The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
Phase: NA
Conditions: Refractive Ametropia
Sponsor: Alcon Research

 
 
 
 
 
Clinical Performance of Two Reusable  
Silicone Hydrogel Contact Lenses 
 
 
STUDY ID  
CLL949‐C024 
 
 
PROTOCOL 
 
 
NCT05766787 

Document ID: 
V-CLN-0035929 
Status: Approved, Version: 3.0 
Approved Date: 13 Apr 2023 
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Alcon – Business Use Only 
 
Device Protocol for CLL949-C024 
Title: Clinical Performance of Two Reusable Silicone Hydrogel Contact 
Lenses 
Protocol Number: 
CLL949-C024 
Clinical Investigation 
Type:  
Interventional 
Test Product: 
Alcon serafilcon A contact lenses 
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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Status: Approved, Version: 3.0 
Approved Date: 13 Apr 2023 
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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 CLL949-C024 ........................................................................................... 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 ......................................................................................... 29 
5 
INTRODUCTION ............................................................................................................. 29 
5.1 
Rationale and Background ................................................................................. 29 
5.2 
Purpose of the Study .......................................................................................... 29 
5.3 
Risks and Benefits ............................................................................................. 30 
6 
STUDY OBJECTIVES...................................................................................................... 31 
6.1 
Primary Objective(s) .......................................................................................... 31 
6.2 
Secondary Objective(s) ...................................................................................... 31 
 
 
6.4 
Safety Objective(s) ............................................................................................ 34 
7 
INVESTIGATIONAL PLAN ............................................................................................ 35 
7.1 
Study Design...................................................................................................... 35 
7.2 
Rationale for Study Design................................................................................ 35 
7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations ........................................................................................ 37 
7.3 
Rationale for Duration of Treatment/Follow-Up ............................................... 37 
7.4 
Rationale for Choice of Comparator Product .................................................... 37 
7.5 
Data Monitoring Committee .............................................................................. 37 
8 
STUDY POPULATION .................................................................................................... 37 
8.1 
Inclusion Criteria ............................................................................................... 38 
8.2 
Exclusion Criteria .............................................................................................. 39 
8.3 
Rescreening of Subjects ..................................................................................... 40 
9 
TREATMENTS ADMINISTERED................................................................................... 40 

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9.1 
Investigational Product(s) .................................................................................. 40 
9.2 
Other Medical Device or Medication Specified for Use During the Study ....... 44 
9.3 
Treatment Assignment / Randomization ........................................................... 44 
9.4 
Treatment masking ............................................................................................ 45 
9.5 
Accountability Procedures ................................................................................. 46 
9.6 
Changes to concomitant medications, treatments/ procedures .......................... 47 
10 STUDY PROCEDURES AND ASSESSMENTS ............................................................. 47 
10.1 Informed Consent and Screening ...................................................................... 48 
10.2 Description of Study Procedures and Assessments ........................................... 49 
10.2.1 
Demographics .................................................................................... 49 
10.2.2 
Medical History ................................................................................. 49 
10.2.3 
Investigational Product Compliance .................................................. 49 
10.2.4 
Adverse Event Collection: Safety Assessment .................................. 49 
10.2.5 
Slit Lamp Biomicroscopy: Safety Assessment .................................. 49 
10.2.6 
Device Deficiencies: Safety Assessment ........................................... 50 
10.2.7 
Best Corrected Visual Acuity: Safety Assessment ............................ 50 
10.2.8 
Additional Study Assessments .......................................................... 50 
10.3 Unscheduled Visits ............................................................................................ 50 
10.4 Discontinued Subjects ....................................................................................... 51 
10.4.1 
Screen Failures .................................................................................. 51 
10.4.2 
Discontinuations ................................................................................ 51 
10.4.3 
Schedule of Procedures and Assessments for Subjects 
Discontinued from Investigational Product ....................................... 51 
10.5 Clinical Study Termination ................................................................................ 52 
10.5.1 
Follow-Up of Subjects After Study Participation has Ended ............ 52 
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 52 
11.1 General Information .......................................................................................... 52 
11.2 Monitoring for Adverse Events ......................................................................... 55 
11.3 Procedures for Recording and Reporting .......................................................... 56 
11.4 Return Product Analysis .................................................................................... 58 
11.5 Unmasking of the Study Treatment ................................................................... 58 
11.6 Follow-Up of Subjects with Adverse Events ..................................................... 58 
11.7 Pregnancy in the Clinical Study ........................................................................ 59 
12 ANALYSIS PLAN ............................................................................................................ 59 

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12.1 Subject Evaluability ........................................................................................... 59 
12.2 Analysis Sets...................................................................................................... 59 
12.2.1 
Safety Analysis Set ............................................................................ 59 
12.2.2 
Full Analysis Set ................................................................................ 60 
12.2.3 
Per Protocol Analysis Set .................................................................. 60 
12.3 Demographic and Baseline Characteristics ....................................................... 60 
12.4 Effectiveness Analyses ...................................................................................... 60 
12.4.1 
Analysis of Primary Effectiveness Endpoint(s)................................. 60 
12.4.1.1 
Statistical Hypotheses ........................................................ 61 
12.4.1.2 
Analysis Methods............................................................... 61 
12.5 Handling of Missing Data .................................................................................. 65 
12.6 Safety Analyses.................................................................................................. 65 
12.7 Interim Analyses and Reporting ........................................................................ 66 
12.8 Sample Size Justification ................................................................................... 66 
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 68 
13.1 Subject Confidentiality ...................................................................................... 68 
13.2 Completion of Source Documents and Case Report Forms .............................. 68 
13.3 Data Review and Clarifications ......................................................................... 69 
13.4 Sponsor and Monitoring Responsibilities.......................................................... 69 
13.5 Regulatory Documentation and Records Retention .......................................... 70 
13.6 Quality Assurance and Quality Control ............................................................. 70 
14 ETHICS ............................................................................................................................. 71 
15 REFERENCES .................................................................................................................. 72 
15.1 Regulations and Standards................................................................................. 72 
 
 
 
 
List of Tables 
Table 2–1 
List of Acronyms and Abbreviations Used in This Protocol ........................... 13 

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Table 3–1 
Schedule of Study Procedures and Assessment ............................................... 23 
Table 6–1 
Primary Objective(s) ........................................................................................ 31 
 
 
Table 6–3 
Safety Objective(s)........................................................................................... 34 
Table 9–1 
Test Product ..................................................................................................... 40 
Table 9–2 
Comparator Product ......................................................................................... 42 
 
 
 
List of Figures 
Figure 7-1 
Study Design .................................................................................................... 35 
Figure 11-1 
Categorization of All Adverse Events .............................................................. 53 
Figure 11-2 
Categorization of All Serious Adverse Events ................................................. 53 
 
 
 

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1 GLOSSARY OF TERMS 
Names of Test Product(s) 
Throughout this document, test product(s) will be referred to 
as Alcon serafilcon A contact lenses 
Name of Comparator 
Product(s) 
ACUVUE® OASYS with HYDRACLEAR® PLUS 
Technology  
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. 
Anticipated Serious 
Adverse Device Effect 
(ASADE) 
 
An effect which by its nature, incidence, severity, or 
outcome has been identified in the risk assessment. 

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

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Interventional Clinical Trial  A pre- or postmarket clinical investigation where the 
assignment of a subject to a particular medical device is 
decided in advance by a clinical investigation plan, or 
diagnostic or monitoring procedures requested in the CIP are 
in addition to those available as normal clinical practice and 
burden the subject. 
Investigational Product 
A preventative (vaccine), a therapeutic (drug or biologic), 
device, diagnostic, or palliative used as a test or comparator 
product in a clinical trial, including a product with a 
marketing authorization when used or assembled 
(formulated or packaged) in a way different from the 
authorized form, or when used for an unauthorized 
indication, or when used to gain further information about 
the authorized form. 
Malfunction 
Failure of an investigational medical device to perform in 
accordance with its intended purpose when used in 
accordance with the instructions for use or clinical 
investigation plan (CIP), or investigator’s brochure (IB). 
Nonserious Adverse Event 
Adverse event that does not meet the criteria for a serious 
adverse event. 
Randomized Subject 
Any subject who is assigned a randomized treatment. 
Serious Adverse Device 
Effect (SADE) 
Adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 

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

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Serious Health Threat 
Signal from any adverse event or device deficiency that 
indicates an imminent risk of death or a serious deterioration 
in the health in subjects, users, or other persons, and that 
requires prompt remedial action for other subjects, users, or 
other persons. 
Note: This would include events that are of significant and 
unexpected nature such that they become alarming as a 
potential serious health hazard or possibility of multiple 
deaths occurring at short intervals.  
Significant Nonserious 
Adverse Event 
A significant non-serious adverse event is a symptomatic, 
device-related, non-sight-threatening adverse event that 
warrants discontinuation of any contact lens wear for greater 
than or equal to 2 weeks. 
Refer to Section 11 for additional Significant Nonserious 
AEs. 
Study Start 
The start of the study is considered to coincide with the 
enrollment of the first patient.  
Study Completion 
The completion of the study is considered to coincide with 
the study-level last subject last visit or the decision to 
terminate the trial, whichever is later. 
Unanticipated Serious 
Adverse Device Effect 
(USADE) 
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has not been identified in the risk 
assessment.  

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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 
ACUVUE® OASYS with HYDRACLEAR® PLUS Technology 
ASADE 
Anticipated serious adverse device effect 
BCVA 
Best corrected visual acuity 
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 
DEP 
Deviations and evaluability plan 
Diff 
difference 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EN 
European Standard 
FAS 
Full analysis set 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
 
 
IB 
Investigator’s brochure 
ICF 
Informed consent form 
IEC 
Independent ethics committee 
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 
Number of subjects 
N/A 
Not applicable 
NI 
Noninferiority 
OD 
Right eye 
OS 
Left eye 
OU 
Both eyes 
PP 
Per Protocol 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 

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Abbreviation 
Definition 
SD 
Standard deviation 
Seq 
sequence 
SLE 
Slit lamp examination 
SOP 
Standard operating procedure 
 
 
UCL 
Upper confidence limit 
US 
United States 
USADE 
Unanticipated serious adverse device effect 
VA 
Visual acuity 
 
 
 
 

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3 PROTOCOL SUMMARY 
Investigational 
product type 
Device 
Study type 
Interventional  
Investigational 
products 
Test Product: Alcon serafilcon A contact lenses (LID022821)  
Comparator Product:  ACUVUE® OASYS with HYDRACLEAR® 
PLUS Technology contact lenses 
Purpose and 
Scientific 
Rationale for 
the Study 
The purpose of this study is to assess the clinical performance of the 
investigational Alcon serafilcon A contact lenses as compared to 
marketed ACUVUE® OASYS with HYDRACLEAR® PLUS 
Technology contact lenses when worn on a daily wear modality. 
 
 
 
 
 The design of this study is 
justified based upon preclinical and clinical testing, as described within 
the investigator’s brochure. AOHP contact lenses were chosen as the 
comparator product because these lenses also are reusable contact lenses 
(see Package Insert for AOHP contact lenses). Subjects will be provided 
with CLEARCARE® Cleaning & Disinfecting Solution to use with the 
study lenses.  

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Brief 
Summary of 
the Protocol 
This study aims to compare the clinical performance 
 
 at the end of the 
replacement cycles of Alcon serafilcon A contact lenses compared to 
ACUVUE® OASYS with HYDRACLEAR® PLUS Technology contact 
lenses, when worn on a daily wear modality. Volunteer subjects aged 18 
or over who are habitual spherical soft contact lens wearers (excluding 
current/previous AOHP habitual lens wearers and daily disposable lens 
wearers), have at least 3 months of contact lens wearing experience, and 
who wear their habitual lenses at least 5 days per week and at least 8 
hours per day, will be included. This is a prospective, randomized, 
double-masked, bilateral, crossover study. The expected outcome of this 
study is to demonstrate noninferiority in the visual acuity at distance 
when wearing Alcon serafilcon A contact lenses compared to AOHP 
contact lenses 
 
 
.   
Objective(s) 
• 
The primary objective of this study is to demonstrate 
noninferiority in the visual acuity at distance when wearing Alcon 
serafilcon A contact lenses compared to ACUVUE® OASYS with 
HYDRACLEAR® PLUS Technology contact lenses when worn 
on a daily wear modality.  
• 
The safety objective is to describe the safety profile of the study 
products. 
Endpoint(s)  
 
Primary Efficacy 
• 
Distance visual acuity (logMAR) with study lenses at Week 1  

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

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Study Design 
This will be a multisite, prospective, randomized, double masked, 
bilateral, crossover study comparing 2 reusable soft contact lenses. The 
expected duration of subject participation in the study is approximately 
28 days (~14 days per each lens type), with 7 scheduled visits. Subjects 
will be asked to wear their habitual spectacles only (no contact lens 
wear) during the washout periods for 2 (at least 48 hours) to 4 days after 
Visit 1 and after Visit 4. 
Subject 
population 
Planned number of subjects enrolled/consented: ~185 
Planned number of completed subjects: 168 
Sites and 
Locations 
Planned number of clinical sites: ~ 14 
Planned locations (initial list of locations, which may change during start 
up or conduct according to study needs): US 
Key inclusion 
criteria 
(See Section 
8.1 for a 
complete list of 
inclusion 
criteria) 
• 
Successful wear of spherical soft contact lenses in both eyes for a 
minimum of 5 days per week and 8 hours per day during the past 
3 months. 
• 
Manifest cylinder of ≤ -0.75 D in each eye. 
• 
Best corrected visual acuity (BCVA) 20/25 Snellen (0.10 
logMAR) or better in each eye. 
Key exclusion 
criteria 
(See Section 
8.2 for a 
complete list of 
exclusion 
criteria) 
• 
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. 
• 
Habitual AOHP contact lens wearers and current habitual wearers 
of any daily disposable contact lenses. 
Data analysis 
and sample 
size 
justification 
Planned Data Analysis 
 
 
  
 

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Endpoint 
Comparison 
Statistical Model 
Primary 
Distance VA 
Alcon serafilcon A 
contact lenses vs 
AOHP contact 
lenses  
Mixed effects repeated 
measures 
NI margin = 0.05 (logMAR) 
 
Sample Size Justification 
Sample size calculation is based on a prior clinical study 
 
which evaluated performance of Alcon serafilcon A contact lenses and 
AOHP contact lenses.  

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Associated 
materials 
• 
CLEARCARE® Cleaning & Disinfecting Solution supplied by 
sponsor to be provided to subjects for use during the study. 
• 
Lubrication/rewetting drops will not be permitted. 
• 
CLEARCARE® Plus with Hydraglyde Cleaning & Disinfecting 
Solution is not recommended. 
 

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Lens 1 
(Period 1) 
Lens 2 
 (Period 2) 
 
 
Procedure/ 
Assessment 
Pres
cree
ning 
Visit 1 
Screening / 
Baseline 
Visit 2 
Dispense 
Lens 1 
[2 (at least 
48 hours) – 
4 days after 
Visit 1 
(Washout 
period with 
habitual 
spectacles 
only after 
Visit 3 
Week 1 
Follow-up 
Lens 1 
[7 -0/+ 1 
days after 
Visit 2] 
Visit 4 
Week 2 
Follow- up 
Lens 1 
[7 -0/+ 1 
days after 
Visit 3)] 
Visit 5 
Dispense 
Lens 2 
[2 (at least 
48 hours) – 
4 days after 
Visit 4 
(Washout 
period with 
habitual 
spectacles 
only after 
Visit 6 
Week 1 
Follow-up 
Lens 2 
[7 -0/+ 1 
days after 
Visit 5] 
Visit 7 
Week 2 
Follow-up 
Lens 2 
/Exit 
[7 -0/+ 1 
days after 
Visit 6)] 
Early 
Exit 
Unsche
duled 
Visit 

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 (X) Assessment performed as necessary, e.g., decrease of VA by 2 lines or more with investigational product (IP) 
* Source only (source transferred to the sponsor upon request) 
α Comprehensive details of all AEs will be documented in the source records, however limited collection will be utilized in the eCRF (see MOP for details).  
 
 
 
 
 

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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. 
Refer to Appendix A for detailed description of amendments.  
5 INTRODUCTION 
5.1 Rationale and Background 
The investigational contact lens (Alcon serafilcon A) is intended for the optical correction of 
refractive ametropia in persons with nondiseased eyes. This study will evaluate the on-eye 
clinical performance of investigational Alcon serafilcon A contact lenses compared against 
marketed ACUVUE® OASYS with HYDRACLEAR® PLUS Technology contact lenses to 
evaluate product performance in the intended population, when worn on a daily wear 
modality. 
 
 ACUVUE® OASYS with HYDRACLEAR® PLUS Technology contact lenses were 
chosen as the comparator product because these lenses also are reusable contact lenses (see 
Package Insert for ACUVUE® OASYS with HYDRACLEAR® PLUS Technology contact 
lenses). The intended use of this contact lens is vision correction; therefore, the measurement 
of distance VA is planned as the primary effectiveness endpoint. 
 
 
 
  
5.2 Purpose of the Study 
The purpose of this study is to assess the clinical performance of the investigational Alcon 
serafilcon A contact lenses as compared to marketed ACUVUE® OASYS with 
HYDRACLEAR® PLUS Technology contact lenses. The primary objective of this study is to 
demonstrate noninferiority in the visual acuity at distance when wearing Alcon serafilcon A 
contact lenses compared to ACUVUE® OASYS with HYDRACLEAR® PLUS Technology 

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contact lenses when worn on a daily wear modality. 
 
 
 
 
 
 
 
 
At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards. 
 
 
 
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 test contact lens are features 
consistent with successful contact lens wear. 
The Alcon serafilcon A contact lenses and AOHP contact lenses can be worn on daily wear 
modality until the end of their respective wear cycles. 
 
   
A summary of the known potential risks and benefits associated with the investigational 
Alcon serafilcon A contact lens can be found in the investigator’s brochure (see Package 
Insert for AOHP contact lenses). Risks are minimized by compliance with the eligibility 
criteria and study procedures, and through close supervision by a licensed clinician during 
exposure to the study lenses. The potential harms associated with on-eye exposure to the new 
lens materials include toxicity response, blurred vision, and ocular discomfort. In general, the 
risks with the investigational contact lens are anticipated to be similar to other marketed soft 
contact lenses. 

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The site personnel will educate subjects on proper hygiene and lens handling, and compliance 
with the use of contact lenses according to the protocol. Subjects should be instructed not to 
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. 
There may also be unknown risks to use of test product. Any risk to subjects in this clinical 
study will be minimized by compliance with the eligibility criteria and study procedures, 
clinical oversight, and monitoring  
Refer to the IB for additional information. 
6 STUDY OBJECTIVES 
6.1 Primary Objective(s) 
Table 6–1 
Primary Objective(s) 
Objective(s) 
Endpoint(s) 
The primary objective of this study is to 
demonstrate noninferiority in the visual 
acuity at distance when wearing Alcon 
serafilcon A contact lenses compared to 
AOHP contact lenses when worn in a daily 
wear modality.  
• 
Distance visual acuity (logMAR) 
with study lenses at Week 1 
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. 
• 
Adverse events 
• 
Biomicroscopy findings 
• 
Device deficiencies 

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The investigational contact lens is intended for the optical correction of refractive ametropia 
in persons with nondiseased eyes. 
The purpose of this study is to assess the clinical performance of the investigational Alcon 
serafilcon A contact lenses as compared to marketed AOHP contact lenses. 
 
 
 Procedures for measurement 
 were selected based 
on common practice for these assessments. The design of this study is justified based upon 
preclinical and clinical testing, as described within the investigator’s brochure. 
 
 AOHP contact 
lenses were chosen as the comparator product because these lenses also are reusable contact 
lenses (see Package Insert for AOHP contact lenses).  
The intended use of this contact lens is vision correction; therefore, the measurement of 
distance VA is planned as the primary effectiveness endpoint. 
 
 
 
  
The crossover design will ensure that the same subject is exposed to both the test and 
comparator lens materials;
 
. 
The study will only include normal 
 contact lens wearers to ensure the 
subjects participating in this trial represent the average clinic population and a population that 
can detect differences between lens materials. The study will exclude any current/habitual 
AOHP lens and daily disposable contact lens wearers, and any previous wearers of AOHP 
lens in the past 6 months prior to consent and any previous daily disposable contact lens 
wearers in the past 3 month prior to consent in order to reduce potential bias of wearers to 
their habitual contact lenses. 
 
 
 
.  

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7.2.1 
Purpose and Timing of Interim Analyses and Resulting Design 
Adaptations 
Interim analysis will not be performed.  
7.3 Rationale for Duration of Treatment/Follow-Up 
Subjects will wear each study product bilaterally for their respective wear cycles on a daily 
wear modality. 
 
. The lenses will be provided by a qualified 
unmasked study staff member in such a manner that the subject and the investigator remain 
masked to the lens type. 
 
 
 
 
 
 
7.4 Rationale for Choice of Comparator Product 
AOHP contact lenses were chosen as the comparator product because these lenses also are 
reusable contact lenses (see Package Insert for AOHP contact lenses). 
7.5 Data Monitoring Committee 
Not applicable. 
8 STUDY POPULATION 
Volunteer subjects aged 18 or over who are habitual spherical soft contact lens wearers 
(excluding current/previous ACUVUE® OASYS with HYDRACLEAR® PLUS Technology 
habitual lens wearers and daily disposable lens wearers), have at least 3 months of contact 
lens wearing experience, and who wear their habitual lenses at least 5 days per week and at 
least 8 hours per day.  
One specific group of subjects will be recruited for this study: normal contact lens wearers. 

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The study population includes approximately 185 volunteer subjects to be enrolled at 
approximately ~14 sites, with approximately 14 subjects enrolled per site. The study 
population will consist of subjects with normal eyes (other than the need for optical 
correction for myopia), who are adapted, existing wearers of soft contact lenses in both eyes 
for at least the past 3 months and who wear contact lenses at least 5 days per week and at 
least 8 hours per day.  
8.1 Inclusion Criteria 
Written informed consent must be obtained before any study specific assessment is 
performed. Upon signing informed consent, the subject is considered enrolled in the study 
Subjects eligible for inclusion in this study must fulfill all of the following criteria: 
1. Subject must be at least 18 years of age.  
2. Subject must be able to understand and must sign an informed consent form (ICF) 
that has been approved by an Institutional Review Board (IRB). 
3. Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 
days per week and 8 hours per day during the past 3 months. 
4. Manifest cylinder of ≤ -0.75 D in each eye. 
5. Best corrected visual acuity (BCVA) 20/25 Snellen (0.10 logMAR) or better in each 
eye. 
6. Subject must possess spectacles and be willing to wear habitual spectacles for vision 
correction when study lenses are not worn, as needed.  
7. Subject must be willing to stop wearing their habitual contact lenses for the duration 
of study participation. 
8. 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. 
9. Subject must be willing to wear contact lenses for at least 16 hours per day on the 
day prior to week 1 and on the day prior to week 2 follow up visits for both test and 
comparator lenses. 

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10. Subject must be able to be successfully fit with test and comparator lenses. 
 
8.2 Exclusion Criteria 
 Subjects fulfilling any of the following criteria are not eligible for participation in this study. 
 
1. Any anterior segment infection, inflammation, or abnormality or disease (including 
systemic) that contraindicates contact lens wear, as determined by the investigator. 
2. Any use of systemic or ocular medications for which contact lens wear could be 
contraindicated, as determined by the investigator. 
3. History of 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 twelve weeks immediately prior to enrollment for 
this trial. 
9. Current or history of intolerance, hypersensitivity, or allergy to any component of 
the study products. 
10. 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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11. Any use of topical ocular medications and artificial tear or rewetting drops that 
would require instillation during contact lens wear. 
12. The investigator, his/her staff, family members of the investigator, family members 
of the investigator’s staff, or individuals living in the households of the 
aforementioned persons may not participate in the study.  
13. Participation of the subject in a clinical trial within the previous 30 days or currently 
enrolled in any clinical trial. 
14. Habitual AOHP contact lens wearers and current habitual wearers of any daily 
disposable contact lenses. 
16. Currently pregnant, as stated by the subject 
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): 
Alcon serafilcon A contact lenses 
Comparator Product(s) (If 
applicable): 
ACUVUE® OASYS with HYDRACLEAR® PLUS 
Technology contact lenses 
Table 9–1 
Test Product 
Test Product 
Alcon serafilcon A contact lenses 
Manufacturer 
Alcon Laboratories, Inc. 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
USA 
Indication for use 
and intended 
The investigational contact lens is intended for the optical 
correction of refractive ametropia in persons with nondiseased eyes.  

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purpose in the 
current study  
Product description 
and parameters 
available for this 
study 
• Material - serafilcon A 
• Water content 55 ± 2% 
• Power range: -1.00 to -6.00 D in 0.25 steps 
• Base curve (mm): 8.4 mm 
• Diameter (mm): 14.2 mm  
Usage 
• Wear:  
o Daily Wear  
o Bilateral 
 
  
 
 
 
 
 
• Replacement lenses will not be provided to the subject. In the 
event a lens needs to be replaced, the subject must return to the 
site for a replacement lens. Until the replacement lens is 
obtained, the subject must store both study lenses in the 
provided lens care solution and wear their habitual spectacles.   
• Exposure: Study lenses are to be worn during typical contact 
lens wearing hours, on all days during the study lens wearing 
period, at least 10 hours per day, over each treatment period (7 
days (-0/+1) according to randomization assignment). Subjects 
will be asked to wear their study lenses for 16 hours on the days 
prior to each Follow-up Visit (Visit 3, 4, 6, & 7).  
• Lens Care: Cleaned and disinfected with CLEAR CARE® 
Cleaning & Disinfecting Solution after each use.  
Number/Amount of 
product to be 
provided to the site 
Provided in bags of (25) lenses per power per bag  
Packaging 
description 
• Blister foil pack 

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Labeling description • Lens Foil label includes: 
- 
material name and identifier 
- 
base curve 
- 
diameter 
- 
manufacturing protocol number 
- 
packing solution 
- 
power 
- 
lot number 
- 
expiration date 
- 
content statement 
- 
investigational device statement 
- 
sponsor information 
Storage conditions 
Store at room temperature. 
Lens Care 
Cleaned and disinfected with CLEARCARE® Cleaning & 
Disinfecting Solution after each use. 
Supply 
Refer to the MOP for a detailed description 
 
Table 9–2 
Comparator Product 
Comparator 
Product(s) 
ACUVUE® OASYS with HYDRACLEAR® PLUS Technology 
contact lenses 
Manufacturer 
Johnson & Johnson Vision 
Indication for Use 
The comparator contact lens is intended for the optical correction of 
refractive ametropia in persons with nondiseased eyes 
Product description 
and parameters 
available for this 
study 
• Material: senofilcon A  
• Water content: 38% 
• Power range: -1.00 to -6.00 D in 0.25 steps 
• Base curve (mm): 8.4 mm and 8.8 mm 
• Diameter (mm): 14.0 mm 
 
Formulation 
See package insert for AOHP contact lenses 
Usage 
• Wear: 

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o Daily Wear 
o Bilateral 
 
  
 
 
 
 
 
• Replacement lenses will not be provided to the subject. In the 
event a lens needs to be replaced, the subject must return to the 
site for a replacement lens. Until the replacement lens is 
obtained, the subject must store both study lenses in the 
provided lens care solution and wear their habitual spectacles.   
• Exposure: Study lenses are to be worn during typical contact 
lens wearing hours, on all days during the study lens wearing 
period, at least 16 hours a week, over each treatment period (14 
day (-0/+1) according to randomization assignment). Subjects 
will be asked to wear their study lenses for 16 hours a week 
prior to each Follow-up Visit (Visit 3, 4, 6, & 7).  
• Lens Care: Cleaned and disinfected with CLEAR CARE® 
Cleaning & Disinfecting Solution after each use. 
Number/Amount of 
Product to be 
Provided to the 
subject 
Each Site will procure their own comparator lenses. 
Packaging 
description 
Provided in commercial packaging 
Labeling description Commercial foil. 
Storage conditions 
Store at room temperature 
Lens Care 
Cleaned and disinfected with CLEAR CARE® Cleaning & 
Disinfecting Solution after each use.  
Supply 
Refer to the MOP for a detailed description 
• Each site will procure their own comparator lenses. 
• CLEAR CARE® contact lens solution supplied by sponsor 
to be provided to the subject 

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9.2 Other Medical Device or Medication Specified for Use During the 
Study 
During the clinical study, additional medical devices and/or medications that are required in 
conjunction with the treatment include the following: 
• 
CLEAR CARE® Cleaning & Disinfecting Solution supplied by sponsor to be provided 
to subjects for use during the study. 
• 
Lubrication/rewetting drops will not be permitted. 
9.3 Treatment Assignment / Randomization 
Subjects will be randomized in a 1:1 manner to receive treatment (lens) in crossover 
sequence: test product then comparator product or comparator product then test product, 
respectively. 
Sequence 
EDC/randomization integration system 
Lens Name 
Sequence 1 
LID022821/AOHP 
Alcon serafilcon A/AOHP 
Sequence 2 
AOHP/LID022821 
AOHP/Alcon serafilcon A 
 
Only after signing the ICF, a subject will be assigned a subject number by the electronic data 
capture system. 
A randomization list will be generated using a validated system that automates the random 
assignment of treatment (lens sequence) to randomization numbers in the specified ratio. 
Subjects will be assigned treatment (lens sequence) according to the randomization list 
uploaded in the randomization system. The randomization list will be generated and 
maintained by the study sponsor 
At Visit 1 after completion of BCVA (OD, OS, logMAR distance with manifest refraction), 
biomicroscopy, and fitting of investigational products (trial assessments for test and 
comparator) all eligible subjects will be randomized via the EDC/randomization integration 
system to one of the treatments (lens sequences). The investigator or delegate will access the 
respective system after confirming that the subject meets all the eligibility criteria. A 
randomization number will be automatically assigned to the subject according to the subject 
randomization list but will not be communicated to the site user. The EDC/randomization 
integration system will inform the site user of the treatment (lens sequence) assignment to be 
dispensed to the subject. 

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9.4 Treatment masking 
This study is double masked with subjects randomized to use Alcon serafilcon A and AOHP 
for the duration of the two 2-week treatment periods.  

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In the event of a medical emergency where the knowledge of subject treatment is required, an 
individual investigator will have the ability to unmask the treatment assignment for a specific 
subject after contacting an appropriate study sponsor representative if time allows.  
9.5 Accountability Procedures 
Upon receipt of the IPs, the investigator or delegate must conduct an inventory. During the 
study, designated unmasked study staff must provide the IPs to the subjects in accordance 
with their randomization assignment. Throughout the study, the investigator or delegate must 
maintain records of IP dispensation and collection for each subject. This record must be made 
available to the study monitor for the purposes of verifying the accounting of IP supplies. 
Any discrepancies and/or deficiencies between the observed disposition and the written 
account must be recorded along with an explanation. All IPs sent to the investigator must be 
accounted for by study sponsor personnel, and in no case be used in an unauthorized 
situation. 
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 

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• 
Any study lenses or solutions associated with a device deficiency or with any product-
related adverse event (i.e., ADE or SADE) are returned to the study sponsor for 
investigation, unless otherwise directed by the sponsor. Refer to Section 11 of this 
protocol for additional information on the reporting of device deficiencies and AEs and 
the return of study products associated with these events. 
The investigator is responsible for proper disposition of all unused IPs at the conclusion of 
the study, according to the instructions provided in the MOP. 
9.6 Changes to concomitant medications, treatments/ procedures 
After the subject is enrolled into the study, the investigator must instruct the subject to notify 
the study site about: 
• 
Any new medications  
• 
Alterations in dose or dose schedules for current medications,  
• 
Any medical procedure or hospitalization that occurred or is planned 
• 
Any nondrug therapies (including physical therapy and blood transfusions).  
The investigator must document this information in the subject’s case history source 
documents. 
10 STUDY PROCEDURES AND ASSESSMENTS 
Subjects will be expected to attend 7 office visits, as shown below. 
Visit # 
Visit Type 
Visit Window 
Visit 1 
Screening/Baseline  
N/A 
Visit 2 
Dispense Lens 1 
2 (at least 48 hours) - 4  
days after Visit 1 (Washout 
period with habitual spectacles 
only after Visit 1) 
Visit 3 
Week 1 Follow-up Lens 1  
7 -0/+ 1 days after Visit 2 
Visit 4 
Week 2 Follow- up Lens 1 
7 -0/+ 1 days after Visit 3 

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Visit 5 
Dispense Lens 2 
2 (at least 48 hours) - 4 days 
after Visit 4 (Washout period 
with habitual spectacles only 
after Visit 4) 
Visit 6 
Week 1 Follow-up Lens 2  
7 -0/+ 1 days after Visit 5 
Visit 7 
Week 2 Follow-up Lens 2/Exit 
7 -0/+ 1 days after Visit 6 
 
Unscheduled Visits and Early Exit 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 to determine assigned lens sequence. Subjects will 
be provided the assigned lenses to take home at Visit 2, Visit 3, Visit 5 and Visit 6. 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. 

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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 
Collect medical history information, including information on all medications used within the 
past 30 days. Include herbal therapies, vitamins, and all over-the-counter as well as 
prescription medications. Throughout the subject’s participation, obtain information on any 
changes in medical health and/or the use of concomitant medications. 
Medical History and Concomitant Medications will be collected in the eCRF as outlined in 
the MOP 
10.2.3 Investigational Product Compliance 
Review subject compliance with the IP usage and adjunct product usage and collect all used 
and unused study IPs and other products that were dispensed. 
10.2.4 Adverse Event Collection: Safety Assessment 
Assess and record any adverse events that are observed or reported since the previous visit, 
including those associated with changes in concomitant medication dosing 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. 

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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.  
10.2.7 Best Corrected Visual Acuity: Safety Assessment 
LogMAR visual acuity testing for both eyes must be performed prior to any assessment 
requiring administration of eye drops to dilate the eyes, or any assessment requiring contact 
with the eye.  
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 non-study 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 or concomitant medication 
• 
Biomicroscopy 
• 
Review lens wear calendar 
The investigator may perform additional procedures for proper diagnosis and treatment of the 
subject. The investigator must document this information in the subject’s case history source 
documents. 
If during an unscheduled visit the subject is discontinuing the IP or discontinuing from the 
study, the investigator must conduct Exit procedures according to Table 3-1 Schedule of 
Study Procedures and Assessments and Section 10.4.3, as possible. 

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10.4 Discontinued Subjects 
10.4.1 Screen Failures 
Subjects who were excluded from the study after signing the informed consent and prior to 
randomization to IP. 
The investigator must document the reason for screen failure in the subject’s case history 
source documents. 
Subject numbers must not be reused. 
10.4.2 Discontinuations 
Discontinued subjects are individuals who voluntarily withdraw or are withdrawn from the 
study by the investigator after signing the informed consent, including screen failures.  
Subject numbers of discontinued subjects must not be reused (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. 
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 and the MOP for details. 

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10.5 Clinical Study Termination 
The study sponsor reserves the right to suspend or close the investigational site or suspend or 
terminate the study in its entirety at any time. 
If the clinical study is prematurely terminated or suspended by the study sponsor:  
• 
The study sponsor must: 
o Immediately notify the investigator(s) and subsequently provide 
instructions for study termination. 
o Inform the investigator and the regulatory authorities of the 
termination/suspension and the reason(s) for the termination/suspension.  
• 
The investigator must: 
o Promptly notify the IRB/IEC of the termination or suspension and of the 
reasons.  
o Provide subjects with recommendations for poststudy treatment options as 
needed. 
The investigator may terminate the site’s participation in the study for reasonable cause. 
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. 

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Figure 11-1 
Categorization of All Adverse Events 
ADE
Device /
procedure-
related?
Symptomatic, 
device-related, non 
sight-threatening, 
D/C lens wear?
Meets 
seriousness 
criteria?
SAE
All AEs
AE
Significant     
non-serious AE
Yes
Yes
 
Figure 11-2 
Categorization of All Serious Adverse Events 
All SAEs
Device /
procedure 
related?
SAE
SADE
Anticipated?
Unanticipated 
SADE
No
Yes
No
Anticipated 
SADE
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 

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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 
• 
Hyphema 
• 
Neovascularization within the central 6 mm of the cornea 
• 
Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment 
visit that fails to resolve 
• 
Uveitis (anterior, intermediate, or posterior) 
• 
Corneal abrasion affecting ≥ 50% of corneal surface area 
 
Significant Non-Serious Adverse Events 
A significant non-serious AE is a device-related, non-sight threatening adverse event that 
warrants discontinuation of any contact lens wear for greater than or equal to 2 weeks. In 
addition, the investigator must report any occurrence of the following as a Significant Non- 
Serious Adverse Event: 
• 
Peripheral non-progressive non-infectious ulcers 
• 
All symptomatic corneal infiltrative events 
• 
Corneal staining score greater than or equal to grade 3 (Refer to MOP for grading 
scales) [Grading scale is based on ISO 11980:2012 unless specified differently in 
MOP] 
• 
Temporary vision loss as defined by loss of 2 or more lines of BCVA from enrollment 
visit that persists for 2 or more weeks 
• 
Neovascularization score greater than or equal to grade 2 (Refer to MOP for grading 
scales) [Grading scale is based on ISO 11980:2012 unless specified differently in 
MOP] 

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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 and 
Contact Lens Care Products. 
 
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 
11.2 Monitoring for Adverse Events 
At each visit, after the subject has had the opportunity to spontaneously mention any problems, 
the investigator should inquire about AEs by asking the standard questions shown below and 
report as applicable: 
• 
“Have you had any health problems since your last study visit?” 
• 
“Have there been any changes in the medicines you take because of a new health issue 
since your last study visit?” 
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 or questionnaire response that is 
clinically relevant, in the opinion of the Investigator, is to be reported as an AE. These clinically 
relevant changes will be reported regardless of causality.  
 

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11.3 Procedures for Recording and Reporting 
AEs are collected from the time of informed consent. Any preexisting medical conditions or 
signs/symptoms present in a subject prior to the start of the study (i.e., before informed consent 
is signed) are not considered AEs in the study and should be recorded in the Medical History 
section of the eCRF. 
 
 
 
  
   
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. 
Furthermore, the investigator must document all device deficiencies reported or observed with 
test and control 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: 
• 
ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device 
Effect eCRF within 24 hours of the investigator’s or site’s awareness.  
• 
Device deficiencies are documented on the Device Deficiency eCRF within 24 hours 
of the investigator’s or site’s awareness.  
• 
A printed copy of the completed Serious Adverse Event and Adverse Device Effect 
and/or Device Deficiency eCRF must be included with product returns. 
• 
Additional relevant information after initial reporting must be entered into the eCRF as 
soon as the data become available.   
• 
Document any changes to concomitant medications on the appropriate source form. 
• 
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 msus.safety@Alcon.com 
according to the timelines outlined above; however, the reported information must be entered 
into the EDC system once it becomes operational. 

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In addition to recording all AEs into the EDC system, any AEs and device deficiencies for 
non-study marketed devices/products (e.g., CLEAR CARE® Cleaning & Disinfecting 
Solution used concomitantly during the study will be considered and processed as 
spontaneous following the postmarket 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. 
Note: depending upon the nature of the AE or device deficiency being reported, the study 
sponsor may request copies of applicable portions of the subject’s medical records. The 
investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC. 
Intensity and Causality Assessments 
Where appropriate, the investigator must assess the intensity (severity) of the AE based on 
medical judgment with consideration of any subjective symptom(s), as defined below: 
Intensity (Severity) 
Mild  An AE is mild if the subject is aware of but can easily tolerate the sign or symptom. 
Moderate  
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities. 
Severe  An AE is severe if the sign or symptom is incapacitating and results in the subject’s 
inability to work or engage in their usual activities. 
For every AE in the study, the investigator must assess the causality (related or not related to 
the medical device or study procedure). An assessment of causality will also be performed by 
study sponsor utilizing the same definitions, as shown below: 
Causality 
Related 
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study procedure has 
not been demonstrated, but there is a reasonable possibility that the AE was caused by the 
medical device or study procedure. 

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Not Related  An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (i.e., there are other more likely causes for the AE). 
The study sponsor will assess the AEs and may upgrade the investigator’s assessment of 
seriousness and/or causality. The study sponsor will notify the investigator of any AEs that is 
upgraded from non-serious to serious or from unrelated to related. 
11.4 Return Product Analysis 
Study sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol.  
Alcon study products associated with device deficiencies and/or product related AEs should 
be returned and must include the Complaint # which will be provided by study sponsor after 
the case is entered in the study sponsor’s Global Product Complaint Management System 
(GPCMS).  
11.5 Unmasking of the Study Treatment  
Masked information on the identity of the assigned medical device should not be disclosed 
during the study Reference Section 9.4 for details on masked and unmasked persons. If the 
treatment code needs to be broken in the interest of subject safety, the investigator is 
encouraged to contact an appropriate study sponsor representative prior to unmasking the 
information if there is sufficient time. Dependent upon the individual circumstances (i.e., 
medical emergency), the code may be broken prior to contact with the study sponsor. The 
study sponsor must be informed of all cases in which the code was broken and of the 
circumstances involved. Additionally, the study sponsor may be required to unmask the 
information in order to fulfill expedited regulatory reporting requirements. 
11.6 Follow-Up of Subjects with Adverse Events  
The investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study.  
The investigator should provide the study sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of discontinuation, 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 
completed the study should be documented and available upon the study sponsor’s request. 

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All complaints received after this time period will be considered and processed as 
spontaneous (following the post-market vigilance procedures) and should be communicated 
to the medical device’s manufacturer as per local requirements.  The investigator should also 
report complaints on non-Alcon products directly to the manufacturer as per the 
manufacturer’s instructions or local regulatory requirements. 
11.7 Pregnancy in the Clinical Study 
Women who are pregnant (as stated by the subject) at the time of study entry are 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, standard 
deviation (SD), median, minimum, and maximum, as well as confidence intervals (CIs) or 
confidence limits where applicable. Categorical variables will be summarized with 
frequencies and percentages from each category.  
Any deviations to the analysis plan will be updated during the course of the study as part of a 
protocol amendment or will be detailed in the clinical study report. 
12.1 Subject Evaluability 
Final subject evaluability must be determined prior to breaking the code for masked treatment 
(lens sequence) assignment and locking the database, based upon the Deviations and 
Evaluability Plan (DEP). 
12.2 Analysis Sets 
12.2.1 Safety Analysis Set 
Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. 
As such, the safety analysis set will include all subjects/eyes exposed to any study lenses 
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. 

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12.2.2 Full Analysis Set 
The full analysis set (FAS) is the set of all randomized subjects who are exposed to any study 
lenses
 
 evaluated in this study. 
12.2.3 Per Protocol Analysis Set 
The per protocol (PP) analysis set is a subset of FAS and excludes all data/subjects that have 
met any of the critical deviation or evaluability criteria identified in the DEP.  
12.3 Demographic and Baseline Characteristics 
Demographic information will be summarized by lens sequence and overall. Frequencies and 
percentages will be presented for categorical variables such as sex, age group, race, and 
ethnicity. Number of observations, mean, SD, median, minimum, and maximum will be 
presented for continuous variables such as age. 
12.4.1 Analysis of Primary Effectiveness Endpoint(s) 
The primary objective of this study is to demonstrate noninferiority in the VA at distance 
when wearing Alcon serafilcon A contact lenses compared to AOHP contact lenses when 
worn on a daily wear modality. 
The primary endpoint is distance VA with study lenses at Week 1, collected for each eye in 
logMAR. 

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12.4.1.1 Statistical Hypotheses 
The null and alternative hypotheses are formulated in terms of the predefined margin of 0.05 
for noninferiority:  
H0: µ(T) – µ(C) ≥ 0.05  
Ha: µ(T) – µ(C) < 0.05  
where µ(T) and µ(C) denote the mean distance VA at Week 1 for Alcon serafilcon A and AOHP, 
respectively, on the logMAR scale. 
12.4.1.2 Analysis Methods 
A mixed effects repeated measures model will be utilized to test these hypotheses. The model 
will include terms for lens, period, sequence, visit, and lens by visit interaction. Within 
subject correlation due to eye and crossover will also be accounted for in the model. Lens 
difference (Alcon serafilcon A minus AOHP) and the corresponding one-sided 95% upper 
confidence limit (UCL) will be computed at Week 1. Noninferiority will be declared if the 
UCL is less than 0.05. 

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12.5 Handling of Missing Data 
All data obtained in evaluable subjects/eyes will be included in the analysis. No imputation 
for missing values will be carried out for
 
 
12.6 Safety Analyses 
The safety endpoints are:  
• 
AEs  
• 
Biomicroscopy findings  
• 
Device Deficiencies  
There are no safety hypotheses planned in this study. The focus of the safety analysis will be 
a comprehensive descriptive assessment of occurrence of adverse events as well as the other 
listed parameters.  
All AEs occurring from the time a subject signs informed consent to study exit will be 
accounted for in the reporting. Safety analyses will be conducted using the safety analysis set 
on a treatment-emergent basis. Descriptive summaries (frequencies and percentages) for 
ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities 
Preferred Terms. AEs leading to study discontinuation and SAEs will be identified. Individual 
subject listings will be provided, as necessary.  
Individual subject listings will be provided for AEs that occur after signing informed consent 
but prior to exposure to IP.  
Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy 
parameter, counts and percentages of eyes that experience an increase of ≥ 2 grades from 
baseline (last assessment prior to study lens exposure) to any subsequent visit within the 
same period will be presented. A supportive listing will be generated which will include all 
biomicroscopy data from all visits within the same period for those eyes experiencing the 
increase.  
Two listings for device deficiencies, prior to exposure to study contact lenses and treatment-
emergent, will be provided. Additionally, each device deficiency category will be tabulated.  

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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 
Sample size calculation is based on a prior clinical study 
) which evaluated 
performance of Alcon serafilcon A and AOHP. 

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13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS 
13.1 Subject Confidentiality 
The investigator must ensure that the subject’s identity is kept confidential throughout the 
course of the study. In particular, the investigator must keep an enrollment log with 
confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. The study sponsor may collect a copy of the enrollment log without 
any directly identifying subject information.  
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 

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• 
Date of informed consent 
• 
Dates of visits 
• 
Documentation that protocol specific procedures were performed 
• 
Results of study parameters, as required by the protocol 
• 
IP accountability records 
• 
Documentation of AEs and other safety parameters (if applicable) 
• 
Records regarding medical histories and the use of concomitant therapies prior to and 
during the study 
• 
Date of study completion and reason for early discontinuation, if applicable 
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the CRF are consistent with the original source data. 
Only designated individuals at the site will complete the CRFs. The CRFs must be completed 
at regular intervals following the clinical study visit schedule. It is expected that all data 
reported have corresponding entries in the source documents. The principal investigator is 
responsible for reviewing and certifying that the CRFs are accurate and complete. The only 
subject identifiers recorded on the CRFs will be subject number, and subject demographic 
information.  
13.3 Data Review and Clarifications 
A review of CRF data to the subject’s source data will be completed by the site monitor to 
ensure completeness and accuracy. After the CRFs have been completed, additional data 
clarifications and/or additions may be needed as a result of the data cleaning process. Data 
clarifications are documented and are part of each subject’s CRF. 
13.4 Sponsor and Monitoring Responsibilities 
The study sponsor will select principal investigators that are qualified by education, training, 
and experience to assume responsibility for the proper conduct of this clinical trial.  
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. 

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The study sponsor will designate a monitor to conduct the appropriate site visits at the 
appropriate intervals according to the study monitoring plan. The clinical investigation will 
be monitored to ensure that the rights and well-being of the subjects are protected, the 
reported data are accurate, complete, and verifiable from the source documents, and the study 
is conducted in compliance with the current approved protocol (and amendments[s], if 
applicable), with current GCP, and with applicable regulatory requirements. 
The site may not screen subjects or perform the informed consent process on any subject until 
it receives a notification from an appropriate study sponsor representative that the site may 
commence conducting study activities. Monitoring will be conducted periodically while the 
clinical study is ongoing. Monitoring methods may include site visits, telephone, written and 
fax correspondence. Close out visits will take place after the last visit of the last subject at the 
site. 
A coordinating investigator may be identified by the study sponsor to review and endorse the 
final study report. In cases where a coordinating investigator is engaged, the study sponsor 
will select the coordinating investigator based upon their experience, qualifications, active 
study participation, and their willingness and availability to take on this role. 
13.5 Regulatory Documentation and Records Retention 
The investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the study sponsor and the investigator’s files will be reviewed as part of the 
ongoing study monitoring. Financial information is to be kept separately.  
Additionally, the investigator must keep study records and source documents consistent with 
the terms of the clinical study agreement with the study sponsor. If the investigator retires, 
relocates, or for any other reason withdraws from responsibility of keeping the study records, 
then the study sponsor must be notified, and suitable arrangements made for retention of 
study records and source documents needed to comply with national and international 
regulations. 
13.6 Quality Assurance and Quality Control 
The study sponsor will secure agreement from all involved parties to ensure direct access to 
all study related sites, source data and documents, and reports for the purpose of monitoring 
and auditing by the study sponsor, and inspection by domestic and foreign regulatory 
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 

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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 and Good Clinical Practices 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 
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 informed consent form, any other written 
information given to subjects, and any advertisements planned for subject recruitment must 
be approved by an IRB/IEC. The investigator must provide documentation of the IRB/IEC 
approval to the study sponsor. The approval must be dated and must identify the applicable 
protocol, amendments (if any), informed consent form, assent form (if any), all applicable 
recruiting materials, written information for subject, and subject compensation programs. The 
IRB/IEC must be provided with a copy of the Package Insert, any periodic safety updates, 
and all other information as required by local regulation and/or the IRB/IEC. Any additional 
requirements imposed by the IEC 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 

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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 
subject’s medical records) and must provide a duplicate copy to each subject according to 
local regulations.  
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 

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• 
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 

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