Two Daily Disposable Contact Lenses in Symptomatic Patients
Phase: NA
Conditions: Myopia
Sponsor: Alcon Research

Page 1 of 39
___________________________________________________________________________
Title:
Two Daily Disposable Contact Lenses in Symptomatic Patients
Protocol Number:
Sponsor Name and 
Address:
Test Product(s):
Investigator Agreement:
CLS312-P001 / NCT03628599
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 76134-2099
DAILIES TOTAL1® Water Gradient silicon hydrogel daily 
disposable contact lenses (DAILIES TOTAL1)
I have read the clinical study described herein, recognize its 
confidentiality, and agree to conduct the described trial in 
compliance with Good Clinical Practice (GCP), the ethical 
principles contained within the Declaration of Helsinki, this 
protocol, and all applicable regulatory requirements. 
Additionally, I will comply with all procedures for data 
recording and reporting, will permit monitoring, auditing, and 
inspection of my research center, and will retain all records until 
notified by the Sponsor.
Principal Investigator:
Signature
Date
Name:
Address:
SEE Protocol Template, Vision Care version 2.0, approved 09 SEP 2017
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1
PROTOCOL SYNOPSIS
Trial Sponsor
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 76134-2099
Name of Test Product(s)
DAILIES TOTAL1 Water Gradient silicon hydrogel daily 
disposable contact lenses (DAILIES TOTAL1)
Name of Control 
Product(s)
ACUVUE OASYS® 1-DAY with HydraLuxe™Technology 
(Acuvue Oasys 1-Day)
Title of Trial
Two Daily Disposable Contact Lenses in Symptomatic 
Patients
Protocol Number
CLS312-P001
Number of Sites
Country
~4
US
Planned Duration of 
Exposure 
Test Product: 28 days (±2 days)
Control Product: 28 days (±2 days)
Number of Subjects 
Target to complete: 30
Planned to enroll: ~36
Study Population
Volunteer subjects aged 18 or over who are symptomatic 
contact lens wearers and who wear their habitual monthly or 
bi-weekly replacement lenses at least 3 days per week and at 
least 5 hours per day
Objective(s)
The overall objective of the study is to evaluate the 
performance of Acuvue Oasys 1-Day and DAILIES 
TOTAL1 with respect to visual acuity, 
 
 in a symptomatic study population of monthly or 
bi-weekly replacement lens wearers
Endpoints
Primary Effectiveness

VA (4-Week Follow-up)
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Safety

AEs

Biomicroscopy findings

Device deficiencies
Assessments
Effectiveness

VA (Snellen distance)

Manifest refraction

BCVA (Snellen distance with manifest refraction)
Safety

AEs

Biomicroscopy

Device deficiencies
Study Design
Prospective
Single-masked 
(trial subject)
Single-masked 
(Investigator)
Double-masked
Single group
Parallel group
Crossover
Other 
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Open-label
Other
Contralateral
Bilateral
Monocular lens wear
Randomized
Test Product Details
Primary 
component/material
delefilcon A
Product Name
DAILIES TOTAL1
Manufacturer
Alcon
Other 
The lenses will be available 
in -2.00 D to -6.00 D in
0.25 D steps and -6.50 D 
to -8.50 D in 0.50 D steps
Control Product Details
Primary 
component/material
senofilcon A
Product Name
Acuvue Oasys 1-Day
Manufacturer
Johnson & Johnson
Other 
The lenses will be available 
in -2.00 D to -6.00 D in 0.25 D 
steps and -6.50 D to -8.50 D in 
0.50 D steps
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.
 
4. Soft contact lens wearers in both eyes during the past 3 
months.
5. Manifest cylinder ≤ 0.75 D in each eye.
6. BCVA 20/25 or better in each eye.
7. Subject must be willing to wear the study lenses at least 
3 days per week and at least 8 hours per day
8. Subject must be willing to stop wearing their habitual 
contact lenses for the duration of study participation.
Exclusion Criteria
1. 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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2. Any use of systemic or ocular medications for which 
contact lens wear could be contraindicated, as 
determined by the Investigator.
3. History of refractive surgery or plan to have refractive 
surgery during the study or irregular cornea in either eye.
4. Ocular or intraocular surgery (excluding placement of 
punctal plugs) within the previous 12 months or planned 
during the study.
5. Biomicroscopy findings at screening that are moderate 
(Grade 3) or higher and/or corneal vascularization that is 
mild (Grade 2) or higher.
6. Current or history of pathologically dry eye in either eye 
that, in the opinion of the Investigator, would preclude 
contact lens wear.
7. Current or history of herpetic keratitis in either eye.
8. Eye injury in either eye within 12 weeks immediately 
prior to enrollment for this trial.
9. Current or history of intolerance, hypersensitivity, or 
allergy to any component of the study products.
10. Wearing habitual contact lenses in an extended wear 
modality (routinely sleeping in lenses for at least 1 night 
per week) over the last 3 months prior to enrollment.
11. Any use of topical ocular medications that would require 
instillation during contact lens wear.
12. The Investigator, his/her staff, family members of the 
Investigator, family members of the Investigator’s staff, 
or individuals living in the households of the 
aforementioned persons may not participate in the study. 
13. Participation of the subject in a clinical trial within the 
previous 30 days or currently enrolled in any clinical 
trial.
14. Monocular subjects (only one eye with functional 
vision). 
Associated Materials
No lens care products will be used. Commercial re-wetting 
drops will be permitted as needed but not provided.  
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Table 1-1
Schedule of Study Procedures and Assessments
Procedure/ Assessment
Pre-screening
Visit 1
(Day 1)
Visit 2
(Day 7
± 2 days)
Visit 3
(Day 28
± 2 days)
Unscheduled Visit
Early Exit
Baseline / 
Fitting / 
Dispense 
1-week 
Follow-up
4-week 
Follow-up 
/ Exit
Informed Consent
-

-
-
-
-
Demographics
-

-
-
-
-
Medical History
-





Concomitant Medications
-

()
()
()
()
Inclusion/Exclusion
-

-
-
-
-
VA w/ habitual correction
(OD, OS, Snellen distance)*
-
a
-
-
-
-
Manifest refraction*
-

()
()
()
()
BCVA (OD, OS, Snellen 
distance with manifest 
refraction)*
-

()
()
()
()
Biomicroscopy
-





Dispense study lenses
-

-
-
-
-
VA w/ study lenses (OD, OS, 
Snellen distance)
-



()

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Procedure/ Assessment
Pre-screening
Visit 1
(Day 1)
Visit 2
(Day 7
± 2 days)
Visit 3
(Day 28
± 2 days)
Unscheduled Visit
Early Exit
Baseline / 
Fitting / 
Dispense 
1-week 
Follow-up
4-week 
Follow-up 
/ Exit
AEs
-





Device deficiencies 
-





Exit Form
-
()
()
()
()

a Performed based on habitual lenses 
() assessment performed as necessary, eg, decrease of VA by 2 lines or more with investigational product (IP)
* Source only
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1.1
Abbreviations
Abbreviation
Definition
Acuvue Oasys 
1-Day or 
AO1D
ACUVUE OASYS 1-DAY with HydraLuxe Technology
ADE
Adverse device effect
AE
Adverse event
ASADE
Anticipated serious adverse device effect
BCVA
Best corrected visual acuity
CFR
Code of Federal Regulations
CL
Contact lens
D
Diopter
D/C
Discontinue
DAILIES 
TOTAL1 or 
DT1
DAILIES TOTAL1 Water Gradient silicon hydrogel daily disposable 
contact lenses
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
OU
Both eyes
SAE
Serious adverse event
SADE
Serious adverse device effect
US
United States
USADE
Unanticipated serious adverse device effect
VA
Visual acuity
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2
TABLE OF CONTENTS
Two Daily Disposable Contact Lenses in Symptomatic Patients..............................................1
1
PROTOCOL SYNOPSIS ....................................................................................................2
1.1
Abbreviations ......................................................................................................8
2
TABLE OF CONTENTS.....................................................................................................9
List of Tables............................................................................................................................11
List of Figures..........................................................................................................................11
3
INTRODUCTION.............................................................................................................12
3.1
Study Rationale and Purpose.............................................................................12
3.2
Trial Objective...................................................................................................12
3.3
Risks and Benefits.............................................................................................13
3.4
Subject Population.............................................................................................13
3.5
Outline of Study ................................................................................................14
4
TREATMENTS ADMINISTERED...................................................................................14
4.1
Identity of Study Treatments .............................................................................14
4.2
Accountability Procedures.................................................................................15
5
STUDY PROCEDURES AND ASSESSMENTS.............................................................16
5.1
Visits and Examinations ....................................................................................16
5.1.1
Visit 1 (Day 1) – Baseline/Fitting/Dispense......................................16
5.1.2
Visit 2 (Day 7 ± 2 Days) – 1-Week Follow-up..................................18
5.1.3
Visit 3 (Day 28 ± 2 Days) – 4-Week Follow-up / Exit......................20
5.2
Unscheduled Visits ............................................................................................21
5.3
Discontinued Subjects .......................................................................................22
5.4
Clinical Study Termination................................................................................22
6
ANALYSIS PLAN ............................................................................................................23
6.1
Subject Evaluability...........................................................................................23
6.2
Analysis Data Sets.............................................................................................23
6.2.1
Safety Analysis Set............................................................................23
6.3
Demographic and Baseline Characteristics.......................................................24
6.4
Effectiveness Analyses ......................................................................................24
6.4.1
Primary Effectiveness........................................................................24
6.4.1.1
Statistical Hypotheses........................................................24
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6.4.1.2
Analysis Methods ..............................................................24
24
25
25
6.5
Subgroup Analyses ............................................................................................25
6.6
Handling of Missing Data .................................................................................25
6.7
Multiplicity........................................................................................................25
6.8
Safety Analysis ..................................................................................................25
6.9
Interim Analyses................................................................................................26
6.10
Sample Size Justification...................................................................................26
7
ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................27
7.1
General Information ..........................................................................................29
7.2
Monitoring for Adverse Events .........................................................................32
7.3
Procedures for Recording and Reporting ..........................................................32
7.4
Return product analysis .....................................................................................34
7.5
Follow-Up of Subjects with Adverse Events.....................................................35
7.6
Pregnancy in the Clinical Study........................................................................35
8
CONFIDENTIALITY, BIAS, AND MASKING...............................................................35
8.1
Subject Confidentiality and Methods Used to Minimize Bias..........................35
8.2
Unmasking of the Study Treatment...................................................................36
9
DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................36
9.1
Completion of Source Documents and Case Report Forms..............................36
9.2
Data Review and Clarifications.........................................................................37
9.3
Regulatory Documentation and Records Retention ..........................................37
10 ETHICS AND COMPLIANCE.........................................................................................38
10.1
Compliance........................................................................................................38
10.2
Institutional Review Board (IRB) .....................................................................38
11 PROTOCOL AMENDMENT HISTORY..........................................................................39
12 REFERENCES ..................................................................................................................39
12.1
References applicable for all clinical trials .......................................................39
12.1.1
US references applicable for clinical trials........................................39
12.2
References for this clinical trial.........................................................................39
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List of Tables
Table 1-1
Schedule of Study Procedures and Assessments ...............................................6
List of Figures
Figure 7–1
Categorization of All AEs................................................................................29
Figure 7-2
Categorization of All Serious Adverse Events.................................................30
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3
INTRODUCTION
3.1
Study Rationale and Purpose
The contact lenses for this study are intended for the optical correction of refractive myopia
in persons with non-diseased eyes who are dryness symptomatic with their habitual 
weekly/monthly contact lenses.
The primary purpose of this study is to conduct a pilot study with DAILIES TOTAL1 and 
Acuvue Oasys 1-Day to guide the protocol development of the subsequent larger scale head-
to-head phase 4 trial. Additionally, this study is being conducted to re-fit habitual
weekly/monthly symptomatic wearers into DAILIES TOTAL1 and Acuvue Oasys 1-Day
 
 
 
The primary endpoint was selected to support the overall study objective. Procedures for 
measurement of this endpoint are standard in eye care professional practice. The design of 
this study is justified based upon preclinical and clinical testing, as described within the 
product´s Instructions for Use. Acuvue Oasys 1-Day contact lenses were chosen as the 
control product because these lenses have the same wear modality and a similar material to 
the DAILIES TOTAL1 lenses. 
There are no immediate plans to submit the results of this study for publication; however, the 
results may be offered for publication if they are of scientific interest, or if the results relate 
to a product that is subsequently approved or cleared for marketing.
3.2
Trial Objective
The overall objective of the study is to evaluate the performance of DAILIES TOTAL1 and 
Acuvue Oasys 1-Day with respect to VA, 
 in a symptomatic study 
population of monthly or bi-weekly replacement lens wearers.
The primary objective is to evaluate VA after approximately 4 weeks of lens wear. 
 
 
Data collected may be used for the sample size calculation of a claims trial with DAILIES 
TOTAL1 and Acuvue Oasys 1-Day.
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The safety objective is to describe the safety profile of the investigational products through 
evaluation of AEs, biomicroscopy findings, and device deficiencies.
3.3
Risks and Benefits
Contact lenses may offer improved peripheral vision and the convenience of not wearing 
spectacles. There is no intended clinical benefit to the subject; additionally, both study lenses 
have the potential to reduce dryness symptoms while wearing contact lenses. Material 
properties and design characteristics of the contact lens in development are features 
consistent with successful contact lens wear.
DAILIES TOTAL1 and ACUVUE OASYS 1-DAY 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 inserts. 
The DAILIES TOTAL1 and Acuvue Oasys 1-Day 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 DAILIES TOTAL1 
lenses 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 potential harms associated with on-eye exposure to 
the new lens materials include toxicity response, blurred vision, and ocular discomfort. In 
general, the risks with the contact lens are anticipated to be similar to other marketed daily 
disposable soft contact 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 36 volunteer subjects to be enrolled at 
approximately 4 sites, with approximately 9 subjects enrolled per site. The study population 
will consist of subjects aged 18 or over with normal eyes (other than the need for optical 
correction for myopia), who are adapted, existing wearers of weekly/monthly soft contact 
lenses in both eyes and positive for dryness symptoms with their habitual contact lenses 
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Subjects may be pre-screened for dryness symptoms and 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 prospective, multi-site, randomized, parallel-group, open-label study 
comparing 2 daily disposable contact lenses. The expected duration of subject participation in 
the study is approximately 4 weeks, with 3 scheduled visits. The study is expected to be 
completed in approximately 8 weeks.
4
TREATMENTS ADMINISTERED
Subjects will be randomized in a 1:1 manner to receive treatment with DAILIES TOTAL1 or
Acuvue Oasys 1-Day.
4.1
Identity of Study Treatments
DESCRIPTION OF TEST AND CONTROL PRODUCTS
Test Lens
Control Lens
Lens
DAILIES TOTAL1
Acuvue Oasys 1-Day
Material
delefilcon A
senofilcon A
Water Content
33%
38%
Base Curve (mm)
8.5
8.5 and 9.0
Diameter (mm)
14.1
14.3
Rx powers to be available 
in this study
-2.00 D to -6.00 D in
0.25 D steps and -6.50 D 
to -8.50 D in 0.50 D steps
-2.00 D to -6.00 D in
0.25 D steps and -6.50 D 
to -8.50 D in 0.50 D steps
Packaging, Labeling, and 
Supply

Blister foil pack

Commercial foil

Commercial Packaging

Lenses will be provided in 
30 count boxes per power.

Lenses should be stored at 
room temperature.

Blister foil pack

Commercial foil

Commercial Packaging

Sites will procure the 
control lenses.

Lenses should be stored 
at room temperature.
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Usage

Wear: 
o
Daily wear
o
Bilateral, parallel group

Replacement period: daily disposable

Exposure: Goal is at least 8 hours per day, at least 3 days 
per week over a 4-week period

Lens Care: N/A
4.2
Accountability Procedures
Upon receipt of the study lenses, the Investigator or delegate will conduct an inventory. 
Designated study staff will provide the study lenses to the subjects in accordance with their 
randomization schedule. Throughout the study, the Investigator or delegate must maintain 
records of study treatment dispensation and collection for each subject. This record must be 
made available to the study monitor for the purposes of verifying the accounting of clinical 
supplies. Any discrepancies and/or deficiencies between the observed disposition and the 
written account must be recorded along with an explanation. 
It is the Investigator’s responsibility to ensure that:

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.
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5
STUDY PROCEDURES AND ASSESSMENTS
5.1
Visits and Examinations
5.1.1
Visit 1 (Day 1) – Baseline/Fitting/Dispense
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.
5
Perform Snellen VA with habitual correction (in source).

OD, OS, distance only, contact lenses

Over-refraction if necessary to determine the best contact lens-corrected VA 
and determine final study lens power(s)
6
Perform a manifest refraction (in source)
7
Perform Snellen BCVA with manifest refraction (in source).

OD, OS, distance only
Note: Distance BCVA must be 20/25 or better in each eye for the subject to qualify for the 
study.
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8
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
9
Determine study lens powers based upon the manifest refraction and habitual lens 
powers.
10
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.
11
Based upon the randomized treatment assignment, have the subject insert the 
appropriate study lenses.

Keep all lidding foils of lenses used during lens fit process for study lens 
accountability.
12
Evaluate the study lenses by performing the following:

Snellen VA with study lenses (OD and OS, at distance)*
*VA w/study lenses must be 20/40 OU or better for subject to leave the office
15
Assess and record any AEs and device deficiencies reported or observed during the 
study visit.
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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
Dispense study lenses. Provide the subject with written and verbal instructions on 
lens wear. 
Verbal instruction only: If the subject experience an unusual feeling after lens 
insertion (ie, discomfort), the lens may be inverted. Remove and insert the lens 
again.
17
Schedule Visit 2 to take place after 7 ± 2 days of lens wear.
18
Note: If for some reason a subject is unable to wear a study lens for the duration of this visit 
window, instruct the subject to return to the site for an Unscheduled Visit, including, if 
possible, lens removal on site. The subject should then be scheduled to return to the clinic 
for Visit 2 (if possible) or exited from the study.
5.1.2
Visit 2 (Day 7 ± 2 Days) – 1-Week Follow-up
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 and adjunct product usage. 
5
Perform a manifest refraction (as needed) (in source)
6
Perform Snellen BCVA with manifest refraction (as needed) (in source) 

OD, OS, distance only
Note: Perform BCVA if there is a decrease of VA by 2 lines or more with IP
7
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
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
Conjunctival compression/indention

Chemosis

Corneal infiltrates

Other findings
8
Evaluate the study lenses by performing the following:

Snellen VA with study lenses (OD and OS, at distance)
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 regardless of their enrollment status 
(screen failure or randomized).
13
Schedule Visit 3 to take place after 28± 2 days of lens wear
14
Note: If for some reason a subject is unable to wear a study lens for the duration of this 
visit window, instruct the subject to return to the site for an Unscheduled Visit, including, if 
possible, lens removal on site. The subject should then be scheduled to return to the clinic 
for Visit 3 (if possible) or exited from the study.
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5.1.3
Visit 3 (Day 28 ± 2 Days) – 4-Week Follow-up / 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 a manifest refraction (as needed) (in source)
6
Perform Snellen BCVA with manifest refraction (as needed) (in source)

OD, OS, distance only
Note: Perform BCVA if there is a decrease of VA by 2 lines or more with IP
7
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
8
Evaluate the study lenses by performing the following:

Snellen VA with study lenses (OD and OS, at distance)
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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 regardless of their enrollment status 
(screen failure or randomized).
13
Perform Snellen VA with habitual correction.

OD, OS, distance only, contact lenses
Note: If this VA with habitual correction shows a decrease of 2 lines or more versus 
Visit 1 baseline VA with habitual correction, then BCVA with MR is required to 
confirm a potential loss in VA for AE reporting requirements (see Section 7).
14
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
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
Perform biomicroscopy (assessments with or without lenses, as possible)
In addition, all procedures for Visit 3 (4-Week Follow-up/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 
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 
procedures outlined at Visit 3, as applicable.
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.
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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(s) 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.
6
ANALYSIS PLAN
Continuous variables will be summarized using the number of observations, mean, standard 
deviation, median, minimum, and maximum. Categorical variables will be summarized with 
counts and percentages from each category. Any deviations to this analysis plan will be 
updated during the course of the study as part of a protocol amendment or will be detailed in 
the clinical study report.
6.1
Subject Evaluability
The final subject evaluability will be determined prior locking the database, based on the 
Deviations and Evaluability Plan.
6.2
Analysis Data Sets
6.2.1
Safety Analysis Set
Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. 
As such, the safety analysis set will include all subjects/eyes exposed to any study lenses
evaluated in this study. For treatment-emergent safety analyses, subjects/eyes will be 
categorized under the actual study lenses exposed.
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6.3
Demographic and Baseline Characteristics
Demographic information (age, sex, ethnicity, race) will be summarized on the safety 
analysis set. Baseline data pertaining to habitual lens 
 will also be summarized on the safety analysis set.
6.4
Effectiveness Analyses
This study defines one primary endpoint, 
 
 The safety analysis set will be used for all effectiveness analyses.
6.4.1
Primary Effectiveness
The primary objective of this study is to evaluate VA after approximately 4 weeks of lens 
wear. The primary endpoint is distance VA with study lenses, collected in Snellen at the 
4-week follow-up visit, for each eye. Conversion will be made to the logMAR scale.
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
Counts and percentage in each Snellen VA category will be provided, and descriptive 
statistics (number of observations, mean, standard deviation, median, minimum, maximum) 
for the logMAR converted values will be presented.
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6.5
Subgroup Analyses
It is not expected that demographic or baseline characteristics will have an impact on the 
study results in this study. No subgroup analyses are planned.
6.6
Handling of Missing Data
All data obtained in evaluable subjects/eyes will be included in the analyses. No imputation 
for missing values will be carried out.
6.7
Multiplicity
No multiplicity adjustment needs to be considered for the effectiveness endpoints since no 
formal hypothesis testing will be conducted.
6.8
Safety Analysis
The safety endpoints for this study are AEs, biomicroscopy findings, and device deficiencies. 
Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be 
presented by Medical Dictionary for Regulatory Activities Preferred Terms. AEs leading to 
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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 (Visit 1) to any subsequent visit will be presented. A supportive listing will be 
generated which will include all biomicroscopy data from all visits for these eyes 
experiencing the increase.
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. 
6.9
Interim Analyses
There are no plans to conduct an interim analysis and no criteria by which the study would be 
terminated early based upon statistical determination.
6.10 Sample Size Justification
For VA with a sample size of 15 in each treatment group, a two-sided 95% confidence 
interval for the difference of 2 means will extend 0.05 from the observed difference in means 
with an assumed common standard deviation of 0.07.
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7
ADVERSE EVENTS AND DEVICE DEFICIENCIES
Terms and Definitions
Adverse Event (AE)
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 (test product). Note: For subjects, 
this definition includes events related to the test product, the 
control product, or the procedures involved. For users or other 
persons, this definition is restricted to events related to the test 
product.
Adverse Device 
Effect (ADE)
AE related to the use of an investigational medical device (test 
product) or control product. 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 test product 
or control product.
Anticipated Serious 
Adverse Device 
Effect (ASADE)
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, safety, or performance. Note: This definition 
includes malfunctions, use errors, and inadequate labeling.
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 that either 
resulted in:
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 
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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.
c) in-patient hospitalization or prolonged hospitalization.
Note: Planned hospitalization for a pre-existing condition, 
without serious deterioration in health, is not considered 
an SAE. In general, hospitalization signifies that the 
individual remained at the hospital or emergency ward for 
observation and/or treatment (usually involving an 
overnight stay) that would not have been appropriate in the 
physician's office or an out-patient setting. Complications 
that occur during hospitalization are adverse events. If a 
complication prolongs hospitalization or fulfills any other 
serious criteria, the event is serious. When in doubt as to 
whether “hospitalization” occurred, the event should be 
considered serious.
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.
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.
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 
(USADE)
Serious adverse device effect which by its nature, incidence, 
severity or outcome has not been identified in the risk management 
file.
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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 (test product).
Figure 7–1
Categorization of All AEs
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Figure 7-2
Categorization of All Serious Adverse Events
Specific Events Relevant to this Protocol 
Serious Adverse Events 
In addition to reporting all AEs (serious and non-serious) meeting the definitions, the 
Investigator must report any occurrence of the following as an SAE:

An ocular infection including a presumed infectious ulcer with any of the following 
characteristics: 
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
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
Hyphema

Neovascularization within the central 6 mm of the cornea

Permanent vision loss as defined by loss of 2 or more lines of BCVA [VA w/ study lenses 
(OD, OS), Snellen distance] from enrollment visit that fails to resolve; this loss should be 
confirmed with Manifest Refraction BCVA

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 

Temporary vision loss as defined by loss of 2 or more lines of BCVA [VA w/ study lenses 
(OD, OS), Snellen distance]from enrollment visit that persists for 2 or more weeks this 
loss should be confirmed with Manifest Refraction BCVA

Neovascularization score greater than or equal to Grade 2 
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. 
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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/solution 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:

“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?”
Additionally, changes in any protocol-specific parameters and/or questionnaires evaluated 
during the study are to be reviewed by the Investigator. Any untoward (unfavorable and 
unintended) change in a protocol-specific parameter or questionnaire response that is 
clinically relevant, in the opinion of the Investigator, is to be reported as an AE. These 
clinically relevant changes will be reported regardless of causality.
7.3
Procedures for Recording and Reporting
AEs are collected from the time of informed consent. Any pre-existing medical conditions or 
signs/symptoms present in a subject prior to the start of the study (ie, before informed 
consent is signed) are not considered AEs in the study and should be recorded in the Medical 
History section of the eCRF.
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In addition, temporary lens awareness or visual changes during the fitting process are not 
considered AEs if the Investigator assesses that the symptom(s) can reasonably resolve within 
the anticipated adaptation period.

ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device Effect 
eCRF within 24 hours of the Investigator’s or site’s awareness. 

Device deficiencies are documented on the Device Deficiency eCRF within 24 hours of 
the Investigator’s or site’s awareness. 

A printed copy of the completed Serious Adverse Event and Adverse Device Effect and/or 
Device Deficiency eCRF must be included with product returns.

Additional relevant information after initial reporting must be entered into the eCRF as 
soon as the data become available.

Document any changes to concomitant medications on the appropriate eCRFs.

Document all relevant information from Discharge Summary, Autopsy Report,

Certificate of Death, etc, if applicable, in narrative section of the Serious Adverse Event
and Adverse Device Effect eCRF.
Note: Should the EDC system become non-operational, the site must complete the 
appropriate paper Serious Adverse Event and Adverse Device Effect and/or Device Deficiency
Form. The completed form is emailed to the Study Sponsor at msus.safety@alcon.com
according to the timelines outlined above; however, the reported information must be entered 
into the EDC system once it becomes operational.
Study Sponsor representatives may be contacted for any protocol related question.
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC.
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Intensity and Causality Assessments
Where appropriate, the Investigator must assess the intensity (severity) of the AE based upon 
medical judgment with consideration of any subjective symptom(s), as defined below:
Intensity (Severity)
Mild
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom.
Moderate
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities.
Severe
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities.
For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by Study Sponsor utilizing the same definitions, as shown below:
Causality
Related
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study 
procedure has not been demonstrated, but there is a reasonable possibility that 
the AE was caused by the medical device or study procedure.
Not Related
An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (ie, there are other more likely causes for the AE).
The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
seriousness and/or causality. The Study Sponsor will notify the Investigator of any AEs that 
are upgraded from non-serious to serious or from unrelated to related.
7.4
Return product analysis
Alcon products associated with device deficiencies and/or product related AEs should be 
returned and must include the Complaint # which will be provided by Study Sponsor after the 
case is entered in the Study Sponsor’s Global Product Complaint Management System. These 
products should be returned to the Sponsor at the end of the study, unless instructed otherwise 
by the Sponsor. 
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7.5
Follow-Up of Subjects with Adverse Events
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study. 
The Investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, database lock).
Any additional data received up to 1 month after subject discontinuation or exit must be 
documented and available upon the Study Sponsor’s request. All complaints received after 
this time period will be considered and processed as spontaneous and should be 
communicated to the medical device’s manufacturer as per local requirements.
The Investigator should also report complaints on non-Alcon products (ie, the control lenses)
directly to the manufacturer as per the manufacturer’s instructions or local regulatory 
requirements.
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. Pregnancy should be included in the Medical History section 
of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant 
during the study. Pregnancy is not reportable as an AE; however, complications may be 
reportable and will be decided on a case–by-case basis.
8
CONFIDENTIALITY, BIAS, AND MASKING
8.1
Subject Confidentiality and Methods Used to Minimize Bias
The Investigator must ensure that the subject’s anonymity is maintained throughout the
course of the study. In particular, the Investigator must keep an enrollment log with
confidential identifying information that corresponds to the subject numbers and initials of
each study participant. At the end of the clinical study, the Sponsor will collect a copy of the
enrollment log without any identifying subject information. All documents submitted to the
Sponsor will identify the subjects exclusively by number and demographic information. No
other personally identifying information should be transmitted to the Sponsor.
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Sponsor personnel (other than site monitors, lead clinical site manager, person responsible for 
generating the randomization schedule, and unmasked clinical data managers) involved in 
reporting, obtaining, and/or reviewing the clinical evaluations will be masked to the identity 
of the contact lens being administered. This level of masking will be maintained throughout 
the conduct of the study. Unmasking will occur only after all planned study data have been 
validated, and the database locked.
This study is open label with randomized subjects to use either DAILIES TOTAL1 or Acuvue 
Oasys 1-Day for the duration of the 4-week treatment period.
Visual acuity is the primary endpoint and the study is controlled DAILIES TOTAL1 or 
Acuvue Oasys 1-Day wearers will be excluded.
8.2
Unmasking of the Study Treatment
Not applicable; this study is open-label.
9
DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS
9.1
Completion of Source Documents and Case Report Forms
The nature and location of all source documents will be identified to ensure that original data 
required to complete the eCRFs exist and are accessible for verification by the site monitor, 
and all discrepancies shall be appropriately documented via the query resolution process. 
Study monitors are appointed by the Study Sponsor and are independent of study site staff. If 
electronic records are maintained, the method of verification must be determined in advance 
of starting the study. 
At a minimum, source documents should include the following information for each subject:

Subject identification (name, sex, race/ethnicity)

Documentation of subject eligibility

Date of informed consent

Dates of visits

Documentation that protocol specific procedures were performed

Results of study parameters, as required by the protocol

IP accountability records

Documentation of AEs and other safety parameters (if applicable)
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
Records regarding medical histories and the use of concomitant therapies prior to and 
during the study

Date of study completion and reason for early discontinuation, if applicable
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the eCRF are consistent with the original source data.
Only designated individuals may complete the eCRFs. The eCRFs will be submitted at 
regular intervals following the clinical study visit schedule. It is expected that all data 
reported will have corresponding entries in the source documents. The Principal Investigator 
is responsible for reviewing and certifying that the eCRFs are accurate and complete. The 
only subject identifiers recorded on the eCRFs will be subject number, and subject 
demographic information.
9.2
Data Review and Clarifications
Upon completion of the eCRFs, a targeted review of the eCRF data to the subject’s source 
data will be completed by the site monitor to ensure completeness and accuracy. Additional 
data clarifications and/or additions may be needed as a result of the data cleaning process.
Data clarifications are documented and are part of each subject’s eCRFs.
9.3
Regulatory Documentation and Records Retention
The Investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the Sponsor and the Investigator’s files will be reviewed as part of the ongoing 
study monitoring. Financial disclosure is not subject to regulatory inspection and should be 
kept separately. 
Additionally, the Investigator must keep study records and source documents until the 
Sponsor provides written approval for their destruction. If the Investigator retires, relocates, 
or for any other reason withdraws from responsibility of keeping the study records, the 
Sponsor must be notified and suitable arrangements made for retention of study records and 
source documents needed to comply with national and international regulations (generally 
2 years after discontinuing clinical development or after the last marketing approval).
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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.
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 
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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.
11 PROTOCOL AMENDMENT HISTORY
Version
Brief Description and Rationale
1
Initial Version of this document
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
Not applicable.
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Date/Time 
(mm/dd/yyyy GMT):
Signed by:
Justification:
Clinical Project Lead
Global Device Medical Safety
biostatistics
07/20/2018 15:20:06
07/20/2018 09:27:32
07/19/2018 20:04:50
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