Clinical Performance of Two Commercial, Daily Disposable Contact Lenses
Phase: NA
Conditions: Refractive Errors, Ametropia, Myopia
Sponsor: Alcon Research



Document ID: 
V-CLN-0010987 
Status: Approved, Version: 5.0 
Approved Date: 26 Aug 2021 
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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 Practices; applicable 
international and national regulations, laws, guidelines, and standards; the conditions of 
approval imposed by the reviewing IRB or regulatory authority; and in accordance with 
the ethical medical research principles outlined in the Declaration of Helsinki.  
• 
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: 
Phone Number:  
Off-hours Emergency 
Phone Number: 
 
 
 

Document ID: 
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Table of Contents 
Device Protocol for CLU484-P002 ........................................................................................... 1 
Table of Contents ....................................................................................................................... 3 
List of Tables .............................................................................................................................. 5 
List of Figures ............................................................................................................................ 6 
1 
GLOSSARY OF TERMS .................................................................................................... 7 
2 
LIST OF ACRONYMS AND ABBREVIATIONS ........................................................... 14 
3 
PROTOCOL SUMMARY ................................................................................................. 15 
4 
PROTOCOL AMENDMENTS ......................................................................................... 22 
5 
INTRODUCTION ............................................................................................................. 23 
5.1 
Rationale and Background ................................................................................. 23 
5.2 
Purpose of the Study .......................................................................................... 23 
5.3 
Risks and Benefits ............................................................................................. 24 
6 
STUDY OBJECTIVES...................................................................................................... 24 
6.1 
Primary Objective(s) .......................................................................................... 24 
6.2 
Secondary Objective(s) ...................................................................................... 25 
 
 
6.4 
Safety Objective(s) ............................................................................................ 25 
7 
INVESTIGATIONAL PLAN ............................................................................................ 26 
7.1 
Study Design...................................................................................................... 26 
7.2 
Rationale for Study Design................................................................................ 27 
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations ........................................................................................ 27 
7.3 
Rationale for Duration of Treatment/Follow-Up ............................................... 27 
7.4 
Rationale for Choice of Comparator Product .................................................... 27 
7.5 
Data Monitoring Committee .............................................................................. 28 
8 
STUDY POPULATION .................................................................................................... 28 
8.1 
Inclusion Criteria ............................................................................................... 28 
8.2 
Exclusion Criteria .............................................................................................. 29 
8.3 
Rescreening of Subjects ..................................................................................... 30 
9 
TREATMENTS ADMINISTERED................................................................................... 30 

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9.1 
Investigational Product(s) .................................................................................. 30 
9.2 
Other Medical Device or Medication Specified for Use During the Study ....... 34 
9.3 
Treatment Assignment / Randomization ........................................................... 34 
9.4 
Treatment masking ............................................................................................ 35 
9.5 
Accountability Procedures ................................................................................. 37 
9.6 
Changes to concomitant medications, treatments/ procedures .......................... 37 
10 STUDY PROCEDURES AND ASSESSMENTS ............................................................. 38 
10.1 Informed Consent and Screening ...................................................................... 38 
10.2 Description of Study Procedures and Assessments ........................................... 38 
10.2.1 
Demographics .................................................................................... 38 
10.2.2 
Medical History ................................................................................. 38 
10.2.3 
Investigational Product compliance .................................................. 39 
10.2.4 
Adverse Event Collection: Safety Assessment .................................. 39 
10.2.5 
Slit Lamp Biomicroscopy: Safety Assessment .................................. 39 
10.2.6 
Device Deficiencies: Safety Assessment ........................................... 39 
10.3 Unscheduled Visits ............................................................................................ 39 
10.4 Discontinued Subjects ....................................................................................... 40 
10.4.1 
Screen Failures .................................................................................. 40 
10.4.2 
Discontinuations ................................................................................ 40 
10.4.3 
Schedule of Procedures and Assessments for Subjects 
Discontinued from Investigational Product ....................................... 40 
10.5 Clinical Study Termination ................................................................................ 41 
10.5.1 
Follow-up of subjects after study participation has ended ................ 41 
 
 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 42 
11.1 General Information .......................................................................................... 42 
11.2 Monitoring for Adverse Events ......................................................................... 44 
11.3 Procedures for Recording and Reporting .......................................................... 45 
11.4 Return product analysis (if applicable) .............................................................. 47 
11.5 Unmasking of the Study Treatment ................................................................... 47 
11.6 Follow-Up of Subjects with Adverse Events ..................................................... 47 
11.7 Pregnancy in the Clinical Study ........................................................................ 48 
12 ANALYSIS PLAN ............................................................................................................ 48 
12.1 Subject Evaluability ........................................................................................... 48 

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12.2 Analysis Sets...................................................................................................... 48 
12.2.1 
Safety Analysis Set ............................................................................ 48 
12.2.2 
Full Analysis Set ................................................................................ 49 
 
 
12.3 Demographic and Baseline Characteristics ....................................................... 49 
12.4 Effectiveness Analyses ...................................................................................... 49 
12.4.1 
Analysis of Primary Effectiveness Endpoint(s)................................. 49 
12.4.1.1 
Statistical Hypotheses ........................................................ 50 
12.4.1.2 
Analysis Methods............................................................... 50 
 
 
 
 
 
 
12.5 Handling of Missing Data .................................................................................. 53 
12.6 Safety Analyses.................................................................................................. 53 
12.7 Interim Analyses and Reporting ........................................................................ 54 
12.8 Sample Size Justification ................................................................................... 54 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 55 
13.1 Subject Confidentiality ...................................................................................... 55 
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 .......................................... 57 
13.6 Quality Assurance and Quality Control ............................................................. 57 
14 ETHICS ............................................................................................................................. 58 
15 REFERENCES .................................................................................................................. 59 
15.1 Regulations and Standards................................................................................. 59 
15.2 Scientific and Other References ........................................................................ 60 
 
 
 
 
List of Tables 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol ........................... 14 

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Table 3–1 
Schedule of Study Procedures and Assessments ............................................. 20 
Table 6–1 
Primary Objective(s) ........................................................................................ 24 
 
 
Table 6–3 
Safety Objective(s)........................................................................................... 25 
Table 9–1 
Test Product ..................................................................................................... 30 
Table 9–2 
Comparator Product ......................................................................................... 32 
 
 
 
List of Figures 
Figure 11-1 
Categorization of All Adverse Events .............................................................. 42 
Figure 11-2 
Categorization of All Serious Adverse Events ................................................. 42 
 
 
 

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1 GLOSSARY OF TERMS 
Names of test product(s) 
Throughout this document, test product(s) will be referred to 
as: DAILIES TOTAL1® contact lenses (DT1). 
Name of Comparator 
Product(s) 
Throughout this document, comparator product(s) will be 
referred to as: BAUSCH+LOMB INFUSE ™ contact lenses 
(Infuse) 
Adverse Device Effect 
(ADE) 
 
Adverse event related to the use of an investigational 
medical device or comparator.  
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.  
Adverse Event (AE) 
 
Untoward medical occurrence, unintended disease or injury, 
or untoward clinical signs (including abnormal laboratory 
findings) in subjects, users or other persons, whether or not 
related to the investigational medical device or comparator 
and whether anticipated or unanticipated.  
Note: For subjects, this definition includes events related to 
the investigational medical device, comparator, or the 
procedures involved. For users or other persons, this 
definition is restricted to the use of   investigational medical 
device or comparator. 
Requirements for reporting Adverse Events in the study can 
be found in Section 11. 
Anticipated Serious 
Adverse Device Effect 
(ASADE) 
 
An effect which by its nature, incidence, severity, or 
outcome has been identified in the risk assessment. 

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Approved Date: 26 Aug 2021 
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Clinical Investigation Plan 
(CIP) 
 
The document(s) stating the rationale, objectives, design, 
and prespecified analysis, methodology, organization, 
monitoring, conduct, and record-keeping of the clinical 
investigation.  
Note: The protocol and other documents referenced in the 
protocol (for example, the Statistical Analysis Plan, the 
Manual of Procedures, the Deviations and Evaluability 
Plan, and the Protocol Monitoring Plan) comprise the CIP. 
Clinical Investigation 
Report (CIR) / Clinical 
Study Report 
The document describing the design, execution, statistical 
analysis, and results of a clinical investigation. The Clinical 
Investigation Report is synonymous with the Clinical Study 
Report. 
Device Deficiency 
 
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, usability, safety, or 
performance.  
Note: This definition includes malfunctions, use errors, and 
inadequacy in the information supplied by the manufacturer 
including labelling related to the investigational medical 
device or the comparator. 
Requirements for reporting Device Deficiencies in the study 
can be found in Section 11. 
Enrolled Subject 
Any subject who signs an informed consent form for 
participation in the study. 
Point of Enrollment 
The time at which, following recruitment and before any 
clinical investigation-related procedures are undertaken, a 
subject signs and dates the informed consent form. 

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Interventional Clinical Trial  A pre- or postmarket clinical investigation where the 
assignment of a subject to a particular medical device is 
decided in advance by a clinical investigation plan, or 
diagnostic or monitoring procedures requested in the CIP are 
in addition to those available as normal clinical practice and 
burden the subject. 
Investigational Product 
A preventative (vaccine), a therapeutic (drug or biologic), 
device, diagnostic, or palliative used as a test or comparator 
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 an investigational medical device to perform in 
accordance with its intended purpose when used in 
accordance with the instructions for use or clinical 
investigation plan (CIP), or investigator’s brochure (IB). 
Noninterventional Study 
 
Clinical investigation that draws inferences about the 
possible effect of an intervention on subjects, but the 
investigator has not assigned subjects into intervention 
groups based on a protocol and has not made any attempts to 
collect data on variables beyond those available throughout 
the course of normal clinical practice and burden to the 
subject. 
NOTE: The term “noninterventional” is synonymous with 
“observational.” 
Nonserious Adverse Event 
Adverse event that does not meet the criteria for a serious 
adverse event. 

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Postmarketing / 
Postauthorization 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 noninterventional study and may also 
fall within the definition of a postapproval study. 
Product Complaint 
 
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 Subject 
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. 

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Serious Adverse Event 
(SAE) 
 
Adverse event that led to any of the following:  
• Death. 
• A serious deterioration in the health of the subject, users 
or other persons as defined by one or more of the 
following:  
a) a life-threatening illness or injury   
Note: Life-threatening means that the individual was 
at immediate risk of death from the event as it 
occurred, i.e., it does not include an event which 
hypothetically might have caused death had it 
occurred in a more severe form. 
b) any potentially sight-threatening event or permanent 
impairment to a body structure or a body function 
including chronic diseases. 
c) inpatient hospitalization or prolonged 
hospitalization. 
 
d) a medical or surgical intervention to prevent a) or b).  
e) any indirect harm as a consequence of incorrect 
diagnostic test results when used within 
manufacturer’s instructions for use. 
• Fetal distress, fetal death, congenital abnormality or 
birth defect including physical or mental impairment. 
Note: Planned hospitalization for a preexisting condition, or 
a procedure required by the CIP, without serious 
deterioration in health, is not considered a serious adverse 
event.  
Refer to Section 11 for additional SAEs. 

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Serious Health Threat 
 
Signal from any adverse event or device deficiency that 
indicates an imminent risk of death or a serious deterioration 
in the health in subjects, users, or other persons, and that 
requires prompt remedial action for other subjects, users, or 
other persons. 
Note: This would include events that are of significant and 
unexpected nature such that they become alarming as a 
potential serious health hazard or possibility of multiple 
deaths occurring at short intervals.  
Study Start 
The start of the study is considered to coincide with the 
enrollment of the first patient.  
Study Completion 
The completion of the study is considered to coincide with 
the study-level last subject last visit or the decision to 
terminate the trial, whichever is later. 
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 
assessment.  
Use Error 
 
User action or lack of user action while using the medical 
device that leads to a different result than that intended by 
the manufacturer or expected by the user.  
Note: 
a) Use error includes the inability of the user to 
complete a task. 
b) Use errors can result from a mismatch between the 
characteristics of the user, user interface, task, or 
use environment. 
c) Users might be aware or unaware that a use error 
has occurred. 
d) An unexpected physiological response of the patient 
is not by itself considered a use error. 
e) A malfunction of a medical device that causes an 
unexpected result is not considered a use error.” 

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Vulnerable Subject 
 
An individual who is unable to fully understand all aspects 
of the investigation that are relevant to the decision to 
participate, or who could be manipulated or unduly 
influenced as a result of a compromised position, 
expectation of benefits or fear of retaliatory response. 
 
 
 

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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 
BCVA 
Best corrected visual acuity 
CFR 
Code of Federal Regulations 
CIP 
Clinical Investigation Plan 
CIR 
Clinical Investigation Report 
CRF 
Case report form 
CTT 
Clinical Trial Team 
D 
Diopter 
DEP 
Deviations and evaluability plan 
DFU 
Directions for use 
DT1 
DAILIES TOTAL1® contact lenses 
eCRF 
Electronic case report form 
EDC 
Electronic Data Capture 
GCP 
Good Clinical Practice 
IB 
Investigator’s brochure 
ICF 
Informed consent form 
Infuse 
BAUSCH+LOMB INFUSE ™ contact lenses  
IP 
Investigational product 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
LID 
Lens Identification Number 
LogMAR 
Logarithm of the minimum angle of resolution 
mm 
Millimeter 
MOP 
Manual of procedures 
N/A 
Not applicable 
NI 
Noninferiority 
PI 
Principal investigator 
SD 
Standard deviation 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SLE 
Slit lamp examination 
SOP 
Standard operating procedure 
T2B 
Top-2-Box 
US 
United States 
VA 
Visual acuity 
VAS 
Visual Analog Scale 
 
 

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3 PROTOCOL SUMMARY 
Investigational 
product type 
Device 
Study type 
Interventional 
Investigational 
products 
Test Product: DT1 contact lenses  
Comparator Product: Infuse contact lenses 
Purpose and 
Scientific Rationale 
for the Study 
To compare the clinical performance of DT1 contact lenses with 
Infuse contact lenses 
 
  
 
 
 
Objective(s) 
The primary objective of this study is to demonstrate 
noninferiority (NI) in visual acuity (VA) at distance when wearing 
DT1 contact lenses compared to Infuse contact lenses.  
 
 
 
 
Endpoint(s)  
 
Primary Effectiveness  
• 
Distance VA (logMAR) with study lenses 
  
 
  
 
 
 
 
 
 
 
 
 

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Safety 
• 
Adverse events 
• 
Biomicroscopy findings 
• 
Device deficiencies 
Assessment(s)  
Effectiveness 
• 
Distance VA (logMAR) with habitual correction  
• 
Manifest refraction and BCVA with manifest refraction 
• 
Distance visual acuity (LogMAR) with study lenses 
 
 
 
  
 
  

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Safety 
• 
Biomicroscopy 
• 
Adverse Events 
• 
Device deficiencies 
Study Design 
This will be a prospective, randomized, 
 
, controlled, double-masked, crossover, daily 
wear clinical study. Subject participation in the study will be 
approximately 3 weeks with 16-22 days of lens wear. 
DT1 (Test): 8 (-0/+3) days 
Infuse (Comparator): 8 (-0/+3) days 
 
 
 
 
 
  
Subject population 
Planned number of subjects enrolled/consented: ~110 
Planned number of completed subjects: 100 
Sites and Locations 
Planned number of clinical sites: ~ 8  
Planned locations (initial list of locations, which may change 
during start up or conduct according to study needs): United States 

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Key inclusion 
criteria 
(See Section 8.1 for a 
complete list of 
inclusion criteria) 
• 
Habitual soft contact lens wearers in both eyes, aged 18 or over 
who have at least 3 months of contact lens wearing experience, 
and who wear their habitual lenses at least 5 days per week and 
at least 10 hours per day. 
• 
To qualify, subjects must have a manifest refraction of ≤ 0.75 
D in each eye, and a BCVA (with manifest refraction) better 
than or equal to 20/25 (Snellen) or 0.10 (logMAR) in each eye 
Key exclusion 
criteria 
(See Section 8.2 for a 
complete list of 
exclusion criteria) 
• 
Current/previous DT1 and Infuse habitual lens wearers and any 
monovision & multifocal lens wearers. 
• 
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. 
Data analysis and 
sample size 
justification 
Planned Data Analysis 
To address the primary and key exploratory effectiveness 
objectives, planned analyses are summarized below: 
Endpoint 
Comparison 
Statistical Method 
Primary 
Distance VA 
DT1 vs Infuse 
Noninferiority 
Mixed effect repeated 
measures  
NI margin = 0.05 (logMAR) 

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Visit 
Visit 1 
Screening/Baseline/ 
Dispense Lens 1 
 
 
 
Visit 2 
Week 1 Follow-
up Lens 1 / 
Dispense Lens 2 
Visit 3 
Week 1 
Follow-up 
Lens 2 / Exit 
Early Exit 
Unscheduled Visit  
 
 
 
 
 
 
 
 
8 (-0/+3) days after 
Visit 1 
 
 
 
 
 
 
 
8 (-0/+3) days 
after Visit 2 
N/A 
N/A 
AEs 
X 
X 
X 
X 
X 
Device Deficiencies 
X 
X 
X 
X 
X 
Exit Form 
(X) 
(X) 
X 
X 
(X) 
(X) assessment performed as necessary, e.g., decrease of VA by 2 lines or more with investigational product (IP) 
 
 
  
 
   
 
 
 
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.  

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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. 
  
5 INTRODUCTION 
5.1 Rationale and Background 
It is estimated that soft contact lenses account for over 90% of lens fits. Moreover, almost 
32% of soft contact lenses were prescribed in a daily disposable modality.  DT1 contact 
lenses were introduced as a unique dual technology that combines a low water content 
silicone hydrogel core, to achieve optimal oxygen supply, with a high water content hydrogel 
surface to provide a highly lubricious, wettable lens.  Previous studies support the hypothesis 
that Water Gradient Technology in DT1 lenses produces superior clinical performance and 
subjective acceptance. 
5.2 Purpose of the Study 
The purpose of this study is to evaluate the overall clinical performance of DT1contact lenses 
when compared to another commercially available daily disposable contact lens, Infuse. 
 
 
 The design of this study is justified based upon 
preclinical and clinical testing, as described within the package insert. Infuse contact lenses 
were chosen as the comparator product because these lenses have the same wear modality. 
At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards. 
 
 
 
 
 
 
 
 

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5.3 Risks and Benefits 
The clinical investigation process risks are managed through appropriate training and 
monitoring according to the protocol-specific monitoring plan. Investigational device risks, 
including risks associated with use of device and methods and procedures for application of 
device, are defined in the product labeling and are managed through review of safety 
assessments outlined in this protocol.  
Contact lenses may offer improved peripheral vision and the convenience of not wearing 
spectacles. Material properties and design characteristics of the contact lens in development 
are features consistent with successful contact lens wear. 
The test products are for daily wear use under a daily disposable wear modality; further 
details on any known potential risks and benefits can be found in the package insert. The test 
products are not intended for use with a cleaning/disinfecting solution, and the 
biocompatibility with lens care solutions and any associated clinical effects are unknown. 
A summary of the known potential risks and benefits associated with the DT1 and Infuse 
contact lenses can be found in the package insert. Risks are minimized by compliance with 
the eligibility criteria and study procedures, and through close supervision by a licensed 
clinician during exposure to the study lenses 
  
6 STUDY OBJECTIVES 
6.1 Primary Objective(s) 
Table 6–1 
Primary Objective(s) 
Objective(s) 
Endpoint(s) 
 
 
Demonstrate noninferiority in the VA at 
distance when wearing DT1 contact lenses 
compared to Infuse contact lenses. 
 
Distance VA (logMAR) with study lenses 
 
 
 

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6.2 Secondary Objective(s) 
Not Applicable 
6.4 Safety Objective(s)  
Table 6–3 
Safety Objective(s) 
Objective(s) 
Endpoint(s) 

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7.2 Rationale for Study Design  
This study design is justified based upon an evaluation of the results of relevant preclinical 
and clinical testing, as described within the package inserts.  
The crossover design will ensure that the same subject is exposed to both the test and 
comparator lens materials; 
 
 study will include only those 
subjects who are current wearers of spherical soft contact lenses in both eyes with at least 3 
months wearing experience, with a minimum wearing time of 5 days per week and 10 hours 
per day. 
 
Furthermore, the subjects will not be permitted to use lubrication/rewetting drops during the 
duration of the study as this may confound the primary effectiveness endpoint. The study will 
exclude any habitual DT1and Infuse contact lens wearers in the past 3 months prior to 
consent in order to reduce potential bias of wearers to their habitual contact lenses. The study 
will also exclude subjects who wish to wear their contact lenses in monovision modality 
during the study and multifocal lens wearers. 
 
 
 
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations 
An interim analysis will not be performed. 
7.3 Rationale for Duration of Treatment/Follow-Up 
Subjects will wear each study product bilaterally for approximately 1 week.
 
 
 The primary 
 
will be assessed on approximately after 1 week of wearing each study product
 
 
. 
7.4 Rationale for Choice of Comparator Product 
B+L Infuse spherical, daily disposable contact lenses were chosen as the comparator product 
because these lenses have the same wear modality and replacement schedule 

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7.5 Data Monitoring Committee 
• 
Not Applicable 
8 STUDY POPULATION 
The study population consists of male and female subjects (18 years or older) with a 
diagnosis of refractive ametropia (myopia and hyperopia)It is aimed to enroll (consent) 
approximately 110 subjects in approximately 8 sites throughout the United States, with a 
target of 100 total subjects completed, with 13 (intended minimum) to 14 (maximum) 
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; however, 
unanticipated circumstances may shorten or lengthen this time and would not require 
amendment of this protocol. Because a 10% screening failure rate is expected, approximately 
110 subjects are expected to be enrolled.  
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 
 Subject must be at least 18 years of age. 
2 
Subject must be able to understand and must sign an ICF that has been approved by 
an IRB. 
3 
Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 
days per week and 10 hours per day during the past 3 months. 
4 
 Manifest cylinder ≤ 0.75 D in each eye. 
5 
BCVA (with manifest refraction) better than or equal to 0.10 (logMAR) in each eye. 
 
 
 
 
 
 
 

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8.2 Exclusion Criteria 
Subjects fulfilling any of the following criteria are not eligible for participation in this study. 
1 
 Current/previous DT1and Infuse habitual lens wearers and any monovision & 
multifocal lens wearers. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
11 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. 

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8.3 Rescreening of Subjects 
Rescreening of subjects is not allowed in this study. 
9 TREATMENTS ADMINISTERED 
9.1 Investigational Product(s) 
Test Product(s): 
DAILIES TOTAL1 contact lenses  
 
Comparator Product(s) (If 
applicable): 
Infuse contact lenses  
 
Table 9–1 
Test Product 
Test Product 
DAILIES TOTAL1 contact lenses (DT1) 
 
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 use of this contact lens is for vision correction. 

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Product description 
and parameters 
available for this 
study 
• Material: delefilcon A 
• Water content: 33%  
• Power range: -1.00 to -6.00 D,  0.25 D steps 
• Base curve (mm): 8.5 
• Diameter (mm): 14.1 
Formulation 
Refer to package insert 
Usage 
• Wear: 
o Daily Wear 
o Bilateral 
• Replacement period: Daily Disposable 
• Exposure: Approximately 10 hours per day, every day over an 
8-11 day period 
 
 
 
 
• Lens Care: N/A 
Number/Amount of 
product to be 
provided to the 
subject 
At the dispense visit, sites will ensure that subjects are given 
adequate lenses to last until the next planned study visit, allowing 
for planned and unplanned lens replacements.  
Packaging 
description 
Blister foil pack 
Labeling description Lens Foil label includes: 
• lens identifier 
• base curve 
• diameter 
• packing solution 
• power 
• lot number 
• expiration date 
 
 
• content statement 
• investigational device statement 
• sponsor information 

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• country of origin 
• Provided in packages  of approximately 12 lenses per power, 
identified with the following: 
- 
a color coded label stating the protocol number 
- 
lens identifier 
- 
power 
- 
an investigational use only statement 
- 
tracking number 
Storage conditions 
Lenses should be stored at room temperature 
Additional 
information 
N/A  
Supply 
• Fitting sets will be provided by the sponsor before the start of 
the study to be used during Visit 1. Fitting sets will include 
sphere powers ranging from -1.00 to -6.00D, in -0.25D steps.  
• Small inventories of each power will be provided for dispense to 
subjects at Visit 1.  If needed, additional IP can be ordered and 
provided upon request. 
Refer to the MOP for a detailed description 
 
Table 9–2 
Comparator Product 
Comparator 
Product(s) 
Infuse contact lenses (Infuse) 
 
Manufacturer 
 Bausch + Lomb 
Indication for Use 
 The intended use of this contact lens is for vision correction 
Product description 
and parameters 
available for this 
study 
• Material: kalifilcon A 
• Water content:  45% 
• Power range:  -1.00 to  -6.00 D,  in 0.25 D  steps 
• Base curve (mm):  8.6 
• Diameter (mm):  14.2 
Formulation 
Refer to package insert 
Usage 
• Wear: 

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o
Daily Wear
o
Bilateral
•
Replacement period: Daily Disposable
•
Exposure: Approximately 10 hours per day, every day over an
8-11 day period
•
Lens Care: N/A
Number/Amount of 
Product to be 
Provided to the 
subject 
At the dispense visit, sites will ensure that subjects are given 
adequate lenses to last until the next planned study visit, allowing 
for planned and unplanned lens replacements. 
Packaging 
description 
Blister foil pack 
Labeling description Lenses have investigational labeling, which includes: lens identifier 
•
base curve
•
diameter
•
packing solution
•
power
•
lot number
•
expiration date
•
content statement
•
investigational device statement
•
Sponsor information
•
country of origin
•
Provided in packages of approximately 12  lenses per power,
identified with the following:
-
a color coded label stating the protocol number
-
lens identifier
-
power
-
an investigational use only statement

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-
tracking number
Storage conditions 
Lenses should be stored at room temperature 
Additional 
identifying 
information 
 N/A 
Supply 
•
Fitting sets will be supplied in packages of 12 per power,
ranging from -1.00 to -6.00D, in -0.25D steps.
•
Small inventories of each power will be provided for dispense to
subjects at Visit 1.  If needed, additional IP can be provided
upon request.
Refer to the MOP for a detailed description 
More information on the test product can be found in the 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 manner to 
receive one of 2 lens sequences:  
Sequence 
EDC/randomization 
integration system 
Lens Name 
Sequence 1 
 
DT1/Infuse 
Sequence 2 
 
Infuse/DT1 
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 (lens sequence) to randomization numbers in the specified ratio. 

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Subjects will be assigned treatment (lens sequence) according to the randomization list 
uploaded in the randomization 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/randomization integration 
system to one of the treatments (lens sequences). The investigator’s 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/randomization 
integration system will inform the site user of the treatment (lens sequence) assignment to be 
dispensed to the subject. 
9.4 Treatment masking 
This study is double-masked. All members associated with the study (at the site and the study 
sponsor) are masked to the assigned treatment 
 

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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. 
 
 
  
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.  

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9.5 Accountability Procedures 
Upon receipt of the IPs, the investigator or delegate must conduct an inventory. 
 
 
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. 
The investigator should make every effort to collect unused lenses, foils, and supplies from 
subjects. 
It is the investigator’s responsibility to ensure that: 
• 
All study products are accounted for and not used in any unauthorized manner 
• 
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 (i.e., 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 nondrug therapies (including physical therapy and blood transfusions).  

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The investigator must document this information in the subject’s case history source 
documents. 
 
10 STUDY PROCEDURES AND ASSESSMENTS 
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. 
Medical History and Concomitant Medications will be collected in the eCRF as outlined in 
the MOP.  

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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 since the previous visit, 
including those associated with changes in concomitant medication dosing. 
10.2.5 Slit Lamp 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. 
10.3 Unscheduled Visits 
If a subject visit occurs between any regularly scheduled visit and the visit is conducted by 
study personnel, this visit must be documented as an Unscheduled Visit. If the subject seeks 
medical attention outside the clinic (for example, at an Emergency Room) or at the clinic but 
is seen by nonstudy personnel, the investigator is to capture adverse event-related information 
on the Adverse Event form upon becoming aware. 
During all unscheduled visits, the investigator must conduct the following procedures:  
• 
Collect Adverse Event information 
• 
Record changes in medical condition or concomitant medication 
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. 

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10.4 Discontinued Subjects 
10.4.1 Screen Failures 
Subjects who were excluded from the study after signing the informed consent and prior to 
randomization to product/dispense of study product. 
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. 
Subject numbers of discontinued subjects must not be re-used (i.e., subject replacement is not 
allowed). 
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 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  
Other than screen failures, if a subject discontinues from the study, the subject should 
undergo an Early Exit Visit. Refer to Table 3–1 

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10.5 Clinical Study Termination 
The study sponsor reserves the right to suspend or close the investigational site or suspend 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 poststudy 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. 

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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 product). Refer to the 
Glossary of Terms and figures below for categories of AEs and SAEs. 
Figure 11-1 
Categorization of All Adverse Events 
 
 
ADE
Device /
procedure-
related?
Meets 
seriousness 
criteria?
SAE
All AEs
AE
No
No
Yes
Yes
 
 
Figure 11-2 
Categorization of All Serious Adverse Events 
 

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All SAEs
Device /
procedure 
related?
SAE
SADE
No
Yes
 
 
Specific Events Relevant to this Protocol 
Serious Adverse Events 
In addition to reporting all AEs (serious and nonserious) meeting the definitions, the 
investigator must report any occurrence of the following as an SAE: 
• 
An ocular infection including a presumed infectious ulcer with any of the following 
characteristics:  
o Central or paracentral location 
o Penetration of Bowman’s membrane 
o Infiltrates > 2 mm diameter 
o Iritis 
o Increase in intraocular pressure 
o Culture positive for microorganisms 
o Increasing size or severity at subsequent visits 
• 
Any central or paracentral corneal event (such as neovascularization) that results in 
permanent opacification 
• 
Hypopyon 

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• 
Hyphema 
• 
Neovascularization within the central 6 mm of the cornea 
• 
Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment 
visit that fails to resolve 
• 
Uveitis (anterior, intermediate, or posterior) 
• 
Corneal abrasion affecting ≥ 50% of corneal surface area 
 
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 (i.e., 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 (e.g., incorrect lens power/diameter/base 
curve/color) 
• 
Lens/solution cloudy 
• 
Lens surface/edge defect 
• 
Torn lens during handling/in pack 
• 
Packaging deficit (e.g., mislabeled product, tampered seal, leaking bottle/container) 
• 
Suspect product contamination 
• 
Lack of performance 
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 shown 
below and report as applicable: 
• 
“Have you had any health problems since your last study visit?” 
• 
“Have there been any changes in the medicines you take because of a new health issue 
since your last study visit?” 

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In addition, 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 preexisting medical conditions or 
signs/symptoms present in a subject prior to the start of the study (i.e., 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 comparator products 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: 
• 
All SAEs must be reported immediately (within 24 hours) of the investigator’s or site’s 
awareness. 
• 
ADEs that do not meet seriousness criteria and device deficiencies must be reported 
within 10 calendar days 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 eCRF and 
Adverse Device Effect(for related AEs) eCRF. 

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Note: Should the EDC system become nonoperational, the site must complete the appropriate 
paper Serious Adverse Event and Adverse Device Effect and/or Device Deficiency Form. The 
completed form is emailed to the study sponsor at msus.safety@alcon.com for US 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. 
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. 
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. 

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Not Related  An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (i.e., 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 nonserious to serious or from unrelated to related. 
11.4 Return product analysis (if applicable) 
Study sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol.  
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). 
11.5 Unmasking of the Study Treatment 
Masked information on the identity of the assigned medical device should not be disclosed 
during the study. 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 (i.e. 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 (i.e., database lock).  

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All complaints received after 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 (i.e., Infuse contact 
lenses) 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 .An Alcon form will be utilized to 
capture all pregnancy- related information until birth of the child. 
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 
frequencies 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 
(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 

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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. 
 
 
 
12.3 Demographic and Baseline Characteristics 
Demographic information will be summarized by lens sequence and overall. Frequencies 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, 
 
 will use the FAS as the primary analysis set. 
 
 
  
The primary effectiveness 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 DT1 contact lenses compared to Infuse contact lenses. The primary endpoint is 
distance VA with study lenses, collected for each eye in logMAR. 

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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 DT1 and Infuse, 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, period, and sequence as fixed effects. Within-subject correlation 
due to eye and the crossover design will also be accounted for in the model. Lens difference 
(DT1 minus Infuse) 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.  

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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 (frequencies and percentages) for 
ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities 
Preferred Terms. AEs leading to study discontinuation 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 applicable 
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.  
Two listings for device deficiencies, prior to exposure to study contact lenses and treatment-
emergent, will be provided. Additionally, each device deficiency category will be tabulated.  
No inferential testing will be conducted for the safety analyses. 

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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 
 which evaluated 
performance of DT1 and Infuse. 
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 0.0497 for paired 
differences, 80% power can be attained with a sample size of 8 (4 per sequence).  

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13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS 
13.1 Subject Confidentiality 
The investigator must ensure that the subject’s identity is kept confidential 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. The study sponsor may collect a copy of the enrollment log without 
any directly identifying subject information.  
The study sponsor may share patient-level data collected in this trial with qualified 
researchers to help facilitate product development or enhancements in research that is not 
directly related to the study objectives. The Informed Consent explains this to the study 
subject.  
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: 

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• 
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. 
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 select principal investigators that are qualified by education, training, 
and experience to assume responsibility for the proper conduct of this clinical trial.  

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The study sponsor is financially funding this clinical trial and will compensate the 
investigator and/or the Institution(s) at which the study is conducted in accordance with a 
signed clinical trial agreement. 
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.  
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 

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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 
Investigations are conducted in compliance with Good Clinical Practices; international and 
national regulations, laws and guidelines; the conditions of approval imposed by reviewing 
IRBs/IECs or regulatory authorities; and in accordance with the ethical medical research 
principles outlined in the Declaration of Helsinki.  
• 
The SOPs of the study sponsor and contract research organizations participating in the 
conduct of the clinical study and all other applicable regulations shall apply.  
• 
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 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. 

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Voluntary informed consent must be obtained in writing from every subject. The obtaining of 
consent 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 the required 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 if 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 if required by 
current regulations and, if applicable, in other public databases as required by local country 
regulations. 
15 REFERENCES 
15.1 Regulations and Standards 
The following references may be applicable in whole or in part for this clinical trial. 
• 
ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products - 
Guidance for clinical investigations 
• 
EN ISO 14155:2020 - Clinical investigation - Investigation of medical devices - Medical 
Devices for human subjects - Human Subjects - Good Clinical Practice 

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• 
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 
15.2 Scientific and Other References 
Not applicable. There are no references. 

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