Clinical Assessment of Two Daily Wear Reusable Soft Silicone Hydrogel Contact Lenses
Phase: NA
Conditions: Refractive Errors
Sponsor: Alcon Research



Document ID: 
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Approved Date: 02 Dec 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: 
 
 
 

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Table of Contents 
Device Protocol for CLY935-C018 ........................................................................................... 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 ................................................................................................. 15 
4 
PROTOCOL AMENDMENTS ......................................................................................... 22 
5 
INTRODUCTION ............................................................................................................. 22 
5.1 
Rationale and Background ................................................................................. 22 
5.2 
Purpose of the Study .......................................................................................... 22 
5.3 
Risks and Benefits ............................................................................................. 23 
6 
STUDY OBJECTIVES...................................................................................................... 24 
6.1 
Primary Objective(s) .......................................................................................... 24 
6.2 
Secondary Objective(s) ...................................................................................... 24 
 
 
6.4 
Safety Objective(s) ............................................................................................ 25 
7 
INVESTIGATIONAL PLAN ............................................................................................ 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 ........................................................................................ 28 
7.3 
Rationale for Duration of Treatment/Follow-Up ............................................... 28 
7.4 
Rationale for Choice of Comparator Product .................................................... 28 
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................................................................................... 31 

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9.1 
Investigational Product(s) .................................................................................. 31 
9.2 
Other Medical Device or Medication Specified for Use During the Study ....... 35 
9.3 
Treatment Assignment / Randomization ........................................................... 35 
9.4 
Treatment masking ............................................................................................ 36 
9.5 
Accountability Procedures ................................................................................. 37 
9.6 
Changes to concomitant medications, treatments/ procedures .......................... 38 
10 STUDY PROCEDURES AND ASSESSMENTS ............................................................. 38 
10.1 Informed Consent and Screening ...................................................................... 39 
10.2 Description of Study Procedures and Assessments ........................................... 39 
10.2.1 
Demographics .................................................................................... 40 
10.2.2 
Medical History and Concomitant Medications ................................ 40 
10.2.3 
Investigational Product compliance .................................................. 40 
10.2.4 
Adverse Event Collection: Safety Assessment .................................. 40 
10.2.5 
Slit Lamp Biomicroscopy: Safety Assessment .................................. 40 
10.2.6 
Device Deficiencies: Safety Assessment ........................................... 40 
10.2.7 
Additional Study Assessments .......................................................... 41 
10.3 Unscheduled Visits ............................................................................................ 41 
10.4 Discontinued Subjects ....................................................................................... 41 
10.4.1 
Screen Failures .................................................................................. 41 
10.4.2 
Discontinuations ................................................................................ 42 
10.4.3 
Schedule of Procedures and Assessments for Subjects 
Discontinued from Investigational Product ....................................... 42 
10.5 Clinical Study Termination ................................................................................ 42 
10.5.1 
Follow-up of subjects after study participation has ended ................ 43 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 43 
11.1 General Information .......................................................................................... 43 
11.2 Monitoring for Adverse Events ......................................................................... 45 
11.3 Procedures for Recording and Reporting .......................................................... 46 
11.4 Return product analysis, if applicable ............................................................... 48 
11.5 Unmasking of the Study Treatment ................................................................... 48 
11.6 Follow-Up of Subjects with Adverse Events ..................................................... 49 
11.7 Pregnancy in the Clinical Study ........................................................................ 49 
12 ANALYSIS PLAN ............................................................................................................ 49 
12.1 Subject Evaluability ........................................................................................... 50 

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12.2 Analysis Sets...................................................................................................... 50 
12.2.1 
Safety Analysis Set ............................................................................ 50 
12.3 Demographic and Baseline Characteristics ....................................................... 50 
12.4 Effectiveness Analyses ...................................................................................... 50 
12.4.1 
Analysis of Primary Effectiveness Endpoint(s)................................. 50 
12.4.1.1 
Statistical Hypotheses ........................................................ 50 
12.5 Handling of Missing Data .................................................................................. 52 
12.6 Safety Analyses.................................................................................................. 52 
12.7 Sample Size Justification ................................................................................... 53 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 53 
13.1 Subject Confidentiality ...................................................................................... 53 
13.2 Completion of Source Documents and Case Report Forms .............................. 53 
13.3 Data Review and Clarifications ......................................................................... 54 
13.4 Sponsor and Monitoring Responsibilities.......................................................... 54 
13.5 Regulatory Documentation and Records Retention .......................................... 55 
13.6 Quality Assurance and Quality Control ............................................................. 55 
14 ETHICS ............................................................................................................................. 55 
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 ............................................. 20 
Table 6–1 
Primary Objective(s) ........................................................................................ 24 
 
 

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Table 6–3 
Safety Objective(s)........................................................................................... 25 
Table 9–1 
Test Product ..................................................................................................... 31 
Table 9–2 
Comparator Product ......................................................................................... 33 
Table 9–3 
Unmasked Sponsor Members Associated with the Study................................ 36 
 
List of Figures 
 
 
Figure 11-1 
Categorization of All Adverse Events .............................................................. 43 
Figure 11-2 
Categorization of All Serious Adverse Events ................................................. 44 
 
 
 
 

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1 GLOSSARY OF TERMS 
Names of test product(s) 
Throughout this document, test product(s) will be referred to 
as TOTAL30® soft contact lenses (TOTAL30) 
 
Name of Comparator 
Product(s) 
Throughout this document, comparator product(s) will be 
referred to as ACUVUE OASYS® with HYDRACLEAR® 
PLUS contact lenses (AOHP) 
 
Adverse Device Effect 
(ADE) 
 
Adverse event related to the use of an investigational 
medical device (investigational product) or control product. 
Note: This definition includes adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation; any malfunction; 
and use error or intentional misuse of the investigational 
medical device (investigational product) or control product.  
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 (investigational 
product).  
Note: 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 events related to the use of 
investigational medical devices (investigational product) or 
control product. 
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 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. 
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. 
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. 

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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). 
Nonserious Adverse Event 
Adverse event that does not meet the criteria for a serious 
adverse event. 
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. 
Note: Planned hospitalization for a preexisting 
condition, without serious deterioration in health, is 
not considered a serious adverse event. In general, 
hospitalization signifies that the individual remained 
at the hospital or emergency ward for observation 
and/or treatment (usually involving an overnight 
stay) that would not have been appropriate in the 
physician's office or an outpatient setting. 
Complications that occur during hospitalization are 
adverse events. If a complication prolongs 
hospitalization or fulfills any other serious criteria, 
the event is serious. When in doubt as to whether 
“hospitalization” occurred, the event should be 
considered serious. 
d) a medical or surgical intervention to prevent a) or b).  
e) any indirect harm as a consequence of incorrect 
diagnostic test results when used within 
manufacturer’s instructions for use. 

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• 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. 
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 database lock 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 
AOHP soft 
contact lens or 
AOHP 
ACUVUE OASYS with HYDRACLEAR PLUS (AOHP) (senofilcon 
A) 
) 
AOS 
Advanced Ophthalmic Systems 
BCVA  
Best corrected visual acuity 
CE 
Conformitè Europëenne 
CFR  
Code of Federal Regulations 
CIP 
Clinical Investigation Plan 
CIR 
Clinical Investigation Report 
 
 
COL 
Clinical operations lead 
CRF 
Case report form 
CSM 
Clinical site manager 
CTT 
Clinical trial team 
D  
Diopter(s) 
eCRF  
Electronic case report form 
EDC  
Electronic data capture 
FDA  
US Food and Drug Administration 
GCP  
Good Clinical Practice 
GPCMS 
Global Product Complaint Management System 
hr 
Hour 
IB  
Investigator’s brochure 
ICF  
Informed consent form 
IEC  
Independent ethics committee 
IFU 
Instructions for use 
IP  
Investigational product 
IRB  
Institutional review board 
ISO  
International Organization for Standardization 
 
 
logMAR 
Logarithm of the minimum angle of resolution 
mm  
Millimeter 
MOP 
Manual of procedures 
N/A  
Not applicable 
OD 
Right eye 
OS 
Left eye 
SADE  
Serious adverse device effect 
SAE  
Serious adverse event 
SD 
Standard deviation 

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Abbreviation 
Definition 
SLE 
Slit lamp examination 
SOP 
Standard operating procedure 
TOTAL30 soft 
contact lens or 
TOTAL30 
TOTAL30 soft contact lenses 
 
UK 
United Kingdom 
US / USA 
United States of America 
USV 
Unscheduled visit 
VA  
Visual acuity 
 
 
 
 

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3 PROTOCOL SUMMARY 
Investigational 
product type 
Device 
Study type 
Interventional 
Investigational 
products 
Test Product: TOTAL30 soft contact lenses (TOTAL30) 
 
Comparator Product: ACUVUE OASYS with HYDRACLEAR 
PLUS soft contact lenses (AOHP) 
 
Purpose and 
Scientific Rationale 
for the Study 
The overall objective of this clinical study is to describe the 
clinical performance of the TOTAL30 soft contact lens compared 
to the AOHP soft contact lens in a daily wear modality. 
Objective(s) 
The primary objective is to evaluate visual acuity of the 
TOTAL30 soft contact lens and the AOHP soft contact lens. 
 
 
  
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 study lenses 

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Safety 
• Adverse events  
• Biomicroscopy  
• Device deficiencies 
Study Design 
This will be a prospective, randomized, 
 
, bilateral crossover, controlled, subject-masked, daily 
wear clinical study. 
Subjects will be expected to attend 3 visits. The total duration of a 
subject’s participation in the study will be approximately 
1.5 months. Subjects will be expected to wear their study contact 
lenses at least 5 days per week and at least 8 hours per day. On 
visits 2 and 3, subjects will be expected to wear the study lenses at 
least 6 hours prior to the study visit and the visit is to take place 
within ±2 hours of baseline visit time. 
 
 
 

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Subject population 
Volunteer subjects aged ≥ 18 years who are any habitual spherical 
soft contact lens wearers, have at least 3 months of contact lens 
wearing experience, and who would be willing to wear the study 
lenses for at least 5 days per week and at least 8 hours per day. 
Pregnant and breastfeeding women are excluded for this study.  
Planned number of subjects enrolled/consented: ~36  
Planned number of completed subjects: 32 
 
 
Sites and Locations 
Planned number of clinical sites: 1 
Planned locations (initial list of locations, which may change 
during start up or conduct according to study needs): UK 
Key inclusion 
criteria 
(See Section 8.1 for a 
complete list of 
inclusion criteria) 
• Current wearers of any commercial spherical soft contact 
lenses with at least 3 months wearing experience, who would 
be willing to wear the study lenses for a minimum wearing 
time of 5 days per week and 8 hours per day. 
• Able to wear contact lenses within a range of sphere power 
from -1.00 D to -6.00 D (0.25 D steps) and subject willing and 
able to wear the study lenses for the full duration of the study. 
• Willing to NOT use rewetting/lubricating drops at any time 
during the study. 
Key exclusion 
criteria 
(See Section 8.2 for a 
complete list of 
exclusion criteria) 
• Participation of the subject in a clinical trial within the 
previous 14 days or currently enrolled in any clinical trial. 
• Habitual AOHP contact lens wearers (in the past 3 months) 
• Monovision wear during the study. 
Data analysis and 
sample size 
justification 
Planned Analysis 
To address the primary objective, descriptive statistics (number of 
observations, mean, standard deviation, median, minimum, 
maximum) for visual acuity, collected for each eye, on the 
logMAR scale will be provided. No inferential testing will be 
conducted. 

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Sample Size Justification 
Given the feasibility nature of this study, sample size calculation is 
not relevant. 
Associated materials AOSEPT PLUS with HydraGlyde Cleaning & Disinfecting 
Solution will be used for daily cleaning and disinfection.  
Lubrication/rewetting drops will not be permitted during this 
study. 
 

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4 PROTOCOL AMENDMENTS 
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments must be created by the study sponsor and must be 
approved by the IRB/IEC and global and regional Health Authorities, as applicable, prior to 
implementation except when required to mitigate immediate safety risks or when the changes 
involve only logistical or administrative revisions.  
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all subjects currently enrolled in the study must sign 
the approved, revised informed consent (re-consent), as required by the IRB/IEC. 
  
5 INTRODUCTION 
5.1 Rationale and Background 
Daily wear contact lenses are worn during waking hours, often for a full day and then 
removed for cleaning and disinfection prior to reinsertion the following day. Frequent 
replacement daily wear contact lenses are replaced according to the product package 
insert/IFU provided by the contact lens manufacturer. 
New silicone hydrogel materials continue to be developed, possessing unique material 
properties and superior oxygen transmissibility over contact lenses made with conventional 
hydrogel materials. A new lens, known as the TOTAL30 contact lens, has been developed in 
an effort to maintain sustained performance by providing an inherently wettable core material 
with a water gradient surface. The new silicone hydrogel lens has been designed to provide 
favorable performance for daily wear with 1-month replacement. 
In this clinical study, the clinical performance of the TOTAL30 contact lens will be assessed 
and the TOTAL30 contact lens will be compared to the AOHP contact lens in a crossover 
design, both to be worn in a daily wear modality. 
5.2 Purpose of the Study 
The purpose of this study is to assess the clinical performance of the TOTAL30 contact lens 
compared to AOHP. The primary endpoint was selected to address the primary objective of 
the study. Procedures for measurement of these endpoints were selected based on common 
practice for these assessments and some novel assessment techniques. The design of this 
study is justified based upon preclinical and clinical testing, as described within the IFU. 

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AOHP contact lenses were chosen as the comparator product because both of these lenses 
have a frequent replacement schedule.  
 
 
At the end of the study, a clinical study report 
 will be prepared in 
accordance with applicable regulatory requirements and standards. 
 
 
Alcon reserves the right of prior review of any publication or presentation of information 
related to the study. 
 
 
 
 
 
 
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 investigator’s brochure 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 study contact lenses are 
features consistent with successful contact lens wear.  
TOTAL30 and AOHP contact lenses are commercially available for daily wear use under a 
frequent replacement wear modality; further details on any known potential risks and benefits 
can be found in the IFU.  
A summary of the known potential risks and benefits associated with the TOTAL30 and 
AOHP contact lenses can be found in the IFU. There may also be unknown risks to use of the 
TOTAL30 contact lens. Any risk to subjects in this clinical study will be minimized by 
compliance with the eligibility criteria and study procedures, clinical oversight and 
monitoring, and through close supervision by a licensed clinician during exposure to the 
study lenses. The site personnel will educate subjects on proper hygiene and lens handling, as 

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well as compliance with the use of contact lenses and lens care according to the protocol. 
Subjects should be instructed not to wear contact lenses while sleeping or swimming.  
The site personnel will also advise the subjects to remove contact lenses and return for 
prompt follow-up of symptoms, such as ocular discomfort, foreign body sensation, excessive 
tearing, vision changes, or hyperemia.  
6 STUDY OBJECTIVES 
6.1 Primary Objective(s) 
Table 6–1 
Primary Objective(s) 
Objective(s) 
Endpoint(s) 
To evaluate visual acuity of the TOTAL30 
soft contact lens and the AOHP soft contact 
lens. 
Distance VA with study lenses (OD, OS; 
logMAR) 
6.2 Secondary Objective(s) 
Not Applicable. 

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6.4 Safety Objective(s)  
Table 6–3 
Safety Objective(s) 
Objective(s) 
Endpoint(s) 
Describe the safety profile of the study 
products 
• AEs 
• Biomicroscopy findings 
• Device deficiencies 

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7 INVESTIGATIONAL PLAN 
7.1 Study Design 
This is a prospective, randomized, 
 bilateral crossover, 
controlled, subject-masked, daily wear clinical study to be conducted at a single site. Eligible 
habitual soft contact lens wearers will be randomized to 1 of the 2 crossover sequences. 
Subjects will be masked. A designated study staff member will prepare the contact lenses for 
dispensing.  
Subjects will be expected to participate in a pre-screening and attend 3 office visits: 
Screen/Baseline/Dispense Lens Pair 1, Follow-up Lens Pair 1/Dispense Lens Pair 2, Follow-
up Lens Pair 2/Exit. AOHP will be worn for ~14 days and TOTAL30 will be worn for ~28 
days. The total expected duration of participation for each subject is approximately 1.5 
months. Subjects will be randomized to wear the assigned product sequence in both eyes, 
either the test TOTAL30 contact lenses as Pair 1, followed by the comparator AOHP contact 
lenses as Pair 2, or vice versa. All study contact lenses will be prescribed according to 
subject’s prescription and can be optimized per study lens type, however test and comparator 
lenses should be dispensed within ±0.25 D of each other.  
Subjects will be expected to wear their study contact lens in a daily wear modality for at least 
5 days per week 8 hours a day, over a 14 day (AOHP) or 28 day period (TOTAL30). 
AOSEPT PLUS with HydraGlyde Cleaning & Disinfecting Solution will be used for daily 
cleaning and disinfection.  
On the day of Visits 2 and 3, subjects will be asked to wear the study lenses at least 6 hours 
and prior to their study visit. Follow-up visit time to be within ±2 hours of baseline visit time. 
 
 

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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 the test and comparator products bilaterally for approximately 28 and 14 
days, depending on the lens being dispensed. Subjects will remain masked to the lens type. 
The primary 
 variable will be assessed on Day 1 and at Day 28 for test 
product and at Day 14 for comparator product. 
7.4 Rationale for Choice of Comparator Product 
AOHP contact lenses were chosen as the comparator product because these lenses have the 
same wear modality and similar replacement schedule. 
7.5 Data Monitoring Committee 
Not applicable. 
8 STUDY POPULATION 
The study population consists of male and female subjects (aged 18 or over) who are current 
wearers of spherical soft contact lenses in both eyes with a least 3 months wearing 
experience, with a minimum wearing time of 5 days per week and 8 hours per day. Subjects 
who are habitual AOHP contact lens wearers in the past 3 months will be excluded. It is 
aimed to enroll (consent) approximately 36 subjects at 1 site in the United Kingdom, with a 
target of 32 completed subjects 
 
 Estimated time needed to recruit subjects for the study is 
approximately 5 months; however, unanticipated circumstances may shorten or lengthen this 
time and would not require amendment of this protocol. Eligible study population will be 
representative of the study products target population.  
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. 
 

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1. 
Subjects must be ≥ 18 years of age and have capacity to volunteer.   
2. 
Subjects must be able to understand and must sign an informed consent form (ICF) 
that has been approved by an Institutional Review Board (IRB/IEC). 
3. 
Current wearers of any commercial spherical soft contact lenses with at least 3 
months wearing experience, who would be willing to wear the study lenses for a 
minimum wearing time of 5 days per week and 8 hours per day. 
4. 
Manifest cylinder ≤ 0.75 D in each eye (based on the ocular refraction). 
5. 
Able to wear contact lenses within a range of sphere power from -1.00 D to -6.00 D 
(0.25 D steps) and subject willing and able to wear the study lenses for the full 
duration of the study. 
6. 
Best corrected distance visual acuity better than or equal to 0.10 logMAR in each 
eye (as determined by manifest refraction at screening). 
7. 
Subjects must be willing to stop wearing their habitual contact lenses for the 
duration of study participation.   
8. 
Subjects must be willing to NOT use rewetting/lubricating drops at any time during 
the study 
 
 
 
 
   
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. 

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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 twelve weeks immediately prior to enrollment for this 
trial. 
 
 
 
 
10. 
Any use of topical ocular medications and artificial tear or rewetting drops that 
would require instillation during the study. 
11. 
The investigator, his/her staff, family members of the investigator, family members 
of the investigator’s staff, or individuals living in the households of the 
aforementioned persons may not participate in the study. 
12. 
Participation of the subject in a clinical trial within the previous 14 days or currently 
enrolled in any clinical trial. 
13. 
Monovision wear during the study.  
14. 
Habitual AOHP contact lens wearers (in the past 3 months)  
15. 
Currently pregnant or breast-feeding. 
8.3 Rescreening of Subjects 
Rescreening of subjects is not allowed in this study. 
 
 

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9 TREATMENTS ADMINISTERED 
9.1 Investigational Product(s) 
Test Product(s): 
TOTAL30 soft contact lenses (TOTAL30) 
 
Comparator Product(s) (If 
applicable): 
AOHP (senofilcon A) soft contact lenses 
 
Table 9–1 
Test Product 
Test Product 
TOTAL30 soft contact lenses (TOTAL30) 
 
 
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 product is for vision correction. 
Product description 
and parameters 
available for this 
study 
• Material: lehfilcon A  
• Water content: 55%  
• Power range: -1.00 to –6.00 D (0.25 D steps)  
• Base curve (mm): 8.4  
• Diameter (mm): 14.2  
Formulation 
Silicone hydrogel. For additional details, please refer to the 
TOTAL30 IFU. 
Usage 
• Wear: 
o Daily Wear 
o Bilateral 
o Crossover according to randomization 

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• Replacement period: This is a monthly replacement lens, 
however lenses will not have a planned replacement in this 
study.  
• Exposure: At least 8 hours per day, 5 days per week, over a 28 
day period.  
• Lens Care: AOSEPT PLUS with HydraGlyde Cleaning & 
Disinfecting Solution will be used for daily cleaning and 
disinfection.  
• Additional details can be found in the MOP. 
Number/Amount of 
product to be 
provided to the 
subject 
Subjects will be dispensed study lenses at Visit 1 and Visit 2. One 
spare pair of lenses will be provided to the subject.   
Packaging 
description 
Blister foil pack  
Labeling description • Lens Foil label includes (at a minimum): 
- 
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 72 lenses per power, 
identified with the following: 
- 
a color coded label stating the protocol number 
- 
material identifier 
- 
power 
- 
an investigational use only statement 
- 
tracking number 
 

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Training and/or 
experience 
requirements for 
device 
No additional training or experience is required to administer the 
test product.  
Storage conditions 
Stored at room temperature.  
Supply 
Alcon will provide a bulk inventory of lenses for the site to use 
throughout the trial for fitting and dispense.  
Contact lens solution and contact lens case will be provided to the 
subject. 
 
Table 9–2 
Comparator Product 
Comparator 
Product(s) 
ACUVUE OASYS with HYDRACLEAR PLUS (AOHP) 
(senofilcon A) soft contact lenses 
 
Manufacturer 
Johnson & Johnson 
Indication for Use 
The intended use of this product is for vision correction. 
Product description 
and parameters 
available for this 
study 
• Material: senofilcon A  
• Water content: 38% 
• Power range: -1.00 to –6.00 D (0.25 D steps)  
• Base curve (mm): 8.4, 8.8  
• Diameter (mm): 14.0 
Formulation 
Silicone Hydrogel. For additional details, please refer to the AOHP 
IFU. 
Usage 
• Wear: 
o Daily Wear 
o Bilateral 
o Crossover according to randomization 
• Replacement period: This is a 2 week replacement lens, 
however lenses will not have a planned replacement in this 
study.  
• Exposure: At least 8 hours per day, 5 days per week, over a 14 
day period.  

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• Lens Care: AOSEPT PLUS with HydraGlyde Cleaning & 
Disinfecting Solution will be used for daily cleaning and 
disinfection.  
• Additional details can be found in the MOP. 
Number/Amount of 
Product to be 
Provided to the 
subject 
Subjects will be dispensed study lenses at Visit 1 and Visit 2. One 
spare pair of lenses will be provided to the subject.   
Packaging 
description 
Blister foil pack  
Labeling description • Lens Foil label includes (at a minimum): 
- 
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 72 lenses per power, 
identified with the following: 
- 
a color coded label stating the protocol number 
- 
material identifier 
- 
power 
- 
an investigational use only statement 
- 
tracking number 
Training and/or 
experience 
requirements for 
device 
No additional training or experience is required to administer the 
comparator product. 

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Storage conditions 
Lenses to be stored at room temperature. 
Supply 
Alcon will provide a bulk inventory of lenses for the site to use 
throughout the trial for fitting and dispense.  
Contact lens solution and contact lens case will be provided to the 
subject. 
 
More information on the test and comparator products can be found in their individual IFUs. 
9.2 Other Medical Device or Medication Specified for Use During the 
Study 
During the clinical study, additional contact lens solution is required in conjunction with the 
treatment: 
• AOSEPT PLUS with HydraGlyde Cleaning & Disinfecting Solution will be used for 
daily cleaning and disinfection.   
9.3 Treatment Assignment / Randomization 
Subjects will be randomized in a 1:1 ratio to receive treatment in crossover sequence of test 
product then comparator product or comparator product then test product, respectively. 
 
 
 
 
 
  
Only after signing the ICF at Visit 1, a subject will be assigned a subject number by the 
electronic data capture system.  
A randomization list will be generated using a validated system that automates the random 
assignment of treatment arms to randomization numbers in the specified ratio. Subjects will 
be assigned treatment according to the randomization list uploaded in the 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 treatment arms (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 

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randomization list but will not be communicated to the site user. The EDC/randomization 
integration system will inform the site user of the treatment sequence assignment to be 
dispensed to the subject. 
9.4 Treatment masking 
This study is subject-masked, with subjects randomized to use the TOTAL30 contact lenses 
and AOHP contact lenses for the duration of the 28 and 14 day treatment period, respectively. 
 

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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. 
9.5 Accountability Procedures 
Upon receipt of the IPs, the investigator or delegate must conduct an inventory. During the 
study, it is recommended that the investigator delegates staff to provide the IPs to the subjects 
in accordance with their randomization assignment. All members associated with the study at 
the site should make an attempt to remain masked, except for designated staff who will be 
dispensing IP and completing IP dispensation and collection records. These records must be 
made available to the study monitor for the purposes of verifying the accounting of IP 
supplies. Any discrepancies and/or deficiencies between the observed disposition and the 
written account must be recorded along with an explanation. All IPs sent to the investigator 
must be accounted for by study sponsor personnel, and in no case be used in an unauthorized 
situation. 
It is the investigator’s responsibility to ensure that: 
• 
All study products are accounted for and not used in any unauthorized manner 
• 
All unused products are available for return to the study sponsor, as directed 
• 
All used lidding foils are available for return to the study sponsor, as directed 

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Unscheduled Visits and Early Termination Visits are allowed, if necessary. 
Study lenses will be provided to the subjects to take home for daily wear during the course of 
the trial.  
Study randomization will occur at Visit 1 with assigned lenses provided to take home at Visit 
1 and Visit 2. Study contact lens fitting will occur at Visit 1 for both study lenses. If a subject 
cannot be successfully fit (either study lens) according to the study lens fitting guides as 
determined by the investigator, they will be required to exit from the study.  
Lubrication/rewetting drops will not be permitted during this study.  
 
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. All study 
procedures and assessments are to be performed according to the table of procedures 
(Table 3-1). The investigator is responsible for ensuring responsibilities for all procedures 
and assessments are delegated to appropriately qualified site personnel. 

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10.2.1 Demographics 
Obtain demographic information including age, race, and sex. 
10.2.2 Medical History and Concomitant Medications 
Ocular and non-ocular medical history and concomitant medications will be collected at Visit 
1 (and at other visits as needed, i.e., due to AE) and documented in the source documents. All 
relevant medical conditions, including currently active conditions, diagnosed chronic 
conditions, and conditions resolved within the past year will be documented. Habitual lens 
information and medications taken within 30 days prior to Visit 1 will be recorded in the 
source documentation. 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 and record in subject 
source documents. 
10.2.3 Investigational Product compliance 
Review subject compliance with the IP usage and adjunct product usage and collect all used 
and unused study IPs and other products that were dispensed. 
10.2.4 Adverse Event Collection: Safety Assessment 
Assess and record any adverse events that are observed or reported, including those 
associated with changes in concomitant medication dosing since the previous visit in the 
subject source documents.  See Section 11 for further details regarding AE collection and 
reporting. 
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. 
Device deficiencies on comparator lenses should be reported per the manufacturer’s 
guidelines. 

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10.2.7 Additional Study Assessments 
Additional effectiveness assessments will be conducted throughout the course of the study. 
Refer to the MOP and Table 3-1 for details on each of these assessments.  
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 
• 
Collect device deficiency information 
• 
Record changes in medical condition (including pregnancy) or concomitant 
medication 
• 
VA with study lenses 
The investigator may perform additional procedures for proper diagnosis and treatment of the 
subject according to Table 3-1 or at their discretion. The investigator must document this 
information in the subject’s case history source documents and in the eCRF, where 
applicable. 
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 
randomization to product/dispense of study product. 
The investigator must document the reason for screen failure in the subject’s case history 
source documents and in EDC. 
Subject numbers must not be re-used. 

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10.4.2 Discontinuations 
Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the 
study by the investigator after signing 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. 
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.  

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• 
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. 
Breaking of the masked treatment codes will be done after locking the database. 
10.5.1 Follow-up of subjects after study participation has ended  
Following this study, the subject will return to their eye care professional for their routine eye 
care. 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
11.1 General Information 
An AE is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, 
whether or not related to the investigational medical device (test 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
 
 

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Figure 11-2 
Categorization of All Serious Adverse Events 
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 non-serious) meeting the definitions, the 
investigator must report any occurrence of the following as an SAE: 
• 
An ocular infection including a presumed infectious ulcer with any of the following 
characteristics: 
o Central or paracentral location 
o Penetration of Bowman’s membrane 
o Infiltrates >2 mm diameter 
o Iritis 
o Increase in intraocular pressure 
o Culture positive for microorganisms 
o Increasing size or severity at subsequent visits 
• 
Any central or paracentral corneal event (such as neovascularization) that results in 
permanent opacification 
• 
Hypopyon 

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• 
Hyphema 
• 
Neovascularization within the central 6 mm of the cornea  
• 
Permanent vision loss as defined by loss of 2 or more lines of BCVA (i.e., Study Lens 
Distance VA with Over-Refraction or Manifest Refraction BCVA) from enrollment visit 
that fails to resolve 
• 
Uveitis (anterior, intermediate, or posterior) 
• 
Corneal abrasion affecting ≥50% of corneal surface area 
The above events are based on the categories provided in the ISO 11980 and the US FDA 
Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses. 
Device Deficiencies 
A device deficiency is inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. A device deficiency may or may not be 
associated with patient harm (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?” 

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• 
“Have there been any changes in the medicines you take since your last study visit?” 
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 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 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 

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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 source. 
• 
Document all relevant information from Discharge Summary, Autopsy Report, 
• 
Certificate of Death etc., if applicable, in narrative section of the Serious Adverse Event 
and Adverse Device Effect eCRF. 
Note: Should the EDC system become non-operational, the site must complete the 
appropriate paper Serious Adverse Event and Adverse Device Effect and/or Device Deficiency 
Form. The completed form is emailed to the study sponsor at qa.complaints@alcon.com 
according to the timelines outlined above; however, the reported information must be entered 
into the EDC system once it becomes operational. 
Any AEs and device deficiencies for non-study marketed devices/products (i.e., AOSEPT 
PLUS with HydraGlyde Cleaning & Disinfecting Solution) will be considered and processed 
as spontaneous (following the post-market vigilance procedures) and should be 
communicated to the device’s/product’s manufacturer as per local requirements. 
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. 

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Severe  
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities. 
For every AE in the study, the investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by study sponsor utilizing the same definitions, as shown below: 
Causality 
Related 
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study 
procedure has not been demonstrated, but there is a reasonable possibility that 
the AE was caused by the medical device or study procedure. 
Not Related  An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (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 non-serious 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  
Investigators are unmasked in this study. However, the identity of the assigned medical 
device should not be disclosed to subjects who are masked during the study. The Study 
Sponsor must be informed of all cases in which unmasking of the subject(s) has occurred and 
of the circumstances involved. The Study Sponsor should be informed in advance of 
unmasking when possible, except in the event of a medical emergency. Additionally, the 

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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).  
Any additional data received up to 3 months after subject discontinuation or exit must be 
documented and available upon the study sponsor’s request. All complaints received after this 
time period will be considered and processed as spontaneous (following the post-market 
vigilance procedures) and should be communicated to the medical device’s manufacturer as 
per local requirements. 
The investigator should also report complaints on non-Alcon products directly to the 
manufacturer as per the manufacturer’s instructions or local regulatory requirements. 
11.7 Pregnancy in the Clinical Study 
Pregnancy is excluded at the time of enrollment for this study. However, if a subject becomes 
pregnant during study participation, it will be documented on the source. 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. Categorical variables will be summarized with frequencies 
and percentages from each category.  

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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. 
12.2 Analysis Sets 
12.2.1 Safety Analysis Set 
Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. 
As such, the safety analysis set will include all subjects/eyes exposed to any study lenses 
evaluated in this study, 
. For treatment-
emergent safety analyses, subjects/eyes will be categorized under the actual study lenses 
exposed in the corresponding lens sequence. 
12.3 Demographic and Baseline Characteristics 
Demographic and baseline characteristics will be summarized by lens sequence and overall. 
Frequencies and percentages will be presented for categorical variables such as sex, age 
group, and race. 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 one primary endpoint 
. The Safety 
Analysis Set will be used 
 
12.4.1 Analysis of Primary Effectiveness Endpoint(s) 
The primary objective of this study is to evaluate the VA of the TOTAL30 soft contact lens 
and the AOHP soft contact lens. The primary endpoint is distance VA with study lenses, 
collected for each eye in logMAR. 
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 used for continuous variables will be presented. 

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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 (counts and percentages) for ocular 
and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities 
Preferred Terms. AEs leading to study discontinuation, significant non-serious AEs, and 
SAEs will be identified. Individual subject listings will be provided, as necessary. 
Individual subject listings will be provided for AEs that occur after signing informed consent 
but prior to exposure to IP. 
Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy 
parameter, counts and percentages of eyes that experience an increase of ≥ 2 grades from 
baseline (last assessment prior to study lens exposure for each period) 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 of study contact lenses and treatment-
emergent, will be provided. Additionally, each device deficiency category will be tabulated. 
No inferential testing will be done for safety analysis. 

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12.7 Sample Size Justification 
Given the feasibility nature of this study, sample size calculation is not relevant. 
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 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: 
• 
Subject identification (name, sex, race) 
• 
Documentation of subject eligibility 
• 
Date of informed consent 
• 
Dates of visits 
• 
Documentation that protocol specific procedures were performed 
• 
Results of study parameters, as required by the protocol 
• 
IP accountability records 
• 
Documentation of AEs and other safety parameters (if applicable) 

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• 
Records regarding medical histories and the use of concomitant therapies prior to and 
during the study 
• 
Date of study completion and reason for early discontinuation, if applicable 
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the 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.  
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 

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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. 
13.5 Regulatory Documentation and Records Retention 
The investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the study sponsor and the investigator’s files will be reviewed as part of the 
ongoing study monitoring. Financial information is to be kept separately.  
Additionally, the investigator must keep study records and source documents consistent with 
the terms of the clinical study agreement with the study sponsor. If the investigator retires, 
relocates, or for any other reason withdraws from responsibility of keeping the study records, 
then the study sponsor must be notified and suitable arrangements made for retention of study 
records and source documents needed to comply with national and international regulations. 
13.6 Quality Assurance and Quality Control 
The study sponsor will secure agreement from all involved parties to ensure direct access to 
all study related sites, source data and documents, and reports for the purpose of monitoring 
and auditing by the study sponsor, and inspection by domestic and foreign regulatory 
authorities. Quality control will be applied to each stage of data handling to ensure that all 
data are reliable and have been processed correctly. Agreements made by the study sponsor 
with the investigator/institution and any other parties involved in the clinical study will be 
provided in writing as part of the protocol or as a separate agreement. 
14 ETHICS 
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 

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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 IFU, any periodic safety updates, and all other 
information as required by local regulation and/or the IRB/IEC. At the end of the study, the 
investigator must notify the IRB/IEC about the study’s completion. The IRB/IEC also must 
be notified if the study is terminated prematurely. Finally, the investigator must report to the 
IRB/IEC on the progress of the study at intervals stipulated by the IRB/IEC. 
Voluntary informed consent must be obtained in writing from every subject. 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 

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subject’s medical records) and must provide a duplicate copy to each subject according to 
local regulations.  
Human clinical trials liability insurance will be provided for participating subjects. 
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 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 

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