Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1
Phase: NA
Conditions: Refractive Errors, Myopia
Sponsor: Alcon Research



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1
PROTOCOL SYNOPSIS
Trial Sponsor
Alcon Research, LLC
6201 South Freeway
Fort Worth, Texas 76134-2099
Name of Test Product(s)
PRECISION1 (verofilcon A) Soft Contact Lenses 
(PRECISION1)
Name of Control 
Product(s)
Bausch + Lomb Biotrue® ONEday (Biotrue ONEday)
Title of Trial
Clinical Comparison of 2 Daily Disposable Contact Lenses –
Pilot Study 1
Protocol Number
CLE383-P003
Number of Sites
Country
~ 4
US
Planned Duration of 
Exposure 
~ 16 days total duration (test and control)
Test Product: ~ 8 days
Control Product: ~ 8 days
Number of Subjects 
Target to complete: 52
Planned to enroll: ~ 72
Study Population
Volunteer subjects aged 18 or over who are habitual
spherical soft contact lens wearers (excluding 
current/previous PRECISION1, Biotrue ONEday and 
DAILIES TOTAL1® lens wearers), have at least 3 months of 
contact lens wearing experience, and who wear their habitual 
lenses at least 5 days per week and at least 10 hours per day.
 
 
 
 
 
Objective(s)
The primary objective of this study is to evaluate the overall 
performance of PRECISION1 contact lenses when compared 
to Biotrue ONEday.
Endpoints
Primary Effectiveness

Distance VA (logMAR) with study lenses
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Safety

AEs

Biomicroscopy findings

Device deficiencies
Assessments
Effectiveness

Distance VA (logMAR) with study lenses
Safety

AEs

Biomicroscopy
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
Device deficiencies
Study Design
Prospective
Single-masked 
(trial subject)
Single-masked 
(Investigator)
Double-masked
Open-label
Other
Single group
Crossover
Other 
Contralateral
Bilateral
Monocular lens wear
Randomized
Test Product Details
Primary 
component/material
Verofilcon A
Product Name
PRECISION1
Manufacturer
Alcon
 
Control Product Details
Primary 
component/material
nesofilcon A
Product Name
Biotrue ONEday
Manufacturer
Bausch + Lomb
 
Inclusion Criteria
1. Subject must be at least 18 years of age. 
2. Subject must be able to understand and must sign an ICF 
that has been approved by an IRB.
3. Successful wear of spherical soft contact lenses in both 
eyes for a minimum of 5 days per week and 10 hours per 
day during the past 3 months.
 
 
 
 
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7. Subject must be willing to wear contact lenses for at least 
16 hours of lens per day.
 
 
 
 
Exclusion Criteria
1. Current/previous PRECISION1, Biotrue ONEday, and 
DAILIES TOTAL1 lens wearers and any monovision & 
multifocal lens wearers.
2. Any anterior segment infection, inflammation, or 
abnormality or disease (including systemic) that 
contraindicates contact lens wear, as determined by the 
Investigator.
 
 
 
 
 
 
 
 
 
 
 
 
 
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1.1
Abbreviations
Abbreviation
Definition
ADE
Adverse device effect
AE
Adverse event
BCVA
Best corrected visual acuity
Biotrue ONEday 
or Biotrue 
ONEday contact 
lenses
Bausch + Lomb Biotrue ONEday (Biotrue ONEday)
CFR
Code of Federal Regulations
CIP
Clinical investigational plan
D
Diopter
D/C
Discontinue
eCRF
Electronic case report form
EDC
Electronic data capture
FDA
US Food and Drug Administration
GCP
Good Clinical Practice
ICF
Informed consent form
IP
Investigational product
IRB
Institutional review board
ISO
International Organization for Standardization
LogMAR
Logarithm of the minimum angle of resolution
mm
Millimeter
MOP
Manual of procedures
N/A
Not applicable
OD
Right eye
OS
Left eye
PRECISION1 or 
PRECISION1
contact lenses
PRECISION (verofilcon A) Soft Contact Lenses 
SADE
Serious adverse device event
SAE
Serious adverse event
US
United States
V
Visit
VA
Visual acuity
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2
TABLE OF CONTENTS
Clinical Comparison of 2 Daily Disposable Contact Lenses – Pilot Study 1............................1
1
PROTOCOL SYNOPSIS ....................................................................................................2
1.1
Abbreviations ......................................................................................................9
2
TABLE OF CONTENTS...................................................................................................10
List of Tables............................................................................................................................12
List of Figures..........................................................................................................................12
3
INTRODUCTION.............................................................................................................13
3.1
Study Rationale and Purpose.............................................................................13
3.2
Trial Objective...................................................................................................13
3.3
Risks and Benefits.............................................................................................13
3.4
Subject Population.............................................................................................14
3.5
Outline of Study ................................................................................................14
4
TREATMENTS ADMINISTERED...................................................................................15
4.1
Identity of Study Treatments .............................................................................15
4.2
Accountability Procedures.................................................................................16
4.3
Worn Lens Collection, Storage and Return.......................................................17
5
STUDY PROCEDURES AND ASSESSMENTS.............................................................17
5.1
Visits and Examinations ....................................................................................17
5.1.1
Pre-Screening ....................................................................................17
5.1.2
Visit 1 (Day 0) – Screening/Baseline/Dispense Lens 1.....................17
5.1.3
Visit 2 [Day 8 (-0/+3 Days)] – Week 1 Follow-up Lens 1/Dispense 
Lens 2 ................................................................................................19
5.1.4
Visit 3 [Day 8 (-0/+3 Days)] – Week 1 Follow-up Lens 2/Exit ........21
5.2
Unscheduled Visits ............................................................................................22
5.3
Discontinued Subjects .......................................................................................22
5.4
Clinical Study Termination................................................................................23
6
ANALYSIS PLAN ............................................................................................................24
6.1
Subject Evaluability...........................................................................................24
6.2
Analysis Data Sets.............................................................................................24
6.2.1
Safety Analysis Set............................................................................24
6.3
Demographic and Baseline Characteristics.......................................................24
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6.4
Effectiveness Analyses ......................................................................................24
6.4.1
Primary Effectiveness........................................................................25
6.4.1.1
Statistical Hypotheses........................................................25
6.4.1.2
Analysis Methods ..............................................................25
6.6
Handling of Missing Data .................................................................................26
6.8
Safety Analysis ..................................................................................................26
6.10
Sample Size Justification...................................................................................27
7
ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................27
7.1
General Information ..........................................................................................29
7.2
Monitoring for Adverse Events .........................................................................32
7.6
Pregnancy in the Clinical Study........................................................................35
10 ETHICS AND COMPLIANCE.........................................................................................38
10.1
Compliance........................................................................................................38
10.2
Institutional Review Board (IRB) .....................................................................38
12 REFERENCES ..................................................................................................................40
12.1
References applicable for all clinical trials .......................................................40
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12.1.1
US references applicable for clinical trials........................................40
12.2
References for this clinical trial.........................................................................40
List of Tables
Table 1-1
Schedule of Study Procedures and Assessments ...............................................7
List of Figures
Figure 7–1
Categorization of All AEs................................................................................30
Figure 7-2
Categorization of All Serious Adverse Events.................................................30
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3
INTRODUCTION
3.1
Study Rationale and Purpose
 
 
 
 
 
The purpose of this study is to evaluate the overall performance of PRECISION1 contact 
lenses when compared to Biotrue ONEday.
 
 
 
 
Biotrue ONEday contact lenses were chosen as the 
control product because these lenses have the same wear modality.
 
 
.
3.2
Trial Objective
The primary objective of this study is to evaluate the overall performance of PRECISION1 
contact lenses when compared to Biotrue ONEday.
3.3
Risks and Benefits
Contact lenses may offer improved peripheral vision and the convenience of not wearing 
spectacles.
 
PRECISION1 and Biotrue ONEday contact lenses are for daily wear use under a daily 
disposable wear modality; further details on any known potential risks and benefits can be 
found in the package insert. 
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PRECISION1 and Biotrue ONEday contact lenses are not intended for use with a 
cleaning/disinfecting solution, and the biocompatibility with lens care solutions and any 
associated clinical effects are unknown.
A summary of the known potential risks and benefits associated with PRECISION1 can be 
found in the package insert. Risks are minimized by compliance with the eligibility criteria 
and study procedures, and through close supervision by a licensed clinician during exposure 
to the study lenses. 
The site personnel will educate subjects on proper hygiene and lens handling, and compliance 
with the use of contact lenses according to the protocol. Subjects should be instructed not to 
wear contact lenses while sleeping or swimming. The site personnel will also advise the 
subjects to remove contact lenses and return for prompt follow-up of symptoms, such as 
ocular discomfort, foreign body sensation, excessive tearing, vision changes, or hyperemia.
3.4
Subject Population
The study population includes approximately 72 volunteer subjects to be enrolled at 
approximately 4 sites, with approximately 18 subjects enrolled per site. The study population 
will consist of subjects with normal eyes (other than the need for optical correction for 
myopia and astigmatism),
 
 
. 
Subjects must be screened according to the full list of inclusion/exclusion criteria in Section 1
of this protocol. Rescreening of subjects is not allowed in this study.
3.5
Outline of Study
This will be a multi-site, prospective, randomized, crossover, double-masked,
 
study comparing 2 contact lenses. The expected duration of subject 
participation in the study is up to 22 days, with 3 scheduled visits. The study is expected to be 
completed in approximately 7 weeks.
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4
TREATMENTS ADMINISTERED
Subjects will be 
 randomized in a 1:1 manner to 
receive treatment (lens) in a crossover sequence: Test product then Control product, or 
Control product the Test product, respectively. 
Sequence 1: PRECISION1 →Biotrue ONEday
Sequence 2: Biotrue ONEday →PRECISION1
4.1
Identity of Study Treatments
DESCRIPTION OF TEST AND CONTROL PRODUCTS
Test
Control
Lens
PRECISION1
Biotrue ONEday
Material
verofilcon A
nesofilcon A
Water Content
51%
78%
Base Curve (mm)
8.3
8.6
Diameter (mm)
14.2
14.2
 
 
 
 
 
 
 
 
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
All study products are accounted for and not used in any unauthorized manner

All used foils and unused supplies are returned by each subject

All unused products are available for return to the Study Sponsor, as directed

Any study lenses associated with a device deficiency or with any product-related 
adverse event [ie, ADE or SADE] are returned to the Study Sponsor for investigation. 
Refer to Section 7.3 of this protocol for additional information on the reporting of 
device deficiencies and AEs and the return of study products associated with these 
events.
4.3
Worn Lens Collection, Storage and Return
Worn lenses are to be discarded and do not need to be returned to Sponsor, unless in cases of 
AE or Device Deficiency. Refer to MOP for return instructions.
5
STUDY PROCEDURES AND ASSESSMENTS
5.1
Visits and Examinations
5.1.2
Visit 1 (Day 0) – Screening/Baseline/Dispense Lens 1
1
Explain the purpose and nature of the study, and have the subject read, sign, and date 
the IRB-approved informed consent document. Additionally, have the individual 
obtaining consent from the subject and a witness, if applicable, sign and date the 
informed consent document. Provide a photocopy of the signed document to the 
subject and place the original signed document in the subject’s chart. After signing
the ICF, a subject will be assigned a subject number by the EDC system. A signed 
informed consent document defines the point of enrollment.
2
Obtain demographic information and medical history, including information on all 
medications used within the past 30 days. Include herbal therapies, vitamins, and all 
over-the-counter as well as prescription medications.
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6
Perform slit-lamp biomicroscopy (without contact lenses) to evaluate the following:

Limbal hyperemia

Bulbar hyperemia

Corneal staining

Conjunctival staining

Palpebral conjunctival observations

Corneal epithelial edema

Corneal stromal edema

Corneal vascularization

Conjunctival compression/indention

Chemosis

Corneal infiltrates

Other findings
 
 
11
Review inclusion/exclusion criteria to determine if the subject qualifies to be
randomized into the study. If subject qualifies, request randomization. If subject does 
not qualify, exit the subject from the study as a screen failure.
12
Based upon the randomized treatment sequence assignment, dispense (provide) the 
appropriate study lenses (Lens 1). 

Subjects should be instructed to discontinue habitual lens wear after the screening visit

Subjects should be instructed to insert dispensed study lenses after approximately 12 
hours of spectacle wear or no lens wear following Visit 1 
 
 
 
14
Provide the subject with verbal instructions on lens wear.
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15
Assess and record any AEs and device deficiencies reported or observed during the 
study visit.
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time of 
signature of informed consent including those that screen fail.
16
Schedule Visit 2 to take place 8 (-0/+3) days after Visit 1. 

Subjects should be instructed to bring their spectacles to Visit 2.
Note: subjects are required to wear the study lenses for 10 (-2/+6) hours at the follow-up 
visits.
 
 
 
5.1.3
Visit 2 [Day 8 (-0/+3 Days)] – Week 1 Follow-up Lens 1/Dispense 
Lens 2
1
Obtain information on any changes in medical health and/or the use of concomitant 
medications.
2
Record any device deficiencies or AEs, including those associated with changes in 
concomitant medication dosing, which are observed or reported since the previous 
visit.
3
Review subject compliance with lens wear. 
 
5
Perform logMAR VA with study lenses.

OD, OS, distance only.
6
Perform BCVA if there is a decrease of VA by 2 lines or more with study lenses.
Source only.
 
 
 
 
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9
Perform slit-lamp biomicroscopy (without contact lenses) to evaluate the following:

Limbal hyperemia

Bulbar hyperemia

Corneal staining

Conjunctival staining

Palpebral conjunctival observations

Corneal epithelial edema

Corneal stromal edema

Corneal vascularization

Conjunctival compression/indention

Chemosis

Corneal infiltrates

Other findings
11
Dispense (provide) the study lenses (Lens 2). 
 
 
12
 
 
 
13
Provide the subject with verbal instructions on lens wear.
14
Assess and record any AEs and device deficiencies reported or observed during the 
study visit.
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time 
of signature of informed consent including those that screen fail.
15
Schedule Visit 3 to take place 8 (-0/+3) days after Visit 2.

Subjects should be instructed to bring their spectacles to Visit 3.
Note: subjects are required to wear the study lenses for 10 (-2/+6) hours at the follow-up 
visits.
 
 
 
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5.1.4
Visit 3 [Day 8 (-0/+3 Days)] – Week 1 Follow-up Lens 2/Exit
1
Obtain information on any changes in medical health and/or the use of concomitant 
medications.
2
Record any device deficiencies or AEs, including those associated with changes in 
concomitant medication dosing, which are observed or reported since the previous 
visit(s).
3
Review subject compliance with lens wear and adjunct product usage. 
 
5
Perform logMAR VA with study lenses.

OD, OS, distance only.
6
Perform BCVA if there is a decrease of VA by 2 lines or more with study lenses.
Source only.
 
 
 
 
 
 
 
9
Perform slit-lamp biomicroscopy (without contact lenses) to evaluate the following:

Limbal hyperemia

Bulbar hyperemia

Corneal staining

Conjunctival staining

Palpebral conjunctival observations

Corneal epithelial edema

Corneal stromal edema

Corneal vascularization

Conjunctival compression/indention

Chemosis

Corneal infiltrates

Other findings
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12
Assess and record any AEs and device deficiencies reported or observed during the 
study visit.
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time 
of signature of informed consent including those that screen fail.
13
Exit the subject from the study.
5.2
Unscheduled Visits
Any visit that occurs between regularly scheduled visits is an Unscheduled Visit. If a subject 
requires an Unscheduled Visit, he/she must be advised to return to the office wearing the 
study lenses, if at all possible (unless he/she is experiencing a sign or symptom [as indicated 
in Section 3.3 Risks and Benefits]). During all unscheduled visits, the Investigator must 
conduct the following procedures: 

Collect AE and Device Deficiency information

Assess and record changes in medical condition or concomitant medication 

Assess and record VAs

Perform biomicroscopy (assessments with or without lenses, as possible)
In addition, all procedures for Unscheduled Visit/Early Exit should be completed (as 
possible). The Investigator may perform additional procedures for proper diagnosis and 
treatment of the subject. The Investigator must document this information in the subject’s 
case history source documents.
If during an Unscheduled Visit the subject is discontinuing the study lenses or discontinuing 
from the study, the Investigator must conduct Exit procedures according to Table 1-1:
Schedule of Study Procedures and Assessments, as possible.
5.3
Discontinued Subjects
Discontinued subjects are those who withdraw or are withdrawn from the study after signing 
the informed consent, including screen failures. Subjects may discontinue from the study at 
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any time for any reason. Subjects may also be discontinued from the study at any time if, in 
the opinion of the Investigator, their continued participation poses a risk to their health. 
Discontinued subjects will not be replaced (ie, their subject numbers will not be 
re-assigned/re-used).
Should a subject exhibit any clinically relevant signs, symptoms, or other clinical 
observations that possibly could be associated with suspected sensitivity or intolerance to one 
of the study treatments, the Investigator must document those observations on an AE Form.
Any subject who exits early from the study (excluding screen failures) must undergo all Exit 
procedures according to Table 1-1: Schedule of Study Procedures and Assessments.
The Investigator must document the reason for study or treatment discontinuation in the 
subject’s case history source documents.
To ensure the safety of all subjects who discontinue early, Investigators must assess each 
subject and, if necessary, advise them of any therapies and/or medical procedures that may be 
needed to maintain their health.
5.4
Clinical Study Termination
The Study Sponsor reserves the right to close the investigational site or terminate the study in 
its entirety at any time, for reasonable cause.
If the clinical study is prematurely terminated or suspended by the Study Sponsor:

The Study Sponsor must:
o
Immediately notify the Investigator(s) and subsequently provide 
instructions for study termination.
o
Inform the Investigator and the regulatory authorities of the 
termination/suspension and the reason(s) for the termination/suspension, 
as applicable.

The Investigator must:
o
Promptly notify the IRB of the termination or suspension and of the 
reasons. 
o
Provide subjects with recommendations for post-study treatment options 
as needed.
The Investigator may terminate a site’s participation in the study for reasonable cause.
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6.4.1
Primary Effectiveness
The primary objective of this study is to evaluate the overall performance of PRECISION1 
contact lenses when compared to Biotrue ONEday. The primary endpoint is distance VA with 
study lenses, collected in logMAR, for each eye.
6.4.1.1
Statistical Hypotheses
No inferences are to be made on the primary effectiveness endpoint; therefore, no hypotheses 
are formulated.
6.4.1.2
Analysis Methods
Descriptive statistics will be provided. 
 
 
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6.6
Handling of Missing Data
All data obtained in evaluable subjects/eyes will be included in the analysis. No imputation 
for missing values will be carried out.
 
6.8
Safety Analysis
The safety endpoints for this study are AEs, biomicroscopy findings, and device deficiencies. 
All AEs occurring from the time a subject signs informed consent to study exit will be 
accounted for in the reporting. Descriptive summaries (counts and percentages) for ocular 
and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities
Preferred Terms. AEs leading to study discontinuation, significant non-serious AEs, and 
SAEs will be identified. Individual subject listings will be provided, as necessary. 
Individual subject listings will be provided for AEs that occur after signing informed consent 
but prior to exposure to study lenses.
Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy
parameter, counts and percentages of eyes that experience an increase of ≥2 grades from 
baseline (last assessment prior to study lens exposure) to any subsequent visit within the 
same period will be presented. A supportive listing will be generated which will include all 
biomicroscopy data from all visits for these eyes experiencing the increase.
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Two listings (prior to exposure of study lenses and treatment-emergent) of device 
deficiencies, as recorded on the Device Deficiency Form, will be provided. Additionally, each 
device deficiency category will be tabulated. 
No inferential testing will be done for safety analysis. 
 
6.10 Sample Size Justification
No formal sample size calculation is provided given the descriptive and pilot nature of the 
study.
7
ADVERSE EVENTS AND DEVICE DEFICIENCIES
Terms and Definitions
Adverse Event (AE)
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 or comparator.
Note: For subjects, this definition includes events related to the
investigational medical device, comparator, or the procedures 
involved. For users or other persons, this definition is restricted to 
the use of investigational medical devices.
Adverse Device 
Effect (ADE)
AE related to the use of an investigational medical device or
comparator.. Note: This definition includes AEs resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation; any malfunction; and use 
error or intentional misuse of the investigational medical devices 
or comparator.
Anticipated Serious 
Adverse Device 
Effect 
Serious ADE which by its nature, incidence, severity or outcome 
has been identified in the risk management file.
Device Deficiency
Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, usability, safety, or performance. Note: This 
definition includes malfunctions, use errors, and inadequacy in the 
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information supplied by the manufacturer including labelling
related to the investigational medical device or the comparator..
Malfunction
Failure of a medical device to meet its performance specifications 
or otherwise perform as intended. Performance specifications 
include all claims made in the labeling of the device. The intended 
performance of the device refers to the intended use for which the 
device is labeled or marketed.
Non-serious Adverse 
Event
AE that does not meet the criteria for an SAE.
Serious Adverse 
Event (SAE)
AE that led to any of the following:

Death.

A serious deterioration in the health of the subject users or 
other persons as defined by one or more of the following: :
a) a life-threatening illness or injury.
Note: Life-threatening means that the individual was at 
immediate risk of death from the event as it occurred, ie, it 
does not include an event which hypothetically might have 
caused death had it occurred in a more severe form.
b) any potentially sight-threatening event or permanent 
impairment to a body structure or a body function
including chronic diseases.
c) in-patient hospitalization or prolonged hospitalization.
d) a medical or surgical intervention to prevent a) or b). 
e) any indirect harm as a consequence of incorrect diagnostic 
test results when used within manufacturer’s instructions 
for use.

Fetal distress, fetal death, or a congenital abnormality or birth 
defect.
Note: Planned hospitalization for a pre-existing condition, or a
procedure required by the CIP, without serious deterioration in
health, is not considered a serious adverse event.
Refer to Section 7.1 for additional SAEs.
Serious Adverse 
Device Effect 
(SADE)
ADE that has resulted in any of the consequences characteristic of 
an SAE.
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Serious Health Threat
Signal from any adverse event or device deficiency that indicates 
an imminent risk of death or a serious deterioration in the health in 
subjects, users or other persons, and that requires prompt remedial 
action for other subjects, users or other persons
Note: This would include events that are of significant and 
unexpected nature such that they become alarming as a potential 
serious health hazard or possibility of multiple deaths occurring at 
short intervals.
Significant Non-
Serious Adverse 
Event
A significant non-serious AE is a symptomatic, device-related, 
non-sight threatening AE that warrants discontinuation of any 
contact lens wear for greater than or equal to 2 weeks.
Refer to Section 7.1 for additional Significant Non-Serious AEs.
Unanticipated 
Serious Adverse 
Device Effect
Serious adverse device effect which by its nature, incidence, 
severity or outcome has not been identified in the risk management 
file.
Use Error
Act or omission of an act that results in a different medical device 
response than intended by manufacturer or expected by user. 
Note: This definition includes slips, lapses, and mistakes. An 
unexpected physiological response of the subject does not in itself 
constitute a use error.
7.1
General Information
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 or comparator. Refer to the 
Glossary of Terms and figures below for categories of AEs and SAEs.
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o
Central or paracentral location
o
Penetration of Bowman’s membrane
o
Infiltrates > 2 mm diameter
o
Iritis
o
Increase in intraocular pressure
o
Culture positive for microorganisms
o
Increasing size or severity at subsequent visits

Any central or paracentral corneal event (such as neovascularization) that results in 
permanent opacification

Hypopyon

Hyphema

Neovascularization within the central 6 mm of the cornea

Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment 
visit that fails to resolve

Uveitis (anterior, intermediate, or posterior)

Corneal abrasion affecting ≥50% of corneal surface area
Significant Non-Serious Adverse Events
A significant non-serious AE is a symptomatic, device-related, non-sight threatening AE that 
warrants discontinuation of any contact lens wear for greater than or equal to 2 weeks. In 
addition, the Investigator must report any occurrence of the following as a Significant 
Non-Serious AE:

Peripheral non-progressive non-infectious ulcers

All symptomatic corneal infiltrative events

Corneal staining score greater than or equal to Grade 3 (Refer to MOP for grading scales)

Temporary vision loss as defined by loss of 2 or more lines of BCVA from enrollment 
visit that persists for 2 or more weeks

Neovascularization score greater than or equal to Grade 2 (Refer to MOP for grading 
scales)
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The above events are based upon the categories provided in the ISO 11980 and the US FDA 
Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses and 
Contact Lens Care Products. 
Device Deficiencies
A device deficiency is inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. A device deficiency may or may not be 
associated with patient harm (ie, ADE or SADE); however, not all ADEs or SADEs are due 
to a device deficiency. The Investigator should determine the applicable category listed in the 
Device Deficiency eCRF for the identified or suspect device deficiency and report any patient 
harm separately. Examples of device deficiencies include the following: 

Failure to meet product specifications (eg, incorrect lens power/diameter/base 
curve/color)

Lens cloudy

Lens surface/edge defect 

Torn lens during handling/in pack

Packaging deficit (eg, mislabeled product, tampered seal, leaking bottle/container)

Suspect product contamination

Lack of performance
7.2
Monitoring for Adverse Events
At each visit, after the subject has had the opportunity to spontaneously mention any 
problems, the Investigator should inquire about AEs by asking the standard questions shown 
below and report as applicable:

“Have you had any health problems since your last study visit?”

“Have there been any changes in the medicines you take since your last study visit?”
 
 
 
 
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7.6
Pregnancy in the Clinical Study
Women of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. 
 
 
 
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10 ETHICS AND COMPLIANCE
This trial will be conducted in accordance with the ethical principles that have their origin in 
the Declaration of Helsinki and the referenced directives, regulations, guidelines, and/or 
standards.
10.1 Compliance
The Investigator must ensure that all personnel involved in the conduct of the study are 
qualified to perform their assigned responsibilities through relevant education, training, and 
experience. The Investigator and all clinical study staff must conduct the clinical study in 
compliance with the protocol. Deviations from this protocol, regulatory requirements and/or 
GCP must be recorded and reported to the Sponsor prior to database lock. If needed, 
corrective and preventive action should be identified, implemented, and documented within 
the study records.
10.2 Institutional Review Board (IRB)
This trial requires IRB approval prior to initiation. This protocol, subject informed consent, 
and subsequent amendments will be reviewed and approved by an IRB.
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Before clinical study initiation, this protocol, the ICF (and assent form, if applicable), any 
other written information given to subjects, and any advertisements planned for subject 
recruitment must be approved by an IRB. The Investigator must provide documentation of 
the IRB approval to the Study Sponsor. The approval must be dated and must identify the 
applicable protocol, amendments (if any), ICF, assent form (if any), all applicable recruiting 
materials, written information for subject, and subject compensation programs. The IRB must 
be provided with a copy of the Package Insert, any periodic safety updates, and all other 
information as required by local regulation and/or the IRB. At the end of the study, the 
Investigator must notify the IRB about the study’s completion. The IRB also must be notified 
if the study is terminated prematurely. Finally, the Investigator must report to the IRB on the 
progress of the study at intervals stipulated by the IRB.
Voluntary informed consent must be obtained from every subject (and/or legal representative, 
as applicable) prior to the initiation of any screening or other study-related procedures. The 
Investigator must have a defined process for obtaining consent. Specifically, the Investigator, 
or delegate, must explain the clinical study to each potential subject and the subject must 
indicate voluntary consent by signing and dating the approved informed consent form. The 
subject must be provided an opportunity to ask questions of the Investigator, and if required 
by local regulation, other qualified personnel. The Investigator must provide the subject with 
a copy of the consent form written in a language the subject understands. The consent 
document must meet all applicable local laws and provide subjects with information 
regarding the purpose, procedures, requirements, and restrictions of the study, along with any 
known risks and potential benefits associated with the IP, the available compensation, and the 
established provisions for maintaining confidentiality of personal, protected health 
information. Subjects will be told about the voluntary nature of participation in the study and 
must be provided with contact information for the appropriate individuals should questions or 
concerns arise during the study. The subject also must be told that their records may be 
accessed by appropriate authorities and Sponsor-designated personnel. The Investigator must 
keep the original, signed copy of the consent and must provide a duplicate copy to each 
subject according to local regulations. Following this study, the subject will return to their 
eye care professional for their routine eye care and contact lenses.
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12 REFERENCES
12.1 References applicable for all clinical trials

ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products -
Guidance for clinical investigations

ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good 
clinical practice
12.1.1 US references applicable for clinical trials

21 CFR Part 11 - Electronic Records; Electronic Signatures

21 CFR Part 50 - Protection of Human Subjects

21 CFR Part 56 - Institutional Review Boards

21 CFR Part 812 - Investigational Device Exemptions

21 CFR Part 54 - Financial Disclosure by Clinical Investigators

The California Bill of Rights
12.2 References for this clinical trial
Young G, Chalmers RL, Napier L, Hunt C, Kern J. Characterizing contact lens-related 
dryness symptoms in a cross-section of UK softlens wearers. Contact Lens Anterior Eye.
2011;34:64–70.
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