
1- D A Y A C U V U E ®  M OI S T: 8. 5 m m/ 1 4. 2 m m
• 
1- D A Y A C U V U E ®  M OI S T f or A S TI G M A TI S M: 8. 5 m m/ 1 4. 5 m m
• 
1- D A Y A C U V U E ®  M OI S T M U L TI F O C A L: 8. 4 m m/ 1 4. 3 m m
T h e tri al l e n s s h o ul d b e pl a c e d o n e a c h of t h e p ati e nt’s e y e s a n d e v al u at e d 
aft er t h e p ati e nt h a s a dj u st e d t o t h e l e n s e s.
1.  Crit eri a of a Pr o p erl y Fit L e n s
A pr o p erl y ﬁ t l e n s will c e nt er a n d c o m pl et el y c o v er t h e c or n e a (i. e., n o 
li m b al e x p o s ur e), h a v e s ufﬁ ci e nt m o v e m e nt t o pr o vi d e t e ar e x c h a n g e 
u n d er t h e c o nt a ct l e n s wit h t h e bli n k, a n d b e c o mf ort a bl e. T h e l e n s 
s h o ul d m o v e fr e el y w h e n m a ni p ul at e d di git all y wit h t h e l o w er li d, a n d t h e n 
r et ur n t o it s pr o p erl y c e nt er e d p o siti o n w h e n r el e a s e d.
2.  Crit eri a of a Fl at Fitti n g L e n s
A ﬂ at ﬁ tti n g l e n s m a y e x hi bit o n e or m or e of t h e f oll o wi n g c h ar a ct eri sti c s: 
d e c e ntr ati o n, i n c o m pl et e c or n e al c o v er a g e (i. e., li m b al e x p o s ur e), 
e x c e s si v e m o v e m e nt wit h t h e bli n k a n d/ or e d g e st a n d off. If t h e l e n s i s 
j u d g e d t o b e ﬂ at ﬁ tti n g, it s h o ul d n ot b e di s p e n s e d t o t h e p ati e nt.
3.  Crit eri a of a St e e p Fitti n g L e n s
A st e e p ﬁ tti n g l e n s m a y e x hi bit o n e or m or e of t h e f oll o wi n g 
c h ar a ct eri sti c s: i n s ufﬁ ci e nt m o v e m e nt wit h t h e bli n k, c o nj u n cti v al 
i n d e nt ati o n, a n d r e si st a n c e w h e n p u s hi n g t h e l e n s u p di git all y wit h 
t h e l o w er li d. If t h e l e n s i s j u d g e d t o b e st e e p ﬁ tti n g, it s h o ul d n ot b e 
di s p e n s e d t o t h e p ati e nt.
If t h e i niti al tri al b a s e c ur v e i s j u d g e d t o b e ﬂ at or st e e p ﬁ tti n g, t h e alt er n at e 
b a s e c ur v e, if a v ail a bl e, s h o ul d b e tri al ﬁ t a n d e v al u at e d aft er t h e p ati e nt h a s 
a dj u st e d t o t h e l e n s. T h e l e n s s h o ul d m o v e fr e el y w h e n m a ni p ul at e d di git all y 
wit h t h e l o w er li d, a n d t h e n r et ur n t o a pr o p erl y c e nt er e d p o siti o n w h e n 
r el e a s e d. If r e si st a n c e i s e n c o u nt er e d w h e n p u s hi n g t h e l e n s u p, t h e l e n s i s 
ﬁ tti n g ti g htl y a n d s h o ul d n ot b e di s p e n s e d t o t h e p ati e nt.
E.  Fi n al L e n s P o w er ( S p h eri c al)
A s p h eri c al o v er-r efr a cti o n s h o ul d b e p erf or m e d t o d et er mi n e t h e ﬁ n al l e n s 
p o w er aft er t h e l e n s ﬁ t i s j u d g e d a c c e pt a bl e. T h e s p h eri c al o v er-r efr a cti o n 
s h o ul d b e c o m bi n e d wit h t h e tri al l e n s p o w er t o d et er mi n e t h e ﬁ n al l e n s 
pr e s cri pti o n. T h e p ati e nt s h o ul d e x p eri e n c e g o o d vi s u al a c uit y wit h t h e 
c orr e ct l e n s p o w er u nl e s s t h er e i s e x c e s si v e r e si d u al a sti g m ati s m.
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E x a m pl e 1
Dia g n ostic le ns: 
- 2. 0 0 D
S p herical over-refracti o n:  
- 0. 2 5 D
Fi nal le ns p o wer:  
- 2. 2 5 D
E x a m pl e 2
Dia g n ostic le ns: 
- 2. 0 0 D
S p herical over-refracti o n:  
+ 0. 2 5 D
Fi nal le ns p o wer:  
- 1. 7 5 D
If vi si o n i s a c c e pt a bl e, p erf or m a slit l a m p e x a mi n ati o n t o a s s e s s a d e q u at e ﬁ t 
( c e ntr ati o n a n d m o v e m e nt). If t h e ﬁ t i s a c c e pt a bl e, di s p e n s e t h e l e n s e s a n d 
i n str u ct t h e p ati e nt t o r et ur n i n o n e w e e k f or r e a s s e s s m e nt ( s e e P A TI E N T 
M A N A G E M E N T  s e cti o n).
All p ati e nt s s h o ul d b e s u p pli e d wit h a c o p y of t h e P A TI E N T 
I N S T R U C TI O N G UI D E f or t h e s e l e n s e s. C o pi e s ar e a v ail a bl e f or 
d o w nl o a d at w w w. a c u v u e. c o m.
Alt h o u g h m o st a s p e ct s of t h e ﬁ tti n g pr o c e d ur e ar e i d e nti c al f or all t y p e s of s oft 
c o nt a ct l e n s e s, i n cl u di n g t ori c l e n s e s, t h er e ar e s o m e a d diti o n al st e p s a n d/ or 
r ul e s t o f oll o w t o a s s ur e t h e pr o p er ﬁ t of t ori c l e n s e s. 
T h e o nl y n e w st e p s y o u m u st f oll o w i n pr e s cri bi n g 1- D A Y A C U V U E ®  M OI S T 
f or A S TI G M A TI S M ar e t h at y o u m u st d et er mi n e t h e st a bilit y, r e p e at a bilit y, a n d 
drift a n gl e of t h e l e n s a xi s s o t h at y o u c a n pr e s cri b e t h e c orr e ct l e n s a xi s f or t h e 
p ati e nt. 
A. H o w t o D et er mi n e L e n s C yli n d er a n d A xi s Ori e nt ati o n
1.  L o c at e t h e Ori e nt ati o n M ar k s 
To h el p d et er mi n e t h e pr o p er ori e nt ati o n of t h e t ori c l e n s, y o u’ll ﬁ n d t w o 
pri m ar y m ar k s a p pr o xi m at el y 1 m m fr o m t h e l e n s e d g e r e pr e s e nti n g t h e 
v erti c al p o siti o n o n o p p o sit e e n d s of t h e l e n s at 6 a n d 1 2 o’ cl o c k ( Fi g. 1). 
B e c a u s e of t h e l e n s’ b all a sti n g s y st e m, eit h er m ar k c a n r e pr e s e nt t h e v er-
ti c al p o siti o n – t h er e i s n o “t o p” a n d “ b ott o m” a s i n a pri s m- b all a st e d l e n s. 
Y o u d o n’t n e e d t o vi e w b ot h m ar k s t o a s s e s s ori e nt ati o n; si m pl y l o o k f or t h e 
6 o’ cl o c k m ar k a s y o u w o ul d wit h a pri s m- b all a st e d l e n s.
T O RI C FI T TI N G G UI D E LI N E S
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     Fi g ur e 1
Y o u’ll n e e d a slit l a m p bi o mi cr o s c o p e wit h a 1 t o 2 m m p ar all el e pi p e d 
b e a m t o hi g hli g ht t h e m ar k s w h e n t h e l e n s i s ﬁ tt e d t o t h e e y e. T h er e ar e a 
n u m b er of t e c h ni q u e s y o u c a n u s e t o i m pr o v e t h e vi si bilit y of t h e 6 o’ cl o c k 
m ar k. U si n g a p ar all el e pi p e d b e a m a n d m e di u m m a g niﬁ c ati o n ( 1 0 x or 1 5 x), 
sl o wl y p a n d o w n t h e l e n s, l o o ki n g j u st b el o w t h e dir e ct ill u mi n ati o n at t h e 
r etr oill u mi n at e d ar e a. B a c kli g hti n g t h e m ar k t hi s w a y s h o ul d m a k e it m or e 
vi si bl e. S o m eti m e s m a ni p ul ati n g t h e l o w er li d m a y b e n e c e s s ar y t o u n c o v er 
t h e m ar k.
2.  O b s er v e L e n s R ot ati o n a n d St a bilit y 
O b s er v e t h e p o siti o n a n d st a bilit y of t h e “ b ott o m” m ar k. It u s u all y st a bili z e s 
at t h e 6 o’ cl o c k p o siti o n. If it d o e s, c al c ul ati o n of t h e l e n s p o w er will b e 
str ai g htf or w ar d. T h e 6 o’ cl o c k p o siti o n i s n ot a “ m u st”; h o w e v er, t h e 
a b s ol ut e r e q uir e m e nt i s t h at t h e a xi s p o siti o n b e st a bl e a n d r e p e at a bl e. 
T h e m ar k m a y st a bili z e s o m e w h at l eft or ri g ht ( drift) of t h e v erti c al m eri di a n 
a n d still e n a bl e y o u t o ﬁ t a t ori c l e n s f or t h at e y e, a s l o n g a s t h e l e n s al w a y s 
r et ur n s t o t h e s a m e “ drift a xi s” p o siti o n aft er s ettli n g. T h e d e vi ati o n c a n 
b e c o m p e n s at e d f or i n t h e ﬁ n al pr e s cri pti o n. Y o ur o bj e cti v e i s t o e n s ur e 
t h at w h at e v er p o siti o n t h e i niti al l e n s a s s u m e s n e ar 6 o’ cl o c k, t hi s p o siti o n 
m u st b e st a bl e a n d r e p e at a bl e. Wit h f ull e y e m o v e m e nt or h e a v y bli n k, y o u 
m a y s e e t h e m ar k s s wi n g a w a y, b ut t h e y m u st r et ur n q ui c kl y t o t h e ori gi n al 
st a bl e p o siti o n. If t h e l e n s d o e s n ot r et ur n q ui c kl y, y o u m a y n e e d t o s el e ct 
a diff er e nt l e n s. 
3.  A s s e s si n g R ot ati o n 
I m a gi n e t h e e y e a s a cl o c k di al a n d e v er y h o ur r e pr e s e nt s a 3 0° i nt er v al. If 
t h e ori e nt ati o n m ar k of t h e i niti al l e n s st a bili z e s s o m e w h at l eft or ri g ht of t h e 
v erti c al p o siti o n, t h e ﬁ n al l e n s will ori e nt o n t h e e y e wit h t h e s a m e d e vi ati o n. 
Y o u c a n u s e a n a xi s r eti c ul e i n t h e slit l a m p or u s e a li n e- s cri b e d l e n s i n a 
s p e ct a cl e tri al fr a m e t o m e a s ur e or e sti m at e t h e “ drift a n gl e” of t h e c yli n d er 
a xi s. 
To c o m p e n s at e f or t hi s “ drift,” m e a s ur e or e sti m at e t h e “ drift,” t h e n a d d 
or s u btr a ct it fr o m t h e r efr a cti v e a xi s t o d et er mi n e t h e c orr e ct c yli n d er 
a xi s. U s e t h e L A R S ( L eft A d d, Ri g ht S u btr a ct) m et h o d t o d et er mi n e w hi c h 
dir e cti o n t o c o m p e n s at e.
  
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B. Fi n al L e n s P o w er
W h e n t h e di a g n o sti c l e n s h a s it s a xi s ali g n e d i n t h e s a m e m eri di a n a s t h e 
p ati e nt’s r efr a cti v e a xi s, a s p h er o c yli n dri c al o v er-r efr a cti o n m a y b e p erf or m e d 
a n d vi s u al a c uit y d et er mi n e d. H o w e v er, i n t h e c a s e of cr o s s e d a x e s, s u c h a s 
w h e n t h e di a g n o sti c l e n s a xi s i s diff er e nt fr o m t h e s p e ct a cl e c yli n d er a xi s, it i s 
n ot a d vi s a bl e t o p erf or m a f ull s p h er o c yli n dri c al o v er-r efr a cti o n b e c a u s e of t h e 
difﬁ c ult y i n c o m p uti n g t h e r e s ult a nt p o w er. A s p h eri c al o v er-r efr a cti o n wit h o ut 
c yli n d er r efr a cti o n m a y b e p erf or m e d.
If t h e r e q uir e d c yli n d er c orr e cti o n f all s b et w e e n t w o a v ail a bl e c yli n d er p o w er s, 
it i s r e c o m m e n d e d t o pr e s cri b e t h e l o w er c yli n d er p o w er l e n s. S e e b el o w f or 
i n str u cti o n s o n h o w t o d et er mi n e t h e ﬁ n al l e n s p o w er.
1.  F or t h e S p h er e 
If s p h er e al o n e or c o m bi n e d s p h er e a n d c yli n d er R x > 4. 0 0 D, c o m p e n s at e 
f or v ert e x di st a n c e. If s p h er e al o n e or c o m bi n e d s p h er e a n d c yli n d er 
R x < ± 4. 0 0 D, v ert e x c o m p e n s ati o n i s n ot n e c e s s ar y.
2.  F or t h e C yli n d er
A dj u st t h e a xi s b y t h e drift a n gl e u si n g t h e L A R S m et h o d. C h o o s e a c yli n d er 
t h at i s ≤ 0. 5 0 D fr o m t h e r efr a cti v e c yli n d er.
3.  C a s e E x a m pl e s
E x a m pl e 1
M a nif e st ( s p e ct a cl e) r efr a cti o n:
O. D. - 2. 5 0 D / - 1. 2 5 D x 1 8 0° 2 0/ 2 0
O. S. - 2. 0 0 D / - 1. 0 0 D x 1 8 0° 2 0/ 2 0
C h o o s e a di a g n o sti c l e n s f or e a c h e y e wit h a xi s 1 8 0°. Pl a c e t h e l e n s o n 
e a c h e y e a n d all o w a mi ni m u m of 3 mi n ut e s f or it t o e q uili br at e, b a s e d o n 
t h e p ati e nt’s i niti al r e s p o n s e t o t h e l e n s. If t h e l e n s h a s n ot y et st a bili z e d, 
r e c h e c k u ntil st a bl e.
C h e c k t h e ori e nt ati o n of t h e a xi s m ar k. If t h e b ott o m a xi s m ar k i s i n t h e 6 
o’ cl o c k p o siti o n o n b ot h e y e s, c h o o s e t h e a p pr o pri at e c yli n d er a s li st e d 
pr e vi o u sl y. If t h e l e n s h a s n ot y et st a bili z e d, r e c h e c k u ntil st a bl e.
H er e i s t h e R x pr e s cri b e d:
O. D. - 2. 5 0 D / - 1. 2 5 D x 1 8 0°
O. S. - 2. 0 0 D / - 0. 7 5 D x 1 8 0°
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E x a m pl e 2
M a nif e st ( s p e ct a cl e) r efr a cti o n:
O. D. - 3. 0 0 D / - 1. 0 0 D x 9 0° 2 0/ 2 0
O. S. - 4. 7 5 D / - 2. 0 0 D x 9 0° 2 0/ 2 0
C h o o s e di a g n o sti c l e n s e s of - 3. 0 0 D / - 0. 7 5 D x 9 0° f or t h e ri g ht e y e a n d 
- 4. 5 0 D / - 1. 7 5 D x 9 0° f or t h e l eft e y e, t h e n e ar e st l e n s e s a v ail a bl e t o t h e 
s p h eri c al p o w er a n d a xi s n e e d e d. F or t h e l eft e y e, si n c e t h e m a nif e st 
r efr a cti o n c all e d f or - 4. 7 5 D, c o m p e n s ati n g f or v ert e x di st a n c e t h e s p h er e 
i s r e d u c e d b y 0. 2 5 D t o - 4. 5 0 D. T h e c yli n d er p o w er will b e - 1. 7 5 D. Pl a c e 
t h e l e n s o n e a c h e y e a n d all o w a mi ni m u m of 3 mi n ut e s f or it t o e q uili br at e, 
b a s e d o n t h e p ati e nt' s i niti al r e s p o n s e t o t h e l e n s. If t h e l e n s h a s n ot y et 
st a bili z e d, r e c h e c k u ntil st a bl e.
Ri g ht E y e
T h e ori e nt ati o n m ar k o n t h e ri g ht l e n s r ot at e s l eft fr o m t h e 6 o’ cl o c k p o siti o n 
b y 1 0° a n d r e m ai n s st a bl e i n t hi s p o siti o n. C o m p e n s ati o n f or t hi s r ot ati o n 
s h o ul d b e d o n e a s f oll o w s:
C o m p e n s at e t h e 1 0° a xi s drift b y a d di n g it t o t h e m a nif e st r efr a cti o n a xi s.
H er e i s t h e R x pr e s cri b e d:
O. D. - 3. 0 0 D / - 0. 7 5 D x 1 0 0°
L eft E y e
T h e ori e nt ati o n m ar k o n t h e l eft l e n s r ot at e s ri g ht fr o m t h e 6 o’ cl o c k p o siti o n 
b y 1 0° a n d r e m ai n s st a bl e i n t hi s p o siti o n. C o m p e n s ati o n f or t hi s r ot ati o n 
s h o ul d b e d o n e a s f oll o w s:
C o m p e n s at e f or t h e 1 0° a xi s drift b y s u btr a cti n g it fr o m t h e m a nif e st 
r efr a cti o n a xi s. 
H er e i s t h e R x pr e s cri b e d:
O. S. - 4. 5 0 D / - 1. 7 5 D x 8 0° 
If vi si o n i s a c c e pt a bl e, p erf or m a slit l a m p e x a mi n ati o n t o a s s e s s a d e q u at e 
ﬁ t ( c e ntr ati o n a n d m o v e m e nt). If ﬁ t i s a c c e pt a bl e, di s p e n s e t h e l e n s e s 
i n str u cti n g t h e p ati e nt t o r et ur n i n o n e w e e k f or r e a s s e s s m e nt ( s e e 
P A TI E N T M A N A G E M E N T  s e cti o n).
All p ati e nt s s h o ul d b e s u p pli e d wit h a c o p y of t h e P A TI E N T 
I N S T R U C TI O N G UI D E f or t h e s e l e n s e s. C o pi e s ar e a v ail a bl e f or 
d o w nl o a d at w w w. a c u v u e. c o m.
1 7
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 4 4 of 2 2 5
J J V C C O N FI D E N TI A L

A.  Pr e s b y o pi c N e e d s A s s e s s m e nt & P ati e nt E d u c ati o n
M ultif o c al c o nt a ct l e n s e s m a y pr o d u c e c o m pr o mi s e t o vi si o n u n d er c ert ai n 
cir c u m st a n c e s a n d t h e p ati e nt s h o ul d u n d er st a n d t h at t h e y mi g ht n ot ﬁ n d 
t h eir vi si o n a c c e pt a bl e i n s p e ciﬁ c sit u ati o n s (i. e., r e a di n g a m e n u i n a di m 
r e st a ur a nt, dri vi n g at ni g ht i n r ai n y/f o g g y c o n diti o n s, et c.). T h er ef or e, c a uti o n 
s h o ul d b e e x er ci s e d w h e n t h e p ati e nt i s w e ari n g t h e c orr e cti o n f or t h e ﬁ r st 
ti m e u ntil t h e y ar e f a mili ar wit h t h e vi si o n pr o vi d e d i n vi s u all y c h all e n gi n g 
e n vir o n m e nt s. O c c u p ati o n al a n d e n vir o n m e nt al vi s u al d e m a n d s s h o ul d 
b e c o n si d er e d. If t h e p ati e nt r e q uir e s criti c al vi s u al a c uit y a n d st er e o p si s, it 
s h o ul d b e d et er mi n e d b y tri al w h et h er t hi s p ati e nt c a n f u n cti o n a d e q u at el y 
wit h 1- D A Y A C U V U E ®  M OI S T M U L TI F O C A L. W e ari n g t h e s e l e n s e s m a y n ot 
b e o pti m al f or a cti viti e s s u c h a s:
• 
Vi s u all y d e m a n di n g sit u ati o n s s u c h a s o p er ati n g p ot e nti all y d a n g er o u s 
m a c hi n er y or p erf or mi n g ot h er p ot e nti all y h a z ar d o u s a cti viti e s; a n d
• 
Dri vi n g a ut o m o bil e s ( e. g., dri vi n g at ni g ht). P ati e nt s w h o c a n n ot m e et 
t h eir st at e dri v er’s li c e n s e r e q uir e m e nt s wit h t h e 1- D A Y A C U V U E®  M OI S T 
M U L TI F O C A L s h o ul d b e a d vi s e d t o n ot dri v e wit h t hi s c orr e cti o n, O R m a y 
r e q uir e t h at a d diti o n al o v er- c orr e cti o n b e pr e s cri b e d.
1- D A Y A C U V U E ®  M OI S T M U L TI F O C A L i s n ot r e c o m m e n d e d f or p ati e nt s 
w h o h a v e - 1. 0 0 D or gr e at er of r efr a cti v e c yli n d er a s t hi s l e v el of u n c orr e ct e d 
c yli n d er m a y l e a d t o a d diti o n al vi s u al c o m pr o mi s e. T h e s e l e n s e s ar e a v ail a bl e 
i n t h e f oll o wi n g A D D p o w er s: 
• 
L e n s “ L O W” = l o w n e ar A D D l e n s ( M a x A D D + 1. 2 5) 
• 
L e n s “ MI D” = m e di u m n e ar A D D l e n s ( M a x A D D + 1. 7 5) 
• 
L e n s “ H G H” = hi g h n e ar A D D l e n s ( M a x A D D + 2. 5 0)
B.  I niti al P o w er D et er mi n ati o n
A s p e ct a cl e r efr a cti o n s h o ul d b e p erf or m e d t o e st a bli s h t h e p ati e nt’s b a s eli n e 
r efr a cti v e st at u s a n d t o g ui d e i n t h e s el e cti o n of t h e a p pr o pri at e l e n s p o w er. 
R e m e m b er t o c o m p e n s at e f or v ert e x di st a n c e if t h e r efr a cti o n i s gr e at er 
t h a n ± 4. 0 0 D. D et er mi n e t h e s p h eri c al e q ui v al e nt di st a n c e pr e s cri pti o n f or a 
m ultif o c al p ati e nt. D et er mi n e t h e e y e d o mi n a n c e u si n g o n e of t h e m et h o d s 
b el o w:
M U L TI F O C A L FI T TI N G G UI D E LI N E S
1 8
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 4 5 of 2 2 5
J J V C C O N FI D E N TI A L

M et h o d 1    D et er mi n e w hi c h e y e i s t h e “ si g hti n g e y e.” H a v e t h e p ati e nt p oi nt 
t o a n o bj e ct at t h e f ar e n d of t h e r o o m. C o v er o n e e y e. If t h e 
p ati e nt i s still p oi nti n g dir e ctl y at t h e o bj e ct, t h e e y e b ei n g u s e d i s 
t h e d o mi n a nt ( si g hti n g) e y e.
M et h o d 2    D et er mi n e w hi c h e y e d o e s n ot a c c e pt a d d e d pl u s p o w er. Pl a c e a 
+ 1. 0 0 D h a n d- h el d tri al l e n s i n fr o nt of o n e e y e a n d t h e n t h e ot h er 
w hil e t h e di st a n c e r efr a cti v e err or c orr e cti o n i s i n pl a c e f or b ot h 
e y e s w hil e t h e p ati e nt i s vi e wi n g t h e di st a n c e vi s u al a c uit y c h art. 
T h e e y e wit h t h e pl u s o v er it t h at t h e p ati e nt n oti c e s t h e gr e at e st 
r e d u cti o n i n vi si o n i s d et er mi n e d t o b e t h e d o mi n a nt e y e.
C. S el e ct t h e I niti al Tri al L e n s 
1.  F or e a c h e y e, s el e ct t h e tri al l e n s di st a n c e p o w er t h at i s cl o s e st t o t h e 
p ati e nt’s di st a n c e s p h eri c al e q ui v al e nt. R e m e m b er t o c o m p e n s at e f or 
v ert e x di st a n c e if t h e r efr a cti o n i s gr e at er t h a n ± 4. 0 0 D.
2.  S el e ct t h e n e ar p o w er of t h e l e n s b a s e d o n t h e p ati e nt s A D D r a n g e a s 
f oll o w s: 
• 
A D D: + 0. 7 5 D t o + 1. 2 5 D u s e a l o w n e ar A D D ( L O W) l e n s o n e a c h e y e 
• 
A D D: + 1. 5 0 D t o + 1. 7 5 D u s e a m e di u m n e ar A D D ( MI D) l e n s o n e a c h 
e y e 
• 
A D D: + 2. 0 0 D t o + 2. 5 0 D u s e a m e di u m n e ar A D D ( MI D) o n t h e 
d o mi n a nt e y e a n d a hi g h n e ar A D D ( H G H) l e n s o n t h e n o n- d o mi n a nt 
e y e
3.  All o w t h e l e n s e s t o s ettl e f or a mi ni m u m of 1 0 mi n ut e s. 
4.  A s s e s s di st a n c e a n d n e ar vi si o n bi n o c ul arl y a n d m o n o c ul arl y. 
5.  D e m o n str at e t h e vi si o n u n d er v ari o u s li g hti n g c o n diti o n s ( n or m al a n d 
d e cr e a s e d ill u mi n ati o n) a n d at di st a n c e, i nt er m e di at e, a n d n e ar. 
6.  M a k e a dj u st m e nt s i n p o w er a s n e c e s s ar y b a s e d o n t h e di st a n c e o v er-
r efr a cti o n. T h e u s e of h a n d- h el d tri al l e n s e s i s r e c o m m e n d e d. C h e c k t h e 
i m p a ct o n di st a n c e a n d n e ar vi si o n.
7. If vi si o n i s still u n a c c e pt a bl e, m a k e a dj u st m e nt s i n p o w er a s n e c e s s ar y 
( s e e " M ultif o c al Tr o u bl e s h o oti n g" b el o w). If di st a n c e a n d n e ar vi si o n 
ar e a c c e pt a bl e, p erf or m a slit l a m p e x a mi n ati o n t o a s s e s s a d e q u at e 
ﬁ t ( c e ntr ati o n a n d m o v e m e nt). If ﬁ t i s a c c e pt a bl e, di s p e n s e t h e l e n s e s 
i n str u cti n g t h e p ati e nt t o r et ur n i n o n e w e e k f or r e a s s e s s m e nt ( s e e 
P A TI E N T M A N A G E M E N T  s e cti o n).
1 9
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 4 6 of 2 2 5
J J V C C O N FI D E N TI A L

D. M ultif o c al Tr o u bl e s h o oti n g
U n a c c e pt a bl e N e ar Vi si o n
If it h a s b e e n d et er mi n e d t h at n o c h a n g e i s r e q uir e d b a s e d o n t h e o v er-
r efr a cti o n, t h e n a d d + 0. 2 5 D t o t h e s p h eri c al p o w er of t h e n o n- d o mi n a nt e y e.
U n a c c e pt a bl e Di st a n c e Vi si o n
If it h a s b e e n d et er mi n e d t h at n o c h a n g e i s r e q uir e d b a s e d o n t h e o v er-
r efr a cti o n, t h e n m a k e t h e c h a n g e s a s li st e d b el o w:
• 
If t h e p ati e nt i s w e ari n g t w o " L O W" A D D l e n s e s, c h a n g e t h e d o mi n a nt 
e y e t o a 1- D A Y A C U V U E ®  M OI S T s p h er e l e n s wit h a p o w er e q u al t o t h e 
s p h eri c al e q ui v al e nt di st a n c e pr e s cri pti o n.
• 
If t h e p ati e nt i s w e ari n g t w o " MI D" A D D l e n s e s, c h a n g e t h e A D D p o w er i n 
t h e d o mi n a nt e y e t o t h e " L O W" A D D p o w er.
• 
If t h e p ati e nt i s w e ari n g a " MI D" A D D l e n s i n t h e d o mi n a nt e y e a n d a 
" H G H" A D D l e n s i n t h e n o n- d o mi n a nt e y e, c h a n g e t h e n o n- d o mi n a nt e y e 
t o a " MI D" A D D l e n s a n d a d d + 0. 2 5 D t o t h e di st a n c e p o w er.
E. A d a pt ati o n
Vi s u all y d e m a n di n g sit u ati o n s s h o ul d b e a v oi d e d d uri n g t h e i niti al w e ari n g 
p eri o d. A p ati e nt m a y at ﬁ r st e x p eri e n c e s o m e mil d bl urr e d vi si o n, di z zi n e s s, 
h e a d a c h e s a n d a f e eli n g of sli g ht i m b al a n c e. Y o u s h o ul d e x pl ai n t h e 
a d a pt ati o n al s y m pt o m s t o t h e p ati e nt. T h e s e s y m pt o m s m a y l a st f or a bri ef 
mi n ut e or f or s e v er al w e e k s. T h e l o n g er t h e s e s y m pt o m s p er si st, t h e p o or er 
t h e pr o g n o si s f or s u c c e s sf ul a d a pt ati o n.
To h el p i n t h e a d a pt ati o n pr o c e s s, t h e p ati e nt c a n b e a d vi s e d t o ﬁ r st u s e t h e 
l e n s e s i n a c o mf ort a bl e, f a mili ar e n vir o n m e nt s u c h a s i n t h e h o m e.
S o m e p ati e nt s f e el t h at a ut o m o bil e dri vi n g p erf or m a n c e m a y n ot b e o pti m al 
d uri n g t h e a d a pt ati o n pr o c e s s. T hi s i s p arti c ul arl y tr u e w h e n dri vi n g at ni g ht. 
B ef or e dri vi n g a m ot or v e hi cl e, it m a y b e r e c o m m e n d e d t h at t h e p ati e nt b e 
a p a s s e n g er ﬁ r st t o m a k e s ur e t h at t h eir vi si o n i s s ati sf a ct or y f or o p er ati n g 
a n a ut o m o bil e. D uri n g t h e ﬁ r st s e v er al w e e k s of w e ar ( w h e n a d a pt ati o n i s 
o c c urri n g), it m a y b e a d vi s a bl e f or t h e p ati e nt t o o nl y dri v e d uri n g o pti m al 
dri vi n g c o n diti o n s. Aft er a d a pt ati o n a n d s u c c e s s wit h t h e s e a cti viti e s, t h e 
p ati e nt s h o ul d b e a bl e t o dri v e u n d er ot h er c o n diti o n s wit h c a uti o n.
All p ati e nt s s h o ul d b e s u p pli e d wit h a c o p y of t h e P A TI E N T 
I N S T R U C TI O N G UI D E f or t h e s e l e n s e s. C o pi e s ar e a v ail a bl e f or 
d o w nl o a d at w w w. a c u v u e. c o m.
2 0
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 4 7 of 2 2 5
J J V C C O N FI D E N TI A L

A. P ati e nt S el e cti o n
1. M o n o vi si o n N e e d s A s s e s s m e nt
F or a g o o d pr o g n o si s, t h e p ati e nt s h o ul d h a v e a d e q u at el y c orr e ct e d 
di st a n c e a n d n e ar vi s u al a c uit y i n e a c h e y e. T h e a m bl y o pi c p ati e nt or t h e 
p ati e nt wit h si g niﬁ c a nt a sti g m ati s m ( gr e at er t h a n 1. 0 0 D) i n o n e e y e m a y n ot 
b e a g o o d c a n di d at e f or m o n o vi si o n c orr e cti o n wit h t h e s e l e n s e s.
O c c u p ati o n al a n d e n vir o n m e nt al vi s u al d e m a n d s s h o ul d b e c o n si d er e d. 
If t h e p ati e nt r e q uir e s criti c al vi si o n ( vi s u al a c uit y a n d st er e o p si s), it s h o ul d 
b e d et er mi n e d b y tri al w h et h er t hi s p ati e nt c a n f u n cti o n a d e q u at el y wit h 
m o n o vi si o n c orr e cti o n. M o n o vi si o n c o nt a ct l e n s w e ar m a y n ot b e o pti m al 
f or a cti viti e s s u c h a s:
• 
Vi s u all y d e m a n di n g sit u ati o n s s u c h a s o p er ati n g p ot e nti all y d a n g er o u s 
m a c hi n er y or p erf or mi n g ot h er p ot e nti all y h a z ar d o u s a cti viti e s; a n d
• 
Dri vi n g a ut o m o bil e s ( e. g., dri vi n g at ni g ht). P ati e nt s w h o c a n n ot m e et 
t h eir st at e dri v er’s li c e n s e r e q uir e m e nt s wit h m o n o vi si o n c orr e cti o n 
s h o ul d b e a d vi s e d t o n ot dri v e wit h t hi s c orr e cti o n, O R m a y r e q uir e t h at 
a d diti o n al o v er- c orr e cti o n b e pr e s cri b e d.
2. P ati e nt E d u c ati o n
All p ati e nt s d o n ot f u n cti o n e q u all y w ell wit h m o n o vi si o n c orr e cti o n. P ati e nt s 
m a y n ot p erf or m a s w ell f or c ert ai n t a s k s wit h t hi s c orr e cti o n a s t h e y h a v e 
wit h s p e ct a cl e s ( m ultif o c al, bif o c al, trif o c al, r e a d er s, pr o gr e s si v e s). E a c h 
p ati e nt s h o ul d u n d er st a n d t h at m o n o vi si o n, a s w ell a s ot h er pr e s b y o pi c 
alt er n ati v e s, c a n cr e at e a vi si o n c o m pr o mi s e t h at m a y r e d u c e vi s u al a c uit y 
a n d d e pt h p er c e pti o n f or di st a n c e a n d n e ar t a s k s. T h er ef or e, c a uti o n 
s h o ul d b e e x er ci s e d w h e n t h e p ati e nt i s w e ari n g t h e c orr e cti o n f or t h e ﬁ r st 
ti m e u ntil t h e y ar e f a mili ar wit h t h e vi si o n pr o vi d e d i n vi s u all y c h all e n gi n g 
e n vir o n m e nt s ( e. g., r e a di n g a m e n u i n a di ml y lit r e st a ur a nt, dri vi n g at ni g ht 
i n r ai n y/f o g g y c o n diti o n s, et c.). D uri n g t h e ﬁ tti n g pr o c e s s, it i s n e c e s s ar y f or 
t h e p ati e nt t o r e ali z e t h e di s a d v a nt a g e s a s w ell a s t h e a d v a nt a g e s of cl e ar 
n e ar vi si o n, a n d str ai g ht a h e a d a n d u p w ar d g a z e t h at m o n o vi si o n c o nt a ct 
l e n s e s pr o vi d e.
M O N O VI SI O N FI T TI N G G UI D E LI N E S
2 1
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 4 8 of 2 2 5
J J V C C O N FI D E N TI A L

B. E y e S el e cti o n
1.  O c ul ar Pr ef er e n c e D et er mi n ati o n M et h o d s
G e n er all y, t h e n o n- d o mi n a nt e y e i s c orr e ct e d f or n e ar vi si o n. T h e f oll o wi n g 
t w o m et h o d s f or e y e d o mi n a n c e c a n b e u s e d.
M et h o d 1    D et er mi n e w hi c h e y e i s t h e “ si g hti n g e y e.” H a v e t h e p ati e nt 
p oi nt t o a n o bj e ct at t h e f ar e n d of t h e r o o m. C o v er o n e e y e. 
If t h e p ati e nt i s still p oi nti n g dir e ctl y at t h e o bj e ct, t h e e y e 
b ei n g u s e d i s t h e d o mi n a nt ( si g hti n g) e y e.
M et h o d 2    D et er mi n e w hi c h e y e will a c c e pt t h e a d d e d p o w er wit h t h e 
l e a st r e d u cti o n i n vi si o n. Pl a c e a h a n d- h el d tri al l e n s e q u al t o 
t h e s p e ct a cl e n e ar A D D i n fr o nt of o n e e y e a n d t h e n t h e ot h er 
w hil e t h e di st a n c e r efr a cti v e err or c orr e cti o n i s i n pl a c e f or 
b ot h e y e s. D et er mi n e w h et h er t h e p ati e nt f u n cti o n s b e st wit h 
t h e n e ar A D D l e n s o v er t h e ri g ht or l eft e y e.
2.  Ot h er E y e S el e cti o n M et h o d s
Ot h er m et h o d s i n cl u d e t h e “ R efr a cti v e Err or M et h o d” a n d t h e “ Vi s u al 
D e m a n d s M et h o d.”
R efr a cti v e Err or M et h o d
F or a ni s o m etr o pi c c orr e cti o n, it i s g e n er all y b e st t o ﬁ t t h e m or e h y p er o pi c 
(l e s s m y o pi c) e y e f or di st a n c e a n d t h e m or e m y o pi c (l e s s h y p er o pi c) e y e 
f or n e ar.
Vi s u al D e m a n d s M et h o d
C o n si d er t h e p ati e nt’s o c c u p ati o n d uri n g t h e e y e s el e cti o n pr o c e s s t o 
d et er mi n e t h e criti c al vi si o n r e q uir e m e nt s. If a p ati e nt’s g a z e f or n e ar t a s k s 
i s u s u all y i n o n e dir e cti o n, c orr e ct t h e e y e o n t h at si d e f or n e ar.
E x a m pl e: A s e cr et ar y w h o pl a c e s c o p y t o t h e l eft si d e of t h e d e s k will 
f u n cti o n b e st wit h t h e n e ar l e n s o n t h e l eft e y e.
C.  S p e ci al Fitti n g C h ar a ct eri sti c s
1.  U nil at er al Vi si o n C orr e cti o n
T h er e ar e cir c u m st a n c e s w h er e o nl y o n e c o nt a ct l e n s i s r e q uir e d. A s a n 
e x a m pl e, a n e m m etr o pi c p ati e nt w o ul d o nl y r e q uir e a n e ar l e n s, w h er e a s 
a bil at er al m y o p e w o ul d r e q uir e c orr e cti v e l e n s e s o n b ot h e y e s. 
2 2
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P a ge 1 4 9 of 2 2 5
J J V C C O N FI D E N TI A L

E x a m pl e s:
A pr e s b y o pi c e m m etr o pi c p ati e nt w h o r e q uir e s a + 1. 7 5 D A D D w o ul d 
h a v e a + 1. 7 5 D l e n s o n t h e n e ar e y e a n d t h e ot h er e y e l eft wit h o ut 
c orr e cti o n.
A pr e s b y o pi c p ati e nt r e q uiri n g a + 1. 5 0 D A D D w h o i s - 2. 5 0 D m y o pi c i n 
t h e ri g ht e y e a n d - 1. 5 0 D m y o pi c i n t h e l eft e y e m a y h a v e t h e ri g ht e y e 
c orr e ct e d f or di st a n c e a n d t h e l eft e y e u n c orr e ct e d f or n e ar.
2.  N e ar A D D D et er mi n ati o n
Al w a y s pr e s cri b e t h e l e n s p o w er f or t h e n e ar e y e t h at pr o vi d e s o pti m al 
n e ar a c uit y at t h e mi d p oi nt of t h e p ati e nt’s h a bit u al r e a di n g di st a n c e. 
H o w e v er, w h e n m or e t h a n o n e p o w er pr o vi d e s o pti m al r e a di n g 
p erf or m a n c e, pr e s cri b e t h e l e a st pl u s ( m o st mi n u s) of t h e p o w er s.
3.  Tri al L e n s Fitti n g
A tri al ﬁ tti n g i s p erf or m e d i n t h e ofﬁ c e t o all o w t h e p ati e nt t o e x p eri e n c e 
m o n o vi si o n c orr e cti o n. L e n s e s ar e ﬁ t a c c or di n g t o t h e G E N E R A L 
FI T TI N G G UI D E LI N E S f or b a s e c ur v e s el e cti o n d e s cri b e d i n t hi s 
P a c k a g e I n s ert.
C a s e hi st or y a n d a st a n d ar d cli ni c al e v al u ati o n pr o c e d ur e s h o ul d b e u s e d 
t o d et er mi n e t h e pr o g n o si s. D et er mi n e t h e di st a n c e c orr e cti o n a n d t h e 
n e ar c orr e cti o n. N e xt, d et er mi n e t h e n e ar A D D. Wit h tri al l e n s e s of t h e 
pr o p er p o w er i n pl a c e, o b s er v e t h e r e a cti o n t o t hi s m o d e of c orr e cti o n.
All o w t h e l e n s e s t o s ettl e f or a b o ut 2 0 mi n ut e s wit h t h e c orr e ct p o w er 
l e n s e s i n pl a c e. W al k a cr o s s t h e r o o m a n d h a v e t h e p ati e nt l o o k at 
y o u. A s s e s s t h e p ati e nt’s r e a cti o n t o di st a n c e vi si o n u n d er t h e s e 
cir c u m st a n c e s. T h e n h a v e t h e p ati e nt l o o k at f a mili ar n e ar o bj e ct s s u c h 
a s a w at c h f a c e or ﬁ n g er n ail s. A g ai n a s s e s s t h e r e a cti o n. A s t h e p ati e nt 
c o nti n u e s t o l o o k ar o u n d t h e r o o m at b ot h n e ar a n d di st a n c e o bj e ct s, 
o b s er v e t h e r e a cti o n s. O nl y aft er t h e s e vi si o n t e st s ar e c o m pl et e d, s h o ul d 
t h e p ati e nt b e a s k e d t o r e a d pri nt. E v al u at e t h e p ati e nt’s r e a cti o n t o l ar g e 
pri nt ( e. g., t y p e writt e n c o p y) at ﬁ r st a n d t h e n gr a d u at e t o n e w s pri nt a n d 
ﬁ n all y s m all er t y p e si z e s.
Aft er t h e p ati e nt’s p erf or m a n c e u n d er t h e a b o v e c o n diti o n s i s c o m pl et e d, 
t e st s of vi s u al a c uit y a n d r e a di n g a bilit y u n d er c o n diti o n s of m o d er at el y 
di m ill u mi n ati o n s h o ul d b e att e m pt e d.
2 3
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 5 0 of 2 2 5
J J V C C O N FI D E N TI A L

A n i niti al u nf a v or a bl e r e s p o n s e i n t h e ofﬁ c e, w hil e i n di c ati v e of a g u ar d e d 
pr o g n o si s, s h o ul d n ot i m m e di at el y r ul e o ut a m or e e xt e n si v e tri al u n d er 
t h e u s u al c o n diti o n s i n w hi c h a p ati e nt f u n cti o n s.
4.  A d a pt ati o n
Vi s u all y d e m a n di n g sit u ati o n s s h o ul d b e a v oi d e d d uri n g t h e i niti al w e ari n g 
p eri o d. A p ati e nt m a y at ﬁ r st e x p eri e n c e s o m e mil d bl urr e d vi si o n, 
di z zi n e s s, h e a d a c h e s, a n d a f e eli n g of sli g ht i m b al a n c e. Y o u s h o ul d 
e x pl ai n t h e a d a pt ati o n al s y m pt o m s t o t h e p ati e nt. T h e s e s y m pt o m s m a y 
l a st f or a bri ef mi n ut e or f or s e v er al w e e k s. T h e l o n g er t h e s e s y m pt o m s 
p er si st, t h e p o or er t h e pr o g n o si s f or s u c c e s sf ul a d a pt ati o n. 
To h el p i n t h e a d a pt ati o n pr o c e s s, t h e p ati e nt c a n b e a d vi s e d t o ﬁ r st u s e 
t h e l e n s e s i n a c o mf ort a bl e, f a mili ar e n vir o n m e nt s u c h a s i n t h e h o m e.
S o m e p ati e nt s f e el t h at a ut o m o bil e dri vi n g p erf or m a n c e m a y n ot b e 
o pti m al d uri n g t h e a d a pt ati o n pr o c e s s. T hi s i s p arti c ul arl y tr u e w h e n 
dri vi n g at ni g ht. B ef or e dri vi n g a m ot or v e hi cl e, it m a y b e r e c o m m e n d e d 
t h at t h e p ati e nt b e a p a s s e n g er ﬁ r st t o m a k e s ur e t h at t h eir vi si o n i s 
s ati sf a ct or y f or o p er ati n g a n a ut o m o bil e. D uri n g t h e ﬁ r st s e v er al w e e k s of 
w e ar ( w h e n a d a pt ati o n i s o c c urri n g), it m a y b e a d vi s a bl e f or t h e p ati e nt t o 
o nl y dri v e d uri n g o pti m al dri vi n g c o n diti o n s. Aft er a d a pt ati o n a n d s u c c e s s 
wit h t h e s e a cti viti e s, t h e p ati e nt s h o ul d b e a bl e t o dri v e u n d er ot h er 
c o n diti o n s wit h c a uti o n.
D. Ot h er S u g g e sti o n s
T h e s u c c e s s of t h e m o n o vi si o n t e c h ni q u e m a y b e f urt h er i m pr o v e d b y h a vi n g 
y o ur p ati e nt f oll o w t h e s u g g e sti o n s b el o w:
• 
H a v e a t hir d c o nt a ct l e n s ( di st a n c e p o w er) t o u s e w h e n criti c al 
di st a n c e vi e wi n g i s n e e d e d.
• 
H a v e a t hir d c o nt a ct l e n s ( n e ar p o w er) t o u s e w h e n criti c al n e ar 
vi e wi n g i s n e e d e d.
• 
H a v e s u p pl e m e nt al s p e ct a cl e s t o w e ar o v er t h e m o n o vi si o n 
c o nt a ct l e n s e s f or s p e ciﬁ c vi s u al t a s k s m a y i m pr o v e t h e s u c c e s s of 
m o n o vi si o n c orr e cti o n. T hi s i s p arti c ul arl y a p pli c a bl e f or t h o s e p ati e nt s 
w h o c a n n ot m e et st at e dri v er’s li c e n si n g r e q uir e m e nt s wit h m o n o vi si o n 
c orr e cti o n.
• 
M a k e u s e of pr o p er ill u mi n ati o n w h e n c arr yi n g o ut vi s u al t a s k s.
2 4
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 5 1 of 2 2 5
J J V C C O N FI D E N TI A L

M o n o vi si o n ﬁ tti n g s u c c e s s c a n b e i m pr o v e d b y t h e f oll o wi n g s u g g e sti o n s:
• 
R e v er s e t h e di st a n c e a n d n e ar e y e s if a p ati e nt i s h a vi n g tr o u bl e 
a d a pti n g.
• 
R eﬁ n e t h e l e n s p o w er s if t h er e i s tr o u bl e wit h a d a pt ati o n. A c c ur at e 
l e n s p o w er i s criti c al f or pr e s b y o pi c p ati e nt s.
• 
E m p h a si z e t h e b e n eﬁ t s of cl e ar n e ar vi si o n, a n d str ai g ht a h e a d a n d 
u p w ar d g a z e wit h m o n o vi si o n.
T h e d e ci si o n t o ﬁ t a p ati e nt wit h m o n o vi si o n c orr e cti o n i s m o st a p pr o pri at el y 
l eft t o t h e E y e C ar e Pr of e s si o n al i n c o nj u n cti o n wit h t h e p ati e nt aft er c ar ef ull y 
c o n si d eri n g t h e p ati e nt’s n e e d s.
All p ati e nt s s h o ul d b e s u p pli e d wit h a c o p y of t h e P A TI E N T 
I N S T R U C TI O N G UI D E f or t h e s e l e n s e s. C o pi e s ar e a v ail a bl e f or 
d o w nl o a d at w w w. a c u v u e. c o m.
P A TI E N T M A N A G E M E N T
• 
F oll o w t h e a c c e pt e d st a n d ar d of c ar e i n ﬁ tti n g a n d f oll o wi n g u p wit h y o ur 
p ati e nt, e. g., A m eri c a n O pt o m etri c A s s o ci ati o n st a n d ar d of c ar e. 
• 
S c h e d ul e t h e a p pr o pri at e f oll o w- u p e x a mi n ati o n. 
• 
Pr ef er a bl y, at t h e f oll o w- u p vi sit s, l e n s e s s h o ul d h a v e b e e n w or n f or at 
l e a st si x h o ur s. 
• 
Pr o vi d e t h e p ati e nt wit h a c o p y of t h e P A TI E N T I N S T R U C TI O N G UI D E f or 
t h e s e l e n s e s, w hi c h c a n b e f o u n d at w w w. a c u v u e. c o m. R E VI E W T H E S E 
I N S T R U C TI O N S WI T H T H E P A TI E N T S O T H A T H E O R S H E C L E A R L Y 
U N D E R S T A N D S T H E P R E S C RI B E D W E A RI N G A N D R E P L A C E M E N T 
S C H E D U L E S.
T h e w e ari n g s c h e d ul e s h o ul d b e d et er mi n e d b y t h e E y e C ar e Pr of e s si o n al. 
R e g ul ar c h e c k u p s, a s d et er mi n e d b y t h e E y e C ar e Pr of e s si o n al, ar e al s o 
e xtr e m el y i m p ort a nt.
P ati e nt s t e n d t o o v er w e ar t h e l e n s e s i niti all y. T h e E y e C ar e Pr of e s si o n al s h o ul d 
e m p h a si z e t h e i m p ort a n c e of a d h eri n g t o t h e i niti al m a xi m u m w e ari n g s c h e d ul e. 
M a xi m u m w e ari n g ti m e s h o ul d b e d et er mi n e d b y t h e E y e C ar e Pr of e s si o n al 
b a s e d u p o n t h e p ati e nt’s p h y si ol o gi c al e y e c o n diti o n, b e c a u s e i n di vi d u al 
r e s p o n s e t o c o nt a ct l e n s e s v ari e s. 
W E A RI N G S C H E D U L E
2 5
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 5 2 of 2 2 5
J J V C C O N FI D E N TI A L

T h e m a xi m u m s u g g e st e d w e ari n g ti m e f or t h e s e l e n s e s i s:
D A Y
H O U R S
1 
6- 8
2 
8- 1 0
3 
1 0- 1 2
4 
1 2- 1 4
5 a n d after 
all waki n g h o urs
T h e s e l e n s e s ar e i n di c at e d f or d ail y di s p o s a bl e w e ar a n d s h o ul d b e di s c ar d e d 
u p o n r e m o v al.
W h e n di s p o s e d of aft er a si n gl e d ail y u s e, t h e s e l e n s e s m a y r e d u c e t h e ri s k of 
d e v el o pi n g gi a nt p a pill ar y c o nj u n cti viti s. 4
W h e n w or n a s a d ail y di s p o s a bl e l e n s, t h e s e l e n s e s m a y pr o vi d e i m pr o v e d 
c o mf ort f or m a n y p ati e nt s w h o e x p eri e n c e mil d di s c o mf ort a n d it c hi n g 
a s s o ci at e d wit h all er gi e s d uri n g c o nt a ct l e n s w e ar, c o m p ar e d t o l e n s e s r e pl a c e d 
at i nt er v al s of gr e at er t h a n 2 w e e k s.
Cli ni c al r e s e ar c h h a s s h o w n t h at w h e n w or n o n a d ail y di s p o s a bl e b a si s, t h e s e 
l e n s e s m a y pr o vi d e i m pr o v e d c o mf ort f or 2 o ut of 3 p ati e nt s w h o r e p ort e d 
s uff eri n g fr o m di s c o mf ort a s s o ci at e d wit h all er gi e s d uri n g c o nt a ct l e n s w e ar.
4 Th e C L A O J o ur n al, J ul y 1 9 9 9, V ol u m e 2 5, N u m b er 3
T h e E y e C ar e Pr of e s si o n al s h o ul d r e vi e w wit h p ati e nt s t h at n o cl e a ni n g or 
di si nf e cti o n i s n e e d e d wit h d ail y di s p o s a bl e l e n s e s. P ati e nt s s h o ul d al w a y s 
di s p o s e of l e n s e s w h e n t h e y ar e r e m o v e d a n d h a v e r e pl a c e m e nt l e n s e s or 
s p e ct a cl e s a v ail a bl e.
F or c o m pl et e i nf or m ati o n c o n c er ni n g c o nt a ct l e n s h a n dli n g a n d c ar e, r ef er t o 
t h e P A TI E N T I N S T R U C TI O N G UI D E f or t h e s e l e n s e s. C o pi e s ar e a v ail a bl e f or 
d o w nl o a d at w w w. a c u v u e. c o m. 
C ar e f or Sti c ki n g ( N o n- M o vi n g) L e n s e s
D uri n g r e m o v al, if t h e l e n s sti c k s t o t h e e y e, t h e p ati e nt s h o ul d b e i n str u ct e d 
t o a p pl y a f e w dr o p s of t h e r e c o m m e n d e d l u bri c ati n g or r e w etti n g s ol uti o n 
R E P L A C E M E N T S C H E D U L E
L E N S C A R E DI R E C TI O N S
2 6
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 5 3 of 2 2 5
J J V C C O N FI D E N TI A L

dir e ctl y t o t h e e y e a n d w ait u ntil t h e l e n s b e gi n s t o m o v e fr e el y o n t h e e y e b ef or e 
r e m o vi n g it. If n o n- m o v e m e nt of t h e l e n s c o nti n u e s aft er a f e w mi n ut e s, t h e 
p ati e nt s h o ul d  i m m e di at el y c o n s ult t h e E y e C ar e Pr of e s si o n al.
T h e p ati e nt s h o ul d b e i nf or m e d t h at if c h e mi c al s of a n y ki n d ( h o u s e h ol d 
pr o d u ct s, g ar d e ni n g s ol uti o n s, l a b or at or y c h e mi c al s, et c.) ar e s pl a s h e d i nt o 
t h e e y e s, t h e p ati e nt s h o ul d:  F L U S H E Y E S I M M E DI A T E L Y WI T H T A P W A T E R 
A N D I M M E DI A T E L Y C O N T A C T T H E E Y E C A R E P R O F E S SI O N A L O R VI SI T A 
H O S PI T A L E M E R G E N C Y R O O M WI T H O U T D E L A Y.
E a c h U V- a b s or bi n g st eril e l e n s i s s u p pli e d i n a f oil- s e al e d pl a sti c p a c k a g e 
c o nt ai ni n g b uff er e d s ali n e s ol uti o n wit h p o vi d o n e. T h e pl a sti c p a c k a g e i s m ar k e d 
wit h t h e f oll o wi n g: 
• 
1- D A Y A C U V U E ®  M OI S T: b a s e c ur v e, p o w er, di a m et er, l ot n u m b er, a n d 
e x pir ati o n d at e
• 
1- D A Y A C U V U E ®  M OI S T f or A S TI G M A TI S M: b a s e c ur v e, p o w er, 
di a m et er, c yli n d er, a xi s, l ot n u m b er, a n d e x pir ati o n d at e
• 
1- D A Y A C U V U E ®  M OI S T M U L TI F O C A L: b a s e c ur v e, p o w er, di a m et er, 
A D D p o w er, l ot n u m b er, a n d e x pir ati o n d at e
All s eri o u s a d v er s e e x p eri e n c e s a n d a d v er s e r e a cti o n s o b s er v e d i n p ati e nt s 
w e ari n g t h e s e l e n s e s or e x p eri e n c e d wit h t h e s e l e n s e s s h o ul d b e r e p ort e d t o:
J o h n s o n & J o h n s o n Vi si o n C ar e, I n c.
7 5 0 0 C e nt uri o n P ar k w a y
J a c k s o n vill e, F L 3 2 2 5 6
U S A
Tel: 1- 8 0 0- 8 4 3- 2 0 2 0
w w w. a c u v u e. c o m
E M E R G E N CI E S
H O W S U P P LI E D
R E P O R TI N G O F A D V E R S E R E A C TI O N S
2 7
C R- 5 9 4 5, V 9. 0
 
 
P a ge 1 5 4 of 2 2 5
J J V C C O N FI D E N TI A L

APPENDIX D: PRESBYOPIC SYMPTOMS QUESTIONNAIRE
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APPENDIX P: POST-FIT INTERVIEW 
 
  
  
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APPENDIX R:
x
 DETERMINATION OF NEAR ADD
x
 LENS FITTING CHARACTERISTICS
x
SUBJECT REPORTED OCULAR SYMPTOMS
x
 DETERMINATION OF DISTANCE SPHEROCYLINDRICAL 
REFRACTIONS
x
BIOMICROSCOPY SCALE
x
KERATOMETRY PROCEDURE
x
 MEASUREMENT OF COAS WAVEFRONT ABBERATIONS
x
 LENS INSERTION AND REMOVAL
x
WAM-5500 ON-AXIS AUTO REFRACTION MEASUREMENT
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DETERMINATION OF NEAR ADD
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Page 4 of 7
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 LENS FITTING CHARACTERISTICS
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Page 6 of 6 
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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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KERATOMETRY PROCEDURE 
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MEASUREMENT OF COAS WAVEFRONT ABBERATIONS 
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LENS INSERTION AND REMOVAL 
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Title:    
 
Lens Insertion and Removal 
Document Type: 
Work Instructions 
Document Number: 
Revision Number:  2 
 
 
 
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WAM-5500 ON-AXIS AUTO REFRACTION MEASUREMENT
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JJVC CONFIDENTIAL

Title: 
WAM-5500 On-axis Auto Refraction Measurement 
Document Type: 
Clinical Test Procedure 
Document Number:  
 
Revision Number: 3 
 
Page 3 of 3 
 
 
 
CR-5945, V9.0
 
 
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MEASURING PUPIL DIAMETER WITH NEUROPTICS VIP-300 
VARIABLE PUPILLOMETER 
CR-5945, V9.0
 
 
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CR-5945, V9.0
 
 
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CR-5945, V9.0
 
 
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CR-5945, V9.0
 
 
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PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE
Protocol Number and Title: CR-5945, Characterizing Successful Myopic Multifocal Contact 
Lens Wearers
Version and Date: 9.0 Amendment 8, 20 December 2019 
I have read and understand the protocol specified above and agree on its content.   
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the 
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, participant to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that all 
clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and GCP 
guidelines regarding clinical trials during and after study completion. 
I will assure that no deviation from, or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial Subjects. 
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere 
to all ICH2 regulations and GCP guidelines regarding clinical trials during and after study 
completion. 
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training.  
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments. 
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization. 
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
CR-5945, V9.0
 
 
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