Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3
Phase: NA
Conditions: Myopia, Ametropia
Sponsor: Alcon Research



Document ID: 
V-CLN-0010709 
Status: Approved, Version: 2.0 
Approved Date: 22 Jun 2021 
Page 2 of 43 
 
Alcon – Business Use Only 
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: 
V-CLN-0010709 
Status: Approved, Version: 2.0 
Approved Date: 22 Jun 2021 
Page 3 of 43 
 
Alcon – Business Use Only 
1 PROTOCOL SYNOPSIS 
Trial Sponsor 
Alcon  
6201 South Freeway 
Fort Worth, Texas 76134-2099 
Name of Test Product(s) 
PRECISION1 
Name of Control 
Product(s) 
INFUSE 
Title of Trial 
Clinical Comparison of Two Daily Disposable Contact 
Lenses – Pilot Study 3 
Protocol Number 
CLE383-E002 
Number of Sites 
Country 
~ 4 
US  
Clinical Investigation Type 
 Early Feasibility 
 Traditional Feasibility 
 Pivotal (premarket monadic claims) 
 Postmarket Interventional / Confirmatory 
 Postmarket Noninterventional / Observational 
Planned Duration of 
Exposure  
~ 16 days in total duration (test and control) 
Test Product: ~ 8 days 
Control Product: ~ 8 days  
Number of Subjects  
Target to complete: ~ 52 
 
Planned to enroll: ~ 60 
 
Study Population 
Volunteer subjects aged 18 or over who are habitual 
spherical contact lens wearers (excluding current/previous 
PRECISION1 and INFUSE 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. 
 
 
  
 
 
 
 
Objective(s) 
The primary objective of this study is to evaluate the overall 

Document ID: 
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Status: Approved, Version: 2.0 
Approved Date: 22 Jun 2021 
Page 4 of 43 
 
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performance of PRECISION1 contact lenses when compared 
to INFUSE contact lenses. 
Endpoints 
 
Primary Effectiveness 
• Distance VA (logMAR) with study contact lenses 
 
Safety 
• Adverse Events (AEs) 
• Biomicroscopy findings 
• Device deficiencies 
Assessments 
 
Effectiveness 
• VA (logMAR distance) with study lenses  
• VA (logMAR distance) with habitual correction 
• Manifest refraction (sphere, cylinder, axis) 
• BCVA (logMAR distance) with manifest refraction 

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Status: Approved, Version: 2.0 
Approved Date: 22 Jun 2021 
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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 
(stratified by symptomatology): 
  
 
  
 
Test Product Details 
 
Primary 
component/material 
Verofilcon A 
Product Name 
PRECISION1 
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 D 
steps, as available 
Control Details 
 
Primary 
component/material 
Kalifilcon A 
Product Name 
INFUSE 
Manufacturer 
Bausch + Lomb 
400 Somerset Corporate Blvd. 
Bridgewater, NJ 08807 
USA 

Document ID: 
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Status: Approved, Version: 2.0 
Approved Date: 22 Jun 2021 
Page 6 of 43 
 
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Rx Power Range 
-1.00 to -6.00 D in 0.25 D 
steps, as available 
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 soft contact lenses in both 
eyes for a minimum of 5 days per week and 10 hours per 
day during the past 3 months. 
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. 

Document ID: 
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Status: Approved, Version: 2.0 
Approved Date: 22 Jun 2021 
Page 7 of 43 
 
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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. 
14. Current/previous PRECISION1 and INFUSE contact 
lens wearers. 
 
Associated Materials 
Lubrication/re-wetting drops will not be permitted. 

Document ID: 
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Status: Approved, Version: 2.0 
Approved Date: 22 Jun 2021 
Page 8 of 43 
 
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Table 1-1 
Schedule of Study Procedures and Assessments 
 
 
 
 
Visit 1 
Screening / Baseline / 
Fitting 
Lens 1 & 
Lens 2  
Dispense Lens 1 
 
 
 
Visit 2 
Week 1 Follow–up 
Lens 1 ‡ / Dispense 
Lens 2 
 
 
 
Visit 3 
Week 1 
Follow –up 
Lens 2 ‡ / 
Exit 
Early 
Exit 
Unscheduled 
Visit 
Procedure / Assessment 
 
Day 0 
8 (0/+3) days after 
Visit 1 
8 (0/+3) days 
after Visit 2 
N/A 
N/A 
Informed Consent 
- 
X 
- 
- 
- 
- 
Demographics 
- 
X 
- 
- 
- 
- 
Medical History* 
- 
X 
X 
X 
X 
X 
Concomitant Medications* 
- 
X 
X 
X 
X 
X 
Inclusion/Exclusion 
- 
X 
- 
- 
- 
- 
Habitual lens (brand, power), 
solution (brand if applicable)* 
- 
X 
- 
- 
- 
- 
VA w/habitual correction 
(OD, OS, logMAR distance)* 
- 
X 
- 
X 
X 
 
 
 
 
 
 
 
 
Manifest refraction* 
- 
X 
(X) 
(X) 
(X) 
(X) 
BCVA (OD, OS, logMAR distance 
with manifest refraction)* 
- 
X 
(X) 
(X) 
(X) 
(X) 
Biomicroscopy 
- 
X 
X 
X 
X 
X 
VA (logMAR distance) with fitting 
lenses (OD, OS)* 
 
X (with both 
 
lens types) 
- 
- 
- 
- 
Lens fitting assessments 
 
 
• 
Lens movement – primary 
gaze, peripheral gaze 
(overall fit) 
• 
Lens position (Centration) 
- 
X (with both 
 
lens types) 
- 
- 
- 
- 

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Status: Approved, Version: 2.0 
Approved Date: 22 Jun 2021 
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Visit 1 
Screening / Baseline / 
Fitting 
Lens 1 & 
Lens 2  
Dispense Lens 1 
 
 
 
Visit 2 
Week 1 Follow–up 
Lens 1 ‡ / Dispense 
Lens 2 
 
 
 
Visit 3 
Week 1 
Follow –up 
Lens 2 ‡ / 
Exit 
Early 
Exit 
Unscheduled 
Visit 
Procedure / Assessment 
 
Day 0 
8 (0/+3) days after 
Visit 1 
8 (0/+3) days 
after Visit 2 
N/A 
N/A 
• 
Lens surface (front 
surface wettability, front 
surface deposits, back 
surface deposits).  
Keratometry readings 
- 
X 
- 
- 
- 
- 
Randomize 
- 
X 
- 
- 
- 
- 
Dispense (provide) study lenses* 
- 
X 
X 
- 
- 
(X) 
VA w/ study lenses 
(OD, OS, logMAR distance) 
- 
- 
X 
X 
(X) 
(X) 

Document ID: 
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Status: Approved, Version: 2.0 
Approved Date: 22 Jun 2021 
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Visit 1 
Screening / Baseline / 
Fitting 
 Lens 1 & 
Lens 2  
Dispense Lens 1 
 
 
 
Visit 2 
Week 1 Follow–up 
Lens 1 ‡ / Dispense 
Lens 2 
 
 
 
Visit 3 
Week 1 
Follow –up 
Lens 2 ‡ / 
Exit 
Early 
Exit 
Unscheduled 
Visit 
Procedure / Assessment 
 
Day 0 
8 (0/+3) days after 
8 (0/+3) days 
N/A 
N/A 
AEsα 
- 
X 
X 
X 
X 
X 
Device deficiencies 
- 
X 
X 
X 
X 
X 
Exit Form 
- 
(X) 
(X) 
X 
X 
(X) 

Document ID: 
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Status: Approved, Version: 2.0 
Approved Date: 22 Jun 2021 
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(X) Assessment performed as necessary, e.g., reduction of VA by 2 lines or more with investigational product (IP) 
* Source only 
α Comprehensive details of all AEs will be documented in the source records; however, targeted collection will be utilized in the eCRF. 
 
 
  
 
 
 
 
 

Document ID: 
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Status: Approved, Version: 2.0 
Approved Date: 22 Jun 2021 
Page 12 of 43 
 
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1.1 Abbreviations 
Abbreviation 
Definition 
ADE 
Adverse device effect 
AE 
Adverse event 
BCVA 
Best corrected visual acuity 
CFR 
Code of Federal Regulations 
CIP 
Clinical investigation plan 
Control 
INFUSE contact lenses 
 
 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
GCP 
Good Clinical Practice 
IB 
Investigator’s Brochure 
ICF 
Informed consent form 
INFUSE 
or INFUSE 
contact lenses 
INFUSE (kalifilcon A) Soft Contact Lenses 
IP 
Investigational product 
IRB 
Institutional review board 
ISO 
International Organization for Standardization 
 
 
LogMAR 
Logarithm of the minimum angle of resolution 
mm 
Millimeter 
MOP 
Manual of Procedures 
N/A 
Not applicable 
OD 
Right eye 
OS 
Left eye 
PRECISION1 
or 
PRECISION1 
contact lenses 
PRECISION (verofilcon A) Soft Contact Lenses 
SAE 
Serious adverse event 
SADE 
Serious adverse device effect 
Test 
PRECISION1 contact lenses 
US 
United States 
VA 
Visual acuity 
 
 
 
 

Document ID: 
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Status: Approved, Version: 2.0 
Approved Date: 22 Jun 2021 
Page 13 of 43 
 
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2 TABLE OF CONTENTS 
Vision Care SEE Protocol for CLE383-E002 ............................................................................ 1 
1 
PROTOCOL SYNOPSIS .................................................................................................... 3 
1.1 
Abbreviations..................................................................................................... 12 
2 
TABLE OF CONTENTS ................................................................................................... 13 
List of Tables ............................................................................................................................ 15 
List of Figures .......................................................................................................................... 15 
3 
INTRODUCTION ............................................................................................................. 16 
3.1 
Study Rationale and Purpose ............................................................................. 16 
3.2 
Trial Objective ................................................................................................... 16 
3.3 
Risks and Benefits ............................................................................................. 16 
3.4 
Subject Population ............................................................................................. 17 
3.5 
Outline of Study................................................................................................. 17 
4 
TREATMENTS ADMINISTERED................................................................................... 17 
4.1 
Identity of Study Treatments ............................................................................. 18 
4.2 
Accountability Procedures ................................................................................. 19 
 
 
5 
STUDY PROCEDURES AND ASSESSMENTS ............................................................. 20 
5.1 
Visits and Examinations .................................................................................... 20 
 
 
5.1.2 
Visit 1 (Day 0) – Screening/Baseline/Dispense Lens 1 ..................... 20 
5.1.3 
Visit 2 [8 (0/+3 days) after Visit 1] – Week 1 Follow-up Lens 1 / 
Dispense Lens 2 ................................................................................. 22 
5.1.4 
Visit 3 [8 days (0/+3 Days) after Visit 2] – Week 1 Follow-up Lens 
2 / Exit ............................................................................................... 24 
5.2 
Unscheduled Visits ............................................................................................ 26 
5.3 
Discontinued Subjects ....................................................................................... 26 
5.4 
Clinical Study Termination ................................................................................ 27 
6 
ANALYSIS PLAN ............................................................................................................ 27 
6.1 
Subject Evaluability ........................................................................................... 27 
6.2 
Analysis Data Sets ............................................................................................. 28 
6.2.1 
Safety Analysis Set ............................................................................ 28 

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6.3 
Demographic and Baseline Characteristics ....................................................... 28 
6.4 
Effectiveness Analyses ...................................................................................... 28 
6.4.1 
Primary Effectiveness ........................................................................ 28 
6.4.1.1 
Statistical Hypotheses ........................................................ 28 
6.4.1.2 
Analysis Methods............................................................... 28 
 
 
 
 
 
 
 
 
6.6 
Handling of Missing Data .................................................................................. 30 
 
 
6.8 
Safety Analysis .................................................................................................. 30 
 
 
6.10 Sample Size Justification ................................................................................... 31 
7 
ADVERSE EVENTS AND DEVICE DEFICIENCIES ................................................... 31 
7.1 
General Information .......................................................................................... 33 
7.2 
Monitoring for Adverse Events ......................................................................... 35 
7.3 
Procedures for Recording and Reporting .......................................................... 35 
7.4 
Return product analysis (if applicable) .............................................................. 37 
7.5 
Follow-Up of Subjects with Adverse Events ..................................................... 38 
7.6 
Pregnancy in the Clinical Study ........................................................................ 38 
8 
CONFIDENTIALITY, BIAS, AND MASKING ............................................................... 38 
8.1 
Subject Confidentiality and Methods Used to Minimize Bias .......................... 38 
8.2 
Unmasking of the Study Treatment ................................................................... 39 
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 ......................................................................................... 41 
10.1 Compliance ........................................................................................................ 41 
10.2 Institutional Review Board (IRB)...................................................................... 41 
 
12 REFERENCES .................................................................................................................. 42 

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Approved Date: 22 Jun 2021 
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12.1 References applicable for all clinical trials ........................................................ 42 
12.1.1 
US references applicable for clinical trials ........................................ 42 
 
 
 
List of Tables 
Table 1-1 
Schedule of Study Procedures and Assessments ............................................... 8 
 
List of Figures 
Figure 7–1 
Categorization of All AEs ................................................................................ 34 
Figure 7–2 
Categorization of All Serious Adverse Events ................................................. 34 
 
 
 
 

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Status: Approved, Version: 2.0 
Approved Date: 22 Jun 2021 
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3 INTRODUCTION 
3.1 Study Rationale and Purpose 
PRECISION1 is a new daily disposable silicone hydrogel contact lens with a material that 
combines high oxygen transmissibility with a low modulus of elasticity. 
PRECISION1 contact lenses are intended for the optical correction of refractive ametropia in 
persons with non-diseased eyes requiring subjects to wear spectacles for vision correction. 
The purpose of this study is to evaluate the overall performance of PRECISION1 contact 
lenses when compared to INFUSE contact lenses 
 
 
 
 
  
 
 
 
3.2 Trial Objective 
The primary objective of this study is to evaluate the overall performance of PRECISION1 
contact lenses when compared to INFUSE contact lenses. 
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 lenses ensure 
successful contact lens wear. 
PRECISION1 and INFUSE contact lenses are not intended for use with a 
cleaning/disinfecting solution, and the biocompatibility with lens care solutions was not 
tested and any associated clinical effects are unknown. 
A summary of the known potential risks and benefits associated with the study contact lenses 
can be found in the package insert of both study 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.  

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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 60 volunteer subjects to be enrolled at 
approximately 4 sites, with approximately 15 subjects enrolled per site. 
 
 
 
 
 
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 multisite, prospective, randomized, crossover, double-masked, stratified (by 
symptomatology) study comparing 2 contact lenses. The expected duration of subject 
participation in the study is up to 24 days, with 3 scheduled visits. The study is expected to be 
completed in approximately 11 weeks. 
4 TREATMENTS ADMINISTERED 
Subjects will be 
 randomized in a 1:1 manner to 
receive treatment (lens) in a crossover sequence: Test product then Control product, or 
Control product the Test product, respectively. 
Sequence 
EDC/randomization integration system 
Lens Name 
Sequence 1 
 
PRECISION1/INFUSE 
Sequence 2 
 
INFUSE/PRECISION1 
 

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4.1 Identity of Study Treatments 
DESCRIPTION OF TEST AND CONTROL PRODUCTS 
 
Test  
Control 
 
 
 
Lens 
PRECISION1 
INFUSE 
Material 
Verofilcon A 
Kalifilcon A 
Water Content 
51% 
55% 
Base Curve (mm) 
8.3  
8.6 
Diameter (mm) 
14.2  
14.2  
Rx Power Range 
-1.00 to  6.00 D in 0.25 D 
steps, as available 
-1.00 to  6.00 D in 0.25 D steps, 
as available 
Packaging, 
Labeling, and 
Supply 
• Blister foil pack 
• Foil label includes at a 
minimum: 
- 
Identifier 
- 
base curve 
- 
diameter 
- 
packing solution 
- 
power 
- 
lot number 
- 
expiration date 
- 
content statement 
- 
investigational 
device statement 
- 
sponsor information 
- 
country of origin. 
• Provided in ~ 12 lenses per 
power per carton, identified 
with the following at a 
minimum: 
- 
a color coded label 
stating the protocol 
number 
 
 
- 
power 
- 
an investigational 
use only statement 
- 
tracking number. 
• Lenses should be stored at 
room temperature. 
• 
 study 
lenses will be provided by 
the sponsor before the start 
of the study 
• Blister foil pack 
• Foil label includes at a 
minimum: 
- 
Identifier 
- 
base curve 
- 
diameter 
- 
packing solution 
- 
power 
- 
lot number 
- 
expiration date 
- 
content statement 
- 
investigational device 
statement 
- 
sponsor information 
- 
country of origin. 
• Provided in ~ 12 lenses per 
power per carton, identified 
with the following at a 
minimum: 
- 
a color coded label 
stating the protocol 
number 
 
 
- 
power 
- 
an investigational use 
only statement 
- 
tracking number 
• Lenses should be stored at 
room temperature. 
• 
 study lenses 
will be provided by the 
sponsor before the start of the 
study 
Usage 
• Wear:  

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o Daily Wear  
o Bilateral 
• Replacement period: Daily Disposable 
• Exposure:  
o ~16 days total duration (Test and Control) 
 
 
 
 
 
• Lens Care: N/A 
• Both study contact lenses will be used according to their 
registered/approved indications for use and within the approved 
wearing schedule and duration. 
 
4.2 Accountability Procedures 
Upon receipt of the study lenses, the investigator or delegate will conduct an inventory. 
Designated unmasked study staff will provide the study lenses to the subjects in accordance 
with their randomization schedule. Throughout the study, the unmasked 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 unmasked delegate 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. 

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Approved Date: 22 Jun 2021 
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5 STUDY PROCEDURES AND ASSESSMENTS 
5.1 Visits and Examinations 
5.1.2 
Visit 1 (Day 0) – Screening/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. Include herbal therapies, vitamins, and all 
over-the-counter as well as prescription medications. Source only. 
3 
Perform VA logMAR with habitual correction. Source only. 
• 
OD, OS, distance only, spectacles or contact lenses. 
4 
Record habitual lens information (brand, power) and solution (brand if applicable). 
Source only. 
 
 
6 
Perform a manifest refraction. Source only. 
7 
Perform BCVA logMAR with manifest refraction. Source only. 
• 
OD, OS, distance only 
Note: Distance BCVA must be 0.10 logMAR or better in each eye for the subject to 
qualify for the study. 
8 
Perform slit lamp biomicroscopy (without contact lenses) to evaluate the following: 
• 
Limbal hyperemia 
• 
Bulbar hyperemia 
• 
Corneal staining 

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17 
Assess and record any AEs and device deficiencies reported or observed during the 
study visit. 
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time of 
signature of informed consent including those that screen fail. 
18 
Schedule Visit 2 to take place 8 (0/+3) days after Visit 1. 
Note: If for some reason a subject is unable to wear a study lens for the duration of this visit 
window, instruct the subject to return to the site for an Unscheduled Visit, including, if 
possible, lens removal on site. The subject should then be scheduled to return to the clinic for 
Visit 2 (if possible) or exited from the study. 
 
5.1.3 
Visit 2 [8 (0/+3 days) after Visit 1] – Week 1 Follow-up Lens 1 / 
Dispense Lens 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. 

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4 
Perform VA logMAR with study lenses. 
• 
OD, OS, distance only. 
6 
Remove study lenses. 
7 
Perform slit lamp biomicroscopy (without contact lenses) to evaluate the following: 
• 
Limbal hyperemia 
• 
Bulbar hyperemia 
• 
Corneal staining 
• 
Conjunctival staining 
• 
Palpebral conjunctival observations 
• 
Corneal epithelial edema 
• 
Corneal stromal edema 
• 
Corneal vascularization 
• 
Conjunctival compression/indention 
• 
Chemosis 
• 
Corneal infiltrates 
• 
Other findings 
8 
Perform Manifest Refraction and BCVA logMAR distance with manifest refraction if 
there is a decrease of VA with study lenses by 2 lines or more versus VA with fitting 
lenses from Screening. Source only. 
9 
Collect the worn study lenses (Lens 1) from Visit 2 for storage and return 
 
 See MOP for details. 
10 
Dispense (provide) the study lenses (Lens 2). 

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13 
Assess and record any AEs and device deficiencies reported or observed during the 
study visit. 
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time 
of signature of informed consent including those that screen fail. 
14 
Schedule Visit 3 to take place 8 (0/+3) days after Visit 2. 
5.1.4 
Visit 3 [8 days (0/+3 Days) after Visit 2] – Week 1 Follow-up Lens 2 / 
Exit 
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). 

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4 
Perform VA logMAR with study lenses. 
• 
OD, OS, distance only. 
7 
Remove study lenses. 
8 
Perform BCVA logMAR distance with manifest refraction if there is a decrease of 
VA by 2 lines or more with study lenses. Source only. 
9 
Perform slit lamp biomicroscopy (without contact lenses) to evaluate the following: 
• 
Limbal hyperemia 
• 
Bulbar hyperemia 
• 
Corneal staining 
• 
Conjunctival staining 
• 
Palpebral conjunctival observations 
• 
Corneal epithelial edema 
• 
Corneal stromal edema 
• 
Corneal vascularization 
• 
Conjunctival compression/indention 
• 
Chemosis 
• 
Corneal infiltrates 
• 
Other findings 
11 
Perform VA logMAR with habitual correction. Source only. 
• 
OD, OS, distance only, spectacles or habitual contact lenses 
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 

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confirm a potential loss in VA for AE reporting requirements (see Section 7). 
12 
Assess and record any AEs and device deficiencies reported or observed during the 
study visit. 
Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time 
of signature of informed consent including those that screen fail. 
13 
Exit the subject from the study. 
5.2 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 
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 Section 5.3 Discontinued Subjects. 
5.3 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 Exit 
procedures according to Table 1-1: Schedule of Study Procedures and Assessments.  
The investigator must document the reason for study or treatment discontinuation in the 
subject’s case history source documents. 

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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. 
5.4 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:  
• 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 
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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 in the corresponding lens sequence.  
Subjects who are lost to follow-up and their exposure to dispensed study lenses is unknown 
will be included in the safety analysis data set. The visit date for Dispense (Lens 1 or Lens 2) 
 will be used as the first exposure date for the 
respective Lens. 
6.3 Demographic and Baseline Characteristics 
Demographic information (age, sex, ethnicity, race) will be summarized on the Safety 
Analysis Set. 
 
 
6.4 Effectiveness Analyses 
This study defines 1 primary 
 effectiveness 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 PRECISION1 
contact lenses when compared to INFUSE contact lenses. 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 provided. 

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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. 
 
 
 
 
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. 
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 in each crossover 
period) to any subsequent visit within the same period will be presented. A supportive listing 
will be generated which will include all biomicroscopy data from all visits within the same 
period for 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.  
 
 
 
  

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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) 
 
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 
events related to the use of investigational medical devices or 
comparator. 
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. 
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). 

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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 
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 

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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. 
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?
Meets 
seriousness 
criteria?
SAE
All AEs
AE
No
No
Yes
Yes
 
 
Figure 7–2 
Categorization of All Serious Adverse Events 
All SAEs
Device /
procedure 
related?
SAE
SADE
No
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. 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 cloudy 
• Lens surface/edge defect  
• Torn lens during handling/in pack 
• Packaging deficit (e.g., mislabeled product) 
• Suspect product contamination 
• Lack of 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 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 since your last study visit?” 
In addition, 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.  
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 

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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 control products on the Device Deficiency eCRF. The site must submit 
all available information on ADEs, SAEs, and device deficiencies to the study sponsor 
immediately as follows 
• All SAEs must be reported immediately (within 24 hours) of the investigator’s or 
site’s awareness.  
• ADEs that do not meet seriousness criteria and device deficiencies must be reported 
within 10 calendar days of the Investigator’s or site’s awareness.  
• A printed copy of the completed Serious Adverse Event and Adverse Device Effect 
and/or Device Deficiency eCRF must be included with product returns.  
• Additional relevant 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 
 according to the 
timelines outlined above; however, the reported information must be entered into the EDC 
system once it becomes operational. 
Study sponsor representatives may be contacted for any protocol-related question and their 
contact information is provided in the Manual of Procedures that accompanies this protocol. 
Further, depending upon the nature of the AE or device deficiency being reported, the study 
sponsor may request copies of applicable portions of the subject’s medical records. The 

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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). 
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 (if applicable) 
Study Sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol. 

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Alcon products associated with device deficiencies and/or product related AEs should be 
returned and must include the Complaint #, which will be provided by study sponsor after the 
case is entered in the study sponsor’s Global Product Complaint Management System 
(GPCMS).  
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 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 of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. Pregnancy should be included in the Pregnancy eCRF in 
EDC when a pregnant woman enters the study or if 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.  
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 

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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 PRECISION1 or INFUSE for 
the duration of one-week treatment period and then crossover and use the other study product 
for one-week treatment period.  
The subjects, investigators, 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. 
Unmasked study personnel must not disseminate information that is potentially unmasking to 
any masked personnel. The masked and unmasked site personnel must coordinate all study 
activities as necessary to protect masking and minimize bias during the trial.  
8.2 Unmasking of the Study Treatment 
Masked information on the identity of the assigned medical device should not be disclosed 
during the study. If unmasking is required in the interest of subject safety, the investigator is 
encouraged to contact an appropriate study sponsor to obtain unmasking information. 
Additionally, the study sponsor may be required to unmask the information in order to fulfill 
expedited regulatory reporting  
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 

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• Date of informed consent 
• Dates of visits 
• Documentation that protocol specific procedures were performed 
• Results of study parameters, as required by the protocol 
• IP accountability records 
• Documentation of AEs and other safety parameters (if applicable) 
• Records regarding medical histories and the use of concomitant therapies prior to and 
during the study 
• Date of study completion and reason for early discontinuation, if applicable 
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the 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. 
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 

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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. 
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 package inserts, 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, 

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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. 
 
 
 
 
 
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 

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• The California Bill of Rights 

Signature Page for V-CLN-0010709 v2.0
Signature Page for V-CLN-0010709 v2.0