Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens
Phase: NA
Conditions: Refractive Errors
Sponsor: Alcon Research

Page 1 of 44
___________________________________________________________________________
Title:
Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens
Protocol Number:
Sponsor Name and 
Address:
Test Product(s):
Investigator Agreement:
CLY935-C004 / NCT03586167
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 76134-2099
LID014341
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, and all applicable regulatory requirements. 
Additionally, I will comply with all procedures for data 
recording and reporting, will permit monitoring, auditing, and 
inspection of my research center, and will retain all records until 
notified by the Sponsor.
Principal Investigator:
Signature
Date
Name:
Address:
SEE Protocol Template, Vision Care version 2.0, approved 09 SEP 2017
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 2 of 44
1
PROTOCOL SYNOPSIS
Trial Sponsor
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 76134-2099
Name of Test Product(s)
LID014341
Name of Control 
Product(s)
CooperVision® BIOFINITY© contact lenses (BIOFINITY)
Title of Trial
Clinical Performance of a Monthly Replacement Silicone 
Hydrogel Lens
Protocol Number
CLY935-C004
Number of Sites
Country
~ 4
US
Planned Duration of 
Exposure 
Test Product: 30 (-4 / +2) days
Control Product: 30 (-4 / +2) days
Number of Subjects 
Target to complete: 78
Planned to enroll: ~ 86
Study Population
Volunteer subjects aged 18 or over who are habitual monthly 
replacement 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 8 hours 
per day. Pregnant or breast-feeding women are not excluded 
from this study.
Objective(s)
The objective of this study will be to describe the clinical 
performance of an investigational, coated silicone hydrogel 
contact lens over 30 days of daily wear. 
Endpoints
Primary Effectiveness

Distance VA (logMAR)
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 3 of 44
Safety

AEs

Biomicroscopy findings

Device deficiencies
Assessments
Effectiveness

Distance VA (logMAR)

Manifest refraction

BCVA (Snellen distance with manifest refraction)
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 4 of 44
Safety

AEs

Biomicroscopy

Device deficiencies
Study Design
Prospective
Single-masked 
(trial subject)
Single-masked 
(Investigator)
Double-masked
Open-label
Other:
Single group
Parallel group
Crossover
Other
Contralateral
Bilateral
Monocular lens wear
Randomized
Test Product Details
Primary 
component/material
HD13B1 with water gradient 
coating
LID Number
LID014341
Manufacturer
Alcon Laboratories, Inc.
Other 
-1.00D to -6.00D, 0.25D steps
Control Product Details
Primary 
component/material
comfilcon A
Product Name
BIOFINITY
Manufacturer
CooperVision
Other 
-1.00D to -6.00D, 0.25D steps
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 monthly replacement soft 
contact lenses in both eyes for a minimum of 5 days per 
week and 8 hours per day during the past 3 months.
4. Manifest cylinder ≤ 0.75D in each eye.
5. BCVA 20/25 or better in each eye.
6. Subject must be willing to stop wearing their habitual 
contact lenses for the duration of study participation.
7. Able to wear contact lenses within a range of sphere 
power from -1.00D to -6.00D (0.25D steps) and subject 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 5 of 44
willing and able to wear the study lenses for the full 
duration of the study.
 
Exclusion Criteria
1. Any anterior segment infection, inflammation, or 
abnormality or disease (including systemic) that 
contraindicates contact lens wear, as determined by the 
Investigator.
2. Any use of systemic or ocular medications for which 
contact lens wear could be contraindicated, as 
determined by the Investigator.
3. History of refractive surgery or plan to have refractive 
surgery during the study or irregular cornea in either eye.
4. Ocular or intraocular surgery (excluding placement of 
punctal plugs) within the previous 12 months or planned
during the study.
5. Biomicroscopy findings at screening that are moderate 
(Grade 3) or higher and/or corneal vascularization that is 
mild (Grade 2) or higher.
6. Current or history of pathologically dry eye in either eye 
that, in the opinion of the Investigator, would preclude 
contact lens wear.
7. Current or history of herpetic keratitis in either eye.
8. Eye injury in either eye within 12 weeks immediately 
prior to enrollment for this trial.
9. Current or history of intolerance, hypersensitivity, or 
allergy to any component of the study products.
10. Wearing habitual contact lenses in an extended wear 
modality (routinely sleeping in lenses for at least 1 night 
per week) over the last 3 months prior to enrollment.
11. Any use of topical ocular medications and artificial tear 
or rewetting drops that would require instillation during 
contact lens wear.
12. The Investigator, his/her staff, family members of the 
Investigator, family members of the Investigator’s staff, 
or individuals living in the households of the 
aforementioned persons may not participate in the study. 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 6 of 44
13. Participation of the subject in a clinical trial within the 
previous 30 days or currently enrolled in any clinical 
trial.
14. Habitual BIOFINITY contact lens wearers.
Associated Materials
Subjects will also be randomized to use OPTI-FREE®
REPLENISH® multi-purpose disinfection solution (OFR) or 
CLEAR CARE® Cleaning & Disinfecting Solution (CC). 
Lubrication/re-wetting drops will not be permitted during 
lens wear. However, habitual drop usage is allowed up to 
10 minutes prior to lens insertion and any time after lens 
removal.
Table 1-1
Schedule of Study Procedures and Assessments
Procedure/ 
Assessment
Visit 1 
Screen / 
Baseline / 
Dispense
Visit 2
1-Week 
Follow-up
[Day 8 
(-1/+2 days) 
minimum 
6 hrs after 
insertion)]
Visit 3
2-Week 
Follow-up
[Day 15
(±2 days)]
Visit 4
1-Month 
Follow-
up/Exit 
[Day 30 
(-4/+2 days)]
Early Exit
Unscheduled 
Visit
Informed Consent

--
--
--
--
--
Demographics

--
--
--
--
--
Medical History






Concomitant 
Medications






Inclusion/
Exclusion

--
--
--
--
--
Habitual lens
(brand, power) 
and lens care

--
--
--
--
--
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 7 of 44
Procedure/ 
Assessment
Visit 1 
Screen / 
Baseline / 
Dispense
Visit 2
1-Week 
Follow-up
[Day 8 
(-1/+2 days) 
minimum 
6 hrs after 
insertion)]
Visit 3
2-Week 
Follow-up
[Day 15
(±2 days)]
Visit 4
1-Month 
Follow-
up/Exit 
[Day 30 
(-4/+2 days)]
Early Exit
Unscheduled 
Visit
Keratometry 
readings*

--
--


--
Manifest 
refraction*

()
()


()
BCVA (OD, OS, 
Snellen distance 
with manifest 
refraction)*

()
()


()
Biomicroscopy






Dispense study 
lenses

()
()
--
--
()
VA w/ study 
lenses (OD, OS, 
logMAR
distance), (OU* 
as necessary) ^





()
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 8 of 44
Procedure/ 
Assessment
Visit 1 
Screen / 
Baseline / 
Dispense
Visit 2
1-Week 
Follow-up
[Day 8 
(-1/+2 days) 
minimum 
6 hrs after 
insertion)]
Visit 3
2-Week 
Follow-up
[Day 15
(±2 days)]
Visit 4
1-Month 
Follow-
up/Exit 
[Day 30 
(-4/+2 days)]
Early Exit
Unscheduled 
Visit
AEs 






Device 
deficiencies 






Exit Form
()
()
()


()
() assessment performed as necessary, eg, decrease of VA by 2 lines or more with investigational product (IP)
* Source only
^ If subject fitted with monovision, near eye must have distance over-refraction in place to 
assess VA.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 9 of 44
1.1
Abbreviations
Abbreviation
Definition
ADE
Adverse device effect
AE
Adverse event
ASADE
Anticipated serious adverse device effect
BCVA
Best corrected visual acuity
BIOFINITY
CooperVision BIOFINITY contact lenses
CC
CLEAR CARE Cleaning & Disinfecting Solution
CDMA
Clinical Development and Medical Affairs
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
mm
Millimeter
N/A
Not applicable
OD
Right eye
OFR
OPTI-FREE REPLENISH multi-purpose disinfection solution
OS
Left eye
OU
Both eyes
SAE
Serious adverse event
SADE
Serious adverse device effect
US
United States
USADE
Unanticipated serious adverse device effect
VA
Visual acuity
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 10 of 44
2
TABLE OF CONTENTS
1
PROTOCOL SYNOPSIS ....................................................................................................2
1.1
Abbreviations ......................................................................................................9
2
TABLE OF CONTENTS...................................................................................................10
List of Tables............................................................................................................................12
List of Figures..........................................................................................................................12
3
INTRODUCTION.............................................................................................................13
3.1
Study Rationale and Purpose.............................................................................13
3.2
Trial Objective...................................................................................................13
3.3
Risks and Benefits.............................................................................................13
3.4
Subject Population.............................................................................................14
3.5
Outline of Study ................................................................................................14
4
TREATMENTS ADMINISTERED...................................................................................15
4.1
Identity of Study Treatments .............................................................................15
4.2
Accountability Procedures.................................................................................17
17
5
STUDY PROCEDURES AND ASSESSMENTS.............................................................17
5.1
Visits and Examinations ....................................................................................17
5.1.1
Visit 1 (Day 1) – Screen/ Baseline/ Dispense....................................17
5.1.2
Visit 2 (Day 8 -1/ +2 Days) – 1-Week Follow-up .............................20
5.1.3
Visit 3 (Day 15 ± 2 Days) – 2-Week Follow-up................................22
5.1.4
Visit 4 (Day 30 -4/ +2 Days) – 1-Month Follow-up/ Exit.................24
5.2
Unscheduled Visits ............................................................................................26
5.3
Discontinued Subjects .......................................................................................27
5.4
Clinical Study Termination................................................................................27
6
ANALYSIS PLAN ............................................................................................................28
6.1
Subject Evaluability...........................................................................................28
6.2
Analysis Data Sets.............................................................................................28
6.2.1
Safety Analysis Set............................................................................28
6.3
Demographic and Baseline Characteristics.......................................................28
6.4
Effectiveness Analyses ......................................................................................28
6.4.1
Primary Effectiveness........................................................................29
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 11 of 44
6.4.1.1
Statistical Hypotheses........................................................29
6.4.1.2
Analysis Methods ..............................................................29
29
30
30
30
6.6
Handling of Missing Data .................................................................................30
6.7
Multiplicity........................................................................................................30
6.8
Safety Analysis ..................................................................................................30
6.9
Interim Analyses................................................................................................31
6.10
Sample Size Justification...................................................................................31
7
ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................31
7.1
General Information ..........................................................................................33
7.2
Monitoring for Adverse Events .........................................................................36
7.3
Procedures for Recording and Reporting ..........................................................37
7.4
Return product analysis .....................................................................................39
7.5
Follow-Up of Subjects with Adverse Events.....................................................39
7.6
Pregnancy in the Clinical Study........................................................................39
8
CONFIDENTIALITY, BIAS, AND MASKING...............................................................39
8.1
Subject Confidentiality and Methods Used to Minimize Bias..........................39
8.2
Unmasking of the Study Treatment...................................................................40
9
DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................40
9.1
Completion of Source Documents and Case Report Forms..............................40
9.2
Data Review and Clarifications.........................................................................41
9.3
Regulatory Documentation and Records Retention ..........................................41
10 ETHICS AND COMPLIANCE.........................................................................................42
10.1
Compliance........................................................................................................42
10.2
Institutional Review Board (IRB) .....................................................................42
11 PROTOCOL AMENDMENT HISTORY..........................................................................43
12 REFERENCES ..................................................................................................................43
12.1
References applicable for all clinical trials .......................................................43
12.1.1
US references applicable for clinical trials........................................43
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 12 of 44
List of Tables
Table 1-1
Schedule of Study Procedures and Assessments ...............................................6
List of Figures
Figure 7–1
Categorization of All AEs................................................................................34
Figure 7-2
Categorization of All Serious Adverse Events.................................................34
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 13 of 44
3
INTRODUCTION
3.1
Study Rationale and Purpose
This 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 obtain on-eye performance data to inform contact lens product 
development. The primary endpoint was selected to fulfil the primary objective of the study. 
Procedures for measurement of these endpoints were selected based on common practice for 
these assessments. The design of this study is justified based upon preclinical and clinical 
testing, as described within the Investigator’s Brochure. BIOFINITY was chosen as the 
control product because these lenses have the same wear modality.
There are no immediate plans to submit the results of this early clinical development study 
for publication; however, the results may be offered for publication if they are of scientific 
interest, or if the results relate to a product that is subsequently approved or cleared for 
marketing.
3.2
Trial Objective
The objective of this study is to describe the clinical performance of an investigational, 
coated silicone hydrogel contact lens over 30 days of daily wear.
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.
Based upon non-clinical testing and documented rationale for applicability of test results to 
the IP, the new contact lens in development is assessed to be non-toxic and biocompatible for 
on-eye use. Clinical studies involving similar contact lens material coating formulations have 
been completed.
A summary of the known potential risks and benefits associated with the new contact lens in 
development can be found in the Investigator’s Brochure. Risks are minimized by 
compliance with the eligibility criteria and study procedures, and through close supervision 
by a licensed clinician during exposure to the study lenses. The potential harms associated 
with on-eye exposure to the new lens materials include toxicity response, blurred vision, and 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 14 of 44
ocular discomfort. In general, the risks with the new contact lens in development are 
anticipated to be similar to other marketed monthly soft contact lenses.
The site personnel will educate subjects on proper hygiene, 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 86 volunteer subjects to be enrolled at 
approximately 4 sites in the US, with approximately 22 subjects enrolled per site. The study 
population will consist of subjects with normal eyes who are adapted, existing wearers of soft 
contact lenses in both eyes.
Subjects must be screened according to the full list of inclusion/exclusion criteria in Section 1 
of this protocol. 
After informed consent is signed, a separate screening visit is allowed for the following 
criteria:

INC01 – Subject must be at least 18 years of age

EXC13 – Participation of the subject in a clinical trial within the previous 30 days or 
currently enrolled in any clinical trial
This separate screening visit can take place regardless of whether any other criterion has been 
verified.
Rescreening of subjects is not allowed in this study.
3.5
Outline of Study
This will be a multi-site, prospective, randomized, subject-masked, study comparing 
2 contact lenses. The expected duration of subject participation in the study is approximately 
32 days, with 4 scheduled visits. The study is expected to be completed in approximately 
2 months.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 15 of 44
4
TREATMENTS ADMINISTERED
Subjects will be randomized in a 2:2:1:1 manner to one of the following 4 groups:
1. LID014341 + OFR
2. LID014341 + CC
3. BIOFINITY + OFR
4. BIOFINITY + CC
4.1
Identity of Study Treatments
DESCRIPTION OF TEST AND CONTROL PRODUCTS
Test Product
Control Product
LID Number
LID014341
N/A
Lens identified in 
randomization system as: 
LID014341
BIOFINITY
Lens
LID014341
BIOFINITY
Material
HD13B1 with water gradient 
coating
comfilcon A
Water Content
~54%
48%
Base Curve (mm)
8.0 – 8.9
8.6
Diameter (mm)
14.0 – 14.5
14.0
Rx powers to be available 
in this study (D)
-1.00D to -6.00D
(0.25D steps)
-1.00D to -6.00D
(0.25D steps)
Packaging, Labeling, and 
Supply

Blister foil pack

Foil label includes at a 
minimum:
-
lens identifier
-
base curve
-
diameter
-
manufacturing 
protocol number
-
packing solution
-
power
-
lot number
-
expiration date
-
content statement
-
investigational 

Blister foil pack

Commercial foil

Available in commercial 
boxes of ~6 lenses per 
power per box

Lenses should be stored 
at room temperature.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 16 of 44
device statement
-
Sponsor 
information
-
country of origin

Provided in boxes of 
~10 lenses per power, 
identified with the 
following at a minimum:
-
a color coded label 
stating the protocol 
number
-
lens identifier
-
power
-
an investigational 
use only statement
-
tracking number

Lenses should be stored at 
room temperature.
Lens care solutions 
identified in 
randomization systems 
as:
Randomization will also include 2 lens care solutions:

OFR

CC
Usage

Wear: 
o
Daily Wear 
o
Bilateral

Replacement period: Replacement lenses will not be 
provided to the subject. In the event a lens needs to be 
replaced, the subject must return to the site for a 
replacement lens. Until the replacement lens is obtained, 
the subject must store the fellow lens in the provided lens 
care solution and wear their habitual spectacles.

Exposure: At least 8 hours per day, 5 days per week, over 
a 4-week period.
Control lens procurement
Each site will procure their own control lenses. 
 
Lens care solution 
procurement
Alcon will provide lens care solution to each site.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 17 of 44
4.2
Accountability Procedures
Upon receipt of the study lenses, the Investigator or delegate will conduct an inventory. 
Designated study staff will provide the study lenses to the subjects in accordance with their 
randomization schedule. Throughout the study, the Investigator or delegate must maintain 
records of study treatment dispensation and collection for each subject. This record must be 
made available to the study monitor for the purposes of verifying the accounting of clinical 
supplies. Any discrepancies and/or deficiencies between the observed disposition and the 
written account must be recorded along with an explanation. 
It is the Investigator’s responsibility to ensure that:

All study products are accounted for and not used in any unauthorized manner

All used foils and unused supplies are returned by each subject

All unused products are available for return to the Study Sponsor, as directed

Any test lenses associated with a device deficiency or with any product-related adverse 
event [ie, 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.
 
5
STUDY PROCEDURES AND ASSESSMENTS
5.1
Visits and Examinations
5.1.1
Visit 1 (Day 1) – Screen/ Baseline/ 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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 18 of 44
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.
6
Obtain keratometry readings, OD, OS.*
*Source only.
7
Perform a manifest refraction.
8
Perform Snellen BCVA with manifest refraction.

OD, OS, distance only
Note: Distance BCVA must be 20/25 or better in each eye for the subject to qualify for the 
study.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 19 of 44
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
10
Determine study lens powers based upon the manifest refraction and habitual lens 
powers.
11
Review inclusion/exclusion criteria to determine if the subject qualifies to be
randomized into the study. If subject qualifies, request randomization. If subject does 
not qualify, exit the subject from the study as a screen failure.
12
Obtain Randomization of study lens and lens care solution from EDC/IRT 
integration system.
14
Based upon the randomized  assignment, have the subject insert the appropriate 
study lenses, being careful to maintain the correct OD and OS lens assignments

Keep all lidding foils of lenses used during lens fit process for study lens 
accountability.

Follow procedures to maintain masking.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 20 of 44
15
Evaluate the study lenses by performing the following:

logMAR VA with study lenses (OD and OS at distance)* (OU as necessary)^
*Small adjustments can be made in final lenses dispensation. VA w/study lenses must be 
equivalent to 20/40 OU or better for subject to leave the office. Use the logMAR VA from 
final study lenses to record in EDC.  
^Record in source only.
18
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.
19
Dispense randomized lens care. Provide the subject with written and verbal
instructions on lens wear and care. 
20
Schedule Visit 2 to take place 8 -1/ +2 days after Visit 1. Instruct subject on the 
minimum amount of lens wear time for the day of the follow up visit.  
 
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.
5.1.2
Visit 2 (Day 8 -1/ +2 Days) – 1-Week Follow-up
1
Obtain information on any changes in medical health and/or the use of concomitant 
medications.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 21 of 44
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.
6
Evaluate the study lenses by performing the following:

logMAR VA with study lenses (OD and OS at distance) (OU, as necessary)*
* Record in source only.
8
Perform a manifest refraction, if necessary.
9
Perform Snellen BCVA, if necessary.

OD, OS, distance only
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 22 of 44
10
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
Dispense study lenses, if necessary.
13
Schedule Visit 3 to take place 15 ± 2 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 as well as 
lens removal on site, if possible. The subject should then be scheduled to return to the clinic 
for Visit 3 (if possible) or exited from the study.
5.1.3
Visit 3 (Day 15 ± 2 Days) – 2-Week Follow-up
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).
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 23 of 44
6
Evaluate the study lenses by performing the following:

logMAR VA with study lenses (OD and OS at distance) (OU, as necessary)*
* Record in source only.
8
Perform a manifest refraction, if necessary.
9
Perform Snellen BCVA, if necessary.

OD, OS, distance only
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 24 of 44
10
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
Dispense study lenses, if necessary.
13
Schedule Visit 4 to take place 30 -4/ +2 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 as well as 
lens removal on site, if possible. The subject should then be scheduled to return to the clinic 
for Visit 4 (if possible) or exited from the study.
5.1.4
Visit 4 (Day 30 -4/ +2 Days) – 1-Month Follow-up/ 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).
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 25 of 44
8
Evaluate the study lenses by performing the following:

logMAR VA with study lenses (OD and OS at distance) (OU, as necessary)*
* Record in source only.
10
Perform a manifest refraction.
11
Perform Snellen BCVA.

OD, OS, distance only
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 26 of 44
12
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
13
Obtain keratometry readings, OD, OS.*
*Source only.
16
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. During all unscheduled visits, the Investigator must conduct 
the procedures according to 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 case history source 
documents.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 27 of 44
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.
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 (ie, their subject numbers will not be 
re-assigned/re-used).
Should a subject exhibit any clinically relevant signs, symptoms, or other clinical 
observations that possibly could be associated with suspected sensitivity or intolerance to one 
of the study treatments, the Investigator must document those observations on an AE Form.
Any subject who exits early from the study (excluding screen failures) must undergo all 
procedures outlined at Visit 4, as applicable.
The Investigator must document the reason for study or treatment discontinuation in the 
subject’s case history source documents.
To ensure the safety of all subjects who discontinue early, Investigators must assess each 
subject and, if necessary, advise them of any therapies and/or medical procedures that may be 
needed to maintain their health.
5.4
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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 28 of 44

The Investigator must:
o
Promptly notify the IRB of the termination or suspension and of the 
reasons. 
o
Provide subjects with recommendations for post-study 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, as well as confidence intervals where 
applicable. Categorical variables will be summarized with counts and percentages from each 
category. Any deviation 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 the code for masked 
treatment assignment and locking the database, based on the Deviations and Evaluability 
Plan.
6.2
Analysis Data Sets
6.2.1
Safety Analysis Set
Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. 
As such, the safety analysis set will include all subjects/eyes exposed to any study lens
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, power, 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 serve as the primary set for all effectiveness analyses.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 29 of 44
6.4.1
Primary Effectiveness
The primary objective of this study is to describe the clinical performance of an 
investigational, coated silicone hydrogel contact lens over 30 days of wear. The primary 
endpoint is distance VA with study lenses, collected in logMAR scale, 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 as well as a two-sided 95% confidence interval for the mean of each 
study lens will be provided.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 30 of 44
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.
Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be 
presented by Medical Dictionary for Regulatory Activities Preferred Terms. AEs leading to 
study discontinuation, significant non-serious AEs, and SAEs will be identified. Individual 
subject listings will be provided, as necessary.
Individual subject listings will be provided for AEs that occur after signing informed consent 
but prior to exposure to study lenses.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 31 of 44
Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy
parameter, counts and percentages of eyes that experience an increase of ≥2 grades from 
baseline (Visit 1) to any subsequent visit will be presented. A supportive listing will be 
generated which will include all biomicroscopy data from all visits for these eyes 
experiencing the increase.
Two listings (prior to exposure of study lenses and treatment-emergent) of device 
deficiencies, as recorded on the Device Deficiency Form, will be provided. Additionally, each 
device deficiency category will be tabulated. 
No inferential testing will be done for safety analysis.
6.9
Interim Analyses
There are no plans to conduct an interim analysis and no criteria by which the study would be 
terminated early based upon statistical determination.
6.10 Sample Size Justification
No formal sample size calculation is provided given the descriptive nature of the study.
7
ADVERSE EVENTS AND DEVICE DEFICIENCIES
Terms and Definitions
Adverse Event (AE)
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 
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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 32 of 44
Anticipated Serious 
Adverse Device 
Effect (ASADE)
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 
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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 33 of 44
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 
(USADE)
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).
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 34 of 44
Figure 7–1
Categorization of All AEs
Figure 7-2
Categorization of All Serious Adverse Events
Specific Events Relevant to this Protocol 
Serious Adverse Events 
In addition to reporting all AEs (serious and non-serious) meeting the definitions, the 
Investigator must report any occurrence of the following as an SAE:
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 35 of 44

An ocular infection including a presumed infectious ulcer with any of the following 
characteristics: 
o
Central or paracentral location
o
Penetration of Bowman’s membrane
o
Infiltrates > 2 mm diameter
o
Iritis
o
Increase in intraocular pressure
o
Culture positive for microorganisms
o
Increasing size or severity at subsequent visits

Any central or paracentral corneal event (such as neovascularization) that results in 
permanent opacification

Hypopyon

Hyphema

Neovascularization within the central 6 mm of the cornea

Permanent vision loss as defined by loss of 2 or more lines of BCVA from enrollment 
visit that fails to resolve

Uveitis (anterior, intermediate, or posterior)

Corneal abrasion affecting ≥50% of corneal surface area
Significant Non-Serious Adverse Events
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. In 
addition, the Investigator must report any occurrence of the following as a Significant 
Non-Serious AE:

Peripheral non-progressive non-infectious ulcers

All symptomatic corneal infiltrative events

Corneal staining score greater than or equal to Grade 3

Temporary vision loss as defined by loss of 2 or more lines of BCVA from enrollment 
visit that persists for 2 or more weeks

Neovascularization score greater than or equal to Grade 2
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 36 of 44
The above events are based upon the categories provided in the ISO 11980 and the US FDA 
Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses and 
Contact Lens Care Products. 
Device Deficiencies
A device deficiency is inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. A device deficiency may or may not be 
associated with patient harm (ie, 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 (eg, incorrect lens power/diameter/base 
curve/color)

Lens/solution cloudy

Lens surface/edge defect 

Torn lens during handling/in pack

Packaging deficit (eg, mislabeled product, tampered seal, leaking bottle/container)

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:

“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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 37 of 44
7.3
Procedures for Recording and Reporting
AEs are collected from the time of informed consent. Any pre-existing medical conditions or 
signs/symptoms present in a subject prior to the start of the study (ie, before informed 
consent is signed) are not considered AEs in the study and should be recorded in the Medical 
History section of the eCRF.
In addition, temporary lens awareness or visual changes during the fitting process are not 
considered AEs if the Investigator assesses that the symptom(s) can reasonably resolve within 
the anticipated adaptation period.

ADEs or SAEs are documented on the Serious Adverse Event and Adverse Device 
Effect eCRF within 24 hours of the Investigator’s or site’s awareness. 

Device deficiencies are documented on the Device Deficiency eCRF within 24 hours 
of the Investigator’s or site’s awareness. 

A printed copy of the completed Serious Adverse Event and Adverse Device Effect 
and/or Device Deficiency eCRF must be included with product returns.

Additional relevant information after initial reporting must be entered into the eCRF as 
soon as the data become available.

Document any changes to concomitant medications on the appropriate eCRFs.

Document all relevant information from Discharge Summary, Autopsy Report,

Certificate of Death, etc, if applicable, in narrative section of the Serious Adverse 
Event and Adverse Device Effect eCRF.
Note: Should the EDC system become non-operational, the site must complete the 
appropriate paper Serious Adverse Event and Adverse Device Effect and/or Device Deficiency
Form. The completed form is emailed to the Study Sponsor at msus.safety@alcon.com
according to the timelines outlined above; however, the reported information must be entered 
into the EDC system once it becomes operational.
Any AEs and device deficiencies for non-study marketed devices/products (ie, OPTI-FREE 
REPLENISH multi-purpose disinfection solution, and CLEAR CARE Cleaning & 
Disinfecting Solution) will be considered and processed as spontaneous (following the 
postmarket vigilance procedures) and should be communicated to the device’s/product’s 
manufacturer as per local requirements.
Study Sponsor representatives may be contacted for any protocol related question.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 38 of 44
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC.
Intensity and Causality Assessments
Where appropriate, the Investigator must assess the intensity (severity) of the AE based upon 
medical judgment with consideration of any subjective symptom(s), as defined below:
Intensity (Severity)
Mild
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom.
Moderate
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities.
Severe
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities.
For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by Study Sponsor utilizing the same definitions, as shown below:
Causality
Related
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study 
procedure has not been demonstrated, but there is a reasonable possibility that 
the AE was caused by the medical device or study procedure.
Not Related
An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (ie, 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 non-serious to serious or from unrelated to related.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 39 of 44
7.4
Return product analysis
Alcon test products associated with device deficiencies and/or product related AEs should be 
returned and must include a copy of the corresponding AE or Device Deficiency eCRF. 
These products should be returned to the Sponsor at the end of the study, unless instructed 
otherwise by the Sponsor. 
7.5
Follow-Up of Subjects with Adverse Events
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study. 
The Investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, 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.
The Investigator should also report complaints on non-Alcon products (ie, BIOFINITY 
contact lenses) 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 Medical History section 
of the eCRF 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. At the end of the clinical study, the Sponsor will collect a copy of the
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 40 of 44
enrollment log without any identifying subject information. All documents submitted to the
Sponsor will identify the subjects exclusively by number and demographic information. No
other personally identifying information should be transmitted to the Sponsor.
This study is subject masked with subjects randomized to use LID014341 or Biofinity and 
OPTI-FREE REPLENISH multi-purpose disinfection solution or CLEAR CARE Cleaning & 
Disinfecting Solution for the duration of the 4-week treatment period. The Sponsor personnel 
(other than site monitors, lead clinical site manager, CDMA Project 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. Masked study personnel must avoid seeking information 
that may compromise masking. 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 the treatment code needs to be broken in the interest of subject safety, the 
Investigator is encouraged to contact an appropriate Study Sponsor representative prior to 
unmasking the information if there is sufficient time. Dependent upon the individual 
circumstances (ie, medical emergency), the code may be broken prior to contact with the 
Study Sponsor. The Study Sponsor must be informed of all cases in which the code was 
broken and of the circumstances involved. Additionally, the Study Sponsor may be required 
to unmask the information in order to fulfill expedited regulatory reporting requirements.
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. 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 41 of 44
At a minimum, source documents should include the following information for each subject:

Subject identification (name, sex, race/ethnicity)

Documentation of subject eligibility

Date of informed consent

Dates of visits

Documentation that protocol specific procedures were performed

Results of study parameters, as required by the protocol

IP accountability records

Documentation of AEs and other safety parameters (if applicable)

Records regarding medical histories and the use of concomitant therapies prior to and 
during the study

Date of study completion and reason for early discontinuation, if applicable
It is required that the author of an entry in the source documents be identifiable. Direct access 
to source documentation (medical records) must be allowed for the purpose of verifying that 
the data recorded on the eCRF are consistent with the original source data.
Only designated individuals may complete the eCRFs. The eCRFs will be submitted at 
regular intervals following the clinical study visit schedule. It is expected that all data 
reported will have corresponding entries in the source documents. The Principal Investigator 
is responsible for reviewing and certifying that the eCRFs are accurate and complete. The 
only subject identifiers recorded on the eCRFs will be subject number, and subject 
demographic information.
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 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 42 of 44
study monitoring. Financial disclosure is not subject to regulatory inspection and should be 
kept separately. 
Additionally, the Investigator must keep study records and source documents until the 
Sponsor provides written approval for their destruction. If the Investigator retires, relocates, 
or for any other reason withdraws from responsibility of keeping the study records, the 
Sponsor must be notified and suitable arrangements made for retention of study records and 
source documents needed to comply with national and international regulations (generally 
2 years after discontinuing clinical development or after the last marketing approval).
10 ETHICS AND COMPLIANCE
This trial will be conducted in accordance with the ethical principles that have their origin in 
the Declaration of Helsinki and the referenced directives, regulations, guidelines, and/or 
standards.
10.1 Compliance
The Investigator must ensure that all personnel involved in the conduct of the study are 
qualified to perform their assigned responsibilities through relevant education, training, and 
experience. The Investigator and all clinical study staff must conduct the clinical study in 
compliance with the protocol. Deviations from this protocol, regulatory requirements and/or 
GCP must be recorded and reported to the Sponsor prior to database lock. If needed, 
corrective and preventive action should be identified, implemented, and documented within 
the study records.
10.2 Institutional Review Board (IRB)
This trial requires IRB approval prior to initiation. This protocol, subject informed consent, 
and subsequent amendments will be reviewed and approved by an IRB.
Before clinical study initiation, this protocol, the ICF (and assent form, if applicable), any 
other written information given to subjects, and any advertisements planned for subject 
recruitment must be approved by an IRB. The Investigator must provide documentation of 
the IRB approval to the Study Sponsor. The approval must be dated and must identify the 
applicable protocol, amendments (if any), ICF, assent form (if any), all applicable recruiting 
materials, written information for subject, and subject compensation programs. The IRB must 
be provided with a copy of the Investigator’s Brochure 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 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 43 of 44
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 prior to the initiation of any 
screening or other study-related procedures. The Investigator must have a defined process for 
obtaining consent. Specifically, the Investigator, or delegate, must explain the clinical study 
to each potential subject and the subject must indicate voluntary consent by signing and 
dating the approved informed consent form. The subject must be provided an opportunity to 
ask questions of the Investigator, and if required by local regulation, other qualified 
personnel. The Investigator must provide the subject with a copy of the consent form written 
in a language the subject understands. The consent document must meet all applicable local 
laws and provide subjects with information regarding the purpose, procedures, requirements, 
and restrictions of the study, along with any known risks and potential benefits associated 
with the IP, the available compensation, and the established provisions for maintaining 
confidentiality of personal, protected health information. Subjects will be told about the 
voluntary nature of participation in the study and must be provided with contact information 
for the appropriate individuals should questions or concerns arise during the study. The 
subject also must be told that their records may be accessed by appropriate authorities and 
Sponsor-designated personnel. The Investigator must keep the original, signed copy of the 
consent and must provide a duplicate copy to each subject according to local regulations. 
Following this study, the subject will return to their eye care professional for their routine eye 
care and contact lenses.
11 PROTOCOL AMENDMENT HISTORY
Version
Brief Description and Rationale
1
Initial Version of this document
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
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

Page 44 of 44

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
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018

                                                                                                                
                                                                                     
Date/Time 
(mm/dd/yyyy GMT):
Signed by:
Justification:
Management of Affected Area Approval
CDMA Project Lead
Global Device Medical Safety
Clinical Manager
06/19/2018 01:59:30
06/19/2018 03:04:00
06/18/2018 19:40:46
06/18/2018 18:10:20
06/16/2018 14:14:21
biostatistics
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0055118
Protocol - Clinical
18-Jun-2018