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

 
 
 
 
 
Clinical Performance of Two Reusable Silicone Hydrogel 
Contact Lenses 
 
 
 
STUDY ID:  
CLL949‐E005 
 
 
PROTOCOL 
 
 
NCT05431478 
 
 

Document ID: 
V-CLN-0028661 
Status: Approved, Version: 4.0 
Approved Date: 08 Jul 2022 
Page 1 of 42 
 
Alcon – Business Use Only 
 
 
 
Vision Care SEE Protocol for CLL949-E005 
Title: Clinical Performance of Two Reusable Silicone Hydrogel Contact 
Lenses 
 
Sponsor Name and 
Address: 
Alcon Research, LLC and its affiliates (“Alcon”) 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
Test Product(s): 
Alcon serafilcon A contact lenses 
 
 
 
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: 4.0 
Approved Date: 08 Jul 2022 
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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 Practice 
(GCP), the ethical principles contained within the Declaration of Helsinki, this 
protocol, all applicable regulatory authority regulations, and conditions of approval 
imposed by the reviewing IRB or regulatory authority. 
• I will supervise all testing of the device involving human subjects and ensure that 
the requirements relating to obtaining informed consent and IRB review and 
approval are met in accordance with applicable local and governmental regulations. 
• I have read and understand the appropriate use of the investigational product(s) as 
described in the protocol, current Investigator’s Brochure, product information, or 
other sources provided by the sponsor. 
• I understand the potential risks and side effects of the investigational product(s). 
• I agree to maintain adequate and accurate records in accordance with government 
regulations and to make those records available for inspection. 
• I agree to comply with all other requirements regarding the obligations of clinical 
investigators and all other pertinent requirements of the sponsor and government 
agencies. 
• I agree to ensure that all associates, colleagues, and employees assisting in the 
conduct of the study are informed of their obligations in meeting the above 
commitments. 
Have you ever been disqualified as an investigator by any Regulatory Authority? 
 No        Yes 
Have you ever been involved in a study or other research that was terminated? 
 No        Yes 
If yes, please explain here: 
 
 
Principal Investigator: 
 
Signature 
 
 
 
 
 
Date 
Name and professional 
position: 
 
Address: 
 
 

Document ID: 
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Status: Approved, Version: 4.0 
Approved Date: 08 Jul 2022 
Page 3 of 42 
 
Alcon – Business Use Only 
1 PROTOCOL SYNOPSIS 
Trial Sponsor 
Alcon  
6201 South Freeway 
Fort Worth, Texas 76134-2099 
Name of Test Product(s) 
Alcon serafilcon A contact lenses 
Name of Comparator 
Product(s) 
ACUVUE OASYS® 2 Week with HYDRACLEAR® PLUS 
Title of Trial 
Clinical Performance of Two Reusable Silicone Hydrogel 
Contact Lenses 
Protocol Number 
CLL949-E005 
Number of Sites 
Country 
~5 
US 
Clinical Investigation Type 
 
 Early Feasibility 
 Traditional Feasibility 
 Pivotal (premarket monadic claims) 
 Postmarket Interventional / Confirmatory 
 Postmarket Noninterventional / Observational 
Planned Duration of 
Exposure  
~28 days total duration (test, comparator) with wash-out 
Test Product: ~14 days 
Comparator Product: ~14 days 
Number of Subjects  
Target to complete: 60 
Planned to enroll: ~68 
Study Population 
Volunteer subjects aged 18 or over who are habitual 
spherical soft contact lens wearers (excluding 
current/previous Acuvue Oasys 2 Week with Hydraclear 
Plus (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.  
 
 
 
 
 
 
 
Objective(s) 
The objective of this study is to assess the clinical 
performance of two reusable silicone hydrogel contact 
lenses when worn on a daily wear modality. 

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Endpoints 
 
Primary Effectiveness 
• Visual acuity with study lenses at Week 1 Follow-Up 
Safety 
• Adverse Events 
• Biomicroscopy findings 
• Device deficiencies 
Assessments 
 
Effectiveness 
• VA with study lenses (logMAR distance) 
• Manifest refraction 

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Safety 
• AEs 
• Biomicroscopy 
• Device deficiencies 
Study Design 
 
 Prospective 
 Single-masked  
(trial subject) 
 Single-masked 
(investigator) 
 Double-masked 
 Open-label 
 Other 
 Single group 
 Parallel group 
 Crossover 
 Other 
 Contralateral 
 Bilateral 
 Monocular lens wear 
 Randomized 
Test Product Details 
 
Primary 
component/material 
serafilcon A 
Product Name 
Alcon serafilcon A contact 
lenses 
LID Number 
LID022821 
Manufacturer 
Alcon Laboratories, Inc. 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
USA 
Rx Power Range 
-1.00 to -6.00 D in 0.25 steps 
Comparator Product 
Details 
 
Primary 
component/material 
senofilcon A 
Product Name 
Acuvue Oasys 2 Week with 
Hydraclear Plus (AOHP) 
LID Number 
N/A 
Manufacturer 
Johnson & Johnson 
Rx Power Range 
-1.00 to -6.00 D in 0.25 steps 
Other  
Base Curve: 8.4 mm and 8.8 
mm 
Inclusion Criteria 
 
1. Subject must be at least 18 years of age.  

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2. Subject must be able to understand and must sign an ICF 
that has been approved by an IRB. 
3. Successful wear of spherical soft contact lenses in both 
eyes for a minimum of 5 days per week and 8 hours per 
day during the past 3 months. 
4. Manifest cylinder of ≤ 0.75 D in each eye. 
5. BCVA 20/25 Snellen (0.10 logMAR) or better in each 
eye. 
6. Subject must be willing to stop wearing their habitual 
contact lenses for the duration of study participation. 
7. Able to wear contact lenses within a range of sphere 
power from -1.00 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 able to be successfully fit with test and 
comparator lenses. 
Exclusion Criteria 
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. 

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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. 
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/or current 
habitual wearers of any daily disposable contact lenses. 
15. Currently pregnant, as stated by the subject. 
Associated Materials 
• CLEAR CARE® Cleaning & Disinfecting Solution 
supplied by sponsor to be provided to subjects for use 
during the study. 
• Lubrication/re-wetting drops will not be permitted. 

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Lens 1 
(Period 1) 
Lens 2 
(Period 2) 
 
 
Procedure/ Assessment 
Pre-
screeni
ng 
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 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)]  
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)]  
Early 
Exit 
 
Unscheduled 
Visit 

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Lens 1 
(Period 1) 
Lens 2 
(Period 2) 
 
 
Procedure/ Assessment 
Pre-
screeni
ng 
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 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)]  
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)]  
Early 
Exit 
 
Unscheduled 
Visit 

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(X) assessment performed as necessary, e.g., reduction of VA by 2 lines or more with investigational product (IP) 

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1.1 Abbreviations 
Abbreviation 
Definition 
ADE 
Adverse device effect 
AE 
Adverse event 
AOHP 
Acuvue Oasys 2 Week with Hydraclear Plus 
ASADE 
Anticipated serious adverse device effect 
BCVA 
Best corrected visual acuity 
CFR 
Code of Federal Regulations 
CIP 
Clinical investigation plan 
eCRF 
Electronic case report form 
D 
Diopter(s) 
D/C 
Discontinue 
EDC 
Electronic data capture 
FDA 
US 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 
LID 
Lens identification 
LogMAR 
Logarithm of the minimum angle of resolution 
 
 
MOP 
Manual of Procedures 
N/A 
Not applicable 
OD 
Right eye 
OS 
Left eye 
OU 
Both eyes 
SAE 
Serious adverse event 
SADE 
Serious adverse device effect 
SiHy 
Silicon hydrogel 
US or USA 
United States of America 
USADE 
Unanticipated serious adverse device effect 
VA 
Visual acuity 
 
 
 
 

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2 TABLE OF CONTENTS 
Vision Care SEE Protocol for CLL949-E005 ............................................................................ 1 
1 
PROTOCOL SYNOPSIS .................................................................................................... 3 
1.1 
Abbreviations..................................................................................................... 15 
2 
TABLE OF CONTENTS ................................................................................................... 16 
List of Tables ............................................................................................................................ 17 
List of Figures .......................................................................................................................... 18 
3 
INTRODUCTION ............................................................................................................. 19 
3.1 
Study Rationale and Purpose ............................................................................. 19 
3.2 
Trial Objective ................................................................................................... 19 
3.3 
Risks and Benefits ............................................................................................. 19 
3.4 
Subject Population ............................................................................................. 20 
3.5 
Outline of Study................................................................................................. 20 
4 
TREATMENTS ADMINISTERED................................................................................... 20 
4.1 
Identity of Study Treatments ............................................................................. 21 
4.2 
Accountability Procedures ................................................................................. 23 
4.3 
Worn Lens Collection, Storage and Return ....................................................... 23 
5 
STUDY PROCEDURES AND ASSESSMENTS ............................................................. 23 
5.1 
Unscheduled Visits ............................................................................................ 23 
5.2 
Discontinued Subjects ....................................................................................... 24 
5.3 
Clinical Study Termination ................................................................................ 24 
6 
ANALYSIS PLAN ............................................................................................................ 25 
6.1 
Subject Evaluability ........................................................................................... 25 
6.2 
Analysis Data Sets ............................................................................................. 25 
6.2.1 
Safety Analysis Set ............................................................................ 25 
6.3 
Demographic and Baseline Characteristics ....................................................... 26 
6.4 
Effectiveness Analyses ...................................................................................... 26 
6.4.1 
Primary Effectiveness ........................................................................ 26 
6.4.1.1 
Statistical Hypotheses ........................................................ 26 
6.4.1.2 
Analysis Methods............................................................... 26 
 
 
 
 

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6.5 
Subgroup Analyses ............................................................................................ 27 
6.6 
Handling of Missing Data .................................................................................. 27 
6.7 
Multiplicity ........................................................................................................ 27 
6.8 
Safety Analysis .................................................................................................. 27 
6.9 
Interim Analyses ................................................................................................ 28 
6.10 Sample Size Justification ................................................................................... 28 
7 
ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 28 
7.1 
General Information .......................................................................................... 31 
7.2 
Monitoring for Adverse Events ......................................................................... 34 
7.3 
Procedures for Recording and Reporting .......................................................... 35 
7.4 
Return product analysis ..................................................................................... 37 
7.5 
Follow-Up of Subjects with Adverse Events ..................................................... 37 
7.6 
Pregnancy in the Clinical Study ........................................................................ 37 
8 
CONFIDENTIALITY, BIAS, AND MASKING ............................................................... 38 
8.1 
Subject Confidentiality and Methods Used to Minimize Bias .......................... 38 
8.2 
Unmasking of the Study Treatment ................................................................... 38 
9 
DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ............................... 39 
9.1 
Completion of Source Documents and Case Report Forms .............................. 39 
9.2 
Data Review and Clarifications ......................................................................... 40 
9.3 
Regulatory Documentation and Records Retention .......................................... 40 
10 ETHICS AND COMPLIANCE ......................................................................................... 40 
10.1 Compliance ........................................................................................................ 40 
10.2 Institutional Review Board (IRB)...................................................................... 40 
11 PROTOCOL AMENDMENT HISTORY .......................................................................... 41 
12 REFERENCES .................................................................................................................. 42 
13 APPENDIX ....................................................................................................................... 42 
 
List of Tables 
Table 1-1 
Schedule of Study Procedures and Assessments ............................................... 8 
 

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List of Figures 
Figure 7–1 
Categorization of All AEs ................................................................................ 32 
Figure 7-2 
Categorization of All Serious Adverse Events ................................................. 32 
 
 
 
 

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3 INTRODUCTION 
3.1 Study Rationale and Purpose 
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 with marketed AOHP contact lenses. 
 
 
 
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). 
 
 
 
 
.  
3.2 Trial Objective 
The objective of this study is to assess the clinical performance of two reusable silicone 
hydrogel contact lenses when worn on a daily wear modality. 
3.3 Risks and Benefits 
Contact lenses may offer improved peripheral vision and the convenience of not wearing 
spectacles. Material properties and design characteristics of the Alcon serafilcon A contact 
lens are features consistent with successful contact lens wear. 
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. 
3.4 Subject Population 
The study population includes approximately 68 volunteer subjects to be enrolled at 
approximately 5 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.  
Subjects must be screened according to the full list of inclusion/exclusion criteria in Section 1 
of this protocol.  
Rescreening of subjects is not allowed in this study. 
3.5 Outline of Study 
This will be a multi-site, prospective, randomized, double-masked, bilateral, crossover study 
comparing 2 reusable soft contact lenses. The expected duration of subject participation in the 
study 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 of 2 (at least 48 hours) to 4 days after Visit 1 and after Visit 4.   
4 TREATMENTS ADMINISTERED 
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 

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Sequence 2 
AOHP/LID022821 
AOHP/Alcon serafilcon A 
 
4.1 Identity of Study Treatments 
DESCRIPTION OF TEST AND COMPARATOR PRODUCTS 
 
Test 
Comparator 
LID Number 
LID022821 
N/A 
Lens 
Alcon serafilcon A contact 
lenses 
Acuvue Oasys 2 Week with 
Hydraclear Plus (AOHP) 
contact lenses 
Material 
serafilcon A 
senofilcon A 
Water Content 
55 ± 2% 
38% 
Base Curve (mm) 
8.4 mm (Targeted) 
8.4 mm and 8.8 mm 
Diameter (mm) 
14.2 mm (Targeted) 
14.0 mm 
Packaging, Labeling, and 
Supply 
• Blister foil pack 
• Foil label includes at a 
minimum: 
- 
material name 
and/or 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 
~ 25 lenses per power 
per package, identified 
with the following at a 
minimum: 
• Commercial packaging 
• Commercial foil 
• Lenses should be stored at 
room temperature. 

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- 
a color coded 
label stating the 
protocol number 
- 
LID number 
- 
power 
- 
an investigational 
use only 
statement 
- 
handling unit. 
• Lenses should be stored 
at room temperature. 
Usage 
• Wear:  
o Daily Wear  
o Bilateral 
• Replacement period:  
o Test: ~7-day replacement 
o Comparator: ~14-day replacement  
o The unmasked staff must maintain the subject and 
Investigator masking to the study product being 
used. 
• 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 day (-0/+1) for test and 14 day (-0/+1) 
for comparator, according to randomization assignment). 
• Lens Care: Cleaned and disinfected with CLEAR CARE 
Cleaning & Disinfecting Solution after each use. 

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Comparator lens 
procurement 
• Sites will procure the comparator product.  
 
4.2 Accountability Procedures 
Upon receipt of the study lenses, the investigator or delegate will conduct an inventory. 
Designated study staff will provide the study lenses to the subjects in accordance with their 
randomization schedule. Throughout the study, the investigator or delegate must maintain 
records of study treatment dispensation and collection for each subject. This record must be 
made available to the study monitor for the purposes of verifying the accounting of clinical 
supplies. Any discrepancies and/or deficiencies between the observed disposition and the 
written account must be recorded along with an explanation.  
The investigator should make every effort to collect unused lenses, foils, and supplies from 
subjects. 
It is the investigator’s responsibility to ensure that: 
• All study products are accounted for and not used in any unauthorized manner. 
• All unused products are available for return to the Study sponsor, as directed. 
• Any study lenses associated with a device deficiency or with any product-related 
adverse event [i.e., ADE or SADE] are returned to the study sponsor for investigation. 
Refer to Section 7.3 of this protocol for additional information on the reporting of 
device deficiencies and AEs and the return of study products associated with these 
events. 
4.3 Worn Lens Collection, Storage and Return 
Worn lenses from designated sites are to be returned to the study sponsor as indicated in the 
MOP. 
5 STUDY PROCEDURES AND ASSESSMENTS 
5.1 Unscheduled Visits 
Any visit that occurs between regularly scheduled visits is an Unscheduled Visit. If a subject 
requires an Unscheduled Visit, he/she must be advised to return to the office wearing the 
study lenses, if at all possible (unless he/she is experiencing a sign or symptom [as indicated 

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in Section 3.3 Risks and Benefits]). During all unscheduled visits, the investigator must 
conduct all procedures specified in Table 1-1 Schedule of Study Procedures and Assessments.  
The investigator may perform additional procedures for proper diagnosis and treatment of the 
subject. The investigator must document this information in the subject’s source documents. 
If during an Unscheduled Visit the subject is discontinuing from the study, the investigator 
must refer to 5.2 Discontinued Subjects. 
Unplanned Lens Replacement is to be used in the event of a device deficiency or if a lens is 
lost or damaged, so as to maintain lens wear until the follow-up visit. 
5.2 Discontinued Subjects 
Discontinued subjects are those who withdraw or are withdrawn from the study after signing 
the informed consent, including screen failures. Subjects may discontinue from the study at 
any time for any reason. Subjects may also be discontinued from the study at any time if, in 
the opinion of the investigator, their continued participation poses a risk to their health. 
Discontinued subjects will not be replaced (i.e., their subject numbers will not be 
reassigned/reused). 
Should a subject exhibit any clinically relevant signs, symptoms, or other clinical 
observations that possibly could be associated with suspected sensitivity or intolerance to one 
of the study treatments, the investigator must document those observations on an AE Form. 
Any subject who exits early from the study (excluding screen failures) must undergo all 
procedures outlined in Table 1-1, as possible. 
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. 
5.3 Clinical Study Termination 
The study sponsor reserves the right to close the investigational site or terminate the study in 
its entirety at any time, for reasonable cause. 
If the clinical study is prematurely terminated or suspended by the study sponsor:  

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• 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, 
as applicable.  
• The investigator must: 
o Promptly notify the IRB of the termination or suspension and of the 
reasons.  
o Provide subjects with recommendations for poststudy treatment options as 
needed. 
The investigator may terminate a site’s participation in the study for reasonable cause. 
6 ANALYSIS PLAN 
Continuous variables will be summarized using the number of observations, mean, standard 
deviation, median, minimum, and maximum. Categorical variables will be summarized with 
frequencies and percentages from each category.  
Any deviations to this analysis plan will be updated during the course of the study as part of a 
protocol amendment or will be detailed in the clinical study report. 
6.1 Subject Evaluability 
The final subject evaluability will be determined prior to breaking of the code for masked 
treatment (lens) sequence assignment and locking the database, based on the Deviations and 
Evaluability Plan. 
6.2 Analysis Data Sets 
6.2.1 
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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6.3 Demographic and Baseline Characteristics 
Demographic information (age, sex, ethnicity, race) will be summarized on the Safety 
Analysis Set. Baseline data pertaining to habitual lenses, BCVA, and keratometry readings 
will be summarized on the Safety Analysis Set as well. 
6.4 Effectiveness Analyses 
. The Safety 
Analysis Set will be used for all effectiveness analyses. 
Select effectiveness endpoints will also be summarized by period.  
6.4.1 
Primary Effectiveness 
The objective of this study is to assess the clinical performance of two reusable SiHy contact 
lenses when worn on a daily wear modality. The primary endpoint is VA with study lenses at 
Week 1 Follow-Up, collected at distance for each eye in logMAR. 
6.4.1.1 
Statistical Hypotheses 
No inferences are to be made on the primary effectiveness endpoint; therefore, no hypotheses 
are formulated. 
6.4.1.2 
Analysis Methods 
Descriptive statistics will be provided, at each visit.  

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6.5 Subgroup Analyses 
It is not expected that demographics or baseline characteristics will have an impact on the 
study results in this study. No subgroup analyses are planned. 
6.6 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. 
6.7 Multiplicity 
No multiplicity adjustment needs to be considered for the effectiveness endpoints since no 
formal hypothesis testing will be conducted 
6.8 Safety Analysis 
The safety endpoints for this study are AEs, biomicroscopy findings, and device deficiencies. 
All AEs occurring from the time a subject signs informed consent to study exit will be 
accounted for in the reporting. 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, significant nonserious AEs, and SAEs 
will be identified. Individual subject listings will be provided, as necessary. 

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Individual subject listings will be provided for AEs that occur after signing informed consent 
but prior to exposure to study lenses. 
Each biomicroscopy parameter will be tabulated by its grade. For each applicable 
biomicroscopy parameter, frequencies 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 these eyes 
experiencing the increase. 
Two listings (prior to exposure of study lenses and treatment-emergent) of device 
deficiencies, as recorded on the Device Deficiency Form, will be provided. Additionally, each 
device deficiency category will be tabulated.  
No inferential testing will be done for safety analysis.  
6.9 Interim Analyses 
There are no plans to conduct an interim analysis, and no criteria by which the study would 
be terminated early based upon statistical determination. 
6.10 Sample Size Justification 
No formal sample size calculation is provided given the descriptive nature of the study 
7 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
Terms and Definitions 
Adverse Event (AE) 
 
Untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device or comparator and whether 
anticipated or unanticipated. 
Note: For subjects, this definition includes events related to the 
investigational medical device, comparator, or the procedures 
involved. For users or other persons, this definition is restricted to 
the use of investigational medical devices or comparator. 

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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.  
Anticipated Serious 
Adverse Device 
Effect (ASADE) 
 
An effect which by its nature, incidence, severity, or outcome has 
been identified in the risk assessment. 
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. 
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. 
Serious Adverse 
Device Effect 
(SADE) 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
Serious Adverse 
Event (SAE) 
 
Adverse event that led to any of the following:  
• Death. 
• A serious deterioration in the health of the subject, 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 

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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) in-patient 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 Section7.1 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. 
Significant 
Nonserious Adverse 
Event 
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 7.1 for additional Significant Nonserious AEs. 
Unanticipated 
Serious Adverse 
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has not been identified in the risk assessment. 

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Device Effect 
(USADE) 
 
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. 
 
7.1 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 7–1 
Categorization of All AEs 
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
No
No
Yes
Yes
Yes
 
 
Figure 7-2 
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 nonserious) meeting the definitions, the 
investigator must report any occurrence of the following as an SAE: 

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• 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 
• 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 Nonserious Adverse Events 
A significant nonserious AE is a symptomatic, device-related, non-sight-threatening AE 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 
Nonserious AE: 
• Peripheral nonprogressive noninfectious ulcers 
• All symptomatic corneal infiltrative events 
• Corneal staining score greater than or equal to Grade 3 (Refer to MOP for grading 
scales)  
• Temporary vision loss as defined by loss of 2 or more lines of BCVA from enrollment 
visit that persists for 2 or more weeks 

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• Neovascularization score greater than or equal to Grade 2  
The above events are based upon 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 
7.2 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?” 
Additionally, changes in any protocol-specific parameters and/or questionnaires 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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7.3 Procedures for Recording and Reporting 
AEs are collected from the time of informed consent. Any preexisting medical conditions or 
signs/symptoms present in a subject prior to the start of the study (i.e., before informed 
consent is signed) are not considered AEs in the study and should be recorded in the Medical 
History section of the eCRF. 
In addition, temporary lens awareness or visual changes during the fitting process are not 
considered AEs if the investigator assesses that the symptom(s) can reasonably resolve within 
the anticipated adaptation period.  
For each recorded event, the ADEs and SAEs documentation must include: date of 
occurrence, severity, treatment (if applicable), outcome, and assessments of the seriousness 
and causality. In addition, the investigator must document all device deficiencies reported or 
observed with test and comparator products on the Device Deficiency eCRF. The site must 
submit all available information on ADEs, SAEs, and device deficiencies to the study sponsor 
immediately as follows: 
• 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 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 nonoperational, the site must complete the appropriate 
paper Serious Adverse Event and Adverse Device Effect and/or Device Deficiency Form. The 
completed form is emailed to the study sponsor at msus.safety@alcon.com 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 nonstudy marketed devices/products (i.e., CLEAR 
CARE Cleaning & Disinfecting Solution) will be considered and processed as spontaneous 

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(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. 
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 upon 
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. 
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). 

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The study sponsor will assess the AEs and may upgrade the investigator’s assessment of 
seriousness and/or causality. The study sponsor will notify the investigator of any AEs that 
are upgraded from nonserious to serious or from unrelated to related. 
7.4 Return product analysis 
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. These 
products should be returned to the sponsor at the end of the study, unless instructed otherwise 
by the sponsor.  
7.5 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 
discontinuation or 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 1 month after subject discontinuation or exit must be 
documented and available upon the study sponsor’s request. All complaints received after this 
time period will be considered and processed as spontaneous 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. 
7.6 Pregnancy in the Clinical Study 
Women who are pregnant at the time of study entry are excluded from participation. 
However, pregnancy should be included in the pregnancy eCRF when a woman becomes 
pregnant during the study. Pregnancy is not reportable as an AE; however, complications may 
be reportable and will be decided on a case–by-case basis. 

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8 CONFIDENTIALITY, BIAS, AND MASKING 
8.1 Subject Confidentiality and Methods Used to Minimize Bias 
The investigator must ensure that the subject’s anonymity is maintained throughout the 
course of the study. In particular, the investigator must keep an enrollment log with 
confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. All documents submitted to the sponsor will identify the subjects 
exclusively by number and demographic information. No other personally identifying 
information should be transmitted to the sponsor. 
This study is double-masked with subjects randomized to use Alcon serafilcon A or AOHP 
contact lens for the duration of 2-week treatment period.  
The investigator and sponsor personnel (other than site monitors, clinical operations lead, 
person responsible for generating the randomization schedule, and unmasked clinical data 
managers) involved in reporting, obtaining, and/or reviewing the clinical evaluations will be 
masked to the identity of the contact lens being administered. 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.  
8.2 Unmasking of the Study Treatment 
Masked information on the identity of the assigned medical device should not be disclosed 
during the study. In the event of a medical emergency where the knowledge of subject 
treatment is required, individual investigator(s) will have the ability to unmask the treatment 
assignment for a specific subject. If time allows, the appropriate study sponsor representative 
should be contacted prior to unmasking. 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. 

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9 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS 
9.1 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 eCRFs exist and are accessible for verification by the site monitor, 
and all discrepancies shall be appropriately documented via the query resolution process. 
Study 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 should include the following information for each subject: 
• Subject identification (name, sex, race/ethnicity) 
• Documentation of subject eligibility 
• Date of informed consent 
• Dates of visits 
• Documentation that protocol specific procedures were performed 
• Results of study parameters, as required by the protocol 
• IP accountability records 
• Documentation of AEs and other safety parameters (if applicable) 
• Records regarding medical histories and the use of concomitant therapies prior to and 
during the study 
• Date of study completion and reason for early discontinuation, if applicable 
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the eCRF are consistent with the original source data. 
Only designated individuals may complete the eCRFs. The eCRFs will be submitted at 
regular intervals following the clinical study visit schedule. It is expected that all data 
reported will have corresponding entries in the source documents. The principal investigator 
is responsible for reviewing and certifying that the eCRFs are accurate and complete. The 
only subject identifiers recorded on the eCRFs will be subject number and subject 
demographic information. 

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9.2 Data Review and Clarifications 
Upon completion of the eCRFs, a targeted review of the eCRF data to the subject’s source 
data will be completed by the site monitor to ensure completeness and accuracy. 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 eCRFs. 
9.3 Regulatory Documentation and Records Retention 
The investigator is required to maintain up-to-date, complete regulatory documentation as 
indicated by the sponsor and the investigator’s files will be reviewed as part of the ongoing 
study monitoring. Financial disclosure is not subject to regulatory inspection and should be 
kept separately.  
Additionally, the investigator must keep study records and source documents until the 
sponsor provides written approval for their destruction. If the investigator retires, relocates, or 
for any other reason withdraws from responsibility of keeping the study records, the sponsor 
must be notified, and suitable arrangements made for retention of study records and source 
documents needed to comply with national and international regulations (generally 2 years 
after discontinuing clinical development or after the last marketing approval). 
10 ETHICS AND COMPLIANCE 
This trial will be conducted in accordance with the ethical principles that have their origin in 
the Declaration of Helsinki and the referenced directives, regulations, guidelines, and/or 
standards. 
10.1 Compliance 
The investigator must ensure that all personnel involved in the conduct of the study are 
qualified to perform their assigned responsibilities through relevant education, training, and 
experience. The investigator and all clinical study staff must conduct the clinical study in 
compliance with the protocol. Deviations from this protocol, regulatory requirements, and/or 
GCP must be recorded and reported to the sponsor prior to database lock. If needed, 
corrective and preventive action should be identified, implemented, and documented within 
the study records. 
10.2 Institutional Review Board (IRB) 
This trial requires IRB approval prior to initiation. This protocol, subject informed consent, 
and subsequent amendments will be reviewed and approved by an IRB. 

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Before clinical study initiation, this protocol, the ICF (and assent form, if applicable), any 
other written information given to subjects, and any advertisements planned for subject 
recruitment must be approved by an IRB. The investigator must provide documentation of 
the IRB approval to the study sponsor. The approval must be dated and must identify the 
applicable protocol, amendments (if any), ICF, assent form (if any), all applicable recruiting 
materials, written information for subject, and subject compensation programs. The IRB must 
be provided with a copy of the Investigator’s Brochure, any periodic safety updates, and all 
other information as required by local regulation and/or the IRB. At the end of the study, the 
investigator must notify the IRB about the study’s completion. The IRB also must be notified 
if the study is terminated prematurely. Finally, the investigator must report to the IRB on the 
progress of the study at intervals stipulated by the IRB. 
Voluntary informed consent must be obtained from every subject (and/or legal representative, 
as applicable) prior to the initiation of any screening or other study-related procedures. The 
investigator must have a defined process for obtaining consent. Specifically, the investigator, 
or 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, 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 and must provide a duplicate copy to each 
subject according to local regulations. Following this study, the subject will return to their 
eye care professional for their routine eye care and contact lenses. 

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12 REFERENCES 
The following are references that 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 
• 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 
13 APPENDIX 
Not applicable.