Clinical Comparison of DDT2 Contact Lens and a Daily Disposable Contact Lens - Study 1
Phase: NA
Conditions: Refractive Error, Myopia
Sponsor: Alcon Research

Page 1 of 55
Title
Clinical Comparison of DDT2 Contact Lens and a Daily Disposable 
Contact Lens- Study 1
Protocol Number:
Development Stage of 
Project:
Sponsor Name and 
Address:
CLE383-C007/NCT03888469 
Product Support
Alcon Research,
and its affiliates (“Alcon”)
6201 South Freeway
Fort Worth, Texas 76134-2099
Test Product:
DDT2 (Verofilcon A) contact lens
Property of Alcon 
Confidential
May not be used, divulged, published, or otherwise disclosed without the consent of 
Alcon 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 2 of 55
Investigator Agreement:

I have read the clinical study described herein, recognize its confidentiality, and 
agree to conduct the described trial in compliance with Good Clinical Practice 
(GCP), the ethical principles contained within the Declaration of Helsinki, this 
protocol, all applicable regulatory authority regulations, and conditions of approval 
imposed by the reviewing IRB or regulatory authority.

I will supervise all testing of the device involving human subjects and ensure that 
the requirements relating to obtaining informed consent and IRB review and 
approval are met in accordance with applicable local and governmental regulations.

I have read and understand the appropriate use of the investigational product(s) as 
described in the protocol, current Investigator’s Brochure, product information, or 
other sources provided by the Sponsor.

I understand the potential risks and side effects of the investigational product(s).

I agree to maintain adequate and accurate records in accordance with government 
regulations and to make those records available for inspection.

I agree to comply with all other requirements regarding the obligations of clinical 
Investigators and all other pertinent requirements of the Sponsor and government 
agencies.

I agree to ensure that all associates, colleagues, and employees assisting in the 
conduct of the study are informed of their obligations in meeting the above 
commitments.
Have you ever been disqualified as an Investigator by any Regulatory Authority?
No        Yes
Have you ever been involved in a study or other research that was terminated?
No        Yes
If yes, please explain here:
Principal Investigator:
Signature
Date
Name and professional 
position:
Address:
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 3 of 55
Table of Contents
Table of Contents .......................................................................................................................3
List of Tables..............................................................................................................................5
List of Figures............................................................................................................................6
1
GLOSSARY OF TERMS ....................................................................................................7
2
LIST OF ACRONYMS AND ABBREVIATIONS ...........................................................12
3
PROTOCOL SUMMARY.................................................................................................14
4
PROTOCOL AMENDMENTS .........................................................................................22
4.1
Amendments......................................................................................................22
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
6.4
Safety Objective(s)............................................................................................25
7
INVESTIGATIONAL PLAN ............................................................................................25
7.1
Study Design .....................................................................................................25
7.2
Rationale for Study Design ...............................................................................25
7.3
Rationale for Duration of Treatment/Follow-Up...............................................26
7.4
Rationale for Choice of Control Product...........................................................26
7.5
Data Monitoring Committee..............................................................................26
8
STUDY POPULATION ....................................................................................................26
8.1
Inclusion Criteria...............................................................................................27
8.2
Exclusion Criteria..............................................................................................27
8.3
Rescreening of Subjects ....................................................................................28
9
TREATMENTS ADMINISTERED...................................................................................29
9.1
Investigational Product(s)..................................................................................29
9.2
Other Medical Device or Medication Specified for Use During the Study ......32
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 4 of 55
9.3
Treatment Assignment / Randomization ...........................................................32
9.4
Treatment masking ............................................................................................32
9.5
Accountability Procedures.................................................................................34
9.6
Changes to concomitant medications, treatments/ procedures..........................35
10 STUDY PROCEDURES AND ASSESSMENTS.............................................................35
10.1
Informed Consent and Screening ......................................................................36
10.2
Description of Study Procedures and Assessments...........................................36
10.2.1
Demographics....................................................................................36
10.2.2
Medical History.................................................................................36
10.2.3
Investigational Product Compliance..................................................36
10.2.4
AE Collection: Safety Assessment ....................................................37
10.2.5
Slit-Lamp Biomicroscopy: Safety and Effectiveness Assessment ....37
10.2.6
Device Deficiencies: Safety Assessment...........................................37
10.3
Unscheduled Visits ............................................................................................37
10.4
Discontinued Subjects .......................................................................................38
10.4.1
Screen Failures ..................................................................................38
10.4.2
Discontinuations................................................................................38
10.4.3
Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product .............................................................38
10.5
Clinical Study Termination................................................................................39
10.5.1
Follow-up of subjects after study participation has ended ................39
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................39
11.1
General Information ..........................................................................................39
11.2
Monitoring for Adverse Events .........................................................................41
11.3
Procedures for Recording and Reporting ..........................................................41
11.4
Return Product Analysis....................................................................................43
11.4.1
Alcon Marketed Product....................................................................43
11.4.2
Non-Alcon Marketed Product ...........................................................43
11.5
Unmasking of the Study Treatment...................................................................43
11.6
Follow-Up of Subjects with Adverse Events.....................................................44
11.7
Pregnancy in the Clinical Study........................................................................44
12 ANALYSIS PLAN ............................................................................................................44
12.1
Subject Evaluability...........................................................................................45
12.2
Analysis Sets .....................................................................................................45
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 5 of 55
12.2.1
Safety Analysis Set............................................................................45
12.2.2
Full Analysis Set................................................................................45
12.2.3
Per Protocol Analysis Set ..................................................................45
12.3
Demographic and Baseline Characteristics.......................................................45
12.4
Effectiveness Analyses ......................................................................................45
12.4.1
Analysis of Primary Effectiveness Endpoint(s).................................46
12.4.1.1
Statistical Hypotheses........................................................46
12.4.1.2
Analysis Methods ..............................................................46
12.5
Handling of Missing Data .................................................................................49
12.6
Safety Analyses .................................................................................................49
12.7
Interim Analyses and Reporting........................................................................50
12.8
Sample Size Justification...................................................................................50
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................51
13.1
Subject Confidentiality......................................................................................51
13.2
Completion of Source Documents and Case Report Forms..............................51
13.3
Data Review and Clarifications.........................................................................52
13.4
Sponsor and Monitoring Responsibilities .........................................................52
13.5
Regulatory Documentation and Records Retention ..........................................53
13.6
Quality Assurance and Quality Control.............................................................53
14 ETHICS .............................................................................................................................53
15 REFERENCES ..................................................................................................................55
15.1
References applicable for all clinical studies ....................................................55
15.1.1
US references applicable for clinical studies.....................................55
15.2
References for this clinical study ......................................................................55
List of Tables
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol ...........................12
Table 3–1
Schedule of Study Procedures and Assessments .............................................20
Table 6–1
Primary Objective(s)........................................................................................24
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 6 of 55
Table 6–3
Safety Objective(s)...........................................................................................25
Table 9–1
Test Product .....................................................................................................29
Table 9–2
Control Product................................................................................................30
Table 9–3
Unmasked Individuals Associated with the Study...........................................33
List of Figures
Figure 7–1
Study Design....................................................................................................25
Figure 11–1
Categorization of All AEs................................................................................40
Figure 11-2
Categorization of All Serious AEs...................................................................40
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 7 of 55
1
GLOSSARY OF TERMS
Names of test product(s)
Throughout this document, test product(s) will be referred to 
as: DDT2.
Name of Control Product(s)
1-DAY ACUVUE® MOIST Contact Lenses (Acuvue Moist 
or Moist)
Adverse Device Effect
(ADE)
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 (AE)
Any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal 
laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device 
(test product). Note: For subjects, this definition includes 
events related to the test product, the control product, or the 
procedures involved. For users or other persons, this 
definition is restricted to events related to the test product.
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
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 8 of 55
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.
Performance specifications include all claims made in the 
labeling of the device. The intended performance of the 
device refers to the intended use for which the device is 
labeled or marketed.
Non-serious Adverse Event
Adverse event that does not meet the criteria for a serious 
adverse event.
Postmarketing/Post-
authorization study
Any study conducted within the conditions laid down in 
product labelling and other conditions laid down for the 
marketing of the product or under normal conditions of use. 
A postmarketing study falls either within the definitions of 
an interventional or a non-interventional study and may also 
fall within the definition of a post-approval study.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 9 of 55
Product Complaints
Any oral, electronic, or written communication that alleges 
deficiencies related to the identity (labeling), quality, 
durability, reliability, safety, effectiveness, or performance 
of a marketed product, including failure of the product, 
labeling or packaging to meet specifications, whether or not 
the product is related to or caused the alleged deficiency. A 
complaint may allege that an adverse event or medical 
device malfunction has occurred.
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.
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.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 10 of 55
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.
Refer to Section 11 for additional SAEs.
Serious Public Health 
Threat
Any event type which results in imminent risk of death, 
serious deterioration in state of health, or serious illness that 
requires prompt remedial action. This would include: Events 
that are of significant and unexpected nature such that they 
become alarming as a potential public health hazard, eg, 
human immunodeficiency virus (HIV) or Bird Flu.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 11 of 55
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
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
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 12 of 55
2
LIST OF ACRONYMS AND ABBREVIATIONS
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol
Abbreviation
Definition
Acuvue Moist or 
Moist
1-DAY ACUVUE MOIST Contact Lenses
ADE
Adverse device effect
AE
Adverse event
BCVA
Best corrected visual acuity
CFR
Code of Federal Regulations
CI
Confidence interval
COL
Clinical Operations Lead
CRF
Case report form
CSM
Clinical Site Manager
D
Diopter(s)
D/C
Discontinue
DDT2
Daily Disposable T2 Contact Lenses
DEP
Deviations and evaluability plan
DT1
DAILIES TOTAL1 Contact Lenses
eCRF
Electronic case report form
EDC
Electronic data capture
EOD
End of day
FAS
Full analysis set
FDA
US Food and Drug Administration
GCP
Good Clinical Practice
GPCMS
Global Product Complaint Management System
HIV
Human immunodeficiency virus
IB
Investigator’s Brochure
ICF
Informed consent form
ICH
International Council for Harmonization 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 for Standardization
logMAR
Logarithm of the minimum angle of resolution
mm
Millimeter
MOP
Manual of procedures
n
Number
N/A
Not applicable
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 13 of 55
Abbreviation
Definition
NI
Noninferiority
OD
Right eye
OS
Left eye
PP
Per protocol analysis set
SAE
Serious adverse event
SADE
Serious adverse device effect
SD
Standard deviation
US
United States
VA
Visual acuity
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 14 of 55
3
PROTOCOL SUMMARY
Investigational 
product type
Device
Study type
Interventional
Investigational 
products
Test Product: DDT2 Contact Lens (Verofilcon A) 
Control Product: 1-Day ACUVUE MOIST (Acuvue Moist or 
Moist) Contact Lens (etafilcon A)
Purpose and 
rationale
The rationale for this study is to compare the objective and 
subjective performance of DDT2 lenses to Acuvue Moist lenses.
Objective(s)
The primary objective of this study is to demonstrate 
noninferiority in the visual acuity (VA) at distance (distance VA) 
when wearing DDT2 contact lenses compared to Acuvue Moist 
contact lenses. 
 
 
 
 
Endpoint(s)
Primary Effectiveness

Distance VA (OD, OS; logMAR)
 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 15 of 55
 
 
 
 
 
Safety

AEs

Biomicroscopy findings

Device deficiencies
Assessment(s) 
Effectiveness

Distance VA (OD, OS; logMAR)
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 16 of 55
 
 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 17 of 55
 
Safety

AEs

Biomicroscopy

Device deficiencies
Study Design
This is a prospective, randomized, crossover, double masked study 
comparing visual acuity with DDT2 contact lenses vs. Acuvue 
Moist contact lenses.
Subjects will be expected to attend 3 study visits and wear study 
lenses for approximately 14 – 20 days (7 – 10 days for each study 
lens).
Subject population
Volunteer subjects aged 18 or over who are spherical soft contact 
lens wearers (excluding current/previous Moist and DAILIES 
TOTAL1® (DT1) lens wearers), and for the last 3 months have 
worn their habitual lenses at least 5 days per week and at least 8 
hours per day in daily wear modality.
Planned number of subjects enrolled/consented: ~ 92
Planned number of completed subjects: 82
Key inclusion 
criteria
(See Section 8.1 for a 
complete list of 
inclusion criteria)
Current wearers of spherical soft contact lens who are 18 years of 
age or older.
Key exclusion 
criteria
(See Section 8.2 for a 
complete list of 
exclusion criteria)
Previous or current habitual wearers of Acuvue Moist or DT1, or 
wear habitual contact lenses in an extended wear fashion.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 18 of 55
Data analysis and 
sample size 
justification
Planned Analysis
To address the primary 
 
objective , planned analyses are summarized below:
Endpoint
Comparison
Statistical Method
Primary
Distance VA 
DDT2 vs Moist
Noninferiority
Mixed effect repeated 
measures 
NI margin = 0.05 (logMAR)
 
 
 
 
 
 
Sample Size Justification
Sample size calculations for distance VA 
 
 at 80% power, are summarized below:
Endpoint
Assumptions
Type I 
error
N
Primary
Distance VA
SD (paired difference) = 0.068
NI margin = 0.05
One-sided 
0.05
14
 
 
 
 
 
 
 
 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 19 of 55
 
 
Key words
Visual acuity, VA, daily disposable contact lenses
Associated materials
There are no associated materials with this study. Lubrication/re-
wetting drops will not be permitted.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 22 of 55
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.
4.1
Amendments
There are no amendments. This is the first version of the protocol.
5
INTRODUCTION
5.1
Rationale and Background
A recent paper has demonstrated that soft contact lenses continue to dominate contact lens 
prescribing and in the year 2018, soft contact lenses accounted for over 90% of lens fits. 
(Morgan 2019). Furthermore, it was reported that almost 32% of soft contact lenses were 
prescribed in a daily disposable modality. DDT2 is a new daily disposable silicone hydrogel 
contact lens with a material that combines high oxygen transmissibility with a low modulus 
of elasticity. The lens was recently approved by the FDA and will be marketed as 
Precision1™ (verofilcon A) Soft Contact Lenses. 
The rationale for this study is the need to compare the objective and subjective performance 
of the new DDT2 lenses to an already marketed daily disposable contact lens (Acuvue 
Moist).
The primary endpoint for this study was selected to fulfill the primary objective. Procedures 
for measurement of these endpoints were selected based on common practice for these 
assessments. The design of this study is justified based upon previous preclinical and clinical 
testing, as described within the package insert. Moist contact lenses were chosen as the 
control product because these lenses have the same wear modality.
5.2
Purpose of the Study
The primary objective of this study is to demonstrate noninferiority in distance VA when 
wearing DDT2 contact lenses compared to Moist contact lenses. 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 23 of 55
 
 
 
At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards.
The results from this study may be submitted as an abstract to be presented at conferences or 
as a manuscript to a journal if the data generated are of scientific interest.
5.3
Risks and Benefits
Contact lenses have several benefits in that they may offer improved peripheral vision and the 
added convenience of not wearing spectacles. Material properties and design characteristics 
of DDT2 contact lens are features consistent with successful contact lens wear. Based upon 
the pre-clinical and existing clinical data, DDT2 is known to be non-toxic and biocompatible 
for on-eye use. 
Acuvue Moist lenses are intended and marketed for daily wear use under a daily disposable 
wear modality; further details on any known potential risks and benefits can be found in the 
package insert. 
Neither the DDT2 nor the Acuvue Moist contact lenses are intended for use with a 
cleaning/disinfecting solution, and the biocompatibility with lens care solutions and any 
associated clinical effects are unknown. 
A summary of the known potential risks and benefits associated with DDT2 can be found in 
the package insert. Risks are minimized by compliance with the eligibility criteria and study 
procedures, and through close supervision by a licensed clinician during exposure to the 
study lenses. The potential harms associated with on-eye exposure to the new lens materials 
include toxicity response, blurred vision, and ocular discomfort. In general, the risks 
associated with the wear of DDT2 are anticipated to be similar to other marketed daily 
disposable soft contact lenses.
There may also be unknown risks to use of DDT2 contact lenses. Any risk to subjects in this 
clinical study will be minimized by compliance with the eligibility criteria and study 
procedures, clinical oversight and monitoring.
The site personnel will educate subjects on proper hygiene and lens handling, and compliance 
with the use of contact lenses according to the protocol. Subjects should be instructed not to 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 26 of 55
for distance correction in both eyes during the past 3 months for a minimum of 5 days per 
week and 8 hours per day. This will avoid confounding subjective and safety responses in 
non-adapted subjects. Moreover, the subjects will not be permitted to use artificial 
tears/rewetting drops during the course of the study as this may confound the primary 
effectiveness variable. The study will exclude any habitual wearers of Moist or DT1 in order 
to reduce potential bias of wearers to their habitual contact lenses.  This study will also 
exclude subjects who for the last 3 months have worn contact lenses in an extended wear 
modality.  This study aims to compare the performance of two daily disposable contact 
lenses, therefore, subjects wearing lenses in an extended wear modality will be excluded as 
extended wear modality is known to impact the ocular physiology.
7.3
Rationale for Duration of Treatment/Follow-Up
Subjects will wear the lenses in a daily disposable wear modality for 8 -1/+2 days. The lenses 
will be provided by a qualified unmasked study staff member in such a manner that the 
subject and the Investigator remain masked to the lens type. As both the lenses are daily 
disposable lenses, they will be prescribed to be used in a daily disposable modality. The 
subjects will be asked to wear the lenses for at least 7 days, therefore, they are likely to have 
adapted to the lens material prior to collecting objective and subjective measurements.
7.4
Rationale for Choice of Control Product
Both DDT2 and Acuvue Moist are soft contact lenses and are to be prescribed for single use, 
daily disposable wear. Acuvue Moist contact lenses are indicated for the optical correction of 
refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased 
eyes. The lenses are not intended to be cleaned or disinfected and should be discarded after a 
single use.
7.5
Data Monitoring Committee
Not applicable.
8
STUDY POPULATION
The study population consists of male and female subjects age 18 years or older who are 
wearers of soft daily contact lenses. Subjects who wear contact lenses in extended wear 
modality or are previous or current wearers of Acuvue Moist or DT1 contact lenses will be 
excluded. The study aims to enroll approximately 92 subjects at approximately 5 sites in the 
US, with a target of 82 completed subjects. Site-specific targets may vary based upon 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 27 of 55
individual site capabilities. Estimated time needed to recruit subjects for the study is 
approximately 6 weeks.
8.1
Inclusion Criteria
Written informed consent must be obtained before any study specific assessment is 
performed. Upon signing informed consent, the subject will be considered as enrolled in the 
study.
Subjects eligible for inclusion in this study must fulfill all of the following criteria:
1.
Subject must be at least 18 years of age.
2.
Subject must be able to understand and must sign an ICF that has been approved by 
an IRB.
3.
Willing and able to attend all scheduled study visits as required per protocol.
4.
Successful wear of spherical soft contact lenses for distance correction in both eyes 
during the past 3 months for a minimum of 5 days per week and 8 hours per day.
5.
Manifest cylinder of ≤ 0.75 D in each eye.
6.
Best corrected VA of 20/25 or better in each eye.
7.
Able to wear contact lenses within a range of sphere power from -1.00 to -6.00 D 
(0.25 D steps) and VA of 20/25 or better in each eye with fitting set lenses.
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, or abnormality or disease (including 
systemic) that contraindicates contact lens wear, as determined by the Investigator.
2.
Any use of systemic or ocular medications for which contact lens wear could be 
contraindicated, as determined by the Investigator.
3.
History of ocular or intraocular surgery, including refractive surgery and/or irregular 
cornea.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 28 of 55
4.
Biomicroscopy findings at baseline that are moderate (Grade 3) or higher and/or 
corneal vascularization that is mild (Grade 2) or higher.
5.
Current or history of pathologically dry eye in either eye that, in the opinion of the 
Investigator, would preclude contact lens wear.
6.
Current or history of herpetic keratitis in either eye.
7.
Eye injury in either eye within 12 weeks immediately prior to enrollment for this 
trial.
8.
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.
9.
Any use of topical ocular medications and artificial tear or rewetting drops that 
would require instillation during contact lens wear.
10.
Previous or current habitual wearers of Acuvue Moist or DT1.
11.
History of intolerance, hypersensitivity, or allergy to any component of the study 
products.
12.
The Investigator, his/her staff, family members of the Investigator, family members 
of the Investigator’s staff, or individuals living in the households of the 
aforementioned persons may not participate in the study.
13.
Participation of the subject in a clinical trial within the previous 10 days or currently 
enrolled in any clinical trial.
Women of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. Pregnancy should be included in the Medical History section 
of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant 
during the study. Pregnancy is not reportable as an AE; however, complications may be 
reportable and will be decided on a case-by-case basis.
8.3
Rescreening of Subjects
Rescreening of subjects is not allowed in this study.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 31 of 55
available for this 
study

Power range: -1.00  to -6.00 D, 0.25 D steps

Base curve: 8.5 mm

Diameter: 14.2 mm
Formulation
Refer to the package insert
Usage
Wear:

Daily Wear

Bilateral
Replacement period: 

Daily Disposable
Exposure: 

Approximately 10 hours per day (8 - 16 hours), every day, 
over the study treatment duration (8 days -1/+2)
Lens Care: N/A
Number/Amount of 
Product to be 
Provided to the 
subject
Lenses will be provided in packages of  approximately 12 lenses per 
box per power, identified with the following:
-
a color coded label stating the protocol number
-
power
-
an investigational use only statement
-
tracking number
Packaging 
description
Blister foil pack 
Labeling description
Blister foil labels include at a minimum:
-
lens identifier
-
power
-
base curve 
-
diameter
-
lot number
-
packing solution
-
expiration date
-
content statement
-
investigational use statement
-
Sponsor information
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 32 of 55
Storage conditions
Stored at room temperature
Supply
Alcon will provide fitting set and study lenses.
More information on both lenses can be found in their respective package inserts.
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 a crossover sequence of 
DDT2 then Acuvue Moist or Acuvue Moist then DDT2, 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 sequences to randomization numbers in the specified ratio. Subjects 
will be assigned treatment sequences according to the randomization list uploaded in the IRT 
system. The randomization list will be generated and maintained by the Study Sponsor.
At Visit 1, all eligible subjects will be randomized via the EDC/IRT integration system to one 
of the treatment sequences. 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 DDT2 and Acuvue Moist in 
the assigned sequence for the duration of 2 weeks (1 week for each period). Subjects, the 
Investigator, and masked study personnel (site and Sponsor) will be masked to the assigned 
treatment sequence.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 33 of 55
Table 9–3
Unmasked Individuals Associated with the Study
Unmasked Individual
Extent of Unmasking
Rationale
Unmasked Study 
Coordinator
The Unmasked Study 
Coordinator(s) will manage 
IP inventory, as well as IP 
administration. This 
individual will have access 
to IP supply, accountability 
logs, and other documents or 
supplies pertaining to IP. 
The unmasked coordinator 
will also assist with device 
deficiency and AE 
reporting.
The Unmasked Study 
Coordinator(s) will be 
unmasked to allow for 
storage and dispensing, as 
well as accountability for all 
IP.
Clinical Operations Lead 
(COL)
The COL will have access to 
IP supply, accountability 
logs, and other documents or 
supplies pertaining to IP. 
This individual assist with 
masked and unmasked data 
reviews.
The COL will be unmasked 
to allow for oversight of the 
CSM, in conjunction with 
all IP accountability tasks.
Clinical Site Manager 
(CSM)
CSM will have access to IP 
supply, accountability logs, 
and other documents or 
supplies pertaining to IP 
accountability. This 
individual monitors 
unmasked and masked study 
data.
The CSM will be unmasked 
to allow for performance of 
IP accountability, 
management of device 
deficiencies and related AE 
lens returns, and other IP 
related tasks.
Clinical Supplies 
Coordinator
The Clinical Supplies
Coordinator will have access 
to the IP inventory, 
accountability logs and other 
documents or supplies for 
management and 
reconciliation of the IP.
The Clinical Supplies 
Coordinator will be 
unmasked to allow for 
storage, management, and 
distribution of IP inventory 
and other IP related 
products/tasks.
Unmasked Data Manager(s)
The Unmasked Data 
Manager(s) will have access 
to restricted fields in EDC 
that would contain 
unmasking data.
The Unmasked Data 
Manager(s) will be 
unmasked to allow for 
review of all restricted data.
IRT Manager
The IRT Manager will be 
unmasked to allow for 
The IRT manager is 
unmasked to all aspects of 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 34 of 55
Unmasked Individual
Extent of Unmasking
Rationale
system programming, 
testing, and to allow for 
technical oversight of the 
system.
the trial for system 
development purposes.
Randomization Specialist
The Randomization 
Specialist will be unmasked 
to allow for generation of 
the randomization list and 
uploading of that list into the 
IRT system.
Generates and therefore has 
full knowledge of treatment 
codes but otherwise is 
operationally not associated 
with the Clinical Trial Team 
or any decision-making 
aspects related to clinical 
trial design, execution, or 
reporting.
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. 
Refer to Section 11.5.
9.5
Accountability Procedures
Upon receipt of the IPs, the Investigator or delegate must conduct an inventory. During the 
study, the masked Investigator must designate unmasked staff to 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.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 35 of 55
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 AE 
(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.
The Investigator is responsible for proper disposition of all unused IPs at the conclusion of 
the study, according to the instructions provided in the MOP.
9.6
Changes to concomitant medications, treatments/ procedures
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.
10 STUDY PROCEDURES AND ASSESSMENTS
Subjects will be expected to attend 3 office visits over a period of approximately 2 weeks. 
Study lenses will be provided to the subjects to take home for daily wear during the course of 
the trial.
Study randomization will occur at Visit 1 with assigned lenses provided to take home at 
Visit 1 and Visit 2. Study contact lens fitting will occur at Visit 1 for both study lenses. If a 
subject cannot be successfully fit (either study lens) according to the study lens fitting guides 
as determined by the Investigator, they will be considered a screen failure and exited from the 
study.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 36 of 55
Study tests, procedures,
 will be conducted as outlined in the MOP. Worn 
study contact lenses will be disposed of by the subject and used lidding foils will be returned 
to the site.
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.
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 collect all used lidding foils, unused study 
IPs, and other products that were dispensed.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 37 of 55
10.2.4 AE Collection: Safety Assessment
Assess and record any AEs that are observed or reported, including those associated with 
changes in concomitant medication dosing since the previous visit.
10.2.5 Slit-Lamp Biomicroscopy: Safety and Effectiveness Assessment
A slit-lamp exam must be performed on both eyes at every visit.
10.2.6 Device Deficiencies: Safety Assessment
Assess and record any device deficiencies that are reported or observed, including those 
associated with changes in concomitant medication dosing since the previous visit.
Requirements for reporting device deficiencies in the study can be found in Section 11. 
Device deficiencies on comparator lenses should be reported per their manufacturer’s 
guidelines.
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 AE and device deficiency information

Assess and record changes in medical condition or concomitant medication

Perform biomicroscopy (assessments with or without study lenses, as applicable)

Assess and record VAs, as necessary 

Perform lens surface and fitting assessments (study lenses) as applicable
The Investigator may perform additional procedures for proper diagnosis and treatment of the 
subject. The Investigator must document this information in the subject’s case history source 
documents.
If during an Unscheduled Visit the subject is discontinuing the IP or discontinuing from the 
study, the Investigator must conduct Exit procedures according to Table 3-1 Schedule of 
Study Procedures and Assessments, as possible.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 38 of 55
10.4 Discontinued Subjects
10.4.1 Screen Failures
Screen failures are subjects who are excluded from the study after signing the informed 
consent and prior to randomization. This includes subjects who are unable to be fit for study 
lenses using the fitting guide.
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 informed consent, including screen failures.
Subject numbers of discontinued subjects must not be re-used.
Subjects may discontinue from the 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 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.
10.4.3 Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product 
Any subject discontinued from IP will be discontinued from the study and follow exit 
procedures.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 39 of 55
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.
11 ADVERSE 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
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 41 of 55
11.2 Monitoring for Adverse Events
At each visit, after the subject has had the opportunity to spontaneously mention any 
problems, the Investigator should inquire about AEs by asking the standard questions:

“Have you had any health problems since your last study visit?”

“Have there been any changes in the medicines you take since your last study visit?”
Changes in any protocol-specific parameters 
evaluated during the 
study are to be reviewed by the Investigator. Any untoward (unfavorable and unintended) 
change in a protocol-specific parameter 
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.
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. Refer to the 
MOP for additional information on product returns.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 42 of 55

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 faxed or emailed to the Study Sponsor at 1-817-
302-1927 or MSUS.safety@alcon.com according to the timelines outlined above; 
however, the reported information must be entered into the EDC system once it becomes 
operational.
Study Sponsor representatives may be contacted for any protocol related question and their 
contact information is provided in the Manual of Procedures that accompanies this protocol
(page 1).
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 on 
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.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 43 of 55
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.
11.4 Return Product Analysis
Study Sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol.
11.4.1 Alcon Marketed Product
Alcon products associated with device deficiencies and/or product related AEs should be 
returned and must include the Complaint # which will be provided by Study Sponsor after the 
case is entered in the Study Sponsor’s Global Product Complaint Management System 
(GPCMS).
11.4.2 Non-Alcon Marketed Product
When study products include non-Alcon marketed products, and such products are associated 
with device deficiencies and/or product related AEs, in the Investigator should report 
complaints directly to the manufacturer as per the manufacturer’s instructions or local 
regulatory requirements, if applicable.
11.5 Unmasking of the Study Treatment
Masked information on the identity of the assigned medical device 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 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 44 of 55
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 
this time period will be considered and processed as spontaneous (following the postmarket 
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 of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. Pregnancy should be included in the Medical History section 
of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant 
during the study. Pregnancy is not reportable as an AE; however, complications may be 
reportable and will be decided on a case-by-case basis.
12 ANALYSIS 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 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 45 of 55
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 treatment 
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, except for the lenses used at Visit 1 for the purpose of parameter 
optimization and fitting, as they are not intended for the assessment of safety. 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, except for the lenses used for optimization and fitting.
12.2.3 Per Protocol Analysis Set
The per protocol (PP) analysis set is a subset of FAS and excludes all data/subjects that 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, 
 
endpoints. 
 will use the FAS as the primary 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 46 of 55
analysis set.
 
 
 
 
The primary endpoint of distance VA will be tested at one-sided α=0.05 for noninferiority 
 
 
 
12.4.1 Analysis of Primary Effectiveness Endpoint(s)
The primary objective of this study is to demonstrate noninferiority in distance VA when 
wearing DDT2 contact lenses compared to Acuvue Moist contact lenses. The primary 
endpoint is distance VA with study lenses, collected separately for each eye 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(T) – µ(C) ≥ 0.05
Ha: µ(T) – µ(C) < 0.05
where µ(T) and µ(C) denote the mean distance VA for DDT2 and Acuvue Moist, respectively, 
on the logMAR scale.
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 eye and the crossover design will also be accounted for in the 
model. Lens difference (DDT2 minus Moist) and the corresponding one-sided 95% upper 
confidence limit will be computed. Noninferiority in distance VA will be declared if upper 
confidence limit is less than 0.05.
 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 47 of 55
 
 
 
 
 
 
 
 
 
 
 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 49 of 55
 
 
 
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 
 
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 non-serious AEs, and 
SAEs will be identified. Individual subject listings will be provided, as necessary. 
Individual subject listings will be provided for AEs that occur after signing informed consent 
but prior to exposure to 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 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 50 of 55
biomicroscopy data from all visits within the same period for those eyes experiencing the 
increase.
Two listings for device deficiencies, prior to exposure of study contact lenses and treatment-
emergent, will be provided. Additionally, each device deficiency category will be tabulated. 
No inferential testing will be done for safety analysis.
12.7 Interim Analyses and Reporting
There are no plans to conduct an interim analysis and no criteria by which the study would be 
terminated early based upon statistical determination.
12.8 Sample Size Justification
Sample size calculation is based on a prior clinical study (CLE383-C004) which evaluated 
performance of DDT2 and 3 marketed soft contact lenses, including Acuvue Moist. 
Primary Effectiveness
To demonstrate noninferiority (margin = 0.05 in logMAR; ½ line in Snellen) in distance VA 
as a one-tailed hypothesis with α=0.05, and using a standard deviation of 0.068 for paired 
differences, 80% power can be attained with a sample size of 14 (7 per sequence).
 
 
 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 51 of 55
13 DATA 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 
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
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 52 of 55

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.
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 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 53 of 55
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. 
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.
14 ETHICS
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. 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 54 of 55

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 
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 IB, Package Insert, 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 
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

Page 55 of 55
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.
15 REFERENCES
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
Morgan PB, Woods CA, Tranoudis IG, Efron N, Jones L, Aighamdi W, et al. International 
contact lens prescribing in 2018. Contact Lens Spectrum. 2019 (Jan);34:26-32.
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019

                                                                                                                
                                                                                     
Date/Time 
(mm/dd/yyyy GMT):
Signed by:
Justification:
Alcon - Business Use Only 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0056080
08-Mar-2019