Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses
Phase: NA
Conditions: Refractive Errors, Ametropia
Sponsor: Alcon Research



Document ID: 
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Status: Approved, Version: 6.0 
Approved Date: 19 Feb 2021 
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Investigator Agreement: 
• I have read the clinical study described herein, recognize its confidentiality, and 
agree to conduct the described trial in compliance with Good Clinical 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: 
 
 

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1 PROTOCOL SYNOPSIS 
Trial Sponsor 
Alcon Research, LLC 
6201 South Freeway 
Fort Worth, Texas 76134-2099 
Name of Test Product(s) 
LID018869 
Name of Control 
Product(s) 
Control Product 1 (Part A): ACUVUE OASYS® with 
HYDRACLEAR® PLUS (AOHP) 
Control Product 2 (Part B): CooperVision® Biofinity® 
(Biofinity) 
Title of Trial 
Clinical Comparison of Two Daily Wear Frequent 
Replacement Silicone Hydrogel Soft Contact Lenses 
Protocol Number 
CLY935-C020 
Number of Sites 
Country 
~4 
US 
Planned Duration of 
Exposure – Part A 
~60 days total duration (test and control):  
Test Product: ~30 days 
Control Product 1: ~ 30 days (2x ~15 days) 
Planned Duration of 
Exposure – Part B 
~30 days total duration (control only) 
Control Product 2: ~ 30 days 
Number of Subjects – Part 
A  
Target to complete: 60 (~30 per each parallel group) 
Planned to enroll: ~66 
Number of Subjects – Part 
B 
Target to complete: 60 (~ 30 per each parallel group) 
Planned to enroll: ~66 
Study Population 
Volunteer subjects aged 18 or over who are habitual 
spherical 
 soft contact 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 10 hours per day. 
 
 
 
 
 
 
 

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Objective(s)  
The primary objective of this study is to evaluate the overall 
performance of an investigational silicone hydrogel lens 
when compared to AOHP.  
 
 
 
Endpoints 
Primary Effectiveness 
• Distance VA (logMAR) with study lenses 
 
 
 
  
 
  
 
 
  
 
 
  
 
 
 
 
  
 
  
 
 
 
 
 
Safety 
• AEs 
• Biomicroscopy findings 
• Device deficiencies 
Assessments 
 
Effectiveness 
• Distance VA (logMAR) with study lenses 
• Distance VA (Snellen) habitual correction 
• Manifest refraction 
• BCVA (Snellen distance with manifest refraction) 
 
 
  
 
 
 

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Test Product Details 
 
Primary 
component/material 
Lehfilcon A 
Manufacturer 
Alcon 
LID Number 
LID018869 
  
 
Control Product 1 Details 
 
Primary 
component/material 
Senofilcon A 
Manufacturer 
Johnson & Johnson 
LID Number 
N/A 
Product Name 
Acuvue Oasys with Hydraclear 
Plus (AOHP) 
 
 
Control Product 2 Details 
 
Primary 
component/material 
Comfilcon A 
Manufacturer 
CooperVision 
LID Number 
N/A 
Product Name 
Biofinity 
 
 
Inclusion Criteria 
 
1. Subject must be at least 18 years of age.  
2. Subject must be able to understand and must sign an ICF 
that has been approved by an IRB. 
3. Successful wear of spherical contact lenses in both eyes 
for a minimum of 5 days per week and 10 hours per day 
during the past 3 months. 
 
 
 
 
 
6. Subject must possess spectacles and be willing to wear 
habitual spectacles for vision correction when study 
lenses are not worn, as needed. 
 
 
 
 
 
 
 
  
Exclusion Criteria 
1. Any anterior segment infection, inflammation, or 
abnormality or disease (including systemic) that 

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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. 
 
 
 
 
 
 
 
 
6. Current or history of pathologically dry eye in either eye 
that, in the opinion of the Investigator, would preclude 
contact lens wear. 
 
 
 
 
 
 
 
 
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. 
 
 
 
 
 
 
  
 
 
  
 
15. Current habitual wearers of AOHP.€ 

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17. Current habitual wearer of Biofinity family of contact 
lenses (comfilcon A).  
 
 
  
Associated Materials 
• CLEAR CARE® contact lens solution 
 
 
 
 
 
 
 

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1.1 Abbreviations 
Abbreviation 
Definition 
ADE 
Adverse device effect 
AE 
Adverse event 
AOHP 
ACUVUE OASYS with HYDRACLEAR PLUS 
BCVA 
Best corrected visual acuity 
Biofinity 
CooperVision Biofinity 
CFR 
Code of Federal Regulations 
D 
Diopter 
D/C 
Discontinue 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
FDA 
US Food and Drug Administration 
GCP 
Good Clinical Practice 
ICF 
Informed consent form 
IP 
Investigational product 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
LID 
Lens identification 
LogMAR 
Logarithm of the minimum angle of resolution 
 
 
 
 
MR 
Manifest refraction 
N/A 
Not applicable 
OD 
Right eye 
OS 
Left eye 
OU 
Both eyes 
SAE 
Serious adverse event 
SADE 
Serious adverse device effect 
US 
United States 
USV 
Unscheduled visit 
VA 
Visual acuity 
 
 
 
 
 

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3 INTRODUCTION 
3.1 Study Rationale and Purpose 
The new contact lens in development is intended for the optical correction of refractive 
ametropia in persons with non-diseased eyes. The purpose of this study is to evaluate 
performance of two commercially available daily wear frequent replacement silicone 
hydrogel soft contact lenses as compared to investigational test product (LID018869) to 
obtain on-eye performance data 
  
The primary endpoint was selected to address the primary objective of the study. Procedures 
for measurement of these endpoints were selected based on common practice for these 
assessments. 
 
  
 
 
 
 
 
 
 
 
3.2 Trial Objective 
The primary objective of this study is to evaluate the overall performance of an 
investigational silicone hydrogel lens when compared to AOHP. 
 
 
  
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 contact lens in development 
are features consistent with successful contact lens wear.  
 
 
  

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AOHP contact lenses are commercially available for daily wear use under a biweekly 
replacement schedule; Biofinity contact lenses are commercially available for daily wear use 
under a monthly replacement schedule; further details on any known potential risks and 
benefits can be found in the package insert. Refer to Appendix 13.1 and Appendix 13.2. 
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 for Part A and Part B each includes approximately 66 volunteer 
subjects to be enrolled at approximately 4 sites, with approximately 16-18 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. 
 
  
 
 
 
 
  
 

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DESCRIPTION OF TEST AND CONTROL PRODUCTS 
Test Product 
Control Product 1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
stored at room 
temperature. 
• Lenses should be stored at 
room temperature. 
Usage 
• Wear: 
o Daily Wear 
• Wear: 
o Bilateral 

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DESCRIPTION OF TEST AND CONTROL PRODUCTS 
Test Product 
Control Product 1 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• Exposure: ~30 days for each lens assignment. Subjects are 
to wear the lenses every day, at least 10 hours per day. 
 
 
 
  
• Lens Care: Cleaned and disinfected with CLEAR CARE 
contact lens solution 
 
 
 
 
 
 
 
 
. 
  
 
 
 
 
 
 
 
4.2 Identity of Study Treatments – Part B 
DESCRIPTION OF CONTROL PRODUCT 
Control Product 2 
LID Number 
N/A 
Lens identified in 
Biofinity 

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DESCRIPTION OF CONTROL PRODUCT 
Control Product 2 
randomization system as: 
Material 
Comfilcon A 
Water Content 
48% 
Base Curve (mm) 
8.6 mm 
Diameter (mm) 
14.0 mm 
 
 
 
 
  
Packaging, Labeling, and 
Supply 
• Blister foil pack 
• Commercial foil 
• Provided in commercial packaging 
• Lenses should be stored at room temperature. 
Usage 
• Wear: 
o Bilateral 
 
 
 
  
 
 
 
 
 
 
 
 
• Exposure: ~30 days. Subjects are to wear the lenses every 
day, at least 10 hours per day. 
 
 
  
• Lens Care: Cleaned and disinfected with CLEAR CARE 
contact lens solution. 
 
 
 
 
 
 
 
 
 
  
 
 
 

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4.3 Accountability Procedures 
 
Designated study staff will provide the study lenses to the subjects in accordance with their 
randomization schedule. 
 
 
 
 
  
It is the Investigator’s responsibility to ensure that: 
• All study products are accounted for and not used in any unauthorized manner 
 
 
 
 
 
 
 
 
 
 
 
 
 
5 STUDY PROCEDURES AND ASSESSMENTS 
5.1 Visits and Examinations – Part A  
 
 
 
 
 
 

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5.1.2 
Visit 1 (Screen/Baseline/Lens 1: Dispense) 
1 
Explain the purpose and nature of the study, and have the subject read, sign, and date 
the IRB-approved informed consent document. Additionally, have the individual 
obtaining consent from the subject and a witness, if applicable, sign and date the 
informed consent document. Provide a photocopy of the signed document to the 
subject and place the original signed document in the subject’s chart. After signing 
the ICF, a subject will be assigned a subject number by the EDC system. A signed 
informed consent document defines the point of enrollment. 
2 
Obtain demographic information and medical history, including information on all 
medications used within the past 30 days. 
 
 
3 
Record habitual lens information (brand, power) and lens care information (brand). 
4 
Perform VA with habitual correction (OD, OS, Snellen distance). 
 
 
6 
Perform manifest refraction and BCVA with manifest refraction (OD, OS, Snellen 
distance) 
 
Note: Distance BCVA must be 20/25 or better in each eye for the subject to qualify 
for the study. 
7 
Perform slit-lamp biomicroscopy (without contact lenses) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8 
Review inclusion/exclusion criteria to determine if the subject qualifies to be 
randomized into the study. If subject qualifies, randomize in EDC and record lens 
power. If subject does not qualify, exit the subject from the study as a screen failure. 

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9 
Based upon the randomized lens sequence assignment, have the subject insert the 
appropriate Lens 1 study lenses, being careful to maintain the correct OD and OS 
lens assignments. 
 
 
 
 
 
 
 
10 
Evaluate the study lenses by performing: 
• VA with study lenses (logMAR OD and OS, at distance) 
 
 
 
 
 
 
 
 
 
 
 
12 
Assess and record any AEs and device deficiencies reported or observed during the 
study visit. 
 
 
 
13 
Dispense study lens case and lens care solutions (CLEAR CARE contact lens 
solution). 
 
 
 
 
 
 
  

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2 
Record any device deficiencies or AEs, including those associated with changes in 
concomitant medication dosing, which are observed or reported since the previous 
visit(s). Collect any ADE/AE/Device Deficiency lenses
 
 
. 
 
 
5 
Evaluate the study lenses (Lens1) by performing: 
VA with study lenses (logMAR OD and OS, at distance) 
 
 
 
 
 
 
 
 
 
 
 
 
8 
Perform slit-lamp biomicroscopy (without contact lenses) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9 
If warranted, perform Manifest Refraction and BCVA with manifest refraction (OD, 
OS, Snellen distance) 
10 
Based upon the randomized lens sequence, have the subject insert the appropriate 
study Lens 2, being careful to maintain the correct OD and OS lens assignments. 
 
 
 
 
 
 

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11 
Evaluate the study lenses (Lens 2) by performing: 
• VA with study lenses (logMAR OD and OS, at distance) 
 
 
 
 
 
 
 
 
 
 
 
13 
Assess and record any AEs and device deficiencies reported or observed during the 
study visit. 
 
 
14 
Dispense study lens case and lens care solutions (CLEAR CARE contact lens 
solution) 
 
 
 
 
  
15 
Schedule Visit 4 to take place 15 
days after Visit 3. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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9 
Perform slit-lamp biomicroscopy (without contact lenses) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10 
If warranted, perform Manifest Refraction and BCVA with manifest refraction (OD, 
OS, Snellen distance). 
11 
Perform VA with habitual correction (OD, OS, Snellen distance). 
 
 
 
 
12 
Assess and record any AEs and device deficiencies reported or observed during 
the study visit. 
 
 
13 
Exit the subject from the Part A of the study. 
 
5.1.7 
Unscheduled Visit 
1 
Obtain information on any changes in medical health and/or the use of concomitant 
medications. 
2 
Record any device deficiencies or AEs including those associated with changes in 
concomitant medication dosing, which are observed or reported since the previous 
visit(s). Collect any ADE/AE/Device Deficiency lenses 
 

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3 
Perform slit-lamp biomicroscopy (without contact lenses) 
: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5 
Perform VA with habitual correction (OD, OS, Snellen distance). 
6 
Evaluate the study lenses by performing: 
• VA with study lenses (logMAR OD and OS, at distance) 
7 
If applicable, perform manifest refraction and BCVA distance with manifest 
refraction (OD, OS, Snellen) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
12 
Assess and record any AEs and device deficiencies reported or observed during 
the study visit. 
 
 
 
 
 
 
 
 
 

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5.2 Visits and Examinations – Part B  
 
 
 
 
 
 
 
5.2.2 
Visit 1 (Screen/Baseline/Dispense Lens 1) 
1 
Explain the purpose and nature of the study, and have the subject read, sign, and date 
the IRB-approved informed consent document. Additionally, have the individual 
obtaining consent from the subject and a witness, if applicable, sign and date the 
informed consent document. Provide a photocopy of the signed document to the 
subject and place the original signed document in the subject’s chart. After signing 
the ICF, a subject will be assigned a subject number by the EDC system. A signed 
informed consent document defines the point of enrollment. 
2 
Obtain demographic information and medical history, including information on all 
medications used within the past 30 days
 
 
3 
Record habitual lens information (brand, power) and lens care information (brand). 
4 
Perform VA with habitual correction (OD, OS, Snellen distance). 
 
 
 
 
 
 
7 
Perform manifest refraction and BCVA with manifest refraction (OD, OS, Snellen 
distance) 
 
 
 

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8 
Perform slit-lamp biomicroscopy (without contact lenses) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9 
Review inclusion/exclusion criteria to determine if the subject qualifies to be in the 
study. If subject qualifies, record lens power to be dispensed. 
 
 
 
10 
Have the subject insert Lens 1, being careful to maintain the correct OD and OS lens 
assignments. 
 
 
 
 
 
 
11 
Evaluate the study lenses by performing: 
• VA with study lenses (logMAR OD and OS, at distance) 
 
 
 
 
 
 
 
 
 
 
. 
13 
Assess and record any AEs and device deficiencies reported or observed during the 
study visit. 
 
 
 

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6 
 
 
 
 
 
 
 
 
 
 
 
 
 
8 
Perform slit-lamp biomicroscopy 
9 
If warranted, perform Manifest Refraction and BCVA with manifest refraction (OD, 
OS, Snellen distance) 
10 
Assess and record any AEs and device deficiencies reported or observed during the 
study visit. 
 
 
 
 
 
 
 
 
12 
Schedule Visit 3 to take place 15 
days after Visit 2.  
 
 
 
 
 
 
 
 
 
 
 
 
13 
 
 
 
 
 

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5.2.4 Visit 3 (Lens 1: Day 30 Follow-up/Exit) – [15 
 days after Visit 2] 
1 
Obtain information on any changes in medical health and/or the use of concomitant 
medications. 
2 
Record any device deficiencies or AEs, including those associated with changes in 
concomitant medication dosing, which are observed or reported since the previous 
visit(s). Collect any ADE/AE/Device Deficiency lenses 
 
3 
 
4 
 
5 
Evaluate the study lenses by performing: 
VA with study lenses (logMAR OD and OS, at distance) 
6 
 
 
 
 
 
 
 
 
7 
Have the subject remove Lens 1 and collect the worn lenses. Record the study lens 
removal time on day of study visit. 
8 
Perform slit-lamp biomicroscopy (without contact lenses) 
 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9 
If warranted, perform Manifest Refraction and BCVA with manifest refraction (OD, 
OS, Snellen distance) 
10 
Perform VA with habitual correction (OD, OS, Snellen distance). 
Note: If this VA with habitual correction shows a decrease of 2 lines or more versus 
Visit 1 baseline VA with habitual correction, then BCVA with MR is required to 
confirm a potential loss in VA for AE reporting requirements (see Section 7.3 
Procedures for Recording and Reporting). 

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11 
Assess and record any AEs and device deficiencies reported or observed during 
the study visit. 
 
 
 
 
12 
Exit the subject from Part B of the study. 
 
5.2.5 
Unscheduled Visit 
1 
Obtain information on any changes in medical health and/or the use of concomitant 
medications. 
2 
Record any device deficiencies or AEs including those associated with changes in 
concomitant medication dosing, which are observed or reported since the previous 
visit(s). Collect any ADE/AE/Device Deficiency lenses 
 
3 
Perform slit-lamp biomicroscopy (without contact lenses) 
: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The following are to be performed if applicable in the view of the Investigator 
 
 
5 
Perform VA with habitual correction (OD, OS, Snellen distance). 
6 
Evaluate the study lenses by performing: 
• VA with study lenses (logMAR OD and OS, at distance) 
7 
If applicable, perform manifest refraction and BCVA distance with manifest 
refraction (OD, OS, Snellen) 
 
 

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11 
Assess and record any AEs and device deficiencies reported or observed during 
the study visit. 
 
 
 
 
 
 
 
 
 
5.3 Unscheduled Visits 
Any visit that occurs between regularly scheduled visits is an Unscheduled Visit. If
 
 
 
During all unscheduled visits, the Investigator must 
conduct the following procedures:  
• Collect AE and Device Deficiency information 
• Assess and record changes in medical condition or concomitant medication  
• Assess and record VAs 
• Perform biomicroscopy (assessments with or without lenses, as possible) 
In addition, all procedures for Visit 5 (Follow-up/Exit) should be completed (as possible).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 study lenses or discontinuing 
from the study, the Investigator must conduct Exit procedures according to Table 1-1: 
Schedule of Study Procedures and Assessments, as possible. 

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5.4 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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.5 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. 
  
 
 
 
 
 
 
 
 
  
 
 

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6 ANALYSIS PLAN 
Part A and Part B will be summarized and presented separately.  
Continuous variables will be summarized using the number of observations, mean, standard 
deviation, median, minimum, and maximum. Categorical variables will be summarized with 
counts 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 for Part A will be determined prior to breaking the code for 
masked treatment (lens) sequence assignment and locking the respective subject data, based 
on the Deviations and Evaluability Plan (DEP). 
Similarly, final subject evaluability for Part B will be determined prior to locking the 
database, based on the DEP.  

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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. 
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 lens (lens brand, lens care brand) 
 
 will be summarized on the Safety Analysis Set as well. 
6.4 Effectiveness Analyses 
This study defines one primary endpoint 
. The Safety 
Analysis Set will be used for all effectiveness analyses. 
6.4.1 
Primary Effectiveness 
The primary objective of this study is to evaluate the overall performance of an 
investigational silicone hydrogel lens when compared to AOHP. The primary endpoint is 
distance VA with study lenses, collected in logMAR, for each eye. 
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 presented. 
 
 
 
 

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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 for the primary analysis. 
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.  

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All AEs occurring from the time a subject signs informed consent to study exit will be 
accounted for in the reporting. Descriptive summaries (counts and percentages) for ocular 
and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities 
Preferred Terms. AEs leading to study discontinuation, significant non-serious AEs, and 
SAEs will be identified. Individual subject listings will be provided, as necessary.  
 
  
 
 
 
 
 
 
 
  
No inferential testing will be done for safety analysis.  
 
 
 
  
6.10 Sample Size Justification 
No formal sample size calculation is provided given the descriptive and pilot nature of the 
study. 
7 ADVERSE EVENTS AND DEVICE DEFICIENCIES 
Terms and Definitions 
Adverse Event (AE) 
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). Note: For subjects, 
this definition includes events related to the test product, the 
control product, or the procedures involved. For users or other 

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persons, this definition is restricted to events related to the test 
product. 
Adverse Device 
Effect (ADE) 
AE related to the use of an investigational medical device (test 
product) or control product. Note: This definition includes AEs 
resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation; any 
malfunction; and use error or intentional misuse of the test product 
or control product.  
Anticipated Serious 
Adverse Device 
Effect  
Serious ADE which by its nature, incidence, severity or outcome 
has been identified in the risk management file. 
Device Deficiency 
Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. Note: This definition 
includes malfunctions, use errors, and inadequate labeling. 
Malfunction 
Failure of a medical device to meet its performance specifications 
or otherwise perform as intended. Performance specifications 
include all claims made in the labeling of the device. The intended 
performance of the device refers to the intended use for which the 
device is labeled or marketed. 
Non-serious Adverse 
Event 
AE that does not meet the criteria for an SAE. 
Serious Adverse 
Event (SAE) 
AE that led to any of the following: 
• Death. 
• A serious deterioration in the health of the subject that either 
resulted in: 
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, ie, 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. 
c) in-patient hospitalization or prolonged hospitalization. 
Note: Planned hospitalization for a pre-existing condition, 
without serious deterioration in health, is not considered 
an SAE. In general, hospitalization signifies that the 
individual remained at the hospital or emergency ward for 

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observation and/or treatment (usually involving an 
overnight stay) that would not have been appropriate in the 
physician's office or an out-patient setting. Complications 
that occur during hospitalization are adverse events. If a 
complication prolongs hospitalization or fulfills any other 
serious criteria, the event is serious. When in doubt as to 
whether “hospitalization” occurred, the event should be 
considered serious. 
d) a medical or surgical intervention to prevent a) or b).  
e) any indirect harm as a consequence of incorrect diagnostic 
test results when used within manufacturer’s instructions 
for use. 
• Fetal distress, fetal death, or a congenital abnormality or birth 
defect. 
Refer to Section 7.1 for additional SAEs. 
Serious Adverse 
Device Effect 
(SADE) 
ADE that has resulted in any of the consequences characteristic of 
an SAE. 
Significant Non-
Serious Adverse 
Event 
A significant non-serious 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. 
Refer to Section 7.1 for additional Significant Non-Serious AEs. 
Unanticipated 
Serious Adverse 
Device Effect 
Serious adverse device effect which by its nature, incidence, 
severity or outcome has not been identified in the risk management 
file. 
Use Error 
Act or omission of an act that results in a different medical device 
response than intended by manufacturer or expected by user.  
Note: This definition includes slips, lapses, and mistakes. An 
unexpected physiological response of the subject does not in itself 
constitute 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). 

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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
 
 
  
  
 
 

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Device Deficiencies 
A device deficiency is inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. 
 
 
 
 
  
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
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: 
• “Have you had any health problems since your last study visit?” 
• “Have there been any changes in the medicines you take 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.
 
 
 
 
 
 
.  
 
 
 
 
 
 
 
 
  
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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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.  
 
 
 
 
 
 
 
 
 
 
. 
 
 
 
 
 
 
 

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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. 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
8.2 Unmasking of the Study Treatment 
Masked information on the identity of the assigned medical device should not be disclosed 
during the study
 
 
 
. 
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, 

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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.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
. 

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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. 
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 

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be provided with a copy of the Investigator’s Brochure and Package Insert, 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. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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12 REFERENCES 
12.1 References applicable for all clinical trials 
•
ISO 11980:2012 Ophthalmic optics - Contact lenses and contact lens care products -
Guidance for clinical investigations
•
ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good
clinical practice
12.1.1 US references applicable for clinical trials 
•
21 CFR Part 11 - Electronic Records; Electronic Signatures
•
21 CFR Part 50 - Protection of Human Subjects
•
21 CFR Part 56 - Institutional Review Boards
•
21 CFR Part 812 - Investigational Device Exemptions
•
21 CFR Part 54 - Financial Disclosure by Clinical Investigators
•
The California Bill of Rights

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13 APPENDIX 
13.1 Acuvue Oasys Package Insert 

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13.2 Biofinity® (comfilcon A) Package Insert 
 
 
 

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