Objective Vision Evaluation of Two Cosmetic Contact Lenses
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.



Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
the lens, confirm lens is not inverted (correct 
if it is is) and reinsert.  
1.14
Lens Settling 
Allow the study lenses to settle for a 
minimum of 5 minutes.
1.15
Subjective Best 
Sphere Over 
Refraction
Perform subjective best sphere refraction over 
the study lenses with a phoropter (adopt the 
maximum plus to maximum visual acuity 
(MPMVA) approach and use the duo-chrome 
test for binocular balancing) and record the 
best corrected distance visual acuity to the 
nearest letter (OD, OS, OU).
1.16
Lens Power 
Modification (if 
applicable)
Adjust the lens power if the subject’s best 
sphere over-refraction is not plano. 
For each power modification, repeat steps 
(1.13 to 1.16).
Only two power modifications per eye are
allowed. 
1.17
Subject Reported 
Ocular Symptoms
Subjects will respond to a verbal open-ended 
symptoms questionnaire.
1.18
Visual Experience
Subject will spend approximately 20 minutes 
experiencing vision.  During this time please 
instruct subject to look outside (windows or 
physically walk outside), use electronic 
device (phone, computer), read magazine 
print, and experience dim room illumination 
for tasks. A member of the clinical site must 
accompany the subject at all times if outside 
the clinic area.
1.19
Post-Fit 
Questionnaire
The subject will respond to the CLUE/PRO 
Post-Fit Questionnaire.
1.20
Distance ETDRS 
LogMAR Visual 
Acuity- High 
illumination 
Per 
 please confirm 
room illuminance and chart luminance 
acceptable ranges for both high/low contrast 
visual acuity testing.
1. Under high illumination and high chart 
luminance, record the distance (4 meter) 
ETDRS high contrast visual acuity OD 
(HC1) and OU (HC2).
2. Under high illumination and high chart 
luminance, record the distance (4 meter) 
ETDRS low contrast visual acuity OD 
(LC1) and OU (LC2).
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Letter-by-letter results will be recorded into 
the electronic data capture form, which will 
calculate the visual performance score for each 
chart read.  
1.21
Near logMAR 
Visual Acuity- High 
illumination 
Per 
 
please 
confirm 
room 
illuminance and chart luminance acceptable 
ranges for both high/low contrast visual acuity 
testing.  
1. Under high illumination and high chart 
luminance, record the near (40 cm) low 
contrast visual acuity OD and OU (once 
each).
Letter-by-letter results will be recorded into 
the electronic data capture form, which will 
calculate the visual performance score for each 
chart read.   
Regarding Near logMAR VA:
the room illumination will be >400 lux for all 
testing
Regarding the Near logMAR VA 
 
Reference to verification chart and room 
illuminance
 is not applicable
1.22
Distance ETDRS 
LogMAR Visual 
Acuity- with googles
Per 
 please confirm 
room illuminance and chart luminance 
acceptable ranges for both high/low contrast 
visual acuity testing.
1. With the goggles on, under high
illumination and chart luminance, 
record the distance (4 meter) ETDRS 
high contrast visual acuity OD (HC3)
and OU (HC4).  Allow subject to adjust 
to dim condition for 3 minutes.
Letter-by-letter results will be recorded into 
the electronic data capture form, which will 
calculate the visual performance score for 
each chart read.  
1.23
Near logMAR 
Visual Acuity- with
goggles
Per 
 
please 
confirm 
room 
illuminance and chart luminance acceptable 
ranges for both high/low contrast visual acuity 
testing.  
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1. With the goggles on, under high
illumination and chart luminance, 
record the near (40 cm) high contrast 
visual acuity OD and OU (once each).
Allow subject to adjust to dim condition 
for 3 minutes (if not already adjusted)
Letter-by-letter results will be recorded into 
the electronic data capture form, which will
calculate the visual performance score for each 
chart read.   
Regarding Near logMAR VA:
the room illumination will be >400 lux for all 
testing
Regarding the Near logMAR VA 
 
Reference to verification chart and room 
illuminance 
 is not applicable
1.24
Quick Contrast 
Sensitivity Function 
(qCSF)
Conduct OD and OU with 25 trials.  
1.25
Pupillometry 
With the subject facing the qCSF monitor and 
under the same dim light conditions that 
qCSF was measured, take 3 measurements of 
the pupil size of the subjects OD and OS with 
the pupillometer.  
1.26
Quantitative Visual 
Acuity (qVA)
A demonstration trial must be performed 
prior to any data collection
Complete the qVA measurement of the OD 
and OU utilizing the following qVA 
configurations: 
• Number of rows: 15
• Stimulus duration: 3 seconds 
• Test Distance: 4 meters 
• Under low room illumination (4 lux), low 
luminance, high contrast conditions (with the 
M&S mesopic filter placed in front of the 
qVA monitor)
Allow subject to adjust to dim condition for 3 
minutes (if not already adjusted)
EDC to record qVAt (threshold) in logMAR 
and qVAr (range) in lines
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1.27
Visionix VX118 
Wavefront (if 
available)
Measure the wavefront for each eye with the 
Visionix VX118 instrument (using WF 
mode) in dim room illumination.
On the 
Coeff. Aberr. tab, select RL display and 
Night mode, then record the pupil size (in 
mm), HOA (in microns) and the Sph. Aberr. 
(in microns) for each eye.
1.28
Cosmetic Lens Fit 
Assessment (without 
slit-lamp)
The Cosmetic Lens Assessment will be 
assessed by the investigator (without slit-
lamp) in primary gaze and extreme gaze 
(right, left, and upgaze) at a normal 
conversation distance (approximately three 
(3) feet away from the subject).  
1.29
Hula Hoop 
Assessment (without 
slit-lamp)
*if unacceptable 
cosmetic lens fit in 
any gaze*
If there is an unacceptable cosmetic fit in any 
gaze, the Hula Hoop Assessment will be 
assessed by the investigator (without slit-
lamp) in primary gaze and extreme gaze 
(right, left, and upgaze) at a normal 
conversation distance (approximately three 
(3) feet away from the subject).  
1.30
Subjective Lens Fit 
Assessment
Evaluate overall lens fit acceptance 
(acceptable or unacceptable) based on 
centration, movement and other fitting 
characteristics.
An unacceptable fit is deemed by one of the 
following criteria: 
x
limbal exposure at primary gaze or 
with extreme eye movement;
x
edge lift;
x
excessive movement in primary and 
up gaze; or 
x
insufficient movement in all three of 
the following conditions: primary 
gaze, up gaze, and Josephson push up.
If the fit is unacceptable, the subject can 
continue with the study.  
1.31
Photographs/Videos
Photographs/Videos of the lenses on eye may 
be taken if there is an unacceptable cosmetic or 
mechanic lens fit.
1.32
Remove lenses
Have subject remove lenses.  Worn lenses 
can be discarded.  
1.33
Washout
There will be a 5-minute washout between 
lenses
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1.40
Visual Experience
Subject will spend approximately 20 minutes
experiencing vision.  During this time please 
instruct subject to look outside (windows or 
physically walk outside), use electronic 
device (phone, computer), read magazine 
print, and experience dim room illumination 
for tasks. A member of the clinical site must 
accompany the subject at all times if outside 
the clinic area.
1.41
Post-Fit 
Questionnaire
The subject will respond to the CLUE/PRO 
Post-Fit Questionnaire.
1.42
Distance ETDRS 
logMAR Visual 
Acuity- High 
illumination 
Per 
please confirm 
room illuminance and chart luminance 
acceptable ranges for both high/low contrast 
visual acuity testing.
3. Under high illumination and high chart 
luminance, record the distance (4 meter) 
ETDRS high contrast visual acuity OD 
(HC1) and OU (HC2).
4. Under high illumination and high chart 
luminance, record the distance (4 meter) 
ETDRS low contrast visual acuity OD 
(LC1) and OU (LC2).
Letter-by-letter results will be recorded into 
the electronic data capture form, which will 
calculate the visual performance score for each 
chart read.  
1.43
Near logMAR 
Visual Acuity- High 
illumination 
Per 
 
please 
confirm 
room 
illuminance and chart luminance acceptable 
ranges for both high/low contrast visual acuity 
testing.  
2. Under high illumination and high chart 
luminance, record the near (40 cm) low 
contrast visual acuity OD and OU (once 
each).
Letter-by-letter results will be recorded into 
the electronic data capture form, which will 
calculate the visual performance score for each 
chart read.   
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Regarding Near logMAR VA:
the room illumination will be >400 lux for all 
testing
Regarding the Near logMAR VA 
 
Reference to verification chart and room 
illuminance 
 is not applicable
1.44
Distance ETDRS 
LogMAR Visual 
Acuity- with googles
Per 
, please confirm 
room illuminance and chart luminance 
acceptable ranges for both high/low contrast 
visual acuity testing.
2. With the goggles on, under high
illumination and chart luminance, 
record the distance (4 meter) ETDRS 
high contrast visual acuity OD (HC3)
and OU (HC4).  Allow subject to adjust
to dim condition for 3 minutes.
Letter-by-letter results will be recorded into 
the electronic data capture form, which will 
calculate the visual performance score for 
each chart read.  
1.45
Near logMAR 
Visual Acuity- with
goggles
Per 
 
please 
confirm 
room 
illuminance and chart luminance acceptable 
ranges for both high/low contrast visual acuity 
testing.  
2. With the goggles on, under high
illumination and chart luminance, 
record the near (40 cm) high contrast 
visual acuity OD and OU (once each).
Allow subject to adjust to dim condition 
for 3 minutes (if not already adjusted)
Letter-by-letter results will be recorded into 
the electronic data capture form, which will 
calculate the visual performance score for each
chart read.   
Regarding Near logMAR VA:
the room illumination will be >400 lux for all 
testing
Regarding the Near logMAR VA 
 
Reference to verification chart and room
illuminance 
 is not applicable
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Johnson & Johnson Vision Care, Inc.
1.46
Quick Contrast 
Sensitivity Function 
(qCSF)
Conduct OD and OU with 25 trials.  
1.47
Quantitative Visual 
Acuity (qVA)
A demonstration trial must be performed 
prior to any data collection
Complete the qVA measurement of the OD 
and OU utilizing the following qVA 
configurations: 
• Number of rows: 15
• Stimulus duration: 3 seconds 
• Test Distance: 4 meters 
• Under low room illumination (4 lux), low 
luminance, high contrast conditions (with the
M&S mesopic filter placed in front of the 
qVA monitor)
Allow subject to adjust to dim condition for 3 
minutes (if not already adjusted).
EDC to record qVAt (threshold) in logMAR 
and qVAr (range) in lines
1.48
Visionix VX118 
Wavefront (if 
available)
Measure the wavefront for each eye with the 
Visionix VX118 instrument (using WF 
mode) in dim room illumination.
On the 
Coeff. Aberr. tab, select RL display and 
Night mode, then record the pupil size (in 
mm), HOA (in microns) and the Sph. Aberr. 
(in microns) for each eye.
1.49
Cosmetic Lens Fit 
Assessment (without 
slit-lamp)
The Cosmetic Lens Assessment will be 
assessed by the investigator (without slit-
lamp) in primary gaze and extreme gaze 
(right, left, and upgaze) at a normal 
conversation distance (approximately three 
(3) feet away from the subject).  
1.50
Hula Hoop 
Assessment (without 
slit-lamp)
*if unacceptable 
cosmetic lens fit in 
any gaze*
If there is an unacceptable cosmetic fit in any 
gaze, the Hula Hoop Assessment will be 
assessed by the investigator (without slit-
lamp) in primary gaze and extreme gaze 
(right, left, and upgaze) at a normal 
conversation distance (approximately three 
(3) feet away from the subject).  
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
For discontinued subjects, the Investigator will:
x
Complete the current visit (scheduled or unscheduled)
x
Complete the Final Evaluation, indicating the reason that the subject was discontinued 
from the study
x
Record the spherocylindrical refraction with best corrected distance visual acuity, as 
appropriate
x
Collect used test article(s) (worn or brought to the visit) from the subject and discard 
them, unless otherwise stated in Section 7.2
x
Collect all unused test article(s) from the subject
An additional subject may be enrolled if a subject discontinues from the study prematurely. 
In cases where a subject is lost to follow-up, every possible effort must be made to contact the 
subject and determine the reason for discontinuation/withdrawal.  The measures taken to 
follow up must be documented including two written attempts and a certified letter (or 
equivalent) as the final attempt.
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: None
Concomitant therapies that are disallowed include: None
9.1.
Systemic Medications 
Due to the non-dispensing, single visit nature of the study and endpoints being assessed, 
systemic medications will be allowed provided they did not interfere with contact lens wear, 
which will be at the discretion of the investigator.  
Disallowed systemic medications - Not applicable
10. DEVIATIONS FROM THE PROTOCOL 
Investigator will notify study sponsor upon identification of a protocol deviation. Protocol 
deviations must be reported to the sponsor within 24 hours after discovery of the protocol 
deviation. The Investigator will report deviations per IRB/IEC requirements. All deviations 
will be tracked and corrective actions implemented as appropriate. 
If it becomes necessary for the Investigator to implement a deviation in order to eliminate an 
immediate hazard to the trial subject, the Investigator may implement the deviation 
immediately without notification to the sponsor. Within 24 hours after the implemented 
deviation, the Investigator must notify and provide the rationale to the Sponsor and, as 
required, the IEC/IRB. 
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If the deviation potentially impacts the safety of patient or changes the technical integrity of 
the study then it must be reported to IEC/IRB. This is a "Major Deviation".
Minor deviations have no substantive effect on patient safety or technical integrity of the 
study. They are often logistical in nature. The informed consent must also not be contradicted 
by the deviation.
Protocol waivers are prohibited
11. STUDY TERMINATION 
The occurrence of one or more Unanticipated Serious Adverse Device Effect (USADE), or 
any SAE where the relationship to study agent cannot be ruled out, may result in stopping 
further dispensing of test article. In the event of a USADE or SAE, the Sponsor may unmask 
the treatment regimen for the subject(s) and will discuss this with the Investigator before any 
further subjects are enrolled.
The Sponsor will determine when a study will be stopped. The Principal Investigator always 
has the discretion to initiate stopping the study based on patient safety or if information 
indicates the study’s results are compromised.
JJVC reserves the right to terminate the study at any time for any reason. Additionally, the 
IEC/IRB reserves the right to terminate the study if an unreasonable risk is determined. The 
study can be terminated by the Principal Investigator at the individual clinical site due to 
specific clinical observations, if in their opinion, after a discussion with JJVC, it is determined 
that it would be unwise to continue at the clinical site.
JJVC (and the IEC/IRB and DMC, if applicable) will evaluate all adverse events. If it is 
determined that an adverse event presents an unreasonable risk, the investigation, or that part 
of the investigation presenting the risk, will be terminated as soon as possible.
Should the study be terminated (either prematurely or as scheduled), the Investigator will 
notify the IEC/IRB and Regulatory Authority as required by local regulatory requirements.
12. PROCEDURE FOR HANDLING PRODUCT QUALITY COMPLAINTS 
A Product Quality Complaint (PQC) refers to any written, electronic, or oral communication 
that alleges deficiencies related to the identity, quality, durability, reliability, safety, 
effectiveness or performance of test articles after they have been released for clinical trial use.  
Potential complaints may come from a variety of sources including but not limited to subjects, 
clinical research associates (CRA), clinical operations managers (COM), medical monitors, 
and site personnel, etc. The following are not considered product quality complaints:
x
Subject satisfaction inquiries reported via “Subjective Questionnaires” and “Patient 
Reported Outcomes (PRO).”
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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 subject.
Within 24 hours of site personnel becoming aware that a PQC has occurred, the PQC must be 
recorded in the EDC system, which will trigger an automatic email notification to the 
appropriate COM/CRA and Clinical QA representative. In cases where the EDC system in use 
is not configured to send automatic notifications or when an EDC system is not used, the 
COM/CRA is responsible for notifying Clinical QA upon discovery that a PQC has occurred.  
Upon receipt of the EDC notification, the COM/CRA will contact the study site to collect 
additional information which will include: 
x
Date the complaint was received/recorded in the EDC System (Date of Sponsor 
Awareness).
x
Who received the complaint.
x
Study number.
x
Clinical site information (contact name, site ID, telephone number).
x
Lot number(s).
x
Unique Subject Identifier(s).
x
Indication of who first observed complaint (site personnel or subject).
x
OD/OS indication, along with whether 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 (
for test article return instructions).
Once a complaint is received, it will be assessed by the COM, CRA, or trained site personnel 
to determine if it is an Adverse Event/Serious Adverse Event (AE/SAE). If the complaint 
results in an AE/SAE, the COM/CRA, or trained site personnel will follow Section 13 of this 
protocol. If the AE/SAE was potentially the result of a product quality related deficiency, these 
procedures also applies and will be executed in parallel.  
In some cases, a PQC form may be generated in EDC by the site in error. In this event, the 
PQC forms will be marked “Intentionally Left Blank” or “ILB”.  Justification for ILB must be 
documented.
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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. 
This definition includes events related to the investigational medical device or the 
comparator, and to the procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices1
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 adverse event that led to any of the following:
x
Death
x
Serious deterioration in the health of the subject that resulted in any of the following:
x
Life-threatening illness or injury
x
Permanent or persistent impairment of a body structure or a body function
x
Hospitalization or prolongation of patient hospitalization
x
Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function.
x
Chronic disease
x
Fetal distress, fetal death or a congenital physical or mental impairment of birth defect.
Diagnoses and conditions that are considered Ocular Serious Adverse Events include, but not 
limited to:
x
Microbial Keratitis (MK)
x
Iritis (including cells in the anterior chamber)
x
Permanent decrease in best spectacle corrected visual acuity equivalent to 2 acuity lines 
or greater
x
Central Corneal Opacity
x
Central Corneal Neovascularization
x
Uveitis
x
Endophthalmitis
x
Hypopyon
x
Hyphemia
x
Penetration of Bowman’s Membrane
x
Persistent Epithelial Defect
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x
Limbal cell Damage leading to Conjunctivalization
Significant Adverse Events – are defined as events that are symptomatic and warrant 
discontinuation (temporary or permanent) of the contact lens wear
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 – are defined as those events that are usually asymptomatic 
and usually do not warrant discontinuation of contact lens wear but may cause a reduction in 
wear time.  However, the Investigator may choose to prescribe treatment 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.
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, 
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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 0).
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 subject. The assessment of 
severity is made irrespective of test article, study treatment or study procedure relationship or 
seriousness of the event and should be evaluated according to the following scale:
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x
Mild – Event is noticeable to the subject, but is easily tolerated and does not interfere 
with the subject’s daily activities.
x
Moderate – Event is bothersome, possible requiring additional therapy, and may 
interfere with the subject’s daily activities.
x
Severe – Event is intolerable, necessitates additional therapy or alteration of therapy 
and interferes with the subject’s daily activities.
13.3. Documentation and Follow-Up of Adverse Events 
The recording and documenting of adverse events (ocular and non-ocular) begin when the 
subjects are exposed to the test article, study treatment or study procedure.  Adverse events 
reported before the use of test article, start of study treatment, or study procedures will be 
recorded as medical history. However, if the condition deteriorates at any time during the study 
it will be recorded and reported as an AE. Untoward medical events reported after the subject’s 
exit from the study will be recorded as adverse events at the discretion of the Investigator.
Upon finding an adverse event, the Principal Investigator will document the condition in the 
subject record and in the eCRFs. He/she will complete the Adverse Event /eCRF.  
Complete descriptions of all adverse events must be available in the subject record. All 
Adverse Events including local and systemic reactions not meeting the criteria for “serious 
adverse events” shall be captured on the appropriate case report form or electronic data system. 
All adverse events occurring while the subject is enrolled in the study must be documented 
appropriately regardless of relationship.  
It is the Investigator’s responsibility to maintain documentation of each reported adverse event. 
All adverse events will be followed in accordance with applicable licensing requirements. Such 
documentation will include the following:
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, if related to the visual system.
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 
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infection is microbial in nature. If cultures are collected, the date of culture collection and 
laboratory utilized will be recorded. 
Changes in the severity of an AE shall be documented to allow an assessment of the duration 
of the event at each level of intensity to be performed. Adverse events characterized as 
intermittent require documentation of the onset and duration of each episode. Changes in the 
assessment of relationship to the Test Article shall also be clearly documented.
Subjects who present with an adverse event shall be followed by the Investigator, within 
licensure, until all signs and symptoms have returned to pre-treatment status, stabilized, or 
been satisfactorily resolved. If further treatment beyond licensure is required, the patient will 
be referred to the appropriate health care provider. The Investigator will use his/her clinical 
judgment as to whether a subject reporting with an adverse event will continue in the study. If 
a subject is discontinued from the study, it will be the responsibility of the Investigator to 
record the reason for discontinuation. The Investigator will also document the adverse event 
appropriately and complete the Adverse Event eCRF. Any subjects with ongoing adverse 
events related to the test article, study treatment or study procedures, as of the final study visit 
date, should be followed to resolution of the adverse event or until referral to an appropriate 
health care provider, as recommended by the Investigator. Non-ocular adverse events that are 
not related to the test article, study treatment, or study procedures may be recorded as 
“ongoing” without further follow-up.
13.4. Reporting Adverse Events  
The Investigator will notify the Sponsor of an adverse event by e-mail, facsimile, or telephone 
as soon as possible and no later than 24 hours from discovery for any serious /significant 
adverse events, and 2 days from discovery for any non-significant adverse event. In addition, 
a written report will be submitted by the Principal Investigator to the IEC/IRB according to 
their requirements (Section 13.4.2). The report will comment whether the adverse event was 
considered to be related to the test article, study treatment or study procedures.
13.4.1. Reporting Adverse Events to Sponsor 
Serious/Significant Adverse Events
The Investigator will inform the sponsor of all serious/significant adverse events occurring 
during the study period as soon as possible by e-mail, fax, or telephone, but no later than 24 
hours following discovery of the event. The Investigator is obligated to pursue and obtain 
information requested by the Sponsor in addition to that information reported on the eCRF. All 
subjects experiencing a serious/significant adverse event must be followed up and all outcomes 
must be reported.
When medically necessary, the Investigator may break the randomization code to determine 
the identity of the treatment that the subject received. The Sponsor and study monitor should 
be notified prior to unmasking the test articles.
In the event of a serious/significant adverse event, the Investigator must:
x
Notify the Sponsor immediately.
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x
Obtain and maintain in the subject’s records all pertinent medical information and 
medical judgment for colleagues who assisted in the treatment and follow-up of the 
subject.
x
Provide the Sponsor with a complete case history which includes a statement as to 
whether the event was or was not related to the use of the test article.
x
Notify the IEC/IRB as required by the IEC/IRB reporting procedure according to 
national regulations.
Unanticipated (Serious) Adverse Device Effect (UADE)
In the event of an Unanticipated (Serious) Adverse Device Effect (UADE), the Investigator 
will submit a report of the UADE to the Sponsor and IEC/IRB as soon as possible, but no later 
than 24 hours after the Investigator first learns of the effect. This report is in addition to the 
immediate notification mentioned above.
The Sponsor must conduct an evaluation of the UADE and must report the results of the 
evaluation to FDA, the IEC/IRB and participating Investigators within 10 working days after 
the Sponsor first receives notification of the effect.
Non-Serious Adverse Events
All non-serious adverse events, including non-serious adverse device effects, will be reported 
to the sponsor by the Investigator no later than 2 days from discovery.
13.4.2. Reporting Adverse Events to the Responsible IEC/IRB and Health Authorities 
Adverse events that meet the IEC/IRB requirements for reporting must be reported within the 
IEC/IRB’s written guidelines. Each clinical site will refer to and follow any guidelines set 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
13.5. Reporting of Pregnancy 
Subjects reporting pregnancy (by self-report) during the study will be discontinued after the 
event is recorded as an Adverse Event. Once discontinued, pregnant participants and their 
fetuses will not be monitored for study related purposes. At the Investigator’s discretion, the 
study participant may be followed by the Investigator through delivery. However, this data will 
not be collected as part of the clinical study database. Pregnant participants are not 
discontinued from contact lens or solution related studies for safety concerns, but due to 
general concerns relating to pregnancy and contact lens use. Specifically, pregnant women are 
discontinued due to fluctuations in refractive error and/or visual acuity that occur secondary to 
systemic hormonal changes, and not due to unforeseen health risks to the mother or fetus.
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14. STATISTICAL METHODS 
14.1. General Considerations 
Statistical analysis will be undertaken by the study biostatistician. 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.  
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 study was not designed or powered to test any statistical hypotheses. The purpose of this 
study is to assess the performance of the study lenses with respect to distance and near visual 
acuity (logMAR), qCSF and qVA. Therefore, the sample size of 30 subjects to enroll with 
approximately 25 subjects to complete the study will be sufficient to evaluate the performance 
of the study lenses with respect to the primary endpoint.
14.3. Analysis Populations 
Safety Population:
All subjects who were administered any test article excluding subjects who drop out prior to 
administering any test article. At least one observation should be recorded.
Per-Protocol Population: 
All subjects who have successfully completed all visits and did not substantially deviate from 
the protocol as determined by the trial cohort review committee prior to database hard lock 
(Per-Protocol Population). Justification of excluding subjects with protocol deviations in the 
Per-Protocol Population set will be documented in a memo to file.
Intent-to-Treat (ITT) Population:
All randomized subjects regardless of actual treatment and subsequent withdrawal from study 
or deviation from protocol. At least one observation should be recorded.
14.4. Level of Statistical Significance 
Not applicable
14.5. Primary Analysis  
Distance and near visual acuity, qCSF and qVA will be descriptively summarized by lens type.
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14.6. Secondary Analysis  
Not applicable.
14.7. Other Exploratory Analyses  
Further statistical exploratory analysis can be undertaken, if necessary, at the discretion of the 
clinical project leader.
14.8. Interim Analysis 
An interim analysis will not be conducted on this study. 
14.9. Procedure for Handling Missing Data and Drop-Outs 
Missing or spurious values will not be imputed. The count of missing values will be included 
in the summary tables and listings. 
14.10.
Procedure for Reporting Deviations from Statistical Plan 
The analysis will be conducted according to that specified in above sections. There are no 
known reasons for which it is planned to deviate from these analysis methods. If for any reason 
a change is made, the change will be documented in the study report along with a justification 
for the change.
15. DATA HANDLING AND RECORD KEEPING/ARCHIVING 
15.1. Electronic Case Report Form/Data Collection 
The data for this study will be captured on electronic case report forms (eCRFs) using an EDC 
system (Bioclinica Express 5.5). 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.
External Data 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. Only specifically delegated staff can enter data on a CRF.  Once 
completed, the eCRFs will be reviewed for accuracy and completeness and signed by the 
Investigator. The sponsor or sponsor’s representatives will be authorized to gain access to the 
subject recordation for the purposes of monitoring and auditing the study. 
Edit checks, electronic queries, and audit trails are built into the system to ensure accurate and 
complete data collection. Data will be transmitted from the clinical site to a secure central 
database as forms are completed or updated, ensuring information accuracy, security, and 
confidentiality. After the final database lock, the Investigator will be provided with Individual 
Patient Profiles (IPP) including the full audit trail on electronic media in PDF format for all of 
the study data. The IPP must be retained in the study files as a certified copy of the source data 
for the study. 
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The content and structure of the eCRFs are compliant with ISO14155:2011.1
15.2. Subject Record 
At a minimum, subject record should be available for the following: 
x
subject identification
x
eligibility
x
study identification
x
study discussion
x
provision of and date of informed consent
x
visit dates
x
results of safety and efficacy parameters as required by the protocol
x
a record of all adverse events
x
follow-up of adverse events
x
medical history and concomitant medication
x
test article receipt/dispensing/return records
x
date of study completion
x
reason for early discontinuation of test article or withdrawal from the study, if 
applicable
The subject record is the eCRF or an external record. The author of an entry in the subject 
record must be identifiable. The first point of entry is considered to be the source record.
Adverse event notes must be reviewed and initialed by the Investigator.
15.3 ClinicalTrials.gov  
This study will be registered on ClinicalTrials.gov based on the following: confirmatory study 
meets the requirements for registration.
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 
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with the development of the investigational product and therefore may disclose it as required 
to other clinical investigators and to regulatory agencies. In order to allow the use of the 
information derived from this clinical study, the Investigator understands that he/she has an 
obligation to provide complete test results and all data developed during this study to the 
Sponsor.
16.3. Data Quality Assurance 
Steps will be taken to ensure the accuracy and reliability of data, include the selection of 
qualified investigators and appropriate clinical sites and review of protocol procedures with 
the Principal Investigator. The Principal Investigator, in turn, must ensure that all Sub-
Investigators and clinical site personnel are familiar with the protocol and all study-specific 
procedures and have appropriate knowledge of the study article.
Training on case report form completion will be provided to clinical site personnel before the 
start of the study. The Sponsor will review case report forms for accuracy and completeness 
remotely during the conduct of the study, during monitoring visits, and after transmission to 
data management. Any data discrepancies will be resolved with the Investigator or designee, 
as appropriate.
Quality Assurance representatives from JJVC may visit clinical sites to review data produced 
during the study and to access compliance with applicable regulations pertaining to the conduct 
of clinical trials. The clinical sites will provide direct access to study-related source 
data/documents and reports for the purpose of monitoring and auditing by JJVC and for 
inspection by local and regulatory authorities.
17. CLINICAL 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 versions, 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.
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18. ETHICAL AND REGULATORY ASPECTS 
18.1. Study-Specific Design Considerations 
Potential subjects will be fully informed of the risks and requirements of the study and, during 
the study, subjects will be given any new information that may affect their decision to continue 
participation. Subjects will be told that their consent to participate in the study is voluntary and 
may be withdrawn at any time with no reason given and without penalty or loss of benefits to 
which they would otherwise be entitled. Only subjects who are fully able to understand the 
risks, benefits, and potential adverse events of the study, and provide their consent voluntarily 
will be enrolled.
18.2. Investigator Responsibility 
The Principal Investigator is responsible for ensuring that the clinical study is performed in 
accordance with the signed agreement, the investigational plan, Section 4 of the ICH E6 
guidelines on Good Clinical Practice (GCP),2 and applicable regulatory requirements. GCP is 
an international ethical and scientific quality standard for designing, conducting, recording, 
and reporting studies that involve the participation of human subjects. Compliance with this 
standard provides public assurance that the rights, safety, and well-being of study subjects are 
protected, consistent with the principles of the Declaration of Helsinki 64th WMA General 
Assembly 20133 and that the clinical study data are credible. The Investigator must maintain 
clinical study files in accordance with Section 8 of the ICH E6 guidelines on Good Clinical
Practice (GCP),2 and applicable regulatory requirements.
18.3. Independent Ethics Committee or Institutional Review Board (IEC/IRB) 
Before the start of the study, the Investigator (or Sponsor when applicable) will provide the 
IEC/IRB with current and complete copies of the following documents (where applicable):
x
Final protocol.
x
Sponsor-approved informed consent form (and any other written materials to be 
provided to the subjects)
x
Investigator’s Brochure (or equivalent information).
x
Sponsor-approved subject recruitment materials.
x
Information on compensation for study-related injuries or payment to subjects for 
participation in the study.
x
Investigator’s curriculum vitae, clinical licenses, or equivalent information (unless not 
required, as documented by IEC/IRB).
x
Information regarding funding, name of the Sponsor, institutional affiliations, other 
potential conflicts of interest, and incentives for subjects.
x
Any other documents that the IEC/IRB requests to fulfill its obligation.
This study will be undertaken only after IEC/IRB has given full approval of the final protocol,
the informed consent form, applicable recruiting materials, and subject compensation 
programs, and the Sponsor has received a copy of this approval. This approval letter must be 
dated and must clearly identify the documents being approved.
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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 revisions
x
Revision(s) to informed consent form and any other written materials to be provided to 
subjects
x
If applicable, new or revised subject recruitment materials approved by the Sponsor
x
Revisions to compensation for study-related injuries or payment to subjects for 
participation in the study
x
Investigator’s Brochure revisions
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 revisions that increase subject risk, the revisions and applicable informed consent 
form revisions must be submitted promptly to the IEC/IRB for review and approval before 
implementation of the change(s).
At least once a year, the IEC/IRB will review and reapprove this clinical study. This request 
should be documented in writing.
At the end of the study, the Investigator (or Sponsor where required) will notify the IEC/IRB 
about the study completion. Documentation of this notification must be retained at the clinical 
site and a copy provided to the CRO or Sponsor as applicable.
18.4. Informed Consent 
Each subject or their representative, 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 subject the aims, methods, reasonably anticipated benefits, 
and potential hazards of the study, and any discomfort it may entail. Subjects will be informed 
that their participation is voluntary and that they may withdraw consent to participate at any
time. 
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The subject will be given sufficient time to read the informed consent form and the opportunity 
to ask questions. After this explanation and before entry into the study, consent should be 
appropriately recorded by means of the subject's dated signature. After having obtained the 
consent, a copy of the informed consent form must be given to the subject.
Each subject for this study will complete an assent and a parent or legal guardian must give 
written informed consent according to local requirements after the nature of the study has been 
fully explained. The assent and consent forms must be signed before performance of any study-
related activity. The assent and consent forms that are used must be approved by both the 
Sponsor and by the reviewing IEC/IRB. The assent and informed consent forms should be in 
accordance with principles that originated in the Declaration of Helsinki,3 current ICH2 and 
GCP guidelines, applicable regulatory requirements, and Sponsor policy. Before entry into the 
study or pre-screening, the Investigator or an authorized member of the clinical site personnel 
must explain to the potential subject and parent and/or legal guardian the aims, methods, 
reasonably anticipated benefits, and potential hazards of the study or pre-screening, and any 
discomfort it may entail. Subjects and parent and/or legal guardian will be informed that their 
participation is voluntary and that they may withdraw consent to participate at any time. They 
will be informed that choosing not to participate will not affect the care the subject will receive. 
Finally, they will be told that the Investigator will maintain a subject identification register for 
the purposes of long-term follow-up if needed and that their records may be accessed by health 
authorities and authorized Sponsor personnel without violating the confidentiality of the 
subject, to the extent permitted by the applicable law(s) or regulations. By signing the assent 
and informed consent form, the subject is authorizing such access and agrees to be contacted 
after study completion by health authorities and authorized Sponsor personnel for the purpose 
of obtaining consent for additional safety evaluations if needed.
18.5. Privacy of Personal Data 
The collection, processing and disclosure of personal data and medical information related to 
the Study Subject, and personal data related to Principal Investigator and any clinical site 
personnel (e.g., name, clinic address and phone number, curriculum vitae) is subject to 
compliance with the Health Information Portability and Accountability Act (HIPAA) in the 
United States7 and other applicable personal data protection and security laws and regulations. 
Appropriate measures will be employed to safeguard these data, to maintain the confidentiality 
of the person’s related health and medical information, to properly inform the concerned 
persons about the collection and processing of their personal data, to grant them reasonable 
access to their personal data and to prevent access by unauthorized persons.
All information obtained during the course of the investigation will be regarded as confidential. 
All personal data gathered in this trial will be treated in strictest confidence by Investigators, 
monitors, Sponsor’s personnel and IEC/IRB. No data will be disclosed to any third party 
without the express permission of the subject concerned, with the exception of Sponsor 
personnel (monitor, auditor), IEC/IRB and regulatory organizations in the context of their 
investigation related activities that, as part of the investigation will have access to the CRFs 
and subject records.
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The collection and processing of personal data from subjects enrolled in this study will be 
limited to those data that are necessary to investigate the efficacy, safety, quality, and utility of 
the investigational product(s) used in this study.
These data must be collected and processed with adequate precautions to ensure confidentiality 
and compliance with applicable data privacy protection laws and regulations.
The Sponsor ensures that the personal data will be:
x
processed fairly and lawfully.
x
collected for specified, explicit, and legitimate purposes and not further processed in a 
way incompatible with these purposes.
x
adequate, relevant, and not excessive in relation to said purposes.
x
accurate and, where necessary, kept current.
Explicit consent for the processing of personal data will be obtained from the participating 
subject before collection of data. Such consent should also address the transfer of the data to 
other entities and to other countries.
The subject has the right to request through the Investigator access to his personal data and the 
right to request rectification of any data that are not correct or complete. Reasonable steps 
should be taken to respond to such a request, taking into consideration the nature of the request, 
the conditions of the study, and the applicable laws and regulations.
Appropriate technical and organizational measures to protect the personal data against 
unauthorized disclosures or access, accidental or unlawful destruction, or accidental loss or 
alteration must be put in place. Sponsor personnel whose responsibilities require access to 
personal data agree to keep the identity of study subjects confidential.
19. STUDY RECORD RETENTION 
In compliance with the ICH/GCP guidelines,2 the Investigator/Institution will maintain all 
CRFs and all subject records that support the data collected from each subject, as well as all 
study documents as specified in ICH/GCP2 and all study documents as specified by the 
applicable regulatory requirement(s). The Investigator/Institution will take measures to prevent 
accidental or premature destruction of these documents.
Essential documents must be retained until at least two (2) years after the last approval of a 
marketing application in an ICH region and until there are no pending or contemplated 
marketing applications in an ICH region or until at least two (2) years have elapsed since the 
formal discontinuation of clinical development of the investigational product. These 
documents will be retained for a longer period if required by the applicable regulatory 
requirements or instructed by the Sponsor. It is the responsibility of the Sponsor to inform the 
Investigator/Institution as to when these documents no longer need to be retained.
If the responsible Investigator retires, relocates, or for other reasons withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person who will 
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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 subject in the study.
x
Scheduling a study visit outside the subject’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.
21. PUBLICATION 
This study will be registered on ClinicalTrials.gov by the Sponsor.
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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. Wirth RJ, et al. Development of the Contact Lens User Experience: CLUE Scales.
Optom Vis Sci. 2016;93(8):801-808
6.
 
7. Health Information Portability and Accountability Act (HIPAA). Available at: 
https://www.hhs.gov/hipaa/for-professionals/privacy/index.html
8. EU MDR 2017/745
 
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APPENDIX A: PATIENT REPORTED OUTCOMES (STUDY QUESTIONNAIRES) 
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
This will be provided separately. 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
1-DAY ACUVUE® DEFINE™ Brand Contact Lenses
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APPENDIX D: 
 
 
Near Logmar Visual Acuity Measurement Procedure 
Lens Fitting Characteristics  
Subject Reported Ocular Symptoms/Problems 
Determination Of Distance Spherocylindrical Refractions 
Biomicroscopy Scale  
Distance And Near Visual Acuity Evaluation  
Distance Logmar Visual Acuity Measurement Procedure 
Measuring Pupil Diameter With Neuroptics VIP-200 Variable Pupillometer  
Visual Acuity Chart Luminance And Room Illumination Testing 
 Qcsf Contrast Sensitivity 
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Johnson & Johnson Vision Care, Inc.
 NEAR LOGMAR VISUAL ACUITY MEASUREMENT PROCEDURE 
 
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Johnson & Johnson Vision Care, Inc.
 LENS FITTING CHARACTERISTICS 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 SUBJECT REPORTED OCULAR SYMPTOMS/PROBLEMS 
 
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Johnson & Johnson Vision Care, Inc.
 
DETERMINATION 
OF 
DISTANCE 
SPHEROCYLINDRICAL 
REFRACTIONS 
 
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Johnson & Johnson Vision Care, Inc.
 BIOMICROSCOPY SCALE 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 DISTANCE AND NEAR VISUAL ACUITY EVALUATION 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 
DISTANCE 
LOGMAR 
VISUAL 
ACUITY 
MEASUREMENT 
PROCEDURE 
 
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Johnson & Johnson Vision Care, Inc.
 MEASURING PUPIL DIAMETER WITH NEUROPTICS VIP-200 
VARIABLE PUPILLOMETER 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
 VISUAL ACUITY CHART LUMINANCE AND ROOM ILLUMINATION 
TESTING 
 
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Johnson & Johnson Vision Care, Inc.
 QCSF CONTRAST SENSITIVITY 
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX E: WORK AID: AST qVA-Custom 100  
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX F: WAVEFRONT AND TOPOGRAPHY MEASUREMENT USING 
VISIONIX VX118  
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
APPENDIX G: COSMETIC FIT AND HULA HOOP  
 
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Johnson & Johnson Vision Care, Inc.
APPENDIX H: VISUAL EXPERIENCE WORK AID  
 
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Clinical Study Protocol
Johnson & Johnson Vision Care, Inc.
PROTOCOL COMPLIANCE INVESTIGATOR(S) SIGNATURE PAGE 
Protocol Number and Title: CR-6396 Objective Vision Evaluation of Two Cosmetic Contact 
Lenses
Version and Date: 2.0 29 January 2020
I have read and understand the protocol specified above and agree on its content.  
I agree to conduct this study according to ISO 14155,1 GCP and ICH guidelines,2 the
Declaration of Helsinki,3 United States (US) Code of Federal Regulations (CFR),4 and the 
pertinent individual country laws/regulations and to comply with its obligations, subject to 
ethical and safety considerations. The Principal Investigator is responsible for ensuring that all 
clinical site personnel, including Sub-Investigators adhere to all ICH2 regulations and GCP 
guidelines regarding clinical trials during and after study completion.
I will assure that no deviation from or changes to the protocol will take place without prior 
agreement from the Sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants.
I am responsible for ensuring that all clinical site personnel including Sub-Investigators adhere 
to all ICH2 regulations and GCP guidelines regarding clinical trials during and after study 
completion.
All clinical site personnel involved in the conduct of this study have completed Human 
Subjects Protection Training. 
I agree to ensure that all clinical site personnel involved in the conduct of this study are 
informed about their obligations in meeting the above commitments.
I shall not disclose the information contained in this protocol or any results obtained from this 
study without written authorization.
Principal 
Investigator:
Signature
Date
Name and Professional Position (Printed)
Institution/Site:
Institution/Site Name
Institution/Site Address
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