Clinical Validation of DACP Digital Design
Phase: NA
Conditions: Refractive Errors
Sponsor: Alcon Research

Page 1 of 59
Title
Clinical Validation of DACP Digital Design
Protocol Number:
Development Stage of 
Project:
Sponsor Name and 
Address:
Test Product:
Investigator Agreement:
CLD523-C001 / NCT03567005
Development
Alcon Research, Ltd. and its affiliates (“Alcon”)
6201 South Freeway
Fort Worth, Texas 76134-2099
DAILIES® AquaComfort Plus® (nelfilcon A) Digital Soft 
Contact Lenses
I have read the clinical study described herein, and recognize its 
confidentiality. I agree to conduct this study in accordance with 
the ethical principles contained within the Declaration of 
Helsinki, and the described study in compliance with the 
protocol, Good Clinical Practice (GCP), ISO 14155, 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 Study Sponsor.
Principal Investigator:
Signature
Date
Name and professional 
position:
Address:
Template version 1.0, approved 09 JUNE 2017
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 2 of 59
Table of Contents
Table of Contents .......................................................................................................................2
List of Tables..............................................................................................................................4
List of Figures............................................................................................................................5
1
GLOSSARY OF TERMS ....................................................................................................6
2
LIST OF ACRONYMS AND ABBREVIATIONS ...........................................................10
3
PROTOCOL SUMMARY.................................................................................................12
4
PROTOCOLAMENDMENTS .........................................................................................20
4.1
Amendments......................................................................................................21
5
INTRODUCTION.............................................................................................................22
5.1
Rationale and Background ................................................................................22
5.2
Purpose of the Study..........................................................................................22
5.3
Risks and Benefits.............................................................................................23
6
STUDY OBJECTIVES......................................................................................................24
6.1
Primary Objective(s) .........................................................................................24
6.2
Secondary Objective(s) .....................................................................................24
24
6.4
Safety Objective(s)............................................................................................24
7
INVESTIGATIONAL PLAN ............................................................................................25
7.1
Study Design .....................................................................................................25
7.2
Rationale for Study Design ...............................................................................27
7.3
Rationale for Duration of Treatment/Follow-Up...............................................27
7.4
Rationale for Choice of Control Product...........................................................27
7.5
Data Monitoring Committee..............................................................................27
8
STUDY POPULATION ....................................................................................................27
8.1
Inclusion Criteria...............................................................................................28
8.2
Exclusion Criteria..............................................................................................29
8.3
Rescreening of Subjects ....................................................................................30
9
TREATMENTS ADMINISTERED...................................................................................30
9.1
Investigational Product(s)..................................................................................30
9.2
Other Medical Device or Medication Specified for Use During the Study ......34
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 3 of 59
9.3
Treatment Assignment / Randomization ...........................................................34
9.4
Treatment masking ............................................................................................34
9.5
Accountability Procedures.................................................................................36
9.6
Changes to concomitant medications, treatments/ procedures..........................37
10 STUDY PROCEDURES AND ASSESSMENTS.............................................................37
10.1
Informed Consent and Screening ......................................................................38
10.2
Description of Study Procedures and Assessments...........................................39
10.2.1
Demographics....................................................................................39
10.2.2
Medical History.................................................................................39
10.2.3
Investigational Product compliance ..................................................39
10.2.4
Adverse Event Collection: Safety Assessment..................................39
10.2.5
Biomicroscopy: Safety Assessment...................................................39
10.2.6
Device Deficiencies: Safety Assessment...........................................39
39
10.3
Unscheduled Visits ............................................................................................40
10.4
Discontinued Subjects .......................................................................................41
10.4.1
Screen Failures ..................................................................................41
10.4.2
Discontinuations................................................................................41
10.4.3
Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product .............................................................42
10.5
Clinical Study Termination................................................................................42
10.5.1
Follow-up of subjects after study participation has ended ................42
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................42
11.1
General Information ..........................................................................................42
11.2
Monitoring for Adverse Events .........................................................................45
11.3
Procedures for Recording and Reporting ..........................................................46
11.4
Return product analysis .....................................................................................48
11.5
Unmasking of the Study Treatment...................................................................48
11.6
Follow-Up of Subjects with Adverse Events.....................................................48
11.7
Pregnancy in the Clinical Study........................................................................49
12 ANALYSIS PLAN ............................................................................................................49
12.1
Subject Evaluability...........................................................................................49
12.2
Analysis Sets .....................................................................................................49
12.2.1
Safety Analysis Set............................................................................49
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 4 of 59
12.2.2
Full Analysis Set................................................................................49
12.2.3
Per Protocol Analysis Set ..................................................................50
12.3
Demographic and Baseline Characteristics.......................................................50
12.4
Effectiveness Analyses ......................................................................................50
12.4.1
Analysis of Primary Effectiveness Endpoint(s).................................50
12.4.1.1
Statistical Hypotheses........................................................50
12.4.1.2
Analysis Methods ..............................................................50
12.4.2
Analysis of Secondary Effectiveness Endpoints ...............................51
12.4.2.1
Statistical Hypotheses........................................................51
12.4.2.2
Analysis Methods ..............................................................51
.......................51
52
53
12.5
Handling of Missing Data .................................................................................53
12.6
Safety Analyses .................................................................................................53
54
12.8
Sample Size Justification...................................................................................54
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................54
13.1
Subject Confidentiality......................................................................................54
13.2
Completion of Source Documents and Case Report Forms..............................55
13.3
Data Review and Clarifications.........................................................................56
13.4
Sponsor and Monitoring Responsibilities .........................................................56
13.5
Regulatory Documentation and Records Retention ..........................................56
13.6
Quality Assurance and Quality Control.............................................................57
14 ETHICS .............................................................................................................................57
15 REFERENCES ..................................................................................................................59
15.1
References applicable for all clinical studies ....................................................59
15.1.1
US references applicable for clinical studies.....................................59
15.2
References for this clinical study ......................................................................59
List of Tables
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol ...........................10
Table 3–1
Schedule of Study Procedures and Assessments .............................................19
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 5 of 59
Table 6–1
Primary Objective(s)........................................................................................24
Table 6–2
Secondary Objective(s)....................................................................................24
Table 6–3
Safety Objective(s)...........................................................................................24
Table 9–1
Test Product .....................................................................................................30
Table 9–2
Control Product................................................................................................32
34
List of Figures
Figure 7-1
Study Flow Chart .............................................................................................26
Figure 11–1
Categorization of All Adverse Events..............................................................43
Figure 11-2
Categorization of All Serious Adverse.............................................................43
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 6 of 59
1
GLOSSARY OF TERMS
Names of test product(s)
DAILIES® AquaComfort Plus® Digital Soft Contact Lenses
(DACP Digital)
Name of Control Product(s)
DAILIES® AquaComfort Plus® Sphere Soft Contact Lenses
(DACP)
Adverse Device Effect
Adverse event related to the use of an investigational 
medical device (test product) or control product. Note: This 
definition includes adverse events 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.
Adverse Event
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.
Requirements for reporting Adverse Events in the study can 
be found in Section 11.
Anticipated Serious 
Adverse Device Effect
Serious adverse device effect 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.
Requirements for reporting Device Deficiencies in the study 
can be found in Section 11.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 7 of 59
Enrolled Subject
Any subject who signs an informed consent form for 
participation in the study.
Interventional Clinical Trial
A research trial that prospectively assigns, whether 
randomly or not, human participants or groups of humans to 
one or more health-related interventions to evaluate the 
effects on health outcomes, and/or a research trial in which 
diagnostic or monitoring procedures beyond standard of care 
are conducted and generate outcomes for use in analysis of
data.
Investigational Product
Is defined as a preventative (vaccine), a therapeutic (drug or 
biologic), device, diagnostic, or palliative used as a test or 
control product in a clinical trial, including a product with a 
marketing authorization when used or assembled 
(formulated or packaged) in a way different from the 
authorized form, or when used for an unauthorized 
indication, or when used to gain further information about 
the authorized form.
Malfunction
Failure of a medical device to perform in accordance with its 
intended purpose when used in accordance with the 
instructions for use or clinical investigation plan.
Non-serious Adverse Event
Adverse event that does not meet the criteria for a serious 
adverse event.
Randomized Subjects
Any subject who is assigned a randomized treatment.
Serious Adverse Device 
Effect (SADE)
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event.
Serious Adverse Event 
(SAE)
Adverse event 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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 8 of 59
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.
c. in-patient hospitalization or prolonged 
hospitalization.
Note: Planned hospitalization for a pre-
existing condition, without serious 
deterioration in health, is not considered a 
serious adverse event. 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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 9 of 59
Refer to Section 11 for additional SAEs.
Significant Non-Serious 
Adverse Event
Is a symptomatic, device-related, non-sight threatening 
adverse event that warrants discontinuation of any contact 
lens wear for greater than or equal to 2 weeks.
Refer to Section 11 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.
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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 10 of 59
2 LIST OF ACRONYMS AND ABBREVIATIONS
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol
Abbreviation
Definition
ADE
Adverse device effect
AE
Adverse event
DACP or DACP 
lens(es)
DAILIES AquaComfort Plus Sphere Soft Contact Lenses
DACP Digital or 
DACP Digital 
lens(es)
DAILIES AquaComfort Plus Digital Soft Contact Lenses
BCVA
Best corrected visual acuity
CFR
Code of Federal Regulations
CI
Confidence interval
CRF
Case report form
CSM
Clinical site manager
CTT
Clinical trial team
D
Diopter
D/C
Discontinue
DEP
Deviations and evaluability plan
eCRF
Electronic case report form
EDC
Electronic data capture
FAS
Full Analysis Set
FDA
Food and Drug Administration
GCP
Good Clinical Practice
IB
Investigator’s brochure
ICF
Informed consent form
ICH
International Council for Harmonisation of Technical Requirements 
for Pharmaceuticals for Human Use
IEC
Independent ethics committee
IP
Investigational product
IRB
Institutional review board
IRT
Interactive response technology
ISO
International Organization of Standardization
LCSM
Lead clinical site manager
LID
Lens identification
LogMAR
Logarithm of the minimum angle of resolution
MEDDEV
Designation indicating a guidance document from the European 
Commission
mm
Millimeter
MOP
Manual of procedures
N
Number
N/A
Not applicable
OD
Right eye
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 11 of 59
Abbreviation
Definition
OS
Left eye
OU
Both eyes
PP
Per protocol analysis set
pt
Point
PVA
Polyvinyl alcohol
RAVE
Medidata electronic data capture and management
SADE
Serious adverse device effect
SAE
Serious adverse event
SD
Standard deviation
SLE
Slit-lamp examination
SOP
Standard operating procedure
US
United States
USADE
Unanticipated serious adverse device effect
VA
Visual acuity
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 12 of 59
3 PROTOCOL SUMMARY
This is a prospective, randomized, bilateral crossover, double-masked, controlled study. The 
study population will include approximately 60 subjects across approximately 4 US sites
enrolling approximately 15 subjects per site to meet the required target of 48 completed 
subjects. The study will consist of volunteer subjects with normal eyes (other than correction 
for refractive error) aged 18 to 35. Subjects should have at least 2 months of experience 
wearing DACP soft contact lenses on a daily wear, daily disposable basis, be using digital 
devices at least 4 hours per day at least 5 days per week, and experience symptoms of eye 
strain.
Subjects will be randomly assigned in a 1:1 manner to either receive DACP Digital or DACP
lenses for use during Period 1 of the study. For Period 2, the contact lenses that were not 
allocated for use in Period 1 will then be assigned per the specified sequence group:
Sequence Group
1) DACP Digital → DACP
2) DACP → DACP Digital
Subjects will wear each study product in a daily wear, daily disposable modality for 
7 ± 2 days per study product, with up to 4 scheduled visits.

Visit 1 – Baseline/Fitting

Visit 2 – Dispense Study Product 1 [0 - 7 days from Visit 1]

Visit 3 – 1-Week Follow-up Study Product 1 [7 ± 2 days from Visit 2] / Dispense 
Study Product 2

Visit 4 – 1-Week Follow-up Study Product 2 [7 ± 2 days from Visit 3] / Exit
The following assessments will be performed for each study product (see Section 10 for 
details):

Distance VA with study lenses (logMAR, 
OU) 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 13 of 59
Subjects will also be asked to complete the following series of questionnaires related to their 
lens wearing experiences with each study product:
Investigational 
product type
Device
Study type
Interventional
Investigational 
products
Test Product: DACP Digital lenses
Control Product: DACP lenses
Purpose and 
rationale
The overall purpose of this study is to evaluate the visual 
performance of the DACP Digital lens by assessing Distance VA 
as the primary variable compared to the commercially available 
DACP lens.
Objective(s)

The primary objective is to demonstrate noninferiority in 
Distance VA with DACP Digital when compared to DACP 
at the 1-Week Follow-up Visit.

The secondary objective is to demonstrate noninferiority in 
subjective overall vision with DACP Digital when 
compared to DACP at the 1-Week Follow-up Visit.
Endpoint(s)
Primary Effectiveness

Distance VA (logMAR, OU)
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 14 of 59
Secondary Effectiveness

Overall Vision
 
Safety

AEs

Biomicroscopy findings 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 15 of 59

Device deficiencies
Assessment(s) 
Effectiveness

Distance VA with habitual correction (logMAR)

Subjective ratings as related to 
 vision,
 
 
Safety

AEs

Biomicroscopy

Device deficiencies
Study Design
This is a prospective, randomized, bilateral crossover, double-
masked, controlled study. Subject participation in the study will be 
approximately 2 weeks with up to 4 visits where subjects will 
bilaterally wear the 1st study lens from the assigned lens sequence 
(Study Product 1) for approximately 7 ± 2 days before crossing 
over into the 2nd study lens of the assigned lens sequence (Study 
Product 2) bilaterally for approximately 7 ± 2 days.
Subject population
Volunteer subjects aged 18 to 35 with normal eyes (other than 
correction for refractive error), currently wearing DACP soft 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 16 of 59
contact lenses on a daily wear, daily disposable basis. Subjects 
should have at least 2 months of DACP wearing experience, wear 
these lenses at least 5 days per week and at least 8 hours per day, 
use digital devices at least 4 hours per day at least 5 days per 
week, experience symptoms of eye strain, and require distance 
contact lenses in a power range from -1.50 D to -3.75 D.
Key inclusion 
criteria
(See Section 8.1 for a 
complete list of 
inclusion criteria)

Current wearers of commercial spherical DACP. Wearers 
with at least 2 months wearing experience in their current 
DACP lenses, with a minimum wearing time of 5 days per 
week and 8 hours per day.

Currently using digital devices (computer, tablet, and/or 
smart phone) for a minimum of 5 days per week and 4 hours 
per day.

Currently experiencing symptoms of eye strain from using 
technology.

Requiring spherical contact lens distance correction in each 
eye within the range of -1.50 D to -3.75 D in 0.25 D steps.

Manifest astigmatism less than or equal to 0.75 D (at 
screening).

Best corrected distance VA greater than or equal to 0.1 
(20/25) in each eye.
Key exclusion 
criteria
(See Section 8.2 for a 
complete list of 
exclusion criteria)

Any anterior segment infection, inflammation, or 
abnormality or disease (including systemic) that 
contraindicates contact lens wear, as determined by the 
Investigator.

History of refractive surgery or irregular cornea.

Ocular or intraocular surgery within the previous 12 months 
(excluding placement of punctal plugs) or during the study.

Biomicroscopy findings at screening that are moderate 
(Grade 3) or higher and/or corneal vascularization that is 
mild (Grade 2) or higher in either eye at screening.

Current or history of herpetic keratitis in either eye.

Eye injury within 12 weeks immediately prior to enrollment 
for the study.

Wearing habitual contact lenses in an extended wear 
modality (routinely sleeping in lenses for at least 1 night per 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 17 of 59
week) over the last 3 months prior to enrollment.
Data analysis and 
sample size 
justification
To address the primary and secondary effectiveness endpoints, 
planned analyses are summarized below:
Endpoint
Comparison
Statistical Method
Primary
Distance VA
DACP Digital vs. DACP
Noninferiority 
(margin = 0.05 logMAR)
Mixed effect 
repeated measures 
model
Secondary
Overall vision 
DACP Digital vs. DACP
Noninferiority 
(margin = 1.0)
Mixed effect 
repeated measures 
model
A sequential gatekeeping strategy will be implemented to control 
multiplicity, thereby controlling the overall type I error at one-
sided 0.05.
No inferential testing will be carried out for safety endpoints.
Sample size calculation for primary and secondary effectiveness 
endpoints is summarized below:
Endpoint
Assumptions
Power
N per 
sequence
Primary
Distance VA
Paired 
differences 
SD = 0.098
80% 
(one-sided α = 0.05)
18
Secondary
Overall vision
Paired 
differences 
SD = 2.29
80% 
(one-sided α = 0.05)
24
Key words

DACP Digital

DACP

Visual acuity
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 18 of 59
Associated materials
None. With the use of daily disposable lenses, lens care is not 
required.
To prevent confounding the effectiveness endpoints, 

Use of lubrication/re-wetting drops will not be permitted at 
any time during study. 

Use of near aid (eg, reading glasses) will not be permitted at 
any time during study.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 19 of 59
Table 3–1
Schedule of Study Procedures and Assessments
Procedure/ Assessment
Pre-screening
Visit 1
Visit 2
0-7 days
from V1
Visit 
3
Visit 
3
Visit 4
7 (±2) 
days
from V3
Unscheduled Visit
Early Exit
7 (±2) days
from V2
Baseline/
Fitting
Dispense 
Study 
Product
1
Follow-up
Study Product 1
Dispense
Study Product 2
Follow-up
Study Product 2 /
Exit
Digital Use Time
*




Symptomatology Questionnaire
*
Informed consent

Demographics

Medical history






Concomitant Medications

()
()
()
()
)
()
Inclusion/Exclusion

Distance VA w/habitual lenses 
(logMAR, OD, OS)*

Over-refraction w/ habitual 
lenses (OD, OS)*

Manifest refraction*

()
()
()
()
()
 

()
()
()
()
()
Biomicroscopy






Dispense study lenses / Rx


VA w/ study lenses (
 
OU, logMAR distance) 
 




()

 


 




()
()
 
sites)


()
()



()

Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 20 of 59
Procedure/ Assessment
Pre-screening
Visit 1
Visit 2
0-7 days
from V1
Visit 
3
Visit 
3
Visit 4
7 (±2) 
days
from V3
Unscheduled Visit
Early Exit
7 (±2) days
from V2
Baseline/
Fitting
Dispense 
Study 
Product
1
Follow-up
Study Product 1
Dispense
Study Product 2
Follow-up
Study Product 2 /
Exit
Subjective ratings with study 
lenses


()


()
()
 



()
()



()
()
()
()
AEs 






Device deficiencies






Exit form
()
()
()

()

() assessment performed as necessary, eg, decrease of VA by 2 lines or more with investigational product (IP)
* Source only
4 PROTOCOL AMENDMENTS
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments must be created by the Study Sponsor and must be 
approved by the IRB/IEC and global and regional Health Authorities, as applicable, prior to 
implementation except when required to mitigate immediate safety risks or when the changes 
involve only logistical or administrative revisions. 
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all subjects currently enrolled in the study must sign 
the approved, revised informed consent (re-consent), as required by the IRB/IEC.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 21 of 59
4.1
Amendments
Amendment 1
Purpose of Amendment:  To clarify Inclusion Criteria for subject eligibility
Rationale:  Revision of certain Inclusion Criteria to improve enrollment rate across all sites 
without compromising quality of data
Current Study Status:  Active, enrolling subjects.
Case Report Form Revision Required:
Yes
X No
Informed Consent Modifications Required:
Yes
X No
Applicable Investigators:
X All
Selected (list below)
Itemized Changes:
1
Changed From Section 3:
Subjects should have at least 3 months of 
experience wearing DACP soft contact 
lenses on a daily wear, daily disposable 
basis, be using digital devices at least 4 
hours per day at least 5 days per week, and 
experience symptoms of eye strain.
Changed To Section 3:
Subjects should have at least 2 months of 
experience wearing DACP soft contact 
lenses on a daily wear, daily disposable 
basis, be using digital devices at least 4 
hours per day at least 5 days per week, and 
experience symptoms of eye strain.
2
Changed From Section 3 (Subject 
Population):
Subjects should have at least 3 months of 
DACP wearing experience, wear these 
lenses at least 5 days per week and at least 
8 hours per day, use digital devices at least 
4 hours per day at least 5 days per week, 
experience symptoms of eye strain, and 
require distance contact lenses in a power 
range from -1.50 D to -3.75 D.
Changed To Section 3 (Subject 
Population):
Subjects should have at least 2 months of 
DACP wearing experience, wear these 
lenses at least 5 days per week and at least 
8 hours per day, use digital devices at least 
4 hours per day at least 5 days per week, 
experience symptoms of eye strain, and 
require distance contact lenses in a power 
range from -1.50 D to -3.75 D.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 22 of 59
3
Changed From Section 3 (Key Inclusion 
Criteria):
Current wearers of commercial spherical 
DACP. Wearers with at least 3 months 
wearing experience in their current DACP
lenses, with a minimum wearing time of 5 
days per week and 8 hours per day.
Changed To Section 3 (Key Inclusion 
Criteria):
Current wearers of commercial spherical 
DACP. Wearers with at least 2 months 
wearing experience in their current DACP
lenses, with a minimum wearing time of 5 
days per week and 8 hours per day.
4
Changed From Section 8.1 (Inclusion 
Criteria):
Current wearers of commercial spherical 
DAILIES AquaComfort Plus. Wearers with 
at least 3 months wearing experience in 
their current DAILIES AquaComfort Plus
correction, with a minimum wearing time 
of 5 days per week and 8 hours per day.
Changed To Section 8.1 (Inclusion 
Criteria):
Current wearers of commercial spherical 
DAILIES AquaComfort Plus. Wearers with 
at least 2 months wearing experience in 
their current DAILIES AquaComfort Plus
correction, with a minimum wearing time 
of 5 days per week and 8 hours per day.
5 INTRODUCTION
5.1
Rationale and Background
The objective of the DACP Digital project is to introduce a modification to the DAILIES 
AquaComfort Plus Contact Lens (DACP) family, 
 
 
 
 
This clinical evaluation is a performance verification trial 
 
 The primary and secondary endpoints were selected to fulfil the primary 
and secondary objectives of the study. Procedures for measurement of these endpoints were 
selected based on common practice for these assessments. 
5.2
Purpose of the Study
The overall purpose of this study is to evaluate the visual performance of the DACP Digital 
lens by assessing Distance VA as the primary variable compared to the commercially 
available DACP lens.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 23 of 59
At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards.
There are no immediate plans to submit the results of this development 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.
5.3
Risks and Benefits
Contact lenses are intended to offer correction of ametropia, improved peripheral (side) 
vision, the convenience of not wearing spectacles, a non-permanent device application, and a 
perceived improvement of cosmetic appearance (over spectacles). Material properties and 
design characteristics of DACP Digital lenses are features consistent with successful contact 
lens wear.
Clinical studies involving DACP Digital have not yet been conducted. However, the core lens 
material used for DACP Digital is identical to the currently marketed DACP, for which there 
are multiple clinical studies, postmarket data, and literature reports that established a positive 
benefit/risk ratio for the lens.
In general, the risks with DACP Digital are anticipated to be similar to other marketed daily 
wear daily disposable contact lenses. Specifically, the safety profile is expected to be similar 
to other lenses in the nelfilcon A family since the core lens material used for DACP Digital is 
identical to DACP.
DACP Digital is intended for single use, daily disposable wear. Since DACP Digital is 
disposed of after a single use, lens care cleaning or disinfecting products are not needed and 
were not tested.
A summary of the known potential risks and benefits associated with DACP Digital lenses 
can be found in the IB. Any risks to subjects in this trial 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. 
There may also be unknown risks with the use of DACP Digital lens. During clinical 
exposure, study conditions, controls and oversight by qualified eye care professionals are 
factors designed to further minimize risk to study subjects. Under the conditions of these 
studies, adequate informed consent and subject instructions, scheduled wear, replacement and 
follow-up visit schedules, risks to study subjects are controlled and minimized.  
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 24 of 59
Refer to the IB for additional information.
6 STUDY OBJECTIVES
6.1
Primary Objective(s)
Table 6–1
Primary Objective(s)
Objective(s)
Endpoint(s)
Demonstrate noninferiority in Distance VA 
with DACP Digital when compared to 
DACP at the 1-Week Follow-up Visit.
Distance VA (logMAR, OU)
6.2
Secondary Objective(s)
Table 6–2
Secondary Objective(s)
Objective(s)
Endpoint(s)
Demonstrate noninferiority in subjective 
overall vision with DACP Digital when 
compared to DACP at the 1-Week Follow-
up Visit.
Overall Vision
6.4
Safety Objective(s)
Table 6–3
Safety Objective(s)
Objective(s)
Endpoint(s)
Describe the safety profile of the 
investigational products

AEs

Biomicroscopy findings

Device Deficiencies
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 25 of 59
7 INVESTIGATIONAL PLAN
7.1
Study Design
This is a prospective, randomized, bilateral crossover, double-masked, controlled study.
The study population will include volunteer subjects with normal eyes (other than correction 
for refractive error) aged 18 to 35, and have at least 2 months of experience wearing DACP 
soft contact lenses on a daily wear, daily disposable basis. Subjects must be using digital 
devices at least 4 hours per day at least 5 days per week, and experience symptoms of eye 
strain.
Subjects will be randomly assigned in a 1:1 manner to either receive DACP Digital or DACP 
lenses for use during Period 1 of the study. For Period 2, the contact lenses that were not 
allocated for use in Period 1 will then be assigned per the specified sequence group:
Sequence Group
1) DACP Digital → DACP
2) DACP → DACP Digital
Subjects will wear each study product bilaterally in a daily wear, daily disposable modality 
for 7 ± 2 days per IP, with up to 4 scheduled visits.

Visit 1 – Baseline/ Fitting

Visit 2 – Dispense Study Product 1 [0 - 7 days from Visit 1]

Visit 3 – 1-Week Follow-up Study Product 1 [7 ± 2 days from Visit 2] / Dispense 
Study Product 2

Visit 4 – 1-Week Follow-up Study Product 2 [7 ± 2 days from Visit 3] / Exit
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 26 of 59
Figure 7-1
Study Flow Chart
DACP Digital
DACP
DACP Digital
DACP
Prescreening
(via chart review and screening questions)
Habitual Symptomatic DACP wearers
Order IP
Visit 3
7 days (±2 days) from Visit 2
Follow-up Study Product 1 / Dispense Study Product 2
Visit 4
7 days (±2 days) from Visit 3
Follow-up Study Product 2 / Exit
Visit 2
Dispense Study Product 1
(0 – 7 days from Visit 1)
Visit 1
Baseline / Fitting
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 27 of 59
7.2
Rationale for Study Design 
In this study, the on-eye performance of the investigational DACP Digital lens and the 
commercially available DACP lens will be assessed in a prospective, double-masked, 
bilateral crossover design with 7 ± 2 days of exposure to each study lens. The study design as 
well as the exposure duration of study lenses is supported by the nonclinical and clinical data 
presented in the IB. The study design is well-established.
7.3
Rationale for Duration of Treatment/Follow-Up
The duration of exposure to the investigational product was chosen to address the objective 
of this study, and is aligned with the duration of use of the product in accordance with 
product labeling.
7.4
Rationale for Choice of Control Product
DACP lenses were chosen as the control product to address the study objectives.
DACP contact lenses were chosen as the control product because these lenses have the same 
wear modality, material, and parameters to the test product DACP Digital, and are the 
spherical design as compared to the test product’s aspherical design.
7.5
Data Monitoring Committee
Not Applicable.
8 STUDY POPULATION
The intended study population consists of volunteer subjects aged 18 to 35 with normal eyes 
(other than correction for refractive error), currently wearing DACP soft contact lenses on a 
daily wear, daily disposable basis. Subjects should have at least 2 months of DACP wearing 
experience, wear these lenses at least 5 days per week and at least 8 hours per day, use digital 
devices at least 4 hours per day at least 5 days per week, experience symptoms of eye strain, 
and require distance contact lenses in a power range from -1.50 D to -3.75 D.
It is aimed to enroll approximately 60 subjects in approximately 4 sites in the US, with an 
approximate target of 15 subjects per site. Site-specific targets may vary based upon
individual site capabilities. Estimated time needed to recruit subjects for the study is 
approximately 4 weeks.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 28 of 59
8.1
Inclusion Criteria
Written informed consent must be obtained before any study specific assessment is 
performed. Upon signing informed consent, the subject is considered enrolled in the study.
Subjects eligible for inclusion in this study must fulfill all of the following criteria:
1.
Subjects must be 18 to 35 years of age and be able to understand and sign an 
IRB/IEC approved Informed Consent form.
2.
Current wearers of commercial spherical DAILIES AquaComfort Plus. Wearers 
with at least 2 months wearing experience in their current DAILIES AquaComfort 
Plus correction, with a minimum wearing time of 5 days per week and 8 hours per 
day.
3.
Requiring spherical contact lens distance correction in each eye within the range 
of -1.50 D to -3.75 D in 0.25 D steps.
4.
Currently experiencing symptoms of eye strain from using technology.
5.
Subjects are willing to wear the study lenses each day as possible (including the day 
of the follow-up visits) and at least 8 hours per day unless contact lens wear is 
contraindicated.
6.
Subject must possess spectacles that provide a corrected visual acuity of 0.40
(20/40) or better OU and be willing to wear them (as needed).
7.
Manifest astigmatism less than or equal to 0.75 D (at screening)
8.
Best corrected distance visual acuity greater than or equal to 0.10 (20/25) in each 
eye (as determined by manifest refraction at screening).
9.
Willing to NOT use rewetting/lubricating drops at any time during the study.
10.
Currently using digital devices (computer, tablet, and/or smart phone) for a 
minimum of 5 days per week and 4 hours per day.
11.
Willing to NOT use any near aid (eg, reading glasses) at any time during the study.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 29 of 59
8.2
Exclusion Criteria
Subjects fulfilling any of the following criteria are not eligible for participation in this study.
1.
Any anterior segment infection, inflammation, disease, or abnormality that 
contraindicates contact lens wears as determined by the Investigator.
2.
Any use of systemic medications or ocular medications for which contact lens wear 
could be contraindicated, as determined by the Investigator, including use of any 
topical ocular medications and lubrication drops that would require instillation 
during contact lens wear.
3.
History of refractive surgery or irregular cornea.
4.
Ocular or intraocular surgery within the previous 12 months (excluding placement of 
punctal plugs) or 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 in either eye at screening.
6.
Current or history of pathologically dry eye in either eye.
7.
Current or history of herpetic keratitis in either eye.
8.
Eye injury within 12 weeks immediately prior to enrollment for the study
9.
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.
10.
Monocular subjects (only one eye with functional vision).
11.
Known pregnancy at time of enrollment.
12.
Concurrent participation of the subject in a contact lens or contact lens care product 
clinical trial or within the previous 30 days.
13.
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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 30 of 59
8.3
Rescreening of Subjects
Subjects must be screened according to the full list of inclusion/exclusion criteria in 
Section 8.1 and 8.2 of this protocol.
After informed consent is signed, a separate screening visit is allowed for the following 
criteria:

INC01 – Subject must be 18 to 35 years of age

EXC12 – Participation of the subject in a clinical trial within the previous 30 days or 
currently enrolled in any clinical trial
This separate screening visit can take place regardless of whether any other criterion has been 
verified.
Rescreening of subjects is not allowed in this study.
9 TREATMENTS ADMINISTERED
9.1
Investigational Product(s)
Test Product(s):
DACP Digital soft contact lenses (LID014466)
Control Product(s) (If applicable):
DACP Sphere soft contact lenses (LID007861)
Table 9–1
Test Product
Test Product
DAILIES AquaComfort Plus Digital Soft Contact Lenses (DACP 
Digital) (LID014466)
Manufacturer
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134-2099
USA
Indication for use 
and intended 
purpose in the 
current study 
The intended purpose of this contact lens is for the vision 
correction. 
A limited range of powers is available for use in this study in 
accordance with the study objective.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 31 of 59
Product description 
and parameters 
available for this 
study

Material: Nelfilcon A

Water content: 69%

Power range: -1.50 D to -3.75 D in 0.25 D steps

Base curve (mm): 8.7 (target)

Diameter (mm): 14.0 (target)

Other: Additional details can be found in the IB
Formulation
NA
Usage

Wear:
o
Daily Wear
o
Bilateral

Replacement period: Daily Disposable

Exposure: 7 ± 2 days and at least 8 hours per day

Lens Care: N/A

Additional details can be found in the MOP
Number/Amount of 
product to be 
provided to the 
subject
A box containing 10 lenses (per eye) will be provided to the subject 
at either Visit 1 or Visit 2, based on the subject’s randomized 
sequence assignment.
Packaging 
description
Blister containing phosphate buffered saline solution with wetting 
agents
Labeling description

Lens Foil label includes:
-
material name and/or identifier
-
base curve
-
diameter
-
manufacturing protocol number
-
packing solution
-
power
-
lot number
-
expiration date
-
content statement
-
investigational device statement
-
Sponsor information

Provided in boxes of 10 lenses per power per box, identified 
with the following:
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 32 of 59
-
a color coded label stating the protocol number
-
identifier
-
power
-
an investigational use only statement
-
tracking number
Storage conditions
Stored at room temperature. 
Additional 
identifying 
information
N/A
Supply
Refer to the MOP for a detailed description
Table 9–2
Control Product
Control Product(s)
DAILIES AquaComfort Plus Sphere Soft Contact Lenses (DACP)
(LID007861)
Manufacturer
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, Texas 76134-2099
USA
Indication for Use
The intended of this contact lens is for the vision correction.
A limited range of powers is available for use in this study in 
accordance with the study objective.
Product description 
and parameters 
available for this 
study

Material: Nelfilcon A

Water content: 69%

Power range: -1.50 D to -3.75 D in 0.25 D steps

Base curve (mm): 8.7 (target)

Diameter (mm): 14.0 (target)
Other: Additional details can be found in the IB
Formulation
Nelfilcon A. Additional details can be found in the IB for DACP.
Usage

Wear:
o
Daily Wear
o
Bilateral
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 33 of 59

Replacement period: Daily Disposable

Exposure: 7 ± 2 days and at least 8 hours per day

Lens Care: N/A

Additional details can be found in the MOP
Number/Amount of 
Product to be 
Provided to the 
subject
A box containing 10 lenses (per eye) will be provided to the subject 
at either Visit 1 or Visit 2, based on the subject’s randomized 
sequence assignment.
Packaging 
description
Blister containing phosphate buffered saline solution with wetting 
agents
Labeling description

Lens Foil label includes:
-
material name and/or identifier
-
base curve
-
diameter
-
packing solution
-
power
-
lot number
-
expiration date
-
content statement
-
investigational device statement
-
Sponsor information

Provided in boxes of 10 lenses per power per box, identified 
with the following:
-
a color coded label stating the protocol number
-
identifier
-
power
-
an investigational use only statement
-
tracking number
Storage conditions
Stored at room temperature. 
Additional 
identifying 
information
N/A
Supply
Refer to the MOP for a detailed description
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 34 of 59
9.2
Other Medical Device or Medication Specified for Use During the 
Study
No other medical devices or medications are required to be used in conjunction with the 
treatments during the clinical study.
9.3
Treatment Assignment / Randomization
Subjects will be randomized in a 1:1 ratio to receive treatment in crossover sequence DACP 
Digital then DACP or DACP then DACP Digital respectively.
Only after signing the ICF, a subject will be assigned a subject number by the electronic data 
capture system. 
A randomization list will be generated using a validated system that automates the random 
assignment of treatment arms to randomization numbers in the specified ratio. Subjects will 
be assigned treatment according to the randomization list uploaded in the iMedidata 
BALANCE system. The randomization list will be generated and maintained by the Study 
Sponsor.
IRT
At Visit 1, all eligible subjects will be randomized via the EDC/IRT integration system to one 
of the treatment arms. The Investigator or delegate will access the respective system after 
confirming that the subject meets all the eligibility criteria. A randomization number will be 
automatically assigned to the subject according to the subject randomization list but will not 
be communicated to the site user. The EDC/IRT integration system will inform the site user 
of the treatment sequence assignment to be dispensed to the subject.
9.4
Treatment masking
This study is double-masked, with subjects randomized to use DACP Digital and DACP
lenses (in a crossover fashion) for the duration of the 7 ± 2 day treatment period for each lens 
product. 
 
 
 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 35 of 59
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
.
 
 
 
 
 
 
 
 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 36 of 59
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. 
Masked study personnel must avoid seeking information that may compromise masking. 
Unmasked study personnel must not disseminate information that is potentially unmasking to 
any masked personnel. The masked and unmasked site personnel must coordinate all study 
activities as necessary to protect masking and minimize bias during the study. 
In the event of a medical emergency where the knowledge of subject treatment is required, an 
individual Investigator will have the ability to unmask the treatment assignment for a specific 
subject after contacting an appropriate Study Sponsor representative if time allows. 
Unmasking must be done according to the instructions provided for the study IRT system.
9.5
Accountability Procedures
Upon receipt of the IPs, the Investigator or delegate must conduct an inventory. During the 
study, unmasked designated study staff must provide the IPs to the subjects in accordance 
with their randomization assignment. Throughout the study, the Investigator or delegate must 
maintain records of IP dispensation and collection for each subject. This record must be made 
available to the study monitor for the purposes of verifying the accounting of IP supplies. 
Any discrepancies and/or deficiencies between the observed disposition and the written 
account must be recorded along with an explanation. All IPs sent to the Investigator must be 
accounted for by Study Sponsor personnel, and in no case be used in an unauthorized 
situation.
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, 
unless otherwise directed by the Sponsor. Refer to Section 11 of this protocol for 
additional information on the reporting of device deficiencies and AEs and the return 
of study products associated with these events.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 37 of 59
9.6
Changes to concomitant medications, treatments/ procedures
Changes in concomitant treatments after Visit 1 are not allowed unless needed for the proper 
medical care and treatment of the subject for a specific medical condition.
After the subject is enrolled into the study, the Investigator must instruct the subject to notify 
the study site about:

Any new medications 

Alterations in dose or dose schedules for current medications, 

Any medical procedure or hospitalization that occurred or is planned

Any non-drug therapies (including physical therapy and blood transfusions). 
The Investigator must document this information in the subject’s case history source 
documents.
10STUDY PROCEDURES AND ASSESSMENTS
Subjects will wear each study product in a daily wear, daily disposable modality for 
7 ± 2 days per study product, with up to 4 scheduled visits. Per Inclusion Criteria #5, subjects 
are willing to wear the study lenses each day as possible (including the day of the follow-up 
visits) and at least 8 hours per day unless contact lens wear is contraindicated.

Visit 1 – Baseline/ Fitting

Visit 2 – Dispense Study Product 1 [0 - 7 days from Visit 1]

Visit 3 – 1-Week Follow-up Study Product 1 [7 ± 2 days from Visit 2] / Dispense 
Study Product 2

Visit 4 – 1-Week Follow-up Study Product 2 [7 ± 2 days from Visit 3] / Exit
The following assessments will be performed for each study product:

Distance VA with study lenses (logMAR, 
, OU) 
 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 38 of 59
 
 
.
Subjects will also be asked to complete the following series of questionnaires related to their 
lens wearing experiences with each study product:

Subjective ratings as related to 
 vision,
 
10.1 Informed Consent and Screening
The Investigator or delegate must explain the purpose and nature of the study, and have the 
subject read, sign, and date the IRB/IEC-approved informed consent document. The subject 
must sign the ICF BEFORE any study-specific procedures or assessments can be performed, 
including study-specific screening procedures. Additionally, have the individual obtaining 
consent from the subject and a witness, if applicable, sign and date the informed consent 
document. 
The Investigator or delegate must provide a copy of the signed document to the subject and 
place the original signed document in the subject’s chart, or provide documentation as 
required by local regulations.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 39 of 59
10.2 Description of Study Procedures and Assessments
Detailed descriptions of assessments and procedures are provided in the MOP. The 
Investigator is responsible for ensuring responsibilities for all procedures and assessments are 
delegated to appropriately qualified site personnel.
10.2.1 Demographics
Obtain demographic information including age, race, ethnicity, and sex.
10.2.2 Medical History
Collect medical history information, 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. Throughout the subject’s participation, obtain information on any 
changes in medical health and/or the use of concomitant medications.
10.2.3 Investigational Product compliance
Review subject compliance with the IP usage and adjunct product usage and collect all used 
and unused study IPs and other products that were dispensed.
10.2.4 Adverse Event Collection: Safety Assessment
Assess and record any adverse events that are observed or reported, including those 
associated with changes in concomitant medication dosing since the previous visit.
10.2.5 Biomicroscopy: Safety Assessment
SLE of the cornea, iris/anterior chamber and lens must be performed in both eyes before 
instillation of any diagnostic eye drops.
10.2.6 Device Deficiencies: Safety Assessment
Assess and record any Device Deficiencies that are reported or observed since the previous 
visit. Requirements for reporting device deficiencies in the study can be found in Section 11. 
 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 40 of 59
 
 
10.3 Unscheduled Visits
If a subject visit occurs between any regularly scheduled visits, this visit must be documented 
as an Unscheduled Visit. During all unscheduled visits, the Investigator must conduct the 
following procedures: 

Collect Adverse Event information

Record changes in medical condition or concomitant medication

Biomicroscopy
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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 41 of 59
If during an Unscheduled Visit the subject is discontinuing the IP or discontinuing from the 
study, the Investigator must conduct Early Exit procedures according to Table 3-1 Schedule 
of Study Procedures and Assessments and Section 10.4.3, as possible.
10.4 Discontinued Subjects
10.4.1 Screen Failures
Subjects who were excluded from the study after signing the informed consent, not meeting 
inclusion/exclusion criteria, and prior to randomization to product/dispense (exposure) of 
study product will be considered a screen failure.
The Investigator must document the reason for screen failure in the subject’s case history 
source documents.
Subject numbers must not be re-used.
10.4.2 Discontinuations
Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the 
study by the Investigator after signing the informed consent, including screen failures.
Subject numbers of discontinued subjects must not be re-used.
Subjects may discontinue from study or study treatment at any time for any reason. Subjects 
may also be discontinued from study treatment at any time if, in the opinion of the 
Investigator, continued treatment poses a risk to their health.
For subjects discontinuing from the study, the Investigator must complete all Early Exit 
procedures according to Table 3-1, Schedule of Study Procedures and Assessments, if the 
subject is willing and able, and if, in the opinion of the Investigator it is safe for the subject to 
do so.
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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 42 of 59
10.4.3 Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product 
Other than screen failures, if a subject discontinues from the study the subject should undergo 
an Early Exit Visit. Refer to Table 3-1, Schedule of Study Procedures and assessments.
10.5 Clinical Study Termination
The Study Sponsor reserves the right to close the investigational site or terminate the study in 
its entirety at any time.
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. 

The Investigator must:
o
Promptly notify the IRB/IEC 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 the site’s participation in the study for reasonable cause.
10.5.1 Follow-up of subjects after study participation has ended
Following this study, the subject will return to their eye care professional for their routine eye 
care.
11ADVERSE EVENTS AND DEVICE DEFICIENCIES
11.1 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 article). Refer to the 
Glossary of Terms and figures below for categories of AEs and SAEs.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 43 of 59
Figure 11–1
Categorization of All Adverse Events
Figure 11-2
Categorization of All Serious Adverse
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:
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 44 of 59

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 timepoints

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 
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 device-related, non-sight threatening adverse event 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 Adverse Event:

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 
that persists for 2 or more weeks
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 45 of 59

Neovascularization score greater than or equal to Grade 2 (Refer to MOP for grading 
scales)
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.
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
11.2 Monitoring for Adverse Events
At the study 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 enrolling in the study?”

“Have there been any changes in the medicines you take since enrolling in the study?”
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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 46 of 59
11.3 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.
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.
For each recorded event, the ADEs and SAEs documentation must include: date of 
occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness 
and causality. In addition, the Investigator must document all device deficiencies reported or 
observed with test and control articles on the Device Deficiency eCRF. The site must submit 
all available information on ADEs, SAEs, and device deficiencies to the Study Sponsor 
immediately as follows:

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 to 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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 47 of 59
Study Sponsor representatives may be contacted for any protocol related question and their 
contact information is provided in the Manual of Procedures that accompanies this protocol.
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.
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 is 
upgraded from non-serious to serious or from unrelated to related.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 48 of 59
11.4 Return product analysis
Study Sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol.
When study products include Alcon marketed products (ie, DACP) such products associated 
with device deficiencies and/or product related AEs [ie, ADE or SADE] 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, as 
applicable. These products should be returned to the Sponsor at the end of the study, unless 
instructed otherwise by the Sponsor. Investigational product (ie, DACP Digital) associated 
with device deficiencies and/or product related AEs [ie, ADE or SADE] will also be returned 
for investigation as detailed in the MOP.
11.5 Unmasking of the Study Treatment
Masked information on the identity of the assigned study product should not be disclosed 
during the study (See Section 9.4). If the treatment code needs to be broken in the interest of 
subject safety, the Investigator is encouraged to contact an appropriate Study Sponsor 
representative prior to unmasking the information if there is sufficient time. Dependent upon 
the individual circumstances (ie, medical emergency), the code may be broken prior to 
contact with the Study Sponsor. The Study Sponsor must be informed of all cases in which 
the code was broken and of the circumstances involved. Additionally, the Study Sponsor may 
be required to unmask the information in order to fulfill expedited regulatory reporting 
requirements.
11.6 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 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 49 of 59
this time period will be considered and processed as spontaneous (following the post-market 
vigilance procedures) and should be communicated to the medical device’s manufacturer as 
per local requirements.
The Investigator should also report complaints on non-Alcon products directly to the 
manufacturer as per the manufacturer’s instructions or local regulatory requirements.
11.7 Pregnancy in the Clinical Study
Women who are pregnant at the time of study entry are excluded from participation. If any 
pregnancy is reported during the study, it should be included in the Medical History section 
of the eCRF. Pregnancy is not reportable as an AE; however, complications may be 
reportable and will be decided on a case–by-case basis.
12ANALYSIS PLAN
Continuous variables will be summarized using the number of observations, mean, standard 
deviation (SD), median, minimum and maximum, as well as confidence intervals (CIs) or 
confidence limits where applicable. Categorical variables will be summarized with counts 
and percentages from each category. Any deviations to the 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.
12.1 Subject Evaluability
Final subject evaluability must be determined prior to breaking the code for masked lens 
sequence assignment and locking the database, based upon the Deviations and Evaluability 
Plan (DEP).
12.2 Analysis Sets
12.2.1 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 in the corresponding lens sequence.
12.2.2 Full Analysis Set
The full analysis set (FAS) is the set of all randomized subjects who are exposed to any study
lenses evaluated in this study.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 50 of 59
12.2.3 Per Protocol Analysis Set
The per protocol (PP) analysis set is a subset of FAS and excludes all data/subjects which 
have met any of the critical deviation or evaluability criteria identified in the DEP.
12.3 Demographic and Baseline Characteristics
Demographic and baseline characteristics will be summarized by lens sequence and overall. 
Counts and percentages will be presented for categorical variables such as sex, age group, 
race, and ethnicity. Number of observations, mean, SD, median, minimum, and maximum 
will be presented for continuous variables such as age.
12.4 Effectiveness Analyses
This study defines 1 primary, 1 secondary, 
 effectiveness endpoints. 
All effectiveness evaluations will use the FAS as the primary analysis set.
 
 
 
12.4.1 Analysis of Primary Effectiveness Endpoint(s)
The primary objective of this study is to demonstrate noninferiority in Distance VA with 
DACP Digital when compared to DACP at the 1-Week Follow-up Visit. The primary 
endpoint is distance VA with study lenses, collected bilaterally (OU) in logMAR.
12.4.1.1 Statistical Hypotheses
The null and alternative hypotheses are formulated in terms of the predefined margin of 0.05 
for noninferiority:
H0: μ(DACP D) - μ(DACP) ≥ 0.05
Ha: μ(DACP D) - μ(DACP) < 0.05
where μ(DACP D) and μ(DACP) denote the mean distance VA (in logMAR) for DACP Digital and 
DACP, respectively.
12.4.1.2 Analysis Methods
A mixed effect repeated measures model will be utilized to test these hypotheses. The model 
will include terms for lens, visit, lens by visit interaction, period, and sequence. 
Within-subject correlation due to the crossover will also be accounted for in the model. Lens 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 51 of 59
difference (DACP Digital minus DACP) and the corresponding one-sided 95% upper 
confidence limit will be computed at 1-Week. Noninferiority in VA will be declared if upper 
confidence limit is less than 0.05.
12.4.2 Analysis of Secondary Effectiveness Endpoints
The secondary objective of this study is to demonstrate noninferiority in subjective overall 
vision with DACP Digital when compared to DACP at the 1-Week Follow-up Visit. The 
secondary endpoint is the subjective rating of overall vision on a scale of 1 (Poor) to 
10 (Excellent).
12.4.2.1 Statistical Hypotheses
The null and alternative hypotheses are formulated in terms of the predefined margin of 1.0
for noninferiority:
H0: μ(DACP D) - μ(DACP) ≤ -1.0
Ha: μ(DACP D) - μ(DACP) > -1.0
where μ(DACP D) and μ(DACP) denote the mean overall vision rating for DACP Digital and 
DACP, respectively.
12.4.2.2 Analysis Methods
A mixed effect repeated measures model will be utilized to test these hypotheses. The model 
will include terms for lens, period, and sequence. Within-subject correlation due to crossover 
will also be accounted for in the model. Lens difference (DACP Digital minus DACP) and 
the corresponding one-sided 95% lower confidence limit will be computed. Noninferiority in
overall vision will be declared if lower confidence limit is greater than -1.0.
 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 52 of 59
 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 53 of 59
 
12.5 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 for the primary and secondary effectiveness analyses.
12.6 Safety Analyses
The safety endpoints are: 

AEs

Biomicroscopy findings

Device deficiencies
There are no safety hypotheses planned in this study. The focus of the safety analysis will be 
a comprehensive descriptive assessment of occurrence of adverse events as well as the other 
listed parameters.
All AEs occurring from the time a subject signs informed consent to study exit will be 
accounted for in the reporting. Safety analyses will be conducted using the safety analysis set 
on a treatment-emergent basis. 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 nonserious 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 IP.
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 within the same period for those eyes experiencing the 
increase.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 54 of 59
Two listings for device deficiencies, prior to exposure of study lenses and 
treatment-emergent, will be provided. Additionally, each device deficiency category will be 
tabulated. 
No inferential testing will be done for safety analysis.
 
12.8 Sample Size Justification
Sample size calculation is based on a prior clinical study (M-14-010) which partly evaluated 
performance of DACP Multifocal and DACP lenses.
To demonstrate noninferiority (margin = 0.05 logMAR) as a one-tailed hypothesis with 
α=0.05, and using a standard deviation of 0.098 for paired differences, 80% power can be 
attained with a sample size of 36 (18 per sequence group).
To demonstrate noninferiority (margin = 1.0) as a one-tailed hypothesis with α=0.05, and 
using a standard deviation of 2.29 for paired differences, 80% power can be attained with a 
sample size of 48 (24 per sequence group).
13DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS
13.1 Subject Confidentiality
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 Study Sponsor will collect a copy 
of the enrollment log without any identifying subject information. All documents submitted 
to the Study Sponsor will identify the subjects exclusively by number and demographic 
information. No other personally identifying information will be transmitted to the Study 
Sponsor.
The Study Sponsor may release anonymized study data to external researchers for purposes 
of future research directly related to the study objectives, or future research that is beyond the 
scope of the current study objectives. The Informed Consent Form explains this to study 
subjects. Anonymization means that all identifiable information will be removed from the 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 55 of 59
dataset and all links to the subjects in the study will be removed. Anonymization of the data 
will maintain confidentiality of the subjects who participate in the study so that they cannot 
be identified by external researchers. The anonymized data set will contain records from all 
of the subjects in the current study, but the anonymization process might change the data set 
in some ways, so external researchers will be informed that they might not be able to 
duplicate some of the results from this study.
13.2 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 CRFs exist and are accessible for verification by the site monitor, 
and all discrepancies shall be appropriately documented via the query resolution process. Site
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 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)

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 CRF are consistent with the original source data.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 56 of 59
Only designated individuals at the site will complete the CRFs. The CRFs must be completed 
at regular intervals following the clinical study visit schedule. It is expected that all data 
reported have corresponding entries in the source documents. The Principal Investigator is 
responsible for reviewing and certifying that the CRFs are accurate and complete. The only 
subject identifiers recorded on the CRFs will be subject number, and subject demographic 
information. 
13.3 Data Review and Clarifications
A review of CRF data to the subject’s source data will be completed by the site monitor to 
ensure completeness and accuracy. After the CRFs have been completed, 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 CRF.
13.4 Sponsor and Monitoring Responsibilities
The Study Sponsor will designate a monitor to conduct the appropriate site visits at the 
appropriate intervals according to the study monitoring plan. The clinical investigation will 
be monitored to ensure that the rights and well-being of the subjects are protected, the 
reported data are accurate, complete, and verifiable from the source documents, and the study 
is conducted in compliance with the current approved protocol (and amendments[s], if 
applicable), with current GCP, and with applicable regulatory requirements.
The site may not screen subjects or perform the informed consent process on any subject until 
it receives a notification from an appropriate Study Sponsor representative that the site may 
commence conducting study activities. Monitoring will be conducted periodically while the 
clinical study is ongoing. Monitoring methods may include site visits, telephone, written and 
fax correspondence. Close-out visits will take place after the last visit of the last subject at the 
site.
A Coordinating Investigator may be identified by the Study Sponsor to review and endorse 
the final study report. In cases where a Coordinating Investigator is engaged, the Study 
Sponsor will select the Coordinating Investigator based upon their experience, qualifications, 
active study participation, and their willingness and availability to take on this role.
13.5 Regulatory Documentation and Records Retention
The Investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the Study Sponsor and the Investigator’s files will be reviewed as part of the 
ongoing study monitoring. Financial information is to be kept separately. 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 57 of 59
Additionally, the Investigator must keep study records and source documents consistent with 
the terms of the clinical study agreement with the Study Sponsor. If the Investigator retires, 
relocates, or for any other reason withdraws from responsibility of keeping the study records, 
then the Study Sponsor must be notified and suitable arrangements made for retention of 
study records and source documents needed to comply with national and international 
regulations.
13.6 Quality Assurance and Quality Control
The Study Sponsor will secure agreement from all involved parties to ensure direct access to 
all study related sites, source data and documents, and reports for the purpose of monitoring 
and auditing by the Study Sponsor, and inspection by domestic and foreign regulatory 
authorities. Quality control will be applied to each stage of data handling to ensure that all 
data are reliable and have been processed correctly. Agreements made by the Study Sponsor 
with the Investigator/Institution and any other parties involved in the clinical study will be 
provided in writing as part of the protocol or as a separate agreement.
14ETHICS
This clinical study must be conducted in accordance with the ethical principles contained 
within: 

The Declaration of Helsinki, and in compliance with the ICH E6 GCP Consolidated 
Guideline, ISO 14155:2011, and the applicable US FDA 21 CFR Regulations. 

SOPs of the Study Sponsor and contract research organizations participating in the 
conduct of the clinical study and all other applicable regulations. 

Notifications and timelines for reporting protocol deviations should be based upon
applicable Ethics Committee requirements
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. Use of waivers to deviate from the clinical protocol is prohibited.
Before clinical study initiation, this protocol, the informed consent form, any other written 
information given to subjects, and any advertisements planned for subject recruitment must 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 58 of 59
be approved by an IRB/IEC. The Investigator must provide documentation of the IRB/IEC 
approval to the Study Sponsor. The approval must be dated and must identify the applicable 
protocol, amendments (if any), informed consent form, assent form (if any), all applicable 
recruiting materials, written information for subject, and subject compensation programs. The 
IRB/IEC must be provided with a copy of the Clinical IB, package insert of DACP, any 
periodic safety updates, and all other information as required by local regulation and/or the 
IRB/IEC. At the end of the study, the Investigator must notify the IRB/IEC about the study’s 
completion. The IRB/IEC also must be notified if the study is terminated prematurely. 
Finally, the Investigator must report to the IRB/IEC on the progress of the study at intervals 
stipulated by the IRB/IEC.
Voluntary informed consent must be obtained in writing from every subject and the process 
shall be documented before any procedure specific to the clinical investigation is applied to 
the subject. The Investigator must have a defined process for obtaining consent. Specifically, 
the Investigator, or their 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 and the study, 
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 (file in 
subject’s medical records) and must provide a duplicate copy to each subject according to 
local regulations. 
The Study Sponsor assures that the key design elements of this protocol will be registered on 
www.clinicaltrials.gov as required by current regulations and, if applicable, other public 
databases as required by local country regulations. In addition, results of this study will be 
made publicly available on www.clinicaltrials.gov regardless of outcome as required by 
current regulations and, if applicable, in other public databases as required by local country 
regulations.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

Page 59 of 59
15REFERENCES
15.1 References applicable for all clinical studies

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
15.1.1 US references applicable for clinical studies

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
15.2 References for this clinical study
Not applicable. There are no references.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018

                                                                                                                
                                                                                     
Date/Time 
(mm/dd/yyyy GMT):
Signed by:
Justification:
biostatistics
Global Device Medical Safety
Clinical Project Lead & SME
07/16/2018 20:49:20
07/16/2018 19:00:03
07/14/2018 03:58:10
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0055077
Protocol - Clinical
16-Jul-2018