Clinical Evaluation of Two Monthly Contact Lenses
Phase: NA
Conditions: Refractive Errors
Sponsor: Alcon Research

Page 1 of 43
___________________________________________________________________________
Title:
Clinical Evaluation of Two Monthly Contact Lenses
Protocol Number:
Sponsor Name and 
Address:
Test Product(s):
Investigator Agreement:
CLD523-E001/ NCT03459131
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 76134-2099
Biofinity® Energys™ contact lenses
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:
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0054838
Protocol - Clinical
01-Mar-2018

Pa ge 2 of 4 3
1
P R O T O C O L  S Y N O P SI S
Trial S p o ns or
Alc o n Researc h, Lt d.
6 2 0 1 S o ut h Free wa y
F ort W ort h, Te xas 7 6 1 3 4- 2 0 9 9
Na me of Test Pr o d uct(s)
C o o per V isi o n® BI O FI NI T Y  E N E R G Y S s oft c o ntact le nses
( BI O FI NI TY E N E R G Y S)
Na me of C o ntr ol 
Pr o d uct(s)
C o o per V isi o n BI O FI N I T Y s oft c o ntact le nses ( BI O FI NI T Y)
Title of Trial
Cli nical E val uati o n of T w o M o nt hl y  C o ntact Le nses
Pr ot oc ol N u m ber
C L D 5 2 3 - E 0 0 1
N u m ber of Sites
C o u ntr y
1
U S
Pla n ne d D urati o n of 
E x p os ure 
U p t o 1 8 da y s t otal d urati o n
Test Pr o d uct:  7 da y s (± 2 da y s)
C o ntr ol Pr o d uct:  7 da y s (± 2 d a y s)
N u m ber of S u bjects  
Tar get t o c o m plete:  1 0
Pla n ne d t o e nr oll:  ~ 1 6
St u d y  P o p ulati o n
Vo l u nteer s u bjects a ge d 1 8 t o 3 5 wit h n or mal e y es ( ot her 
t ha n c orrecti o n f or refracti ve err or), c urre ntly weari n g 
BI O FI N I T Y ( or pri vate la bel) s p here s oft c o ntact le nses o n a 
dail y  wear basis.  S u bjects s h o ul d ha ve at least 3 m o nt hs of 
BI O FI N I T Y ( or pri vate la bel) weari n g e x perie nce, wear 
t hese le nses at least 5 da ys per wee k a n d at least 8 h o urs per 
da y, use di gital de vices at least 4 h o urs per da y at least 5 
da y s per wee k, a n d re q uire c o ntact le nses i n a p o wer ra n ge 
fr o m + 6. 0 0 t o -1 0. 0 0 D S.
O bjecti ve(s)
T he pri mar y  o bjecti ve is t o e x pl ore o verall visi o n wit h 
BI O FI N I T Y E N E R G Y S as c o m pare d t o BI O FI NI T Y  le nses 
after 1 wee k of wear .  
T he sec o n dar y  o bjecti ve is t o e val uate t he differe nce i n o ver -
refracti o n of BI O FI N I T Y E N E R G Y S as c o m pare d t o 
BI O FI N I T Y.
E n d p oi nts
Pri mar y  Effecti ve ness

O verall Visi o n
Sec o n dar y  Effecti ve ness

O ver -refracti o n
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8

Pa ge 3 of 4 3
Safet y

A Es

Bi o micr osc o p y fi n di n gs

De vice deficie ncies
Assess me nts
Effecti ve ness

V A wit h st u d y  le nses ( O D, O S, O U / S nelle n, 
Dista nce)

Ma nifest refracti o n

B C V A ( S nelle n dista nce wit h ma nifest refracti o n)

O ver refracti o n wit h st u d y le nses
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8

Pa ge 4 of 4 3
Safet y    

A Es

Bi o micr osc o p y

De vice deficie ncies
St u d y  Desi g n
Pr os pecti ve
Si n gle -mas ke d 
(trial s u bject)
Si n gle -mas ke d (I n vesti gat or)
D o u ble- mas ke d
O pe n -la bel
Ot her 
Si n gle gr o u p
Parallel gr o u p
Cr oss o ver
Ot her 
C o ntralateral
Bilateral
M o n oc ular le ns wear
Ra n d o mize d
Test Pr o d uct 1 Details
Pri mar y  
c o m p o ne nt/ material
c o mfilc o n A
Pr o d uct Na me
BI O FI N I T Y E N E R G Y S
LI D N u m ber
N A
Ma n ufact urer
C o o per Visi o n
Ot her 
+ 6. 0 0 D S t o - 6. 0 0 D S (0. 2 5 ste ps )
- 6. 5 0 D S t o - 1 0. 0 0 D S ( 0. 5 0 ste ps)
C o ntr ol Pr o d uct Details
Pri mar y  
c o m p o ne nt/ material
c o mfilc o n A
Pr o d uct Na me
BI O FI N I T Y
LI D N u m ber
N A
Ma n ufact urer
C o o per Visi o n
Ot her 
+ 6. 0 0 D S t o - 6. 0 0 D S (0. 2 5 ste ps )
- 6. 5 0 D S t o - 1 0. 0 0 D S ( 0. 5 0 ste ps)
I ncl usi o n Criteria
1.
S u bject m ust be 1 8 t o 3 5 y ears of a ge. 
2. S u bject m ust be a ble t o u n dersta n d a n d m ust si g n a n I C F 
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8

Page 5 of 43
that has been approved by an IRB.
3. Successful wear of BIOFINITY (spherical) (or private 
label) 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 ≤ 0.75 D in each eye.
5. BCVA 20/25 or better in each eye.
6. Subject must possess spectacles that provide a corrected 
VA of 20/40 or better OU and be willing to wear them 
(as needed).  
7. Currently using digital devices (computer, tablet, and/or 
smart phone) for a minimum of 5 days per week and 4 
hours per day.
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 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0054838
Protocol - Clinical
01-Mar-2018

Pa ge 6 of 4 3
m o dalit y  (r o uti nely slee pi n g i n le nses f or at least 1 ni g ht 
per wee k) o ve r t he last 3 m o nt hs pri or t o e nr oll me nt.
1 1. A n y  use of t o pical oc ular me dicati o ns t hat w o ul d re q uire 
i nstillati o n d uri n g c o ntact le ns wear.
1 2. T he I n vesti gat or, his/ her staff, fa mil y me m bers of t he 
I n vesti gat or, fa mily me m bers of t he I n vesti gat or’s staff, 
or i n d i vi d uals li vi n g i n t he h o use h ol ds of t he 
af ore me nti o ne d pers o ns ma y  n ot partici pate i n t he st u d y. 
1 3. Partici pati o n of t he s u bject i n a cli nical trial wit hi n t he 
pre vi o us 3 0 da y s or c urre ntl y e nr olle d i n a ny cli nical 
trial.
Ass ociate d Materials 
Le nses will b e care d f or wit h s u bject’s ha bit ual le ns care 
s ol uti o n.
Use of ha bit ual l u bricati n g/re- wetti n g dr o ps will be 
per mitte d d uri n g t he trial. 
If st u d y le nses are n ot a vaila ble f or dis pe nsi n g at Visit 2, use 
of ha bit ual le nses will be per mitte d bet wee n Visits 1 a n d 2, 
u p t o 7 da ys, bef ore dis pe nsi n g of st u d y  le nses.
Ta ble 1- 1
Sc he d ule of St u d y Pr oce d ur es a n d Assess me nts
Pr oce d ure/ Assess me nt
Pre-scree ni n g
Visit 1
Visit 2
0- 7 d a ys
f r o m V1
Visit 3
7 ( ± 2 ) d a ys
f r o m V 2
Visit 4
7 ( ± 2 ) d a ys
f r o m V3
U nsc he d ule d Visit
E arl y E xit
B aseli ne /
Fitti n g
Dis pe nse 
P air 1
F oll o w- u p 
P air 1
Dis pe nse 
P air 2
F oll o w -u p
P air 2 /
E xit
Di gital Use Ti me
*




I nf or me d C o nse nt

De m o gra p hics

Me dical Hist or y
 
 

 
 

C o nc o mita nt Me dicati o ns

() 
()
()
()
)
()
I ncl usi o n/ E xcl usi o n

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8

Pa ge 7 of 4 3
Pr oce d ure/ Assess me nt
Pre-scree ni n g
Visit 1
Visit 2
0- 7 d a ys
f r o m V1
Visit 3
7 ( ± 2 ) d a ys
f r o m V 2
Visit 4
7 ( ± 2 ) d a ys
f r o m V3
U nsc he d ule d Visit
E arl y E xit
B aseli ne /
Fitti n g
Dis pe nse 
P air 1
F oll o w- u p 
P air 1
Dis pe nse 
P air 2
F oll o w -u p
P air 2 /
E xit
Ha bit ual le ns * ( bra n d, p o wer)
/ Le ns care * (bra n d )  / Re-
wetti n g dr o ps * ( Bra n d / 
usa ge) 

Ma nifest refracti o n *

() 
() 
() 
() 
()
B C V A ( O D, O S, S nelle n 
dista nce wit h ma nifest 
refracti o n) *

() 
() 
() 
() 
()
Bi o micr osc o p y
 
 

 
 

Dis pe nse st u d y  le nses / R x


O ver -refracti o n ( O D, O S)


V A w/ st u d y le nses (O D, O S, 
O U, S nelle n dista nce ,)
 
 
 

()

A E s 
 
 
 
 
 

De vice deficie ncies
 
 
 
 
 

E xit F or m
() 
() 
() 
() 
()

(
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8
) assess me nt perf or me d as necessar y, e g, decrease of VA b y 2 li nes or m ore wit h i n vesti gati o nal pr o d uct (I P)
* S o urce o nl y

Page 8 of 43
1.1
Abbreviations
Abbreviation
Definition
ADE
Adverse device effect
AE
Adverse event
BCVA
Best corrected visual acuity
CFR
Code of Federal Regulations
eCRF
Electronic case report form
DS
Diopter sphere
EDC
Electronic data capture
FDA
US Food and Drug Administration
GCP
Good Clinical Practice
ICF
Informed consent form
IEC
Independent ethics committee
IP
Investigational product
IRB
Institutional review board
ISO
International Organization for Standardization
LID
Lens identification
mm
Millimeter
MOP
Manual of procedures
NA
Not applicable
OD
Right eye
OS
Left eye
OU
Both eyes
Rx
Prescription
SAE
Serious adverse event
SADE
Serious adverse device effect
US
United States
VA
Visual acuity
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Document:  
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TDOC-0054838
Protocol - Clinical
01-Mar-2018

Page 9 of 43
2
TABLE OF CONTENTS
Clinical Evaluation of Two Monthly Contact Lenses................................................................1
1
PROTOCOL SYNOPSIS ....................................................................................................2
1.1
Abbreviations ......................................................................................................8
2
TABLE OF CONTENTS.....................................................................................................9
List of Tables............................................................................................................................11
List of Figures..........................................................................................................................11
3
INTRODUCTION.............................................................................................................12
3.1
Study Rationale and Purpose.............................................................................12
3.2
Trial Objective...................................................................................................12
3.3
Risks and Benefits.............................................................................................12
3.4
Subject Population.............................................................................................13
3.5
Outline of Study ................................................................................................13
4
TREATMENTS ADMINISTERED...................................................................................14
4.1
Identity of Study Treatments .............................................................................14
4.2
Accountability Procedures.................................................................................15
4.3
Local Lens Procurement....................................................................................16
4.3.1
Procurement.......................................................................................16
4.3.2
Labeling.............................................................................................16
4.3.3
Handling ............................................................................................16
4.3.4
Dispensing and Accountability..........................................................16
4.3.5
Final Disposition ...............................................................................16
4.4
Worn Lens Collection, Storage and Return.......................................................17
5
STUDY PROCEDURES AND ASSESSMENTS.............................................................17
5.1
Visits and Examinations ....................................................................................17
5.1.1
Visit 1 (Day 0) – Baseline/Fitting......................................................17
5.1.2
Visit 2 (0-7 Days from Visit 1) – Dispense Pair 1.............................18
5.1.3
Visit 3 (7 ± 2 Days from Visit 2) – [Follow-up visit for Pair 1 and 
Dispensing visit for Pair 2]................................................................20
5.1.4
Visit 4 (7 ± 2 Days from Visit 3) – [Follow-up visit for Pair 2 / Exit]
...........................................................................................................22
5.2
Unscheduled Visits ............................................................................................24
5.3
Discontinued Subjects .......................................................................................25
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Page 10 of 43
5.4
Clinical Study Termination................................................................................25
6
ANALYSIS PLAN ............................................................................................................26
6.1
Subject Evaluability...........................................................................................26
6.2
Analysis Data Sets.............................................................................................26
6.2.1
Safety Analysis Set............................................................................26
6.3
Demographic and Baseline Characteristics.......................................................27
6.4
Effectiveness Analyses ......................................................................................27
6.4.1
Primary Effectiveness........................................................................27
6.4.1.1
Statistical Hypotheses........................................................27
6.4.1.2
Analysis Methods ..............................................................27
6.4.2
Secondary Effectiveness....................................................................27
6.4.2.1
Statistical Hypotheses........................................................27
6.4.2.2
Analysis Methods ..............................................................27
28
28
28
6.5
Subgroup Analyses ............................................................................................28
6.6
Handling of Missing Data .................................................................................29
6.7
Multiplicity........................................................................................................29
6.8
Safety Analysis ..................................................................................................29
6.9
Interim Analyses................................................................................................29
6.10
Sample Size Justification...................................................................................30
7
ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................30
7.1
General Information ..........................................................................................32
7.2
Monitoring for Adverse Events .........................................................................35
7.3
Procedures for Recording and Reporting ..........................................................35
7.4
Return product analysis .....................................................................................37
7.5
Follow-Up of Subjects with Adverse Events.....................................................37
7.6
Pregnancy in the Clinical Study........................................................................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
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TDOC-0054838
Protocol - Clinical
01-Mar-2018

Page 11 of 43
9.1
Completion of Source Documents and Case Report Forms..............................39
9.2
Data Review and Clarifications.........................................................................40
9.3
Regulatory Documentation and Records Retention ..........................................40
10 ETHICS AND COMPLIANCE.........................................................................................40
10.1
Compliance........................................................................................................41
10.2
Institutional Review Board (IRB) .....................................................................41
11 PROTOCOL AMENDMENT HISTORY..........................................................................42
12 REFERENCES ..................................................................................................................43
12.1
References applicable for all clinical trials .......................................................43
12.1.1
US references applicable for clinical trials........................................43
12.2
References for this clinical trial.........................................................................43
List of Tables
Table 1-1
Schedule of Study Procedures and Assessments ...............................................6
List of Figures
Figure 7–1
Categorization of All AEs................................................................................32
Figure 7-2
Categorization of All Serious Adverse Events.................................................33
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Page 12 of 43
3
INTRODUCTION
3.1
Study Rationale and Purpose
The purpose of this study is to obtain on-eye performance data to aid contact lens product 
development.  The primary and secondary endpoints were selected to fulfil the primary and 
secondary objectives 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 FDA approval and information, as described within the Package Inserts.
BIOFINITY contact lenses were chosen as the control product because these lenses have the 
same wear modality, material, and parameters to the test product BIOFINITY ENERGYS, 
and are the spherical design as compared to the aspherical design, respectively.
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 primary objective is to explore overall vision with BIOFINITY ENERGYS as compared 
to BIOFINITY lenses after 1 week of wear.  
The secondary objective is to evaluate the difference in over-refraction of BIOFINITY 
ENERGYS as compared to BIOFINITY.  
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.
Both study contact lens are for daily wear use under a weekly/monthly wear modality.  A 
summary of the known potential risks and benefits associated with these marketed contact 
lenses can be found in the package inserts, See MOP. 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. In general, the risks with the marketed contact 
lenses in this study are anticipated to be similar to other marketed weekly/monthly soft 
contact lenses.
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Document:  
Version:  
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2.0; Most-Recent; Effective; CURRENT
TDOC-0054838
Protocol - Clinical
01-Mar-2018

Pa ge 1 3 of 4 3
T he site pers o n nel will e d ucate s u bjects o n pr o per h y gie ne a n d le ns ha n dli n g, a n d c o m p lia nce 
wit h t he use of c o ntact le nses acc or di n g t o t he pr ot oc ol. S u bjects s h o ul d be i nstr ucte d n ot t o 
wear c o ntact le nses w hile slee pi n g or s wi m mi n g. T he site pers o n nel will als o a d vise t he 
s u bjects t o re m o ve c o ntact le nses a n d ret ur n f or pr o m pt f oll o w- u p of s y m pt o ms, s uc h as 
oc ular disc o mf ort, f orei g n b o d y  se nsati o n, e xcessi ve teari n g, visi o n c ha n ges, or h ypere mia.
3. 4
S u bject P o p ul ati o n
T he st u d y  p o p ulati o n i ncl u des a p pr o xi matel y 1 6 v ol u nteer s u bjects t o be e nr olle d at 1 site. 
T he st u d y  p o p ulati o n will c o nsist of s u bjects a ge d 1 8 t o 3 5 wit h n or mal e yes ( ot her t ha n 
c orrecti o n f or refracti ve err or), c urre ntl y weari n g BI O FI NI T Y  s p here s oft c o ntact le nses (or 
pri vate la bel) o n a daily wear basis.  S u bjects s h o ul d ha ve at least 3 m o nt hs of BI O FI NI T Y  
( or pri vate la bel) weari n g e x perie nce, wear t hese le nses at least 5 da y s per wee k a n d at least 8 
h o urs per da y, use di gital de vices at least 4 h o urs per da y at least 5 da ys per wee k, a n d re q uire 
c o ntact le nses i n a p o wer ra n ge fr o m + 6. 0 0 t o -1 0. 0 0 D S.
S u bjects m ust be scree ne d acc or di n g t o t he f ull list of i ncl usi o n/e xcl usi o n criteria i n Secti o n 1
of t his pr ot oc ol.
After i nf or me d c o nse nt is si g ne d, a se parate scree ni n g visit is all o we d f or t he f oll o wi n g 
criteria:

I N C 0 1 – S u bject m ust be 1 8 t o 3 5 y ears of a ge

E X C 1 3 – Partici pati o n of t he s u bject i n a cli nical trial wit hi n t he pre vi o us 3 0 da y s or 
c urre ntl y e nr olle d i n a n y cli nical trial
T his se parate scree ni n g visit ca n ta ke place re gar dless of w het her a n y  ot her criteri o n has bee n 
verifie d.
Rescree ni n g of s u bjects is n ot all o we d i n t his st u d y.
3. 5
O utli ne of St u d y
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8
T his will be a si n gle-site, pr os pecti ve, ra n d o mize d, d o u ble-mas ke d , bilateral cr oss o ver st u d y 
c o m pari n g 2 wee kl y /m o nt hl y  c o ntact le nses. T he e x pecte d d urati o n of s u bject partici pati o n i n 
t he st u d y is 7 ± 2 d a y s per l e ns t yp e , wit h u p t o 4 sc he d ule d visits. T he st u d y is e x pecte d t o 
be c o m plete d i n a p pr o xi matel y  4 wee ks.

Pa ge 1 4 of 4 3
4
T R E A T M E N T S A D MI NI S T E R E D
S u bjects will be ra n d o mize d i n a 1: 1 ma n ner t o recei ve treat me nt i n cr oss o ver se q ue nce ,
BI O FI N I T Y E N E R G Y S t he n BI O FI N I T Y, or B I O FI NI T Y t he n BI O FI NI T Y E N E R G Y S , 
res pecti vely.
4. 1
I de ntit y of St u d y Tr e at me nts
D E S C RI P TI O N O F  TE S T  AN D C O N T R O L  P R O D U C T S
Te st Pr o d uct
C o ntr ol Pr o d uct
Le ns i de ntifie d i n 
ra n d o mizati o n s yste m 
as: 
BI O FI N I T Y E N E R G Y S
BI O FI N I T Y
Le ns
BI O FI N I T Y E N E R G Y S
BI O FI N I T Y
Material
c o mfilc o n A
c o mfilc o n A
Wa ter C o nte nt
4 8 %
4 8 %
Base C ur ve ( m m)
8. 6
8. 6
Dia meter ( m m)
1 4. 0
1 4. 0
R x p o wers t o be 
a vaila ble i n t his st u d y
+ 6. 0 0 D S t o - 6. 0 0 D S (0. 2 5 ste ps )
- 6. 5 0 D S t o - 1 0. 0 0 D S ( 0. 5 0 ste ps)
+ 6. 0 0 D S t o - 6. 0 0 D S (0. 2 5 ste ps)
- 6. 5 0 D S t o - 1 0. 0 0 D S ( 0. 5 0 ste ps)
Pac ka gi n g, La beli n g, 
a n d S u p pl y

Blister f oil pac k i n 
c o m mercial pac ka gi n g

F oil la bel i ncl u des at a 
mi ni m u m:
-
material na me 
-
base c ur ve
-
dia meter
-
pac ki n g s ol uti o n
-
p o wer
-
l ot n u m ber
-
e x pirati o n date
-
c o nte nt state me nt
-
Ma n ufact urer 
i nf or mati o n
-
c o u ntr y of ori gi n.

S ite will pr oc ure st u d y 
le nses l ocally.

Le nses s h o ul d be st ore d at 
r o o m te m perat ure.

Blister f oil pac k i n 
c o m mercial pac ka gi n g

F oil la bel i ncl u des at a 
mi ni m u m:
-
material na me 
-
base c ur ve
-
dia meter
-
pac ki n g s ol uti o n
-
p o wer
-
l ot n u m ber
-
e x pirati o n date
-
c o nte nt state me nt
-
Ma n ufact urer
i nf or mati o n
-
c o u ntr y of ori gi n

Site will pr oc ure st u d y  
le nses l ocally.

Le nses s h o ul d be st ore d at 
r o o m te m perat ure.
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8

Pa ge 1 5 of 4 3
Usa ge

Wear: 
o
Dail y  Wear 
o
Bilateral Cr oss o ver

Re place me nt peri o d: N ot a p plica ble f or 7 ± 2 da y s of wear 
wit h t hese m o nt hl y  le nses. Re place me nt le nses will n ot be 
pr o vi de d t o t he s u bjects. I n t he e ve nt a le ns nee ds t o be 
re place d, t he s u bject m ust ret ur n t o t he site f or a re place me nt 
le ns. 

E x p os ure: U p t o 1 8 da y s t otal durati o n
o
Test Pr o d uct:  7 da y s (± 2 da y s)
o
C o ntr ol Pr o d uct:  7 da y s (± 2 d a y s)

Le ns Care: Clea ne d a n d disi nfecte d wit h s u bject’s ha bit ual le ns 
care s ol uti o n after eac h use

I nstr ucti o ns f or use are pr o vi de d i n t he M O P
4. 2
Acc o u nt a bilit y Pr oce d ures
U p o n recei pt of t he st u d y le nses, t he I n vesti gat or or dele gate will c o n d uct a n i n ve nt or y . 
Desi g nate d u n mas ke d st u d y staff will pr o vi de t he st u d y le nses t o t he s u bjects i n acc or da nce 
wit h t heir ra n d o mizati o n sc he d ule. T hr o u g h o ut t he st u d y , t he I n vesti gat or or dele gate m ust 
mai ntai n rec or ds of st u d y treat me nt dis pe nsati o n a n d c ollecti o n f or eac h s u bject. T his rec or d 
m ust be ma de a vaila ble t o t he st u d y  m o nit or f or t he p ur p oses of verif yi n g t he acc o u nti n g of 
cli nical s u p plies. A n y discre pa ncies a n d/ or deficie nc ies bet wee n t he o bser ve d dis p ositi o n a n d 
t he writte n acc o u nt m ust be rec or de d al o n g wit h a n e x pla nati o n. 
It is t he I n vesti gat or’s res p o nsi bilit y t o e ns ure t hat:

All st u d y  pr o d ucts are acc o u nte d f or a n d n ot use d i n a n y u na ut h orize d ma n ner

All use d f oils a n d u n use d s u p plies are ret ur ne d b y eac h s u bject

All u n use d pr o d ucts are a vaila ble f or ret ur n t o t he St u d y  S p o ns or, as directe d

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8
A n y  st u d y le nses ass ociate d wit h a de vice deficie nc y  or wit h a n y pr o d uct-relate d a d verse 
e ve nt [ie, A D E or S A D E] , t hat are relate d t o c o mf ort or visi o n, are ret ur ne d t o t he St u d y 
S p o ns or f or i n vesti gati o n. Refer t o M O P
of t his pr ot oc ol f or a d diti o nal i nf or mati o n o n t he 
re p orti n g of de vice deficie ncies a n d A Es a n d t he ret ur n of st u d y  pr o d ucts ass ociate d wit h 
t hese e ve nts.

Page 16 of 43
4.3
Local Lens Procurement
Site will procure all study lenses locally and the following procedures are to be followed.
4.3.1
Procurement 
Site will procure commercial lenses through their standard channels. The site must follow any 
recalls from the distributor/manufacturer for locally procured lenses. Site personnel
dispensing lenses must ensure the contact lenses being dispensed are not expired.
4.3.2
Labeling  
All study lenses will be provided to subject in commercial packaging.
4.3.3
Handling
Lenses will be stored in a safe, secure location with limited access and separated from 
general stock. Designated site staff should follow the manufacturer’s instructions on the 
storage requirements of the lenses.
4.3.4
Dispensing and Accountability
Lenses are to be provided to the subjects in accordance with Protocol.  The Investigator or 
delegate is to maintain records of the dispensation and collection of all study lenses.  This 
record will be made available to the Sponsor’s monitor to account for all study lenses. 
It is the Investigator’s responsibility to ensure that all used study lens lidding foils dispensed 
to each subject are saved, and that they are available for the clinical study monitor to perform 
final accountability.  Any discrepancy and/or deficiency must be recorded, with an 
explanation.
4.3.5
Final Disposition
At the conclusion of the study, once the Clinical Study Manager has performed a final 
reconciliation of the accountability records, unused study lenses reimbursed by the Sponsor 
will be returned to the Sponsor.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0054838
Protocol - Clinical
01-Mar-2018

Pa ge 1 7 of 4 3
4. 4
Wo r n Le ns C ollecti o n, St or a g e a n d Ret ur n
See M O P  f or i nstr ucti o ns o n le ns st ora ge a n d ret ur n.
5
S T U D Y  P R O C E D U R E S A N D A S S E S S M E N T S
5. 1
Vi sits a n d E x a mi n ati o ns
Detaile d descri pti o ns of assess me nts a n d pr oce d ures are pr o vi de d bel o w . T he I n vesti gat or is 
res p o nsi ble f or e ns uri n g res p o nsi bilities f or all pr oce d ures a n d assess me nts are dele gate d t o 
a p pr o priatel y q ualifie d site pers o n nel.
5. 1. 1
Vi sit 1 ( D a y 0 ) – B aseli ne/ Fitti n g
1
E x plai n t he p ur p ose a n d nat ure of t he st u d y, a n d ha ve t he s u bject rea d, si g n, a n d date 
t he IR B -a p pr o ve d i nf or me d c o nse nt d oc u me nt. A d diti o nall y , ha ve t he i n di vi d ual 
o btai ni n g c o nse nt fr o m t he s u bject a n d a wit ness, if a p plica ble, si g n a n d date t he 
i nf or me d c o nse nt d oc u me nt. Pr o vi de a p h ot oc o p y of t he si g ne d d oc u me nt t o t he 
s u bject a n d place t he ori gi nal si g ne d d oc u me nt i n t he s u bject’s c hart. After si g ni n g 
t he IC F , a s u bject will be assi g ne d a s u bject n u m ber b y t he E D C s yste m. A si g ne d 
i nf or me d c o nse nt d oc ume nt defi nes t he p oi nt of e nr oll me nt.
2
O btai n de m o gra p hic i nf or mati o n a n d me dical hist or y, i ncl u di n g i nf or mati o n o n all 
me dicati o ns use d wit hi n t he past 3 0 da y s. I ncl u de her bal t hera pies, vita mi ns, a n d all 
o ver -t he-c o u nter as well as prescri pti o n me dicati o ns.
3
Rec or d ha bit ual le ns i nf or mati o n ( bra n d, p o wer) *, le ns care i nf or mati o n ( bra n d)*, 
a n d re-wetti n g dr o ps ( bra n d / usa ge ). *
* S o urce o nly
4 
Perf or m a ma nifest refracti o n. *
* S o urce o nly
5 
Perf or m S nelle n B C V A wit h ma nifest refracti o n. *

O D & O S, dista nce o nl y
N ote: Dist a nce B C V A m ust be 2 0/ 2 5 or better i n e ac h eye f or t he s u bject t o q u alify f or t he 
st u dy. * S o urce o nly .
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8

Pa ge 1 8 of 4 3
6
Perf or m slit -la m p bi o micr osc o py ( wit h o ut c o ntact le nses) t o e val uate t he f oll o wi n g:

Li m bal h y pere mia

B ul bar h y p ere mia

C or neal stai ni n g

C o nj u ncti val stai ni n g

Pal pe bral c o nj u ncti val o bser vati o ns

C or neal e pit helial e de ma

C or neal str o mal e de ma

C or neal vasc ularizati o n

C o nj u ncti val c o m pressi o n/i n de nti o n

C he m osis

C or neal i nfiltrates

Ot her fi n di n gs
7
Deter mi ne st u d y le ns p o wers base d u p o n t he ma nifest refracti o n a n d ha bit ual le ns 
p o wers.
8 
Re vie w i ncl usi o n/e xcl usi o n criteria t o deter mi ne if t he s u bject q ualifies t o be
ra n d o mize d i nt o t he st u d y. If s u bject q ualifies, re q uest ra n d o mizati o n. If s u bject d oes 
n ot q ualif y , e xit t he s u bject fr o m t he st u d y as a scree n fail ure.
1 0
Assess a n d rec or d a n y A Es a n d de vice deficie ncies re p orte d or o bser ve d d uri n g t he 
st u d y visit.
N ote: A Es a n d device deficie ncies m ust be rec or de d f or all e nr olle d s u bjects fr o m t he ti me of 
si g n at ure of i nf or me d c o nse nt i ncl u di n g t h ose t h at scree n f ail.
1 1
If st u d y le ns p o wers ha ve n ot c ha n ge d fr o m ha bit ual R x, t he n ca n use st u d y le nses 
or dere d after Pre -scree ni n g a n d pr ocee d wit h Visit 2.
N ote: Visit 2 m ay occ ur o n s a me d ay as Visit 1 w he n le nses d o n ot h ave t o be re -or dere d.
1 2
If st u d y le ns p o wers ha ve c ha n ge d, t he n st u d y le nses m ust be re-or dere d.  Sc he d ule 
Visit 2 t o ta ke place 0- 7 da y s after Visit 1.
5. 1. 2
Vi sit 2 ( 0-7 D a ys fr o m V isit 1) – Dis pe nse P air  1
1
If Visit 2 occ urs o n sa me da y  as Visit 1, g o t o li ne 5 of t his visit.  
O btai n i nf or mati o n o n a n y  c ha n ges i n me dical healt h a n d/ or t he use of c o nc o mita nt 
me dicati o ns.
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8

Pa ge 1 9 of 4 3
2
Rec or d a n y de vice deficie ncies or A Es i ncl u di n g t h ose ass ociate d wit h c ha n ges i n 
c o nc o mita nt me dicati o n d osi n g, w hic h are o bser ve d or re p orte d si nce t he pre vi o us 
visit.
3
Perf or m S nelle n B C V A wit h ma nifest refracti o n. * ( as necess ary ).

O D & O S, dista nce o nl y
N ote: Perf or m o nly as necess ary , ie, decre ase of V A by 2 li nes or m ore wit h I P. 
* S o urce o nly.
4
Perf or m slit -la m p bi o micr osc o py ( wit h o ut c o ntact le nses) t o e val uate t he f oll o wi n g:

Li m bal h y pere mia

B ul bar h y p ere mia

C or neal stai ni n g

C o nj u ncti val stai ni n g

Pal pe bral c o nj u ncti val o bser vati o ns

C or neal e pit helial e de ma

C or neal str o mal e de ma

C or neal vasc ularizati o n

C o nj u ncti val c o m pressi o n/i n de nti o n

C he m osis

C or neal i nfiltrates

Ot her fi n di n gs
5
Dis pe nse Pair 1 st u d y le nses. Pr o vi de t he s u bject wit h writte n a n d ver bal
i nstr ucti o ns o n le ns wear a n d ha bit ual le ns care .
6 
Base d u p o n t he ra n d o mize d treat me nt se q ue nce assi g n me nt, ha ve t he s u bject i nsert 
t he Pair 1 st u d y le nses.

Kee p all li d di n g f oils of le nses f or st u dy le ns acc o u nt a bility.

F oll o w pr oce d ures t o m ai nt ai n m aski n g.
7
E val uate Pair 1 st u d y le nses b y perf or mi n g t he f oll o wi n g:

S nelle n V A wit h st u d y  le nses,  wit h o ut o ver-refracti o n ( O D, O S, O U at 
dista nce) *

O ver -refracti o n t o deter mi ne t he best c o ntact le ns- c orrecte d V A
* V A w/st u dy le nses m ust be 2 0/ 4 0 O U or better f or s u bject t o le ave t he office
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8

Pa ge 2 0 of 4 3
9
Assess a n d rec or d a n y A Es a n d de vice deficie ncies re p orte d or o bser ve d d uri n g t he 
st u d y visit.
N ote: A Es a n d device deficie ncies m ust be rec or de d f or all e nr olle d s u bjects fr o m t he ti me 
of si g n at ure of i nf or me d c o nse nt i ncl u di n g t h ose t h at scree n f ail.
1 0
Sc he d ule Visit 3 t o ta ke place 7 ± 2 da y s after Visit 2. 
1 1
N ote: If f or s o me reas o n a s u bject is u na ble t o wear a st u d y le ns f or t he d urati o n of 
t his visit wi n d o w, i nstr uct t he s u bject t o ret ur n t o t he site f or a n U nsc he d ule d Visit 
as well as le ns re m o val o n site, if p ossi ble. If st u d y le nses nee d t o be re place d, 
u n mas ke d st u d y  pers o n nel ma y d o s o at t his visit.  T he s u bject s h o ul d t he n be 
sc he d ule d t o ret ur n t o t he cli nic f or Visit 3 (if p ossi ble) or e xite d fr o m t he st u d y.
5. 1. 3
Vi sit 3 ( 7 ± 2 D a ys fro m V isit 2) – [ F oll o w- u p visit f or P air 1 a n d 
Dis pe nsi n g visit f or P air 2]
1
O btai n i nf or mati o n o n a n y  c ha n ges i n me dical healt h a n d/ or t he use of c o nc o mita nt 
me dicati o ns.
2
Rec or d a n y de vice deficie ncies or A Es i ncl u di n g t h ose ass ociate d wit h c ha n ges i n 
c o nc o mita nt me dicati o n d osi n g, w hic h are o bser ve d or re p orte d si nce t he pre vi o us 
visit (s).
3
Re vie w s u bject c o m plia nce wit h le ns wear a n d a dj u nct pr o d uct usa ge.
5
Perf or m S nelle n B C V A wit h ma nifest refracti o n. * (as necess ary ).

O D & O S, dista nce o nl y
N ote: Perf or m o nly as necess ary , ie, decre ase of V A by 2 li nes or m ore wit h I P. 
* S o urce o nly.
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8

Pa ge 2 1 of 4 3
6
E val uate Pair 1 st u d y le nses b y perf or mi n g t he f oll o wi n g:

S nelle n V A wit h st u d y  le nses ( O D, O S, O U at dista nce)
8
Perf or m slit -la m p bi o micr osc o py ( wit h o ut c o ntact le nses) t o e val uate t he f oll o wi n g:

Li m bal h y pere mia

B ul bar h y p ere mia

C or neal stai ni n g

C o nj u ncti val stai ni n g

Pal pe bral c o nj u ncti val o bser vati o ns

C or neal e pit helial e de ma

C or neal str o mal e de ma

C or neal vasc ularizati o n

C o nj u ncti val c o m pressi o n/i n de nti o n

C he m osis

C or neal i nfiltrates

Ot her fi n di n gs
1 0
Dis pe nse Pair 2 st u d y le nses. Pr o vi de t he s u bject wit h writte n a n d ver bal
i nstr ucti o ns o n le ns wear a n d ha bit ual le ns care .
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8

Pa ge 2 2 of 4 3
1 1
E val uate Pair 2 st u d y le nses b y perf or mi n g t he f oll o wi n g:

S nelle n V A wit h st u d y  le nses, wit h o ut o ver-refracti o n ( O D, O S, O U at 
dista nce) *

O ver -refracti o n t o deter mi ne t he best c o ntact le ns- c orrecte d V A
* V A w/st u dy le nses m ust be 2 0/ 4 0 O U or better f or s u bject t o le ave t he office
1 3
Assess a n d rec or d a n y A Es a n d de vice deficie ncies re p orte d or o bser ve d d uri n g t he 
st u d y visit.
N ote: A Es a n d device deficie ncies m ust be rec or de d f or all e nr olle d s u bjects fr o m t he ti me 
of si g n at ure of i nf or me d c o nse nt i ncl u di n g t h ose t h at scree n f ail.
1 4 
Sc he d ule Visit 4 t o ta ke place 7 ± 2 da y s after Visit 3. 
1 5
N ote: If f or s o me reas o n a s u bject is u na ble t o wear a st u d y le ns f or t he d urati o n of 
t his visit wi n d o w, i nstr uct t he s u bject t o ret ur n t o t he site f or a n U nsc he d ule d Visit 
as well as le ns re m o val o n site, if p ossi ble. If st u d y le nses nee d t o be re place d, 
u n mas ke d st u d y  pers o n nel ma y d o s o at t his visit  T he s u bject s h o ul d t he n be 
sc he d ule d t o ret ur n t o t he cli nic f or Visit 4 (if p ossi ble) or e xite d fr o m t he st u d y.
5. 1. 4
Vi sit 4 ( 7 ± 2 D a ys fro m V isit 3) – [ F oll o w- u p visit f or P air 2 / E xit]
1
O btai n i nf or mati o n o n a n y  c ha n ges i n me dical healt h a n d/ or t he use of c o nc o mita nt 
me dicati o ns.
2
Rec or d a n y de vice deficie ncies or A Es i ncl u di n g t h ose ass ociate d wit h c ha n ges i n 
c o nc o mita nt me dicati o n d osi n g, w hic h are o bser ve d or re p orte d si nce t he pre vi o us 
visit(s).
3
Re vie w s u bject c o m plia nce wit h le ns wear a n d a dj u nct pr o d uct usa ge.
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8

Pa ge 2 3 of 4 3
5 
Perf or m S nelle n B C V A wit h ma nifest refracti o n. * (as necess ary ).

O D & O S, dista nce o nl y
N ote: Perf or m o nly as necess ary , ie, decre ase of V A by 2 li nes or m ore wit h I P. 
* S o urce o nly.
6
E val uate Pair 2 st u d y le nses b y perf or mi n g t he f oll o wi n g:

S nelle n V A wit h st u d y  le nses ( O D, O S, O U at dista nce)
8
Perf or m slit -la m p bi o micr osc o py ( wit h o ut c o ntact le nses) t o e val uate t he f oll o wi n g:

Li m bal h y pere mia

B ul bar h y p ere mia

C or neal stai ni n g

C o nj u ncti val stai ni n g

Pal pe bral c o nj u ncti val o bser vati o ns

C or neal e pit helial e de ma

C or neal str o mal e de ma

C or neal vasc ularizati o n

C o nj u ncti val c o m pressi o n/i n de nti o n

C he m osis

C or neal i nfiltrates

Ot her fi n di n gs
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8

Pa ge 2 4 of 4 3
1 0
Assess a n d rec or d a n y A Es a n d de vice deficie ncies re p orte d or o bser ve d d uri n g t he 
st u d y visit.
N ote: A Es a n d device deficie ncies m ust be rec or de d f or all e nr olle d s u bjects fr o m t he ti me 
of si g n at ure of i nf or me d c o nse nt i ncl u di n g t h ose t h at scree n f ail.
1 1
E xit t he s u bject fr o m t he st u d y .
5. 2
U nsc he d ule d Vi sits
A n y  visit t hat occ urs bet wee n re g ularly sc he d ule d visits is a n U nsc he d ule d V isit. If a s u bject 
re q uires a n U nsc he d ule d Visit, he/s he m ust be a d vise d t o ret ur n t o t he office weari n g t he 
st u d y le nses, if at all p ossi ble ( u nless he/s he is e x perie nci n g a si g n or s y m pt o m [as i n dicate d 
i n Secti o n 3. 3 Ris ks a n d Be nefits]). D uri n g all u nsc he d ule d visits, t he I n vesti gat or m ust 
c o n d uct t he f oll o wi n g pr oce d ures: 

Assess a n d rec or d c ha n ges i n me dical c o n diti o n or c o nc o mita nt me dicati o n

Assess a n d rec or d VAs (as a p plica ble)

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8
Perf or m bi o micr osc o p y (assess me nts wit h or wit h o ut le nses, as p ossi ble)

Pa ge 2 5 of 4 3

C ollect A E a n d De vice Deficie nc y  i nf or mati o n
T he I n vesti gat or ma y  perf or m a d diti o nal proce d ures f or pr o per dia g n osis a n d treat me nt of t he 
s u bject. T he I n vesti gat or m ust d oc u me nt t his i nf or mati o n i n t he s u bject’s case hist or y s o urce 
d oc u me nts.   If nee de d, st u d y le nses ma y be re place d b y u n mas ke d site pers o n nel.
If d uri n g a n U nsc he d ule d Visit t he s u bject is disc o nti n ui n g t he st u d y le nses or disc o nti n ui n g 
fr o m t he st u d y, t he I n vesti gat or m ust c o n d uct E xit pr oce d ures acc or di n g t o Ta ble 1 -1: 
Sc he d ule of St u d y  Pr oce d ures a n d Assess me nts, as p ossi ble.
5. 3
Disc o nti n ue d S u bjects
Disc o nti n ue d s u bjects are t h ose w h o wit h dra w or are wit h dra w n fr o m t he st u d y after si g ni n g 
t he i nf or me d c o nse nt, i ncl u di n g scree n fail ures. S u bjects ma y disc o nti n ue fr o m t he st u d y at 
a n y ti me f or a n y reas o n. S u bjects ma y als o be disc o nti n ue d fr o m t he st u d y at a n y ti me if, i n 
t he o pi ni o n of t he I n vesti gat or, t heir c o nti n ue d partici pati o n p oses a ris k t o t heir healt h. 
Disc o nti n ue d s u bjects will n ot be re place d (ie, t heir s u bject n u m bers will n ot be 
re-assi g ne d/re -use d).
S h o ul d a s u bject e x hi bit a n y  cli nicall y rele va nt si g ns, sy m pt o ms, or ot her cli nical 
o bser vati o ns t hat p ossi bl y  c o ul d be ass ociate d wit h s us pecte d se nsiti vit y or i nt olera nce t o o ne 
of t he st u d y  treat me nts, t he I n vesti gat or m ust d oc u me nt t h ose o bser vati o ns o n a n A E F or m.
A n y  s u bject w h o e xits earl y fr o m t he st u d y (e xcl u din g scree n fail ures) m ust u n der g o all 
pr oce d ures o utli ne d at Visit 4 , as a p plica ble.
T he I n vesti gat or m ust d oc u me nt t he reas o n f or st u d y  or treat me nt disc o nti n uati o n i n t he 
s u bject’s case hist or y s o urce d oc u me nts.
To  e ns ure t he safety of all s u bjects w h o di sc o nti n ue early,  In vesti gat ors m ust assess eac h 
s u bject a n d, if necessar y, a d vise t he m of a n y t hera pies a n d/ or me dical pr oce d ures t hat ma y be 
nee de d t o mai ntai n t heir healt h.
5. 4
Cli nic al St u d y Te r mi n ati o n
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8
T he St u d y  S p o ns or reser ves t he ri g ht t o cl ose t he i n vesti gati o nal site or ter mi nate t he st u d y i n 
its e ntiret y at a n y ti me, f or reas o na ble ca use.
If t he cli nical st u dy is pre mat urel y ter mi nate d or s us pe n de d b y t he St u d y S p o ns or: 

Pa ge 2 6 of 4 3

T he St u d y  S p o ns or m ust:
o
I m me diatel y n otif y t he I n vesti gat or(s) a n d s u bse q ue ntl y pr o vi de 
i nstr ucti o ns f or st u d y ter mi nati o n.
o
I nf or m t he I n vesti gat or a n d t he re g ulat or y a ut h orities of t he 
ter mi nati o n/s us pe nsi o n a n d t he reas o n(s) f or t he ter mi nati o n/s us pe nsi o n, 
as a p plica ble. 

T he I n vesti gat or m ust:
o
Pr o m ptl y  n otif y t he I RB of t he ter mi nat i o n or s us pe nsi o n a n d of t he 
reas o ns. 
o
Pr o vi de s u bjects wit h rec o m me n dati o ns f or p ost -st u d y treat me nt o pti o ns 
as nee de d.
T he I n vesti gat or ma y  ter mi nate a site’s partici pati o n i n t he st u d y f or reas o na ble ca use.
6
A N A L Y SI S P L A N
C o nti n u o us varia bles will be s u m marize d usi n g t he n u m ber of o bser vati o ns, mea n, sta n dar d 
de viati o n, me dia n, mi ni m u m, a n d ma xi m u m. Cate g orical varia bles will be s u m marize d wit h 
c o u nts a n d perce nta ges fr o m eac h cate g or y. A n y de viati o ns t o t his a nal y sis pla n will be 
u p date d d uri n g t he c o urs e of t he st u d y as part of a pr ot oc ol a me n d me nt or will be detaile d i n 
t he cli nical st u d y re p ort.
6. 1
S u bject E v al u a bilit y
T he fi nal s u bject e val ua bilit y  will be deter mi ne d pri or t o brea ki n g t he c o de f or mas ke d 
treat me nt se q ue nce assi g n me nt a n d l oc ki n g t he data base, base d o n t he De viati o ns a n d 
E val ua bilit y  Pla n.
6. 2
A n al ysis D at a Sets
6. 2. 1
S afet y A n al ysis Set
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8
Safet y  a nalys es will be c o n d ucte d usi n g t he safet y a nal ys is set o n a treat me nt-e mer ge nt basis. 
As s uc h, t he safet y  a nalysis set will i ncl u de all s u bjects/e y es e x p ose d t o a n y st u d y le nses 
e val uate d i n t his st u d y. F or treat me nt-e mer ge nt safet y a nal ys es, s u bjects/e yes will be 
cate g orize d u n der t he act ual st u d y  le nses e x p ose d. 

Page 27 of 43
6.3
Demographic and Baseline Characteristics
Demographic information (age, sex, ethnicity, race) will be summarized on the Safety 
Analysis Set.  Digital fatigue questionnaire collected at Visit 1 will also be summarized on 
the Safety Analysis Set)
6.4
Effectiveness Analyses
This study defines one primary endpoint, one secondary endpoint 
 
  The Safety Analysis Set will serve as the primary set for all effectiveness analyses.  
6.4.1
Primary Effectiveness
The primary objective of this study is to explore overall vision with BIOFINITY ENERGYS 
as compared to BIOFINITY lenses after 1 week of wear.  The primary endpoint is the 
subjective rating of overall vision, collected binocularly on a scale of 1 (Poor) to 10 
(Excellent).
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.
6.4.2
Secondary Effectiveness
The secondary objective of this study is to evaluate the difference in over-refraction of 
BIOFINITY ENERGYS as compared to BIOFINITY. The secondary endpoint is the over-
refraction, collected in diopters for each eye at Dispense.
6.4.2.1
Statistical Hypotheses
No inferences are to be made on the secondary effectiveness endpoint, therefore no 
hypotheses are formulated.
6.4.2.2
Analysis Methods
Descriptive statistics will be provided.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0054838
Protocol - Clinical
01-Mar-2018

Page 28 of 43
6.5
Subgroup Analyses
It is not expected that demographic or baseline characteristics will have an impact on the 
study results in this study. No subgroup analyses are planned.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0054838
Protocol - Clinical
01-Mar-2018

Page 29 of 43
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. 
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 2 or Visit 1, if Visit 2 and Visit 1 occur on the same date) 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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0054838
Protocol - Clinical
01-Mar-2018

Pa ge 3 0 of 4 3
6. 1 0 S a m ple Size J ustific ati o n
N o f or mal sa m ple size calc ulati o n is pr o vi de d gi ve n t he pil ot a n d descri pti ve nat ure of t he 
st u d y.
7
A D V E R S E E V E N T S A N D D E VI C E D E FI CI E N CI E S
Te r ms a n d Defi niti o ns
A d verse E ve nt ( A E)
A n y  u nt o war d me dical occ urre nce, u ni nte n de d disease or i nj ur y, or 
u nt o war d cli nical si g ns (i ncl u di n g a b n or mal la b orat or y  fi n di n gs) i n 
s u bjects, users or ot her pers o ns, w het her or n ot relate d t o the 
i n vesti gati o nal me dical de vice (test pr o d uct). N ote: F or s u bjects, 
t his defi niti o n i ncl u des eve nts rel ate d t o t he test pro d uct, t he 
c o ntrol pr o d uct, or t he pr oce d ur es i nv olve d. F or users or ot her 
pers o ns, t his defi niti o n is r estricte d t o eve nts rel ate d t o t he test 
pr o d uct.
A d verse De vice 
Ef fect ( A D E)
A E relate d t o t he use of a n i n vesti gati o nal me dical de vice (test 
pr o d uct ) or c o ntr ol pr o d uct . N ote: T his defi niti o n i ncl u des A Es 
res ulti n g fro m i ns ufficie nt or i n a de q u ate i nstr ucti o ns f or use, 
de pl oy me nt, i m pl a nt ati o n, i nst all ati o n, or o per ati o n; a ny 
m alf u ncti o n; a n d use err or or i nte nti o n al mis use of t he test pr o d uct 
or c o ntr ol pr o d uct.
A ntici pate d Seri o us 
A d verse De vice 
Ef fect ( A S A D E)
Seri o us A D E w hic h b y its nat ure, i nci de nce, se verit y  or o utc o me 
has bee n i de ntifie d i n t he ris k ma na ge me nt file.
De vice Deficie nc y
I na de q uac y of a me dical de vice wit h res pect t o its i de ntit y, q ualit y, 
d ura bilit y, relia bilit y, safet y, or perf or ma nce. N ote: T his defi niti o n 
i ncl u des m alf u ncti o ns, use errors, a n d i n a de q u ate l a beli n g.
Malf u ncti o n
Fail ure of a me dical de vice t o meet its perf or ma nce s pecificati o ns 
or ot her wise perf or m as i nte n de d. Perf or ma nce s pecificati o ns 
i ncl u de all clai ms ma de i n t he la beli n g of t he de vice. T he i nte n de d 
perf or ma nce of t he de vice refers t o t h e i nte n de d use f or w hic h t he 
de vice is la bele d or mar kete d.
N o n -seri o us A d verse 
E ve nt
A E t hat d oes n ot meet t he criteria f or a n S A E.
Seri o us A d verse 
E ve nt ( S A E)
A E t hat le d t o a n y of t he f oll o wi n g:

Deat h.
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8

Pa ge 3 1 of 4 3

A seri o us deteri orati o n i n t he healt h of t he s u bject t hat eit her 
res ulte d i n:
a)
a life -t hreate ni n g ill ness or i nj ur y.
N ote: Life -t hre ate ni n g me a ns t h at t he i n divi d u al w as at 
i m me di ate risk of de at h fro m t he eve nt as it occ urr e d, ie, it 
d oes n ot i ncl u de a n eve nt w hic h hy p ot hetic ally mi g ht h ave 
c a use d deat h h a d it occ urr e d i n a m ore severe f or m.
b)
a n y p ote ntiall y si g ht-t hreate ni n g e ve nt or per ma ne nt 
i m pair me nt t o a b o d y str uct ure or a b o d y f u ncti o n.
c)
i n-patie nt h os pitalizati o n or pr ol o n ge d h os pitalizati o n.
N ote: Pl a n ne d h os pit aliz ati o n f or a pr e-existi n g c o n diti o n, 
wit h o ut seri o us deteri or ati o n i n he alt h, is n ot c o nsi der e d 
a n S A E. I n ge ner al, h os pit aliz ati o n si g nifies t h at t he 
i n divi d u al re m ai ne d at t he h os pit al or e merge ncy w ar d f or 
o bserv ati o n a n d/ or tr e at me nt ( us u ally i nv olvi n g a n 
over ni g ht st ay) t h at w o ul d n ot h ave bee n a p pr o pri ate i n t he 
p hysici a n's office or a n o ut - p atie nt setti n g. C o m plic ati o ns 
t h at occ ur d uri n g h os pit aliz ati o n are a dverse eve nts. If a 
c o m plic ati o n prol o n gs h os pit aliz ati o n or f ulfills a ny ot her 
seri o us criteri a, t he eve nt is seri o us. Wh e n i n d o u bt as t o 
w het her “ h os pit aliz ati o n ” occ urr e d, t he eve nt s h o ul d be 
c o nsi dere d seri o us.
d)
a me dical or s ur gical i nter ve nti o n t o pre ve nt a) or b). 
e)
a n y i n direct har m as a c o nse q ue nce of i nc orrect dia g n ostic 
test res ults w he n use d wit hi n ma n ufact urer’s instr ucti o ns 
f or use.

Fetal distress, fetal deat h, or a c o n ge nital a b n or malit y  or birt h 
defect.
Refer t o Secti o n 7. 1 f or a d diti o n al S A Es.
Seri o us A d verse 
De vice Ef fect 
( S A D E)
A D E t hat has res ulte d i n a n y  of t he c o nse q ue nces c haracteristic of 
a n S A E.
Si g nifica nt N o n -
Seri o us A d verse 
E ve nt
A si g nifica nt n o n-seri o us A E is a sy m pt o matic, de vice -relate d, 
n o n- si g ht t hreate ni n g A E t hat warra nts disc o nti n uati o n of a n y  
c o ntact le ns wear f or greater t ha n or e q ual t o 2 wee ks.
Refer t o Secti o n 7. 1 f or a d diti o n al S i g nific a nt N o n-Seri o us A Es.
U na ntici pate d 
Seri o us a d verse de vice effect w hic h b y its nat ure, i nci de nce, 
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8

Page 32 of 43
Serious Adverse 
Device Effect 
(USADE)
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).
Figure 7–1
Categorization of All AEs
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0054838
Protocol - Clinical
01-Mar-2018

Pa ge 3 3 of 4 3
Fi g ur e 7- 2
C ate g oriz ati o n of All Seri o us A d verse E ve nts
S pecific E ve nts Rele v a nt t o t his Pr ot oc ol 
Seri o us A dverse Eve nts 
I n a d diti o n t o re p orti n g all A Es (seri o us a n d n o n -seri o us) meeti n g t he defi niti o ns, t he 
I n vesti gat or m ust re p ort a n y occ urre nce of t he f oll o wi n g as a n S A E:

A n oc ular i nfecti o n i ncl u di n g a pres u me d i nfecti o us ulcer wit h a n y of t he f oll o wi n g 
c haracteristics: 
o
Ce ntral or parace ntral l ocati o n
o
Pe netrati o n of B o w ma n’ s me m bra ne
o
I nfiltrates > 2 m m dia meter
o
Iritis
o
I ncrease i n i ntra oc ular press ure
o
C ult ure p ositi ve f or micr o or ga nis ms
o
I ncreasi n g size or se verit y at s u bse q ue nt visits

A n y  ce ntral or parace ntral c or neal e ve nt (s uc h as ne o vasc ularizati o n) t hat res ults i n 
per ma ne nt o pacificati o n

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8
H y p o p y o n

Pa ge 3 4 of 4 3

H y p he ma

Ne o vasc ularizati o n wit hi n t he ce ntral 6 m m of t he c o r nea

Per ma ne nt visi o n l oss as defi ne d b y l oss of 2 or m ore li nes of B C VA fr o m e nr oll me nt 
visit t hat fails t o res ol ve

U veitis (a nteri or , i nter me diate, or p osteri or)

C or neal a brasi o n affecti n g ≥ 5 0 % of c or neal s urface area
Si g nific a nt N o n -Seri o us A dverse Ev e nts
A si g nifica nt n o n-seri o us A E is a sy m pt o matic, de vice -relate d, n o n-si g ht t hreate ni n g A E t hat 
warra nts disc o nti n uati o n of a n y c o ntact le ns wear f or greater t ha n or e q ual t o 2 wee ks. I n 
a d diti o n, t he In vesti gat or m ust re p ort a n y  occ urre nce of t he f oll o wi n g as a Si g nifica nt 
N o n - Seri o us A E:

Peri p heral n o n - pr o gressi ve n o n-i nfecti o us ulcers

All s y m pt o matic c or neal i nfiltrati ve e ve nts

C or neal stai ni n g sc ore greater t ha n or e q ual t o Gra de 3 (see C L D 5 2 3-E 0 0 1 M O P  f or 
gra di n g scales)

Te m p orar y  visi o n l oss as define d b y l oss of 2 or m ore li nes of B C VA fr o m e nr oll me nt 
visit t hat persists f or 2 or m ore wee ks

Ne o vasc ularizati o n sc ore greater t ha n or e q ual t o Gra de 2 (see C L D 5 2 3-E 0 0 1 M O P  f or 
gra di n g scales)
T he a b ove eve nts ar e b ase d u p o n t he c ate g ories pr ovi de d i n t h e I S O 11 9 8 0 a n d t he U S F D A  
Pr e m arket N otific ati o n ( 5 1 0(k)) G ui d a nce D oc u me nt f or D aily We ar C o nt act Le nses a n d 
C o nt act Le ns C ar e Pro d ucts. 
Device Deficie ncies
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8
A de vice deficie nc y  is i na de q uac y of a me dical de vice wit h res pect t o its i de ntit y, q ualit y, 
d ur a bilit y, relia bilit y, safet y, or perf or ma nce. A de vice deficie nc y  ma y or ma y n ot be 
ass ociate d wit h patie nt har m (ie, A D E or S A D E); h o we ver , n ot all A D Es or S A D Es are d ue 
t o a de vice deficie nc y. T he I n vesti gat or s h o ul d deter mi ne t he a p plica ble cate g or y liste d i n t he 
De vice Deficie nc y  e C R F f or t he i de ntifie d or s us pect de vice deficie nc y a n d re p ort a ny patie nt 
har m se paratel y. E xa m ples of de vice deficie ncies i ncl u de t he f oll o wi n g: 

Pa ge 3 5 of 4 3

Fail ure t o meet pr o d uct s pecificati o ns (e g, i nc orrect le ns p o wer/ dia meter/ base
c ur ve/c ol or)

Le ns/s ol uti o n cl o u d y

Le ns s urface/e d ge defect 

To r n le ns d uri n g ha n dli n g/i n pac k

Pac ka gi n g deficit (e g, misla bele d pr o d uct, ta m pere d seal, lea ki n g b ottle/c o ntai ner)

S us pect pr o d uct c o nta mi nati o n

Lac k of perf or ma nce
7. 2
M o nit ori n g f or A d verse E ve nts
At eac h visit, after t he s u bject has ha d t he o p p ort u nit y  t o s p o nta ne o usly me nti o n a n y 
pr o ble ms, t he I n vesti gat or s h o ul d i n q uire a b o ut A Es b y  as ki n g t he sta n dar d q uesti o ns:

“ Ha ve y o u ha d a n y healt h pr o ble ms si nce y o ur last st u d y  visit?”

“ Ha ve t here b ee n a n y c ha n ges i n t he me dici nes y o u ta ke si nce y o ur last st u d y  visit?”
A d diti o nall y , c ha n ges i n a ny pr ot oc ol -s pecific p ar a meters a n d/ or q uesti o n n aires e val uate d 
d uri n g t he st u d y are t o be re vie we d b y t he I n vesti gat or. A n y u nt o war d ( u nfa v ora ble a n d 
u ni nte n de d) c ha n ge i n a pr ot oc ol -s pecific p ar a meter or q uesti o n n aire res p o nse t hat is 
cli nicall y rele va nt, i n t he o pi ni o n of t he In vesti gat or , is t o be re p orte d as a n A E. T hese 
cli nicall y rele va nt c ha n ges will be re p orte d re gar dless of ca usalit y. 
7. 3
Pr oce d ures f or Rec or di n g a n d Re p orti n g
A Es are c ollecte d fr o m t he ti me of i nf or me d c o nse nt. A n y pre -e xisti n g me dical c o n diti o ns or 
si g ns/s ym pt o ms prese nt i n a s u bject pri or t o t he start of t he st u d y  (ie, bef ore i nf or me d 
c o nse nt is si g ne d) are n ot c o nsi dere d A Es i n t he st u d y  a n d s h o ul d be rec or de d i n t he Me dical 
Hist or y  secti o n of t he e C R F.
I n a d diti o n, te m p orar y le ns a ware ness or vis ual c ha n ges d uri n g t he fitti n g pr ocess are n ot 
c o nsi dere d A Es if t he I n vesti gat or assesses t hat t he s y m pt o m(s) ca n reas o na bl y  res ol ve wit hi n 
t he a ntici pate d a da ptati o n peri o d. 

A D Es or S A Es are d oc u me nte d o n t he Seri o us A dverse Eve nt a n d A dverse Device Effect 
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8
e C R F wit hi n 2 4 h o urs of t he I n vesti gat or ’s or site’s a ware ness. 

Pa ge 3 6 of 4 3

De vice deficie ncies are d oc u me nte d o n t he Device Deficie ncy e C R F wit hi n 2 4 h o urs of 
t he In vesti gat or ’s or site’s a ware ness. 

A pri nte d c o p y of t he c o m plete d Seri o us A dverse Eve nt a n d A dverse Device Effect a n d/ or 
Device Deficie ncy e C R F m ust be i ncl u de d wit h pr o d uct ret ur ns.

A d diti o nal rele va nt i nf or mati o n after i nitial re p orti n g m ust be e ntere d i nt o t he e C R F as 
s o o n as t he data bec o me a vaila ble.

D oc u me nt a n y c ha n ges t o c o nc o mita nt me dicati o ns o n t he a p pr o priate e C R Fs.

D oc u me nt all rele va nt i nf or mati o n fr o m Disc har ge S u m mar y , A ut o ps y  Re p ort,

Certificate of Deat h, etc, if a p plica ble, i n narrati ve secti o n of t he Seri o us A dverse Eve nt
a n d A dverse Device Effect e C R F.
N ote: S h o ul d t he E D C s yste m bec o me n o n - o perati o nal, t he site m ust c o m plete t he 
a p pr o priate pa per Seri o us A dverse Eve nt a n d A dverse Device Effect a n d/ or Device Deficie ncy
F or m. T he c o m plete d f or m is e maile d t o t he St u d y  S p o ns or at ms us.safet y @alc o n.c o m 
acc or di n g t o t he ti meli nes o utli ne d a b o ve; h o we ver, t he re p orte d i nf or mati o n m ust be e ntere d 
i nt o t he E D C s yste m o nce it bec o mes o perati o nal.
St u d y  S p o ns or re prese ntati ves ma y be c o ntacte d f or a n y pr ot oc ol relate d q uesti o n.
F urt her , de pe n di n g u p o n t he nat ure of t he A E or de vice deficie nc y  bei n g re p orte d, t he St u d y 
S p o ns or ma y  re q uest c o pies of a p plica ble p orti o ns of t he s u bject’s me dical rec or ds. T he 
I n vesti gat or m ust als o rep ort all A Es a n d de vice deficie ncies t hat c o ul d ha ve le d t o a S A D E 
acc or di n g t o t he re q uire me nts of re g ulat or y  a ut h orities or IR B/I E C.
I nte nsit y a n d C a us alit y Assess me nts
W here a p pr o priate, t he I n vesti gat or m ust assess t he i nte nsit y  (se verity) of t he A E ba se d u p o n 
me dical j u d g me nt wit h c o nsi derati o n of a n y s u bjecti ve s y m pt o m(s), as defi ne d bel o w:
I nte nsity ( Severity)
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8
Mil d
A n A E is mil d if t he s u bject is a ware of b ut ca n easil y  t olerate t he si g n or 
s ym pt o m.
M o derate  
A n A E is m o derate if t he si g n or s y m pt o m res ults i n disc o mf ort si g nifica nt 
e n o u g h t o ca use i nterfere nce wit h t he s u bject’s us ual acti vities.

Page 37 of 43
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.
7.4
Return product analysis
Study lenses associated ONLY with comfort or vision-related device deficiencies and/or 
comfort or vision related AEs should be returned and must include a hard copy of the 
corresponding AE and/or Device Deficiency CRF. 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).
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0054838
Protocol - Clinical
01-Mar-2018

Page 38 of 43
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 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 
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 double-masked with subjects randomized to use BIOFINITY or BIOFINITY 
ENERGYS for the duration of the 7 ± 2 day treatment period. The Investigator and Sponsor 
personnel (other than 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 with the exception of 
the Clinical Project Lead, who may also remain unmasked throughout 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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0054838
Protocol - Clinical
01-Mar-2018

Pa ge 3 9 of 4 3
8. 2
U n m as k i n g of t he St u d y Tr e at me nt
Mas ke d i nf or mati o n o n t he i de ntit y  of t he assi g ne d medical de vice s h o ul d n ot be discl ose d 
d uri n g t he st u d y. If t he treat me nt c o de nee ds t o be br o ke n i n t he i nterest of s u bject safet y, t he 
I n vesti gat or is e nc o ura ge d t o c o ntact a n a p pr o priate St u d y S p o ns or re prese ntati ve pri or t o 
u n mas ki n g t he i nf or mati o n if t here is s ufficie nt ti me. De pe n de nt u p o n t he i n di vi d ual 
circ u msta nces (ie, me dical e mer ge nc y ), t he c o de ma y be br o ke n pri or t o c o ntact wit h t he 
St u d y  S p o ns or. T he St u d y S p o ns or m ust be i nf or me d of all cases i n w hic h t he c o de was 
br o ke n a n d of t he circ u msta n ces i n v ol ve d. A d diti o nall y, t he St u d y S p o ns or ma y be re q uire d 
t o u n mas k t he i nf or mati o n i n or der t o f ulfill e x pe dite d re g ulat or y re p orti n g re q uire me nts.
9
D A T A  H A N D LI N G A N D A D MI NI S T R A TI V E R E Q UI R E M E N T S
9. 1
C o m pleti o n of S o ur ce D oc u me nts a n d C ase Re p ort F or ms
T he nat ure a n d l ocati o n of all s o urce d oc u me nts will be i de ntifie d t o e ns ure t hat ori gi nal data 
re q uire d t o c o m plete t he e C R Fs e xist a n d are accessi ble f or verificati o n b y t he site m o nit or, 
a n d all discre pa ncies s hall be a p pr o priatel y  d oc u me nte d via t he q uer y res ol uti o n pr ocess. 
St u d y  m o nit ors are a p p oi nte d b y t he St u d y S p o ns or a n d are i n de pe n de nt of st u d y site staff. If 
electr o nic rec or ds are mai ntai ne d, t he met h o d of verificati o n m ust be deter mi ne d i n a d va nce 
of starti n g t he st u d y.  
At a mi ni m u m, s o urce d oc u m e nts s h o ul d i ncl u de t he f oll o wi n g i nf or mati o n f or eac h s u bject:

S u bject i de ntificati o n ( na me, se x, race/et h nicit y)

D oc u me ntati o n of s u bject eli gi bilit y

Date of i nf or me d c o nse nt

Dates of visits

D oc u me ntati o n t hat pr ot oc ol s pecific pr oce d ures were perf or me d

Res ults of st u d y  para meters, as re q uire d by t he pr ot oc ol

I P acc o u nta bilit y rec or ds

D oc u me ntati o n of A Es a n d ot her safet y para meters (if a p plica ble)

Rec or ds re gar di n g me dical hist ories a n d t he use of c o nc o mita nt t hera pies pri or t o a n d 
d uri n g t he st u d y

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8
Date of st u d y  c o m pleti o n a n d reas o n f or early disc o nti n uati o n, if a p plica ble

Page 40 of 43
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 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.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0054838
Protocol - Clinical
01-Mar-2018

Page 41 of 43
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 Insert, any periodic safety updates, and all other 
information as required by local regulation and/or the IRB. At the end of the study, the 
Investigator must notify the IRB about the study’s completion. The IRB also must be notified 
if the study is terminated prematurely. Finally, the Investigator must report to the IRB on the 
progress of the study at intervals stipulated by the IRB.
Voluntary informed consent must be obtained from every subject  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 
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Pa ge 4 2 of 4 3
f or t he a p pr o priate i n di vi d uals s h o ul d q uesti o ns or c o ncer ns arise d uri n g t he st u d y. T he 
s u bject als o m ust be t ol d t hat t heir rec or ds ma y be accesse d by a p p r o priate a ut h orities a n d 
S p o ns or -desi g nate d pers o n nel. T he I n vesti gat or m ust kee p t he ori gi nal, si g ne d c o p y of t he 
c o nse nt a n d m ust pr o vi de a d u plicate c o p y t o eac h s u bject acc or di n g t o l ocal re g ulati o ns. 
F oll o wi n g t his st u d y, t he s u bject will ret ur n t o t h eir e ye care pr ofessi o nal f or t heir r o uti ne e y e 
care a n d c o ntact le nses.
1 1 P R O T O C O L  AM E N D M E N T HI S T O R Y
Versi o n
Brief Descri pti o n a n d R ati o n ale
1
I nitial Versi o n of t his d oc u me nt
2
Secti o n 1, P a ge 6

E xcl usi o n criteria # 1 1 re vise d:
fro m
1 1. A n y  use of t o pical oc ular me dicati o ns a n d artificial tear or 
re wetti n g dr o ps t hat w o ul d re q uire i nstillati o n d uri n g c o ntact le ns 
wear.
t o
1 1. A n y  use of t o pical oc ular me dicati o ns t hat w o ul d re q uire 
i nstillati o n d uri n g c o ntact le ns wear.
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8

Pa ge 4 3 of 4 3
1 2 R E F E R E N C E S
1 2. 1 Refere nces a p plic a ble f or all cli nic al tri als

I S O 11 9 8 0: 2 0 1 2 O p ht hal mic o ptics - C o ntact le nses a n d c o ntact le ns care pr o d ucts -
G ui da nce f or cli nical i n vesti gati o ns

I S O 1 4 1 5 5: 2 0 11 Cli nical i n vesti gati o n of me dical de vices f or h u ma n s u bjects - G o o d 
cli nical practice
1 2. 1. 1 U S refere nces a p plic a ble f or cli nic al tri als

2 1 C F R Part 1 1 - Electr o nic Rec or ds; Electr o nic Si g nat ures

2 1 C F R Part 5 0 - Pr otecti o n of H u ma n S u bjects

2 1 C F R Part 5 6 - I nstit uti o nal Re vie w B oar ds

2 1 C F R Part 8 1 2 - I n vesti gati o nal De vice E xe m pti o ns

2 1 C F R Part 5 4 - Fi na ncial Discl os ure b y Cli nical I n vesti gat ors

T he Calif or nia Bill of Ri g hts
1 2. 2 Refere nces f or t his cli nic al tri al
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 4 8 3 8
P r o t o c o l  -  C l i n i c a l
0 1- Mar- 2 0 1 8
N ot A p plica ble

                                                                                                                
                                                                                     
Date/Time 
(mm/dd/yyyy GMT):
Signed by:
Justification:
03/01/2018 00:28:55
02/28/2018 20:03:36
02/28/2018 12:20:36
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Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
2.0; Most-Recent; Effective; CURRENT
TDOC-0054838
Protocol - Clinical
01-Mar-2018