Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel Contact Lens
Phase: NA
Conditions: Refractive Errors
Sponsor: Alcon Research

 
 
 
 
 
Clinical Assessment of a Daily Disposable Soft Silicone 
Hydrogel Contact Lens 
 
STUDY ID 
CLU484-P003 
 
PROTOCOL 
 
 
NCT06044948 

Document ID: 
V-CLN-0178003 
Status: Approved, Version: 1.0 
Approved Date: 28 Aug 2023 
Page 1 of 47 
 
Alcon – Business Use Only 
 
Device Protocol for CLU484-P003 
Title: Clinical Assessment of a Daily Disposable Soft Silicone Hydrogel 
Contact Lens 
Protocol Number: 
CLU484-P003 
Clinical Investigation 
Type:  
Postmarket Interventional / Confirmatory 
Test Product: 
DAILIES TOTAL1® spherical soft contact lenses (DT1; 
) 
Sponsor Name and 
Address: 
Alcon Research, LLC, and its affiliates (“Alcon”) 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
 
 
 
 
 
 
 
 
 
 
Property of Alcon 
Confidential 
May not be used, divulged, published, or otherwise disclosed without the consent of Alcon 

Document ID: 
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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: 
 
 
 
 

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Table of Contents 
Device Protocol for CLU484-P003 ........................................................................................... 1 
Table of Contents ....................................................................................................................... 3 
List of Tables .............................................................................................................................. 5 
List of Figures ............................................................................................................................ 6 
1 
GLOSSARY OF TERMS .................................................................................................... 7 
2 
LIST OF ACRONYMS AND ABBREVIATIONS ........................................................... 13 
3 
PROTOCOL SUMMARY ................................................................................................. 14 
4 
PROTOCOL AMENDMENTS ......................................................................................... 19 
5 
INTRODUCTION ............................................................................................................. 20 
5.1 
Rationale and Background ................................................................................. 20 
5.2 
Purpose of the Study .......................................................................................... 20 
5.3 
Risks and Benefits ............................................................................................. 20 
6 
STUDY OBJECTIVES...................................................................................................... 21 
6.1 
Primary Objective(s) .......................................................................................... 21 
6.2 
Secondary Objective(s) ...................................................................................... 21 
 
 
6.4 
Safety Objective(s) ............................................................................................ 22 
7 
INVESTIGATIONAL PLAN ............................................................................................ 23 
7.1 
Study Design...................................................................................................... 23 
7.2 
Rationale for Study Design................................................................................ 23 
7.3 
Rationale for Duration of Treatment/Follow-Up ............................................... 23 
7.4 
Data Monitoring Committee .............................................................................. 24 
8 
STUDY POPULATION .................................................................................................... 24 
8.1 
Inclusion Criteria ............................................................................................... 24 
8.2 
Exclusion Criteria .............................................................................................. 25 
8.3 
Rescreening of Subjects ..................................................................................... 26 
9 
TREATMENTS ADMINISTERED................................................................................... 26 
9.1 
Investigational Product(s) .................................................................................. 26 
9.2 
Other Medical Device or Medication Specified for Use During the Study ....... 28 
9.3 
Treatment Assignment / Randomization ........................................................... 28 

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9.4 
Treatment masking ............................................................................................ 28 
9.5 
Accountability Procedures ................................................................................. 29 
9.6 
Changes to concomitant medications, treatments/ procedures .......................... 29 
10 STUDY PROCEDURES AND ASSESSMENTS ............................................................. 30 
10.1 Informed Consent and Screening ...................................................................... 30 
10.2 Description of Study Procedures and Assessments ........................................... 30 
10.2.1 
Demographics .................................................................................... 30 
10.2.2 
Medical History and Concomitant Medications ................................ 30 
10.2.3 
Investigational Product compliance .................................................. 31 
10.2.4 
Adverse Event Collection: Safety Assessment .................................. 31 
10.2.5 
Slit Lamp Biomicroscopy: Safety Assessment .................................. 31 
10.2.6 
Device Deficiencies: Safety Assessment ........................................... 31 
 
 
10.3 Unscheduled Visits ............................................................................................ 31 
10.4 Discontinued Subjects ....................................................................................... 32 
10.4.1 
Screen Failures .................................................................................. 32 
10.4.2 
Discontinuations ................................................................................ 32 
10.4.3 
Schedule of Procedures and Assessments for Subjects 
Discontinued from Investigational Product ....................................... 33 
10.5 Clinical Study Termination ................................................................................ 33 
10.5.1 
Follow-up of subjects after study participation has ended ................ 33 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 33 
11.1 General Information .......................................................................................... 33 
11.2 Monitoring for Adverse Events ......................................................................... 35 
11.3 Procedures for Recording and Reporting .......................................................... 35 
11.4 Return Product Analysis .................................................................................... 37 
11.5 Unmasking of the Study Treatment ................................................................... 37 
11.6 Follow-Up of Subjects with Adverse Events ..................................................... 37 
11.7 Pregnancy in the Clinical Study ........................................................................ 38 
12 ANALYSIS PLAN ............................................................................................................ 38 
12.1 Subject Evaluability ........................................................................................... 38 
12.2 Analysis Sets...................................................................................................... 38 
12.2.1 
Safety Analysis Set ............................................................................ 38 
12.2.2 
Per Protocol Analysis Set .................................................................. 39 

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12.3 Demographic and Baseline Characteristics ....................................................... 39 
12.4 Effectiveness Analyses ...................................................................................... 39 
12.4.1 
Analysis of Primary Effectiveness Endpoint(s)................................. 39 
12.4.1.1 
Statistical Hypotheses ........................................................ 39 
12.4.1.2 
Analysis Methods............................................................... 40 
 
 
 
 
 
 
12.5 Handling of Missing Data .................................................................................. 41 
12.6 Safety Analyses.................................................................................................. 41 
12.7 Interim Analyses and Reporting ........................................................................ 42 
12.8 Sample Size Justification ................................................................................... 42 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 42 
13.1 Subject Confidentiality ...................................................................................... 42 
13.2 Completion of Source Documents and Case Report Forms .............................. 43 
13.3 Data Review and Clarifications ......................................................................... 44 
13.4 Sponsor and Monitoring Responsibilities.......................................................... 44 
13.5 Regulatory Documentation and Records Retention .......................................... 44 
13.6 Quality Assurance and Quality Control ............................................................. 45 
14 ETHICS ............................................................................................................................. 45 
15 REFERENCES .................................................................................................................. 47 
15.1 Regulations and Standards................................................................................. 47 
15.2 Scientific and Other References ........................................................................ 47 
16 APPENDIX A – Protocol Amendments ............................................................................ 47 
 
List of Tables 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol ........................... 13 
Table 3–1 
Schedule of Study Procedures and Assessments ............................................. 18 
Table 6–1 
Primary Objective(s) ........................................................................................ 21 
 
 
Table 6–3 
Safety Objective(s)........................................................................................... 22 

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Table 9–1 
Test Product ..................................................................................................... 26 
 
List of Figures 
Figure 11-1 
Categorization of All Adverse Events ........................................................... 34 
Figure 11-2 
Categorization of All Serious Adverse Events ................................................. 34 
 
 
 
 

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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® spherical soft contact lenses (DT1; 
). 
Name of Comparator 
Product(s) 
N/A 
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 the investigational 
medical device or comparator. 
Requirements for reporting Adverse Events in the study can 
be found in Section 11. 

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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 CIR 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. 
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 CIP, or diagnostic or monitoring 
procedures requested in the CIP are in addition to those 
available as normal clinical practice and burden the subject. 

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Investigational Product (IP) 
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 CIP, or 
investigator’s brochure (IB). 
Nonserious Adverse Event 
Adverse event that does not meet the criteria for a serious 
adverse event. 
Postapproval Study  
 
A study required by the Food and Drug Administration or 
other health authority at the time of approval of a premarket 
approval, humanitarian device exemption, or product 
development protocol application. Postapproval studies are 
conducted to provide patients, health care professionals, the 
device industry, the Food and Drug Administration, and 
other stakeholder’s information on the continued safety and 
effectiveness (or continued probable benefit, in the case of a 
humanitarian device exemption) of approved medical 
devices. 
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. 

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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. 
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. 
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. 

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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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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 
CI 
Confidence interval 
CIP 
Clinical investigation plan 
CIR 
Clinical investigation report 
CL 
Confidence limit 
CRF 
Case report form 
D 
Diopter 
DEP 
Deviations and evaluability plan 
DT1 or DT1 soft 
contact lenses 
DAILIES TOTAL1® spherical soft contact lenses 
eCRF 
Electronic case report form 
EDC 
Electronic Data Capture 
GCP 
Good Clinical Practice 
GPCMS 
Global Product Complaint Management System 
IB 
Investigator’s brochure 
ICF 
Informed consent form 
IEC 
Independent ethics committee 
IP 
Investigational product 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
LID 
Lens Identification 
LogMAR 
Logarithm of the minimum angle of resolution 
m 
Meter 
mm 
Millimeter 
MOP 
Manual of procedures 
N/A 
Not applicable 
OD 
Right Eye 
OS 
Left Eye 
PP 
Per Protocol 
 
 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SD 
Standard deviation 
SLE 
Slit lamp examination 
SOP 
Standard operating procedure 
US 
United States 
VA 
Visual acuity 
 
 

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3 PROTOCOL SUMMARY 
Investigational 
product type 
Device 
Study type 
Interventional 
Investigational 
products 
Test Product: DAILIES TOTAL1 spherical soft contact lenses 
(DT1; 
) 
Comparator Product: N/A 
Purpose and 
Scientific Rationale 
for the Study 
The purpose of this study is to assess the clinical performance of 
DT1 soft contact lenses over approximately 1 week of daily wear. 
The primary 
 endpoints were selected 
to fulfill the primary 
 objectives of the study.  
Brief Summary of 
the Protocol 
This clinical study will evaluate the clinical performance of DT1 
soft contact lenses in habitual spherical soft contact lens wearers, 
excluding habitual wearers of the test product. 
 
 
 
 
Objective(s) 
• 
The primary objective is to evaluate distance VA of the DT1 
soft contact lenses over approximately 1 week of wear.  
• 
To describe the safety profile of the test lenses.  
Endpoint(s)  
 
Primary Effectiveness 
• 
Distance VA (Snellen) with study lenses at Week 1  

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Safety 
• 
AEs 
• 
Biomicroscopy findings 
• 
Device deficiencies 
Assessment(s)  
Effectiveness 
• 
Manifest Refraction 
• 
BCVA with Manifest Refraction (Snellen distance, OD, OS) 
• 
VA with Habitual Correction (Snellen distance, OD, OS) 
• 
Habitual Lens Brand 
• 
Power Optimization  
• 
VA with study lenses (Snellen distance, OD, OS) 

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Safety 
• 
AEs 
• 
Biomicroscopy 
• 
Device deficiencies 
Study Design 
This is a prospective, interventional, nonrandomized, single-arm, 
subject-masked, multicenter, daily wear clinical study in the US 
assessing clinical performance of DT1 soft contact lenses.  
Subjects will be expected to attend 2 visits (Visit 1 Screen/ 
Baseline/ Dispense and Visit 2 Week 1 Follow-up/ Exit). The total 
duration of a subject’s participation in the study as well as 
exposure to the IP is approximately 1 week (6-8 days of lens 
wear). Subjects will be expected to wear their study contact lenses 
each day for the typical number of hours they do with their 
habitual contact lenses. At Visit 2 Follow-up/Exit, subjects will be 
expected to have worn study lenses between 6 to 10 hours that day 
at time of Exit Visit.  
All contact lenses will be prescribed according to subject’s 
manifest refraction and prescription.  
Subject population 
Habitual spherical soft contact lens wearers aged 18 or older, with 
at least 3 months of spherical soft contact lens wearing experience, 
and who wear their habitual contact lenses for at least 5 days per 
week and at least 10 hours per day.  
Planned number of subjects enrolled/consented: approximately 96 
Planned number of completed subjects: 90 
Sites and Locations 
Planned number of clinical sites: approximately 6 
Planned locations (initial list of locations, which may change 
during start up or conduct according to study needs): US 

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Key inclusion 
criteria 
(See Section 8.1 for a 
complete list of 
inclusion criteria) 
• 
Current wearers of commercial 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. 
• 
Manifest cylinder ≤ 0.75 D in each eye 
• 
Best corrected distance VA (as determined by manifest 
refraction at screening) better than or equal to 20/25 
(Snellen) in each eye 
Key exclusion 
criteria 
(See Section 8.2 for a 
complete list of 
exclusion criteria) 
• 
Current or prior habitual DT1 soft contact lens wearers in 
the past 3 months prior to consent  
• 
Monovision contact 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 
 
 

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Refer to Appendix A for detailed description of amendments.  
5 INTRODUCTION 
5.1 Rationale and Background 
DT1 soft contact lenses are indicated for the optical correction of refractive ametropia 
(myopia and hyperopia) in phakic or aphakic persons with nondiseased eyes with up to 
approximately 1.50 diopters (D) of astigmatism that does not interfere with VA. These lenses 
are made from a lens material that is 33% water and 67% (delefilcon A) polymer, a silicone 
containing hydrogel with added phosphatidylcholine. The core lens material containing 33% 
water transitions through a water gradient to a hydrogel surface layer that exceeds 80% water.  
It is estimated that soft contact lenses account for 87% of lens fits in 2019. Moreover, almost 
45% of soft contact lenses were prescribed in a daily disposable modality. DT1 soft 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 soft contact lenses produces desirable clinical 
performance and subjective acceptance. 
5.2 Purpose of the Study 
The purpose of this study is to assess the clinical performance of DT1 soft contact lenses over 
approximately 1 week of daily wear. 
 
 The endpoints for this 
study were selected to fulfil the primary 
 objectives of the study. 
Procedures for measurement of these endpoints were selected based on common practice for 
these assessments. 
At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards. 
There are no immediate plans to submit the results of this study for publication; however, the 
results may be offered for publication if they are of scientific interest, or if the results relate to 
a product that is subsequently approved or cleared for marketing. 
5.3 Risks and Benefits 
The clinical investigation process risks are managed through appropriate training and 
monitoring according to the protocol-specific monitoring plan. Investigational device risks, 

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including risks associated with use of device and methods and procedures for application of 
device, are defined in the IB and/or 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 DT1 soft 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. 
There may also be unknown risks to use of DT1 soft contact lenses. Any risk to subjects in 
this clinical study will be minimized by compliance with the eligibility criteria, study 
procedures, and clinical oversight and monitoring. 
Refer to the product label for additional information. 
6 STUDY OBJECTIVES 
6.1 Primary Objective(s) 
Table 6–1 
Primary Objective(s) 
Objective(s) 
Endpoint(s) 
To evaluate distance VA of the DT1 soft 
contact lenses over approximately 1 week of 
wear 
Distance VA (Snellen) with study lenses at 
Week 1  
6.2 Secondary Objective(s) 
N/A 

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6.4 Safety Objective(s)  
Table 6–3 
Safety Objective(s) 
Objective(s) 
Endpoint(s) 
To describe the safety profile of the test 
lenses  
 
• 
AEs 
• 
Biomicroscopy findings 
• 
Device deficiencies 

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7 INVESTIGATIONAL PLAN 
7.1 Study Design 
This is a prospective, interventional, nonrandomized, single-arm, subject-masked, 
multicenter, daily wear clinical study in the US assessing clinical performance of DT1 soft 
contact lenses. Interim analysis will not be performed.  
The total expected duration of a subject’s participation is approximately 1 week with 
approximately 6-8 days of lens wear. Subjects will be expected to attend 2 office visits, Visit 
1 Screen/Baseline/Dispense and Visit 2 Week 1/Follow-up/Exit. 
 
 
 The study is expected to be 
completed in approximately 1 month. 
7.2 Rationale for Study Design  
 
 The 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 lens 
wear as this may confound the primary effectiveness endpoint. The study will exclude any 
current or prior habitual soft contact lens wearers who wore DT1 soft contact lenses 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 are monovision contact lens or 
multifocal contact lens wearers.   
7.3 Rationale for Duration of Treatment/Follow-Up 
The duration of use of the product is in accordance with product labeling. Subjects will wear 
study lens bilaterally for approximately 1 week in a daily disposable modality. The lenses 
will be over-labelled and provided by a qualified study staff member in such a manner that 
the subject remains masked to the lens type. The primary endpoint 
 endpoints 
will be assessed at Visit 1 Screen/ Baseline/ Dispense and Visit 2 Week 1 Follow-up/ Exit or 
Early Exit. 
 
 

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7.4 Data Monitoring Committee 
N/A 
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 96 subjects in approximately 6 sites throughout the United States, 
 
 
 Estimated time needed to 
recruit subjects for the study is approximately 3 weeks; however, unanticipated circumstances 
may shorten or lengthen this time and would not require amendment of this protocol. Because 
a 3% screening failure rate is expected, approximately 96 subjects are expected to be 
enrolled. 
Sites will be encouraged to enroll subjects that wore habitual lenses made from a variety of 
lens material (e.g., verofilcon A, senofilcon A, nesofilcon A).  
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 able to understand and sign an IRB/IEC approved ICF.  
2. 
Subject must be willing and able to attend all scheduled study visits as required per 
protocol. 
3. 
Subject must be at least 18 years of age. 
4. 
Current wearers of commercial 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. 
5. 
Manifest cylinder ≤ 0.75 D in each eye. 
6. 
Best corrected distance VA (as determined by manifest refraction at screening) 
better than or equal to 20/25 (Snellen) in each eye. 

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7. 
Able to wear contact lenses within a range of sphere power -1.00 to -6.00 D in 0.25 
D step and willing and able to wear the study lenses for the full duration of the 
study. 
8. 
Subject must be willing to stop wearing their habitual contact lenses for the duration 
of study participation. 
9.  
Subject must possess spectacles and be willing to wear habitual spectacles for 
vision correction when study lenses are not worn, as needed for the duration of 
study participation. 
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 refractive surgery or plan to have refractive surgery during the study or 
irregular cornea in either eye. 
4. 
Ocular or intraocular surgery (excluding placement of punctal plugs) within the 
previous 12 months or planned during the study. 
5. 
Biomicroscopy findings at screening that are moderate (Grade 3) or higher and/or 
corneal vascularization that is mild (Grade 2) or higher; presence of corneal 
infiltrates. 
6. 
Current or history of pathologically dry eye in either eye that, in the opinion of the 
investigator, would preclude contact lens wear. 
7. 
Current or history of herpetic keratitis in either eye. 
8. 
Eye injury in either eye within 12 weeks immediately prior to enrollment for this 
trial. 
9. 
Current or history of intolerance, hypersensitivity, or allergy to any component of the 
study product. 

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10. 
Any use of topical ocular medications, artificial tears, or rewetting drops that would 
require instillation during contact lens wear. 
12. 
Participation of the subject in a clinical trial within the previous 30 days or currently 
enrolled in any clinical trial. 
13. 
Monovision contact lens wearers. 
14. 
Current or prior habitual DT1 soft contact lens wearers in the past 3 months prior to 
consent.  
15. 
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. 
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 spherical soft contact lenses 
Comparator Product(s) (If 
applicable): 
N/A 
 
Table 9–1 
Test Product 
Test Product 
DAILIES TOTAL1 spherical soft contact lenses (DT1; 
) 
Manufacturer 
Alcon Laboratories, Inc. 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
USA 
Indication for use 
and intended 
The intended use of this product is for vision correction. 

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purpose in the 
current study  
Product description 
and parameters 
available for this 
study 
• Material: delefilcon A 
• Water content: 33% core 
• Power range: -1.00 to -6.00 D in 0.25 D step 
• 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: Typical contact lens wearing hours each day for a 
period of 6 to 8 days  
• Lens Care: N/A 
Number/Amount of 
product to be 
provided to the 
subject 
At dispense visit, sites will ensure that subjects are given adequate 
lenses to last the entire study. Spare lenses will be provided to the 
subject.   
Packaging 
description 
Blister foil pack 
Labeling description 
Lens foil label includes: 
• 
lens identifier 
• 
base curve 
• 
diameter 
• 
packing solution 
• 
power 
• 
lot number 
• 
expiration date 
• 
LID # 
• 
content statement 
• 
investigational device statement 
• 
sponsor information 
 
Lens inventory will be provided in packages and identified with the 
following: 
• a color-coded label stating the protocol number 

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• LID Number 
• power 
• an investigational use only statement 
• handling unit/tracking number 
Storage conditions 
Lens to be stored at room temperature. 
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 -6.00 D, 
in -0.25 D 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. 
 
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 
Enrolled subjects that meet the inclusion/exclusion criteria will proceed with the study and be 
dispensed study lens.  
Only after signing the ICF, a subject will be assigned a subject number by the electronic data 
capture system. 
Randomization is not applicable for this single product study.  
9.4 Treatment masking 
This study is subject-masked, with all qualified subjects receiving study product. All 
members associated with the study (at the site and the study sponsor) are unmasked to the 
assigned treatment.  

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9.5 Accountability Procedures 
Upon receipt of the IPs, the investigator or delegate must conduct an inventory. During the 
study, investigator or designated study staff must provide the IPs to the subjects. 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 AE 
(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).  
The investigator must document this information in the subject’s case history source 
documents. 

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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 
Study-specific procedures and assessments described here may include standard of care; 
other standard of care procedures performed in the clinical management of the subject are not 
excluded. 
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 and Concomitant Medications 
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. To be completed at all 
visits.  
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 
unused study IPs. 
10.2.4 Adverse Event Collection: Safety Assessment 
Assess and record any AE 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, adnexa, and anterior segment of the eye 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 AE-related information on the 
AE form upon becoming aware. 
During all unscheduled visits, the investigator must conduct the following procedures:  
• 
Collect AE information 
• 
Record changes in medical condition or concomitant medication 
• 
Collect device deficiencies information 
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. 

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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 and Section 10.4.3, as possible. 
10.4 Discontinued Subjects 
10.4.1 Screen Failures 
Subjects who were excluded from the study after signing the informed consent and prior to 
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 dispensing of study product.  
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 and Section 10.4.3, 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. 

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10.4.3 Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product  
N/A; Subjects will not be followed after discontinuation of study treatment. Subjects 
discontinued from study product will be discontinued from the study. Subject should undergo 
an Early Exit Visit.  
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. 
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. Refer to the Glossary of Terms 
and figures below for categories of AEs and SAEs. 

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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 
All SAEs
Device /
procedure 
related?
SAE
SADE
No
Yes
 
 
 

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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 
or worsening of an existing health issue since your last study visit?” 
In addition, changes in biomicroscopy findings 
 evaluated 
during the study are to be reviewed by the investigator. Any untoward (unfavorable and 
unintended) change in a biomicroscopy finding 
 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.  
Responses that are less than favorable on the grading scale should be evaluated by the 
investigator to indicate whether an AE occurred. 
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 (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 ADE and SAE documentation must include: the 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 

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within 10 calendar days of the investigator’s or site’s awareness.  
• 
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 SAE and ADE eCRF. 
 
Note: Should the EDC system become nonoperational, the site must complete the appropriate 
paper SAE and ADE and/or device deficiency form. 
 
 
 
 
Study sponsor representatives may be contacted for any protocol related question and 
their contact information is provided in the MOP 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. 
 

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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 (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 
are upgraded from nonserious 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.  
11.5 Unmasking of the Study Treatment 
Masked information on the identity of the assigned medical device should not be disclosed to 
subjects during the study (refer to Section 9.4). All members associated with the study (at the 
site and the study sponsor) are unmasked to the assigned treatment.  
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.  

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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). Any additional data received up to 3 months, 
after subject has completed the study should 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. 
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. However, pregnancy should be included in the 
corresponding eCRF if a woman becomes pregnant (as stated by the subject) 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, SD, 
median, minimum, and maximum, as well as CIs or CLs where applicable. Categorical 
variables will be summarized with frequencies and percentages from each category. 
Any deviations to this analysis plan will be updated during the course of the study as part of a 
protocol amendment or will be detailed in the clinical study report. 
12.1 Subject Evaluability 
Final subject evaluability must be determined prior to locking the database, based upon the 
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 the study lenses 
evaluated in this study. Lenses used for power optimization at Visit 1 are not considered study 
lenses in this context, as they are not used for intended study treatment. Therefore, any AE or 

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device deficiency occurring after Informed Consent and prior to the initial exposure to the 
study lenses under evaluation in this clinical protocol will be listed as pretreatment. 
12.2.2 Per Protocol Analysis Set 
The per protocol (PP) analysis set is a subset of the safety analysis set 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 
Demographics and baseline information will be summarized. Frequencies and percentages 
will be presented for categorical variables such as age group (< 40 years of age, ≥ 40 years of 
age). 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 effectiveness endpoint,
 
. All effectiveness 
evaluations will use the safety analysis set as the primary analysis set. 
12.4.1 Analysis of Primary Effectiveness Endpoint(s) 
The primary objective of this study is to evaluate distance VA of the DT1 soft contact lenses 
over approximately 1 week of wear.  
The primary endpoint is distance VA with study lenses at Week 1, collected for each eye, in 
Snellen. 
12.4.1.1 Statistical Hypotheses 
No inferences are to be made on the primary effectiveness endpoint; therefore, no hypotheses 
are formulated. 

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12.4.1.2 Analysis Methods 
Descriptive statistics will be provided as frequency and percentage for each Snellen category. 
For the converted logMAR values, descriptive statistics will be provided as number of 
observations, mean, SD, median, minimum, and maximum. 

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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 for effectiveness analyses. 
12.6 Safety Analyses 
The safety endpoints are:  
• 
AEs 
• 
Biomicroscopy findings 
• 
Device deficiencies 
There are no safety hypotheses planned in this study. The focus of the safety analysis will be 
a comprehensive descriptive assessment of occurrence of AEs as well as the other listed 
parameters.  
All AEs occurring from the time a subject signs the 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 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 will be 
presented. A supportive listing will be generated which will include all biomicroscopy data 
from all visits for those eyes experiencing the increase. 

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Two listings for device deficiencies, prior to exposure to study 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. 
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 
Although inferential testing is not planned for the primary 
 
, expected precision of the observed results is provided. With a sample size of 90 
subjects, degrees of precision achieved with the primary effectiveness endpoint 
 
 are as follows: 
Visual acuity 
With the assumed standard deviation of 0.08 
 a one-
sided 95% CI for the mean of distance VA based on t-statistics will extend 0.015 from the 
observed mean. 
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 

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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: 
• 
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.  

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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.  
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.  

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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 
Investigations are conducted in compliance with GCPs; 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 and GCPs outlined within ISO 14155.  
• 
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. The investigator is not allowed to deviate from the protocol 
except to protect the rights, safety, and well-being of human subjects under emergency 
circumstances. Emergency deviations may proceed without prior approval of the sponsor and 
the IRB/IEC, but shall be documented and reported to the sponsor and the IRB/IEC as soon 
as possible. 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 

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records. Failure to implement identified corrective and preventative actions may result in site 
closure by the sponsor. Use of waivers to deviate from the clinical protocol is prohibited. 
Before clinical study initiation, this protocol, the ICF 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), ICF, 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. Any additional requirements imposed by the ethics committee 
or regulatory authority shall be followed. 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. 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 ICF. 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.  

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The study sponsor assures that the key designs of this protocol will be registered on public 
databases where required by current regulations, and, as applicable, results will be posted.   
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 of Medical Devices for Human Subjects - 
Good Clinical Practice 
• 
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, if applicable 
15.2 Scientific and Other References 
Not applicable. There are no references. 
16 APPENDIX A – Protocol Amendments 
There are no amendments. This is the first version of the protocol.