Assessing Fitting Guides in Alcon Multifocal Contact Lenses
Phase: NA
Conditions: Presbyopia, Refractive Errors
Sponsor: Alcon Research

Page 1 of 54
a Novartis company
Short Title
Assessing Fitting Guides in Alcon Multifocal Contact Lenses
Long Title
Assessing Fitting Guides in Alcon Multifocal Contact Lenses
Protocol Number:
Study Phase:
Sponsor Name and 
Address:
CLK027-P001 / NCT03118934
N/A
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 76134-2099
Investigational Products:
1. AIR OPTIX AQUA® Multifocal (AOA MF) Contact
Lens
2. DAILIES® AquaComfort Plus® Multifocal (DACP MF)
Contact Lens
3. DAILIES TOTAL1® Multifocal (DT1 MF) Contact Lens
US IND# / EudraCT
N/A
Indication Studied:
Contact lens wear
Investigator Agreement:
I have read the clinical study described herein, recognize its 
confidentiality, and agree to conduct the described trial in 
compliance with Good Clinical Practice (GCP), the ethical 
principles contained within the Declaration of Helsinki, this 
protocol, 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
1.0; CURRENT; Most-Recent; Effective
TDOC-0053461
Protocol - Clinical
21-Mar-2017

Pa ge 2 of 5 4
1
S Y N O P SI S
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
Pr ot oc ol N u m ber:
C L K 0 2 7 -P 0 0 1
I n vesti g ati o n al 
Pr o d uct s:
1.
AI R O P TI X A Q U A 
M ultif ocal ( A O A M F) 
C o ntact Le ns
2.
D AI LI E S 
A Q U A C O M F O R T 
P L U S M ultif ocal ( D A C P 
M F) C o ntact Le ns
3.
D AI LI E S T O T A L 1
M ultif ocal ( D T 1 M F) 
C o ntact Le ns
St u d y P h ase:
1
2
3
4
N/ A
Acti ve I n gre die nt: 
N/ A
Pr ot oc ol Title:
Assessi n g Fitti n g G ui des i n Alc o n M ultif ocal C o ntact Le nses
I n vesti g at or(s)/ N o. of Sites: M ultice nter; A p pr o xi matel y  2 0 sites
Ce nter L oc ati o n(s)/ 
U S, Ca na da, E U
N o. of S u bjects
D ur ati o n of Tre at me nt:
Re q uire d : 1 6 0, Pla n ne d: 1 8 0 [9 per site ( 6 wee kly/ m o nt hl y  
wearers a n d 3 dail y  dis p osa ble wearers); a p pr o xi matel y 6 0 i n eac h 
test le ns bra n d;
 
1 0 ± 3 da y s
St u d y P o p ul ati o n: 
C urre nt s oft c o ntact le ns wearers nee di n g pres b y o pia -c orrecti o n, 
wit h a near s pectacle A D D of + 0. 5 0 t o + 2. 5 0 D (i ncl usi ve)
O bjecti ve(s):
Pri m ar y O bjecti ve

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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7
T o de m o nstrate n o ni nferi orit y  of t he alter nati ve fitti n g 
g ui de c o m pare d t o t he c urre nt fitti n g g ui de as deter mi ne d 
b y  t he mea n n u m ber of trial le nses nee de d t o fit eac h e ye 
at t he Scree ni n g/ Fitti n g visit f or all Alc o n M F le nses 
c o m bi ne d
 

Pa ge 3 of 5 4
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
Pr ot oc ol N u m ber:
C L K 0 2 7 -P 0 0 1
S afet y O bjecti ve

Assess a n d descri be a d verse e ve nts ( A Es), bi o micr osc o p y  
fi n di n gs, a n d de vice deficie ncies.
Met h o d ol o g y:
T his is a m ulti -ce nter, s u bject -mas ke d, pr os pecti ve, ra n d o mize d,
stratifie d, parallel gr o u p st u d y .
Tre at me nts:
I n vesti g ati o n al Pr o d uct:
AI R O P TI X A Q U A  M ultif ocal 
C o ntact Le ns
R o ute of A d mi nistr 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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7
Le nses will be dis pe nse d t o ha bit ual 
wee kl y/ m o nt hl y  wearers b y  q ualifie d
st u d y staff acc or di n g t o t he 
ra n d o mizati o n pla n. Te st c o ntact 
le nses will be w or n bilaterall y.

Page 4 of 54
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number:
CLK027-P001
Duration of Treatment:
The total duration of treatment will 
be 10 ± 3 days per dispensed lens.
Lenses will be worn on a daily wear 
basis and cared for with their habitual 
lens care solution.
Dosage:
The lenses will be available from 
+6.00 D to -10.00 D (0.25 D steps) 
for sphere and near ADD will be 
+0.5 D to +2.50 D.
Investigational Product:
DAILIES AQUACOMFORT PLUS 
Multifocal Contact Lens
Route of Administration:
Lenses will be dispensed to habitual 
weekly/monthly wearers by qualified
study staff according to the 
randomization plan. Test contact 
lenses will be worn bilaterally.  
Duration of Treatment:
The subjects will wear the lenses for 
10 ± 3 days per dispensed lens under 
a daily wear daily disposable 
modality. The subjects will remove 
and discard the study lenses every 
night and use a new pair of study 
lenses every morning.
Dosage:
Investigational Product:
Route of Administration:
Duration of Treatment:
The lenses will be available from 
+6.00 D to -10.00 D (0.25 D steps) 
for sphere and near ADD will be 
+0.5 D to +2.50 D.
DAILIES TOTAL1 Multifocal 
Contact Lens
Lenses will be dispensed to all 
habitual daily disposable lens 
wearers by qualified study staff.  Test 
contact lenses will be worn 
bilaterally.
The subjects will wear the lenses for 
10 ± 3 days per dispensed lens under 
a daily wear daily disposable 
modality. The subjects will remove 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053461
Protocol - Clinical
21-Mar-2017

Page 5 of 54
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number:
CLK027-P001
Dosage:
and discard the study lenses every 
night and use a new pair of study 
lenses every morning.
The lenses will be available from 
+6.00 D to -10.00 D (in 0.25 D
steps) for sphere and near ADD will 
be +0.5 D to +2.50 D.
Subject Selection:
Inclusion Criteria:
1. Subjects with normal eyes who are not using any ocular 
medications, aged 40-65 and must sign the informed 
consent.
2. Requires a near spectacle ADD of +0.50 D to +2.50 D 
(inclusive).
3. Current full-time soft contact lens wearers (during the past 
1 month for a minimum of 5 days per week, 6 hours per 
day) needing presbyopia correction within the power range 
of lens powers available for the test lenses.
4. Cylinder equal to or lower than - 0.75 D in both eyes.
5. Best corrected VA to 0.18 logMAR (Snellen equivalent 
20/30) or better in each eye at distance (as determined by 
manifest refraction at screening).
6. Willing to wear lenses for a minimum of five days per 
week, six hours per day, and attend all study visits.
7. Uses digital devices (eg, uses a smart phone, tablet, laptop
computer, or desktop computer for at least 2 hours/day and 
5 days/week) and willing to continue the same pattern for 
the duration of the study.
Exclusion Criteria:
1. Any use of systemic or ocular medications for which 
contact lens wear could be contraindicated as determined 
by the Investigator.
2. Current Alcon MF contact lens wearers.
3. Monocular subjects (only one eye with functional vision) 
or subjects fit with only one lens.
4. Anterior segment infection, inflammation or abnormality.
5. Any active anterior segment ocular disease that would 
contraindicate contact lens wear.
6. Biomicroscopy findings observed during the Visit 1 
slit-lamp examination that are moderate (Grade 3) or 
higher and/or corneal vascularization that is mild (Grade 2) 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053461
Protocol - Clinical
21-Mar-2017

Pa ge 6 of 5 4
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
Pr ot oc ol N u m ber:
C L K 0 2 7 -P 0 0 1
or hi g her i n eit her e y e at scree ni n g.
7.
Hist or y  of her petic keratitis, c or neal s ur ger y or irre g ular 
c or nea.
8.
Pri or refracti ve s ur ger y (e g, L A S I K, P R K) .
9.
A pat h ol o gical dr y  e ye t hat precl u des c o ntact le ns wear.
1 0. Use of mec ha nical e y eli d t hera p y or e yeli d scr u bs wit hi n
1 4 da y s bef ore Visit 1 a n d n ot willi n g t o disc o nti n ue 
d uri n g t he st u d y.
1 1. E nr oll me nt of m ore t ha n 1 me m ber of t he sa me h o use h ol d 
i n t he st u d y.
1 2. E nr ol lme nt of site staff or fa mil y / h o use h ol d mem bers of 
t he site staff w h o are liste d o n t he st u d y pers o n nel l o g as 
ha vi n g a r ole i n t he e xec uti o n of t his st u d y .
1 3. Partici pati o n i n a n y  cli nical st u d y wit hi n 3 0 da ys of 
Visit 1.
E n d p oi nts :
Pri m ar y Effecti ve ness

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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7
Mea n n u m ber of trial le nses nee de d t o fit at 
Scree ni n g/ Fitti n g

Pa ge 7 of 5 4
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
Pr ot oc ol N u m ber:
C L K 0 2 7 -P 0 0 1
S afet y

A Es

Bi o micr osc o p y

De vice d eficie ncies
St atistic al Met h o ds:
Pl a n ne d A n al ysis
T hree a nal ys is sets will be defi ne d: Safet y , F ull, a n d Per Pr ot oc ol 
( P P). T he Safet y A nal ys is Set will i ncl u de all s u bjects/e yes 
e x p ose d t o st u d y le nses e val uate d i n t his st u d y, e xce pt f or t h ose 
use d f or trial fit at Visit 1. T he F ull A nal ys is Set ( FA S) will c o nsist 
of s u bjects ra n d o mize d or assi g ne d t o st u d y le nses as a p plica ble, 
a n d e x p ose d t o st u d y le nses i ncl u di n g trial fit at Visit 1 . T he P P 
A nal y sis Set is a s u bset of t he FA S a n d e xcl u des data w hic h meet 
a n y of t he critical de viati o n or n o n-e val ua ble criteria as s pecifie d 
i n t he De viati o ns a n d E val ua bilit y  Pla n ( D E P). T he F A S will ser ve 
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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7
as t he pri mar y a nalys is dataset f or all eff ecti ve ness e val uati o ns
All data fr o m e val ua ble s u bjects will be i ncl u de d i n t he 
eff ecti ve ness a nal ys is; n o i m p utati o n f or missi n g val ues will be 
perf or me d.

Page 8 of 54
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number:
CLK027-P001
Effectiveness
To address the primary effectiveness objective, planned analysis is 
summarized below: 
Endpoint
Comparison
Statistical Method
PRIMARY
Number of lenses 
for fitting at 
Visit 1
Alternative vs Current 
Noninferiority
Mixed effect 
repeated measures 
model
NI margin = 0.5
Safety
Each safety variable will be summarized descriptively. AEs will 
be classified as treatment-emergent, based upon treatment-specific 
exposure, or pre-treatment. Count and percentage will be provided 
by relationship to device, and separate tables will be generated for 
ocular and nonocular AEs. Counts and percentages in each grade 
category will be presented for each biomicroscopy parameter. 
Device deficiencies will also be tabulated. Supporting subject 
listings describing details of each safety variable will be provided. 
No inferential testing will be performed for safety analyses.
Sample Size Justification
When the sample size in each group is 80 (160 eyes), a two-group 
t-test will have 83% power to demonstrate noninferiority with a 
margin of 0.5 (one-sided α=0.05), assuming that the expected 
difference in means is 0.25 and the common standard deviation is 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053461
Protocol - Clinical
21-Mar-2017

Page 9 of 54
Sponsor:
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 
76134-2099
Protocol Number:
CLK027-P001
0.6 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053461
Protocol - Clinical
21-Mar-2017

Pa ge 1 0 of 5 4
2
O V E R VI E W O F  S T U D Y P L A N
Visit 1
Visit 2
Dis pe nse 1 / 
Visit 2 
Dis pe nse 2
Visit 3 
F oll o w -u p 1 
/ Visit 3 
E xit
U S V
Pr oce d ure/ Assess me nt
Scree ni n g 
a n d Fitti n g
Dis pe nsi n g
0- 7 d a ys 
fr o m Visit 1
D a y 1 0 ± 3 –
F oll o w -u p / 
E xit 
U nsc he d ule d 
Visit
Ra n d o mizati o n

Site t o Fitti n g 
G ui de
*
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 / 
C ha n ges i n C o nc o mita nt 
Me d icati o ns




S u b jecti ve ( Ma nifest) 
refracti o n 

() 
()
()
B C V A † ( wit h ma nifest 
refracti o n)

() 
()
()
St u d y  c o ntact le ns 
para meters o pti mizati o n 
a n d fitti n g †

I ncl usi o n/ E xcl usi o n

Ra n d o mizati o n
Wee kl y / M o nt hl y S u bject t o 
st u d y le ns
* *
Dis pe nse 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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7

Pa ge 11 of 5 4
Visit 1
Visit 2
Dis pe nse 1 / 
Visit 2 
Dis pe nse 2
Visit 3 
F oll o w -u p 1 
/ Visit 3 
E xit
U S V
Pr oce d ure/ Assess me nt
Scree ni n g 
a n d Fitti n g
Dis pe nsi n g
0- 7 d a ys 
fr o m Visit 1
D a y 1 0 ± 3 –
F oll o w -u p / 
E xit 
U nsc he d ule d 
Visit
Bi o micr osc o p y




Assess o pti mal 
prescri pti o n

e
()
Assess A Es

f



Assess d e vice d eficie ncies




E xit F or m 
() 
()

()
A E = A d verse E ve nt; B C V A = Best C orrecte d V is ual Ac uit y; l o g M A R = l o garit h mic Mi ni m u m A n gle of 
Res ol uti o n; U S V = U nsc he d ule d V isit; VA = V is ual Ac uit y
e If s u bject nee ds a ne w prescri pti o n, perf or m Visit 2 Dis pe nse 2 a n d Visit 3/ E xit
f A E s are c ollecte d fr om t he ti me of i nf or me d c o nse nt
 
.
(
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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7
) as nee de d, or if a 2- li ne c ha n ge i n c o ntact le ns c orrecte d VA is o bser ve d ( Ma nifest refracti o n a n d B C VA 
o nl y) 
* Pri or t o Visit 1
* * per ra n d o mizati o n sc he me, if wee kl y/ m o nt hl y le ns wearers
† S o urce o nl y

Page 12 of 54
3
ABBREVIATIONS
3.1
List of Abbreviations
Abbreviation
Definition
ADD
Additional power
ADE
Adverse device effect
AE
Adverse event
AOA MF
AIR OPTIX AQUA Multifocal
BCVA
Best corrected visual acuity
D
Diopter
DACP MF
DAILIES AQUACOMFORT PLUS Multifocal
DEP
Deviations and evaluability plan
DT1 MF
DAILIES TOTAL1 Multifocal
ECP
Eye care practitioners
eCRF
Electronic case report form
EDC
Electronic data capture
EU
European Union
FAS
Full Analysis Set
FDA
Food and Drug Administration
GCP
Good Clinical Practice
ICF
Informed consent form
ICH
International Council for Harmonisation of Technical Requirements 
for Pharmaceuticals for Human Use
IEC
Independent ethics committee
IP
Investigational product
IRB
Institutional review board
LASIK
Laser-assisted in situ keratomileusis
logMAR
Logarithmic minimum angle of resolution
MF
Multifocal
MOP
Manual of procedures
N/A
Not applicable
NI
Noninferiority
OD
Right eye
OS
Left eye
OU
Both eyes
PI
Principal Investigator
PP
Per protocol analysis set
PRK
Photorefractive keratectomy
pt
Point 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053461
Protocol - Clinical
21-Mar-2017

Page 13 of 54
Abbreviation
Definition
SADE
Serious adverse device effect
SAE
Serious adverse event
UCL
Upper confidence limit
US
United States
USV
Unscheduled visit
VA
Visual acuity
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053461
Protocol - Clinical
21-Mar-2017

Pa ge 1 4 of 5 4
3. 2
Gl oss ar y of Te r ms
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 t he 
i n vesti gati o nal me dical de vice (test article). 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 article, t he c o ntr ol 
article, 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 article.
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 
article) or c o ntr ol article. N ote: T his defi niti o n i ncl u des A E s 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 
error or i nte nti o n al mis use of t he test article or c o ntr ol article.
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 err ors, 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 nc e of t he de vice refers t o t he i nte n de d use f or w hic h t he 
de vice is la bele d or mar kete d.
Pr o d uct C o m plai nt
A n y  oral, electr o nic, or writte n c o m m u nicati o n t hat alle ges 
deficie ncies relate d t o t he i de ntit y  (la beli n g), q ualit y, d ura bilit y, 
relia bilit y, safety,  effecti ve ness, or perf or ma nce of a mar kete d 
pr o d uct, i ncl u di n g fail ure of t he pr o d uct, la beli n g or pac ka g i n g t o 
meet s pecificati o ns, w het her or n ot t he pr o d uct is relate d t o or 
ca use d t he alle ge d deficie nc y. A c o m plai nt ma y alle ge t hat a n A E or 
me dical de vice malf u ncti o n has occ urre 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 seri o us A E .
Seri o us A d verse 
E ve nt ( S A E)
A E t hat le d t o a ny of t he f oll o wi n g: 

Deat h.

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 de at h h a d it occ urre 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 
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
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Pri nte d B y:  
Pri nt Date:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
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Pa ge 1 5 of 5 4
i m pair me nt t o a b od 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 
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 
rem ai ne d at t he h os pit al or e mer ge 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 s etti 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 ar e A Es . 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. Whe 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 i nstr 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 birth 
defect.
Refer t o Secti o n 7 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 verse de vice ef fect t hat has res ulte d i n a n y of t he c o nse q ue nces 
c haracteristic of a S A E .
Seri o us P u blic Healt h 
T hreat
A n y  e ve nt ty pe w hic h res ults i n i m mi ne nt ris k of deat h, seri o us 
deteri orati o n i n state of healt h, or seri o us ill ness t hat re q uires pr o m pt 
re me dial acti o n. T his w o ul d i ncl u de: E ve nts t hat are of si g nifica nt 
a n d u ne x pecte d nat ure s uc h t hat t he y  bec o me alar min g as a p ote ntial 
p u blic healt h hazar d, e g, h u ma n i m m u n o deficie nc y vir us or 
Cre utzfel dt- Jac o b Disease.
Use Err or
Act or o missi o n of a n act t hat res ults i n a dif fere nt me dical de vice 
res p o nse t ha n i nte n de d b y ma n ufact urer or e x pecte d b y user. 
N ote: T his d efi niti o n i ncl u des sli ps, l a pses, a n d mist akes. A n 
u nex pecte d p hysi ol o gic al res p o nse of t he s u bject d oes n ot i n itself 
c o nstit ute a use error.
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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
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4
TABLE OF CONTENTS
Assessing Fitting Guides in Alcon Multifocal Contact Lenses .................................................1
1
SYNOPSIS .............................................................................................................2
2
OVERVIEW OF STUDY PLAN..........................................................................10
3
ABBREVIATIONS...............................................................................................12
3.1
List of Abbreviations ............................................................................................12
3.2
Glossary of Terms.................................................................................................14
4
TABLE OF CONTENTS......................................................................................16
List of Figures..........................................................................................................................18
5
INTRODUCTION................................................................................................19
5.1
Study Rationale and Background .....................................................................19
5.2
Known and Potential Risks ..............................................................................19
5.3
Risk Minimization............................................................................................21
5.4
Potential Benefits..............................................................................................22
6
ETHICS ................................................................................................................23
7
PROTOCOL AMENDMENTS ............................................................................25
8
SUBJECT POPULATION....................................................................................26
9
TREATMENTS ADMINISTERED......................................................................27
9.1
Identity of Study Treatments ............................................................................27
9.2
Usage ................................................................................................................27
9.3
Accountability Procedures................................................................................28
9.4
Subject Confidentiality and Methods Used to Minimize Bias .........................29
9.5
Study Entry.......................................................................................................29
10
STUDY PROCEDURES ......................................................................................31
10.1
Outline of Study ...............................................................................................31
10.2
Visits and Examinations ...................................................................................32
10.2.1
General Summary of Study Visits ................................................................32
10.2.2
Study Visit Procedures..................................................................................34
10.2.2.1
Visit 1 – Screening/ Fitting Visit...............................................................34
10.2.2.2
Visit 2 – (0-7 days after Visit 1) Dispense 1 / Dispense 2 (if necessary) 
Visit...........................................................................................................35
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10.2.2.3
Visit 3 – (10 ± 3 days after Visit 2) Follow-up 1 / Exit Visit....................37
10.3
Unscheduled Visits ...........................................................................................38
10.4
Discontinued Subjects ......................................................................................39
10.5
Clinical Study Termination...............................................................................40
11
ANALYSIS PLAN ...............................................................................................41
11.1
Subject Evaluability..........................................................................................41
11.2
Analysis Data Sets............................................................................................41
11.2.1
Safety Analysis Set.......................................................................................41
11.2.2
Full Analysis Set...........................................................................................41
11.2.3
Per Protocol Analysis Set .............................................................................41
11.3
Demographic and Baseline Characteristics......................................................42
11.4
Effectiveness Analyses .....................................................................................42
11.4.1
Primary Effectiveness...................................................................................42
11.4.1.1
Statistical Hypotheses...............................................................................42
11.4.1.2
Analysis Methods .....................................................................................43
11.4.2
Secondary Effectiveness...............................................................................43
11.4.2.1
Statistical Hypotheses...............................................................................43
11.4.2.2
Analysis Methods .....................................................................................43
43
44
45
11.5
Handling of Missing Data ................................................................................45
11.6
Multiplicity.......................................................................................................45
11.7
Safety Analysis .................................................................................................45
11.8
Health Economics.............................................................................................46
11.9
Interim Analyses...............................................................................................46
11.10
Sample Size Justification..................................................................................46
12
ADVERSE EVENTS AND DEVICE DEFICIENCIES.......................................47
12.1
General Information .........................................................................................47
12.2
Monitoring for Adverse Events ........................................................................48
12.3
Procedures for Recording and Reporting .........................................................48
12.4
Return Product Analysis...................................................................................50
12.5
Unmasking of the Study Treatment..................................................................50
12.6
Follow-Up of Subjects with Adverse Events....................................................51
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12.7
Pregnancy in the Clinical Trial.........................................................................51
13
DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ..................52
13.1
Completion of Source Documents and Case Report Forms.............................52
13.2
Data Review and Clarifications........................................................................53
13.3
Regulatory Documentation and Records Retention .........................................53
13.4
Clinical Trial Results ........................................................................................53
14
REFERENCES .....................................................................................................54
15
APPENDIX...........................................................................................................54
List of Figures
Figure 10–1
Study Design....................................................................................................32
Figure 12–1
Categorization of All Adverse Events..............................................................47
Figure 12-2
Categorization of All Serious Adverse Events.................................................47
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5
INTRODUCTION
5.1
Study Rationale and Background
Presbyopia is an age-related vision condition in which the crystalline lens gradually loses its 
ability to change shape when acted upon by the ciliary muscle. It typically becomes evident 
by 40 to 45 years of age and it is expressed by a reduction in the ability to define letters or 
objects at near distance. The condition can be corrected by the use of single-vision or bifocal 
spectacles, progressive addition lenses, or multifocal (MF) contact lenses.
Alcon manufactures three MF contact lenses (lotrafilcon B, nelfilcon A, and delefilcon A) 
with the same Precision Profile optical design that allows for the same fitting process with all 
three lenses. The AIR OPTIX AQUA MF (AOA MF) soft contact lenses are made of a lens 
material that is approximately 33% water and 67% lotrafilcon B, a fluoro-silicone containing 
hydrogel which is surface-treated. These lenses may be prescribed for daily wear or extended 
wear for up to 6 nights of continuous wear with removal for disposal, or cleaning and 
disinfection prior to reinsertion, as recommended by the eye care professional.
The DAILIES AQUACOMFORT PLUS MF (DACP MF) daily disposable, soft contact lens 
is made up of 69% water and 31% nelfilcon A polymer (polyvinyl alcohol partially acetalized 
with N-formylmethyl acrylamide). DAILIES TOTAL1 MF (DT1 MF, delefilcon A) daily 
disposable, soft contact lenses feature a unique water gradient composition from a silicone-
rich highly breathable core (33% water) to an ultrasoft hydrophilic surface gel (> 80% water 
at the lens surface).
Some eye care practitioners (ECPs) hesitate offering their presbyopic patients MF contact 
lenses due to the perceived impression of the added time it takes to fit these lenses. The goal 
of this study is to collect data on 2 fitting guides in a population of current soft contact lens 
wearers needing presbyopia correction so that a recommendation can be made on one global 
fitting guide that will reduce the amount of time needed to fit the lenses by the ECPs and will 
optimize patient outcomes.
5.2
Known and Potential Risks
A summary of the known and potential risks and benefits associated with AOA MF, DACP 
MF, and DT1 MF can be found in their respective package inserts.
Safety information about AOA MF, DACP MF, and DT1 MF Control lenses may be found in 
their respective product labeling. The Investigator should advise subjects of the following 
general warnings and precautions with contact lens wear:
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Pa ge 2 0 of 5 4

Seri o us e y e i nj ur y, scarri n g of t he c or nea a n d l oss of visi o n ma y res ult fr o m pr o ble ms 
ass ociate d wit h weari n g c o ntact le nses a n d usi n g le ns care pr o d ucts

E y e pr o ble ms, i ncl u di n g i nfect i o n, c or neal ulcers, c or neal ne o vasc ularizati o n, or iritis 
ca n de vel o p ra pi dl y a n d lea d t o l oss of visi o n if left u natte n de d

N o n -c o m plia nce wit h le ns care i nstr ucti o ns ma y i ncrease t he ris k of de vel o pi n g a 
seri o us e ye i nfecti o n

S m o ki n g a n d/ or s wi m mi n g i ncr eases t he ris k of c or neal ulcers wit h c o ntact le ns wear, 
es peciall y w he n le nses are w or n o ver ni g ht or w hile slee pi n g

T he ris k of ulcerati ve keratitis has bee n s h o w n t o be greater a m o n g users w h o wear 
t heir le nses o ver ni g ht c o m pare d wit h t h ose w h o d o n ot
T h e ris ks wit h c o ntact le ns wear are i ncrease d wit h a pre-e xisti n g or acti ve oc ular i nfecti o n or 
i nfla m mati o n, i m pr o per le ns fit, a n d n o nc o m plia nce wit h re gi me n. S u bjects will be i nstr ucte d 
t o wear b ot h le nses as dail y wear acc or di n g t o i nstr ucti o ns f or use a n d/ or f oll o wi n g t he 
i nstr ucti o ns fr o m t he I n vesti gat or. S u bjects w h o fail t o f oll o w t he i nstr ucti o ns f or re placi n g 
t heir c o ntact le nses c o ul d e x perie nce a n e ye i nfecti o n of t he c or nea or a n e ye i nj ur y. A 
c or neal ulcer c o ul d de vel o p ra pi dl y a n d lea d t o l os s of visi o n. A n i m pr o perl y  fitte d c o ntact 
le ns ma y affect c or neal c ur vat ure a n d res ult i n visi o n fl uct uati o ns u p o n le ns re m o val.
D A C P  M F a n d D T 1 M F are n ot i nte n de d f or use wit h a disi nfecti n g s ol uti o n, a n d t he 
bi oc o m pati bilit y  wit h le ns care s ol uti o ns a n d a n y ass ociate d cli nical effects are u n k n o w n. 
P ote ntial seri o us c o m plicati o ns wit h c o ntact le ns wear are us uall y  acc o m pa nie d b y o ne or 
m ore of t he f oll o wi n g si g ns or s y m pt o ms:

M o derate t o se vere e y e pai n n ot relie ve d b y re m o vi n g t he le ns

F orei g n b o d y se ns ati o n

E xcessi ve teari n g/ oc ular secreti o ns i ncl u di n g m uc o p ur ule nt disc har ge

Oc ular h y pere mia

P h ot o p h o bia

B ur ni n g, sti n gi n g, itc hi n g or ot her pai n ass ociate d wit h t he e y es

C o mf ort is less c o m pare d wit h w he n t he le ns was first place d o n t he e y e

P o or vis ual ac uit y ( VA)/ bl urre d visi 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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7
Rai n b o ws or hal os ar o u n d o bjects

Pa ge 2 1 of 5 4

Feeli n g of dr y ness
S u bjects s h o ul d be i nstr ucte d t o re m o ve t he le nses if a n y  of t he a b o ve si g ns or s ym pt o ms is 
n otice d. A seri o us c o n diti o n s uc h as a c or neal ulcer, i nfecti o n or iritis ma y be prese nt, a n d 
ma y  pr o gress ra pi dl y. Less seri o us reacti o ns s uc h as a brasi o ns, i nfiltrates, a n d bacterial 
c o nj u ncti vitis m ust be ma na ge d t o a v oi d m ore seri o us c o m plicati o ns. 
I n a d diti o n, t he I n vesti gat or s h o ul d a d vise s u bjects of p ossi ble oc ular dr yness, i ncrea se d le ns 
a ware ness/i nt olera nce, or vis ual c ha n ges wit h c o nc o mita nt me dicati o ns or d uri n g pre g na nc y.
T he visi o n wit h m ultif ocal c o ntact le nses c o m pare d t o s pectacles ma y  be less s har p or 
dif fere nt, w hic h ma y be m ore n oticea ble u n der l o w ill u mi nati o n ( di ml y lit r o o m), re d uce d 
visi bilit y  (f o g or hea vy rai n), or is olate d s o urces of ver y bri g ht li g ht ( hea dli g hts of o nc o mi n g 
ve hicle). I n a d diti o n, t he PI  s h o ul d a d vise s u bjects of p ossi ble oc ular dr yness, i ncrease d le ns 
a ware ness/i nt olera nce, or vis ual c ha n ges wit h s o me c o nc o mita nt me dicati o ns or d uri n g 
pre g na nc y.
T he PI  m ust assess f or oc ular c ha n ges t o deter mi ne w het her t o disc o nti n ue or restrict le ns 
wear . E xa m ples i ncl u de t he f oll o wi n g:

Oc ular i nfecti o ns

Ta rsal pa pillar y c ha n ges

L ocal or ge neralize d c or neal e de m a

E pit helial micr oc y sts

E pit helial stai ni n g

I nfiltrates

Ne o vasc ularizati o n

E n d ot helial p ol y me gat his m

C o nj u ncti val i njecti o n

Iritis
5. 3
Ris k  Mi ni miz 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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7
D uri n g t he cli nical st u d y , q ualifie d i n vesti gati o nal site pers o n nel will verif y t hat t he 
dis pe nse d st u d y  le ns p o wer meets i n di vi d ual s u bject nee ds a n d t he st u dy le nses de m o nstrate 
a de q uate ce ntrati o n a n d m o ve me nt o n t he e y e. Trai ne d i n vesti gati o nal site pers o n nel will 
e d ucate s u bjects o n pr o per h y gi e ne a n d st u d y le ns ha n dli n g, a n d c o m plia nce wit h t he use of 

Page 22 of 54
the study MF contact lenses. Subjects should be instructed not to wear study lenses while 
sleeping or during water activities like swimming. Trained investigational site personnel will 
also advise subjects to remove study lenses and return for prompt follow-up of symptoms, 
such as ocular discomfort, foreign body sensation, excessive tearing, vision changes, or 
hyperemia.
Trained investigational site personnel will monitor for AEs from study lens exposure via 
examination and VA testing. Trained investigational site personnel will manage the 
occurrence of AEs as appropriate with study lens discontinuation, study lens administration, 
and continued follow-up.
5.4
Potential Benefits
Contact lenses may offer correction of ametropia, improved peripheral (side) vision, the
convenience of not wearing spectacles, a non-permanent device application, and a perceived 
improvement of cosmetic appearance. Material properties and design characteristics of 
contact lenses used in this study are features consistent with successful contact lens wear. 
There is no intended clinical benefit to the subjects who participate in this study; however, 
subjects will receive study visit assessments free of change (that will not substitute for a 
regular eye exam).
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6
ETHICS
This clinical study will be conducted in accordance with the principles of the Declaration of 
Helsinki, and in compliance with the International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use (ICH) E6 Good Clinical Practice (GCP) 
Consolidated Guideline and other regulations as applicable. The Investigator and all clinical 
study staff will conduct the clinical study in compliance with the protocol. The Investigator 
will ensure that all personnel involved in the conduct of the study are qualified to perform 
their assigned responsibilities through relevant education, training, and experience.
Before clinical study initiation, this protocol, the informed consent form, any other written 
information given to subjects, and any advertisements planned for subject recruitment must 
be approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB). 
The Investigator must provide documentation of the IEC/IRB approval to the Sponsor. The 
approval must be dated and must identify the applicable protocol, amendments (if any), 
informed consent form, all applicable recruiting materials, written information for subject, 
and subject compensation programs. The IEC/IRB must be provided with a copy of the 
Investigator’s Brochure, any periodic safety updates, and all other information as required by 
local regulation and/or the IEC/IRB. At the end of the study, the Investigator will notify the 
IEC/IRB about the study’s completion. The IEC/IRB also will be notified if the study is 
terminated prematurely. Finally, the Investigator will report to the IEC/IRB on the progress of 
the study at intervals stipulated by the IEC/IRB.
Voluntary informed consent will 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 designee, will 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 will 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 investigational product, 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 will be provided with contact 
information for the appropriate individuals should questions or concerns arise during the 
study. The subject also will be told that their records may be accessed by appropriate 
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Page 24 of 54
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.
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7
PROTOCOL AMENDMENTS
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments will be created by the Sponsor and must be approved 
by the IEC/IRB prior to implementation except when required to mitigate immediate safety 
risks or when the changes involve only logistical or administrative revisions. 
Amendments may necessitate that the informed consent and other study-related material be 
revised. If the consent form is revised, all subjects currently enrolled in the study may be 
required by the IEC/IRB to sign the approved, revised informed consent form.
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8
SUBJECT POPULATION
The study population includes approximately 180 subjects to be enrolled at approximately 
20 sites, with approximately 9 subjects enrolled per site. To participate in the study, subjects 
must be current soft contact lens wearers needing presbyopia-correction, with a near 
spectacle ADD of +0.50 D to +2.50 D (inclusive).
The expected duration of subject participation in the study is 10 ± 3 days (7 days minimum) 
and up to 33 days (maximum) for all subjects with a minimum of 2 scheduled visits and a 
maximum of 5 scheduled visits, depending on the necessity to optimize the subject’s 
prescription.
The complete inclusion and exclusion criteria are presented in Section 1.
Each site will enroll approximately 9 subjects (6 will be monthly/weekly habitual lens 
wearers and 3 will be daily disposable habitual lens wearers). 
 
 
 
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9
TREATMENTS ADMINISTERED
Upon signing the informed consent form, subjects will be considered enrolled in the study 
and will be assigned a number in the appropriate numerical sequence. Subject numbers will 
be assigned by the electronic data capture (EDC) system at each investigational site.
Randomization for this study will be implemented in 2 parts. First, each site will be 
randomized to one fitting guide and will fit all subjects at their site using the assigned fitting 
guide (current or alternative). The purpose of this strategy is to reduce the likelihood that 
errors will be made in fitting the trial lenses if trying to use two similar fitting guides.
Randomization of the fitting guide will be stratified by region.
Secondly, subjects who currently wear monthly/weekly contact lenses will be randomized to 
either AOA MF or DACP MF contact lenses (1:1 randomization). Subjects who currently 
wear daily disposable contact lenses will be fitted with DT1 MF contact lenses.
The study lenses will be dispensed in an unmasked manner by a trained study staff member. 
Subjects are unmasked to the study lenses that are dispensed, but will be masked to the fitting 
guides used to fit each eye for all study lenses.
Throughout the study, the Investigator will be responsible for the accounting of all study 
materials and will ensure that the study products are not used in any unauthorized manner.
9.1
Identity of Study Treatments
Investigational Product: 
AIR OPTIX AQUA Multifocal Contact Lens
Investigational Product:
DAILIES AQUACOMFORT PLUS Multifocal Contact Lens
Investigational Product:
DAILIES TOTAL 1 Multifocal Contact Lens
All study lenses (AOA MF, DACP MF, and DT1 MF) will be procured by the investigational 
site(s). All study lenses are Conformité Européene (CE)-marked and FDA/Health Canada 
approved, and will be sourced from commercial stock, including commercial packaging and 
labelling. No over-labelling is required for the test lenses. Storage conditions of the test 
lenses can be found documented in the respective AOA MF, DACP MF, and DT1 MF 
packaging and labeling.
9.2
Usage
The subjects will use the study lenses according to the Instructions for Use provided by the 
product manufacturer, in addition to following instructions from the designated site 
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personnel. All study lenses will be prepared by a trained study staff member and dispensed to 
subjects. All test lenses will be worn bilaterally.
The total duration of lens wear for AIR OPTIX AQUA Multifocal Contact Lenses will be 
10 ± 3 days (7 days minimum) and up to 26 days (maximum) depending on necessity of refit 
dispensing and follow-up visits. The lenses will be available from +6.00 D to -10.00 D 
(0.25 D steps) for sphere and near ADD will be +0.5 D to +2.50 D.  Lenses will be worn on a 
daily wear basis and cared for with their habitual lens care solution.
The total duration of lens wear for DAILIES AQUACOMFORT PLUS Multifocal Contact 
Lenses will be 10 ± 3 days (7 days minimum) and up to 26 days (maximum) depending on 
necessity of refit dispensing and follow-up visits. The lenses will be worn under a daily wear 
daily disposable modality. The subjects will remove and discard the study lenses every night 
and use a new pair of study lenses every morning. The lenses will be available from +6.00 D 
to -10.00 D (0.25 D steps) for sphere and near ADD will be +0.5 D to +2.50 D.
The total duration of lens wear for DAILIES TOTAL 1 Multifocal Contact Lenses will be 
10 ± 3 days (7 days minimum) and up to 26 days (maximum) depending on necessity of refit 
dispensing and follow-up visits. The lenses will be worn under a daily wear daily disposable 
modality. The subjects will remove and discard the study lenses every night and use a new 
pair of study lenses every morning. The lenses will be available from +6.00 D to -10.00 D (in 
0.25 D steps) for sphere and near ADD will be +0.5 D to +2.50 D.
9.3
Accountability Procedures
Upon receipt of the IP, the Investigator or designee will conduct an inventory. Designated 
study staff will prepare (removal of blister label) and provide the study lenses to the subjects 
in accordance with their assigned subject ID number. During the study, the staff designee 
must maintain records of IP 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. Study contact lens associated 
with a device deficiency or with any product-related AEs (eg, adverse device effects 
[ADEs]/serious adverse device effects [SADEs]) must be returned to the Sponsor. Refer to
Section 12 of this protocol for additional information on the reporting of device deficiency or 
product-related AEs.
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9.4
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 subject-masked. Subjects are masked only to the MF fitting guides, and will be 
wearing study lenses for 10 ± 3 days (7 days minimum) and up to 26 days (maximum) 
depending on necessity of refit dispensing and follow-up visits.
Sites will be assigned a fitting guide associated with a random number from the fitting guide 
randomization list, stratified by region. Each site will receive an envelope, next available in 
ascending random number, that contains a card listing the respective fitting guide to use.
Subsequently, habitual weekly/monthly lens wearing subjects will also be randomly assigned 
to study lenses (AOA MF or DACP MF) in numerical order; the randomization schedule will 
be blocked to ensure a balance of study lens allocations within investigational sites. The 
randomization schemes will be generated and maintained by the Sponsor. Only once all study 
data have been verified, validated, and the database locked, will individual subjects be 
unmasked. Refer to Section 12 of this protocol for information on the reporting of AEs.
9.5
Study Entry
Participants will be recruited from the Investigators’ patient population, referrals, or IEC/IRB 
approved recruitment materials. Patients who appear to be eligible subjects will be 
approached for study participation and sign an informed consent form (ICF) prior to the 
commencement of study related procedures.
The PI or designee will explain the study purpose, procedures, and subject responsibilities to 
the potential participant. The subject must be given the opportunity to ask questions and 
allowed time to consider the information provided. The subject’s willingness and ability to 
meet the follow-up requirements will be determined. When it has been established that the
subject may be eligible for possible participation in the study, written informed consent will 
be obtained. Upon signing the ICF, the subject will be enrolled into the study and study 
procedures performed to determine eligibility for randomization if required.
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The original signed copy of the informed consent form will be retained with the subject’s 
medical records, and a copy will be provided to the subject.
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10
STUDY PROCEDURES
10.1
Outline of Study
This is a multicenter, subject-masked, randomized, parallel, stratified, active-controlled 
evaluation to compare the fitting success (determined by the mean number of trial lenses 
needed to successfully fit each eye) using the current MF fitting guide compared to the 
alternative MF fitting guide for all three of the Alcon MF contact lenses (AOA MF, DACP 
MF, and DT1 MF).
Approximately 180 subjects will be enrolled at approximately 20 sites, with approximately 
9 subjects enrolled per site. To participate in the study, subjects must be current soft contact 
lens wearers needing presbyopia-correction, with a near spectacle ADD of +0.50 D to
+2.50 D (inclusive). 
The expected duration of subject participation in the study is 10 ± 3 days (7 days minimum) 
and up to 33 days (maximum) for all subjects with a minimum of 2 scheduled visits, up to 5 
scheduled visits, depending on necessity of refit dispensing and follow-up visits.
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Figure 10–1
Study Design
Visit 1
Screening / Fitting Visit
Visit 3 Exit
Exit Subject
Exit Subject
Yes
NO
Visit 2 Dispense 1
MF Contact Lens Dispensing Visit
0-7 Days
Visit 3 Follow Up 1
Prescription optimization required?
10 ± 3 days
Visit 2 Dispense 2
Repeat Visit 2 procedures and 
dispense new study lenses
10 ± 3 days
Visit 3 Exit
Prescription optimization required?
NO
YES
Assess optimal prescription and 
Exit Subject
10.2
Visits and Examinations
10.2.1
General Summary of Study Visits
The general study design dictates that subjects will be screened and their eligibility confirmed 
at Visit 1. Subjects who are qualified to participate in the study will have their lens 
parameters optimized and their prescription determined at Visit 1 based upon the fitting guide 
assigned to the site prior to site activation.
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Pa ge 3 3 of 5 4
St u d y  le nses fr o m t he fitti n g set may be dis pe nse d t o t he s u bject at V isit 1 if a s ufficie nt 
n u m ber of le nses are a vaila ble i n t he n ote d prescri pti o n. Ot her wise, st u d y  le nses ma y be 
or dere d f or dis pe nsi n g t o s u bject at ‘ Vi sit 2 Dis pe nse 1’ .
F or V isit 2 Dis pe nse 1, su bject s will ret ur n t o t he site 0- 7 da y s fr o m Visit 1 at w hic h ti me 
st u d y le nses will be dis pe nse d base d u p o n t he prescri pti o n deter mi ne d at Visit 1. A series of 
o p ht hal mic assess me nts will be c o n d ucte d o n t he s u bjects wit h st u d y  le nses i nserte d,  
 
 
 S u bjects will be sc he d ule d t o ret ur n t o t he site f or t heir ‘ Vi sit 3 F oll o w- u p 1’ after 1 0 
± 3 da y s of le ns wear i n st u d y le nses.
 
 A series of o p ht hal mic e xa mi nati o ns will be 
c o n d ucte d o n t he s u bject at Visit 3, a n d t heir o pti mal prescri pti o n assesse d.

If t he s u bject is deter mi ne d t o ha ve a s uccessf ul fit f oll o wi n g t he o pti mal prescri pti o n 
assess me nt, t he s u bject ma y  be e xite d fr o m t he st u d y. I n t his case, Visit 3 F oll o w-u p 1 
will f u ncti o n as Visit 3 E xit.

If t he s u bject is deter mi ne d N O T t o ha ve a s uccessf ul fit, a n d re q uires a ne w 
prescri pti o n, t he s u bject is t o be refit base d u p o n t he fitti n g g ui de assi g ne d t o t he site.
A ne w pair of st u d y le nses will be dis pe nse d. 
F or s u bjects w h o d o N O T e xit at Vi sit 3, ‘ Visit 3 F oll o w -u p 1’ will f u ncti o n as ‘ Visit 2 
Dis pe nse 2’. Re peat t he pr oce d ures c o n d ucte d at V isit 2 o n t he s u bject a n d dis pe nse a ne w 
pair of st u d y le n ses wit h t he ne w prescri pti o n. Sc he d ule t he s u bject t o ret ur n t o t he site f or 
‘ Visit 3 E xit’ after 1 0 ± 3 da ys of le ns wear i n st u d y le nses 
F or V isit 3 E xit, c o n d uct t he sa me o p ht hal mic assess me nts t hat were c o n d ucte d f or t he 
s u bject’s Vi sit 3 F oll o w - u p 1, 
 
 Assess t he s u bject’ s o pti mal prescri pti o n f oll o wi n g 
c o m pleti o n of o p ht hal mic assess me nts.

If t he s u bject is deter mi ne d t o ha ve a s uccessf ul fit f oll o wi n g t he o pti mal prescri pti o n 
assess me nt, t he s u bject ma y  be e xite d fr o m 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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7
If t he s u bject is deter mi ne d N O T t o ha ve a s uccessf ul fit wit h t he re-dis pe nse d le nses, 
a re -assess me nt of o pti mal prescri pti o n is t o be c o n d ucte d o n t he s u bject. H o we ver , n o 
a d diti o nal le nses are t o be dis pe nse d f oll o wi n g t he re -assess me nt of prescri pti o n. T he 
s u bject is t he n e xite d fr o m t he st u d y a n d c o nsi dere d N O T t o ha ve ha d a s uccessf ul fit.

Pa ge 3 4 of 5 4
1 0. 2. 2
St u d y Vi sit Proce d ures
1 0. 2. 2. 1
V isit 1 – Scree ni n g/ Fitti n g V isit
1

Re vie w t he I R B/I E C -a p pr o ve d i nf or me d c o nse nt a n d Healt h I ns ura nce 
P orta bilit y  a n d Acc o u nta bilit y Act d oc u me nt ( w here a p plica ble) wit h t he 
s u bject. 

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 I RB /IE C -a p pro ve d i nf or me d c o nse nt d o c u me nt.

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 har t.

Fa miliarize y o urself wit h t he fitti n g g ui de a ssi g ne d t o yo ur site t hat will be 
use d t o fit all s u bjects d uri n g e nr oll me nt. Be s ure t o use o nl y  t he fitti n g g ui de 
assi g ne d t o y o ur site w he n fitti n g st u d y s u bjects.
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 ys. 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
C o n d uct a n o p ht hal mic e xa mi nati o n of b ot h e y es c o nsisti n g of t he f oll o wi n g
assess me nts:

Perf or m t he scree ni n g slit -la m p bi o micr osc o pic e xa m t o e val uate t he
f oll o wi n g:
o
Li m bal h y pere mia
o
B ul bar h y p ere mia
o
Ot her fi n di n gs
4
5
6 
Perf or m a ma nifest refracti o n.
N ote: S u bject m ust be a ble t o be fit wit h le nses wit hi n t he av ail a ble c o nt act le ns p o wer -
ne ar s pect acle A D D of + 0. 5 0 D t o + 2. 5 0 D (i ncl usive) i n b ot h eyes. M a nifest 
asti g m atis m m ust be less t h a n or e q u al t o 0. 7 5 D at scree ni n g. Rec or d o nly i n s o urce 
d oc u me nt .
7
Perf or m dista nce B C V A wit h ma nifest refracti o n

O D

O S
N ote: Dist a nce B C V A m ust be 0 . 1 8 l o g M A R (S nelle n e q uiv ale nt 2 0/ 3 0 ) 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. Rec or d o nly i n s o urce d oc u me nt.
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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7

Page 35 of 54
8
9
10
Review inclusion/exclusion criteria to determine if the subject qualifies to be entered 
into the study. Randomize ONLY those habitual weekly/monthly wearing subjects 
who qualify to be included in the study and record the subject randomization in 
EDC.  Qualified daily disposable lens wearers will also be entered into EDC after 
confirming all eligibility requirements are met.
If the subject does not meet inclusion and exclusion criteria, exit the subject from 
the study within EDC.
Note: The site must assign subject numbers for ALL subjects that sign the informed 
consent document (including screening failures). If the subject does not meet study entry 
criteria, the subject will be considered a screen failure. The minimum data entry 
requirements for a screen failure must be entered into the EDC.
11
Determine study contact lens parameters optimization and fitting using the fitting 
guide which was assigned to your site.
Note: Record only in source document
12
Record the prescription of each study lens placed on each eye (ie, by eye).
13
The PI will 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 regardless of their enrollment status (screen 
failure or randomized).
14
Schedule Visit 2 Dispense 1, to take place 0-7 days after Visit 1.
10.2.2.2
Visit 2 – (0-7 days after Visit 1) Dispense 1 / Dispense 2 (if 
necessary) Visit
1
Obtain information on any changes in medical health and/or the use of concomitant 
medications.
2
Record any AEs or device deficiencies that are observed or reported, including those 
associated with changes in concomitant medication dosing.
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Pa ge 3 6 of 5 4
3
C o n d uct a n o p ht hal mic e xa mi nati o n of b ot h e y es c o nsisti n g of t he f oll o wi n g
assess me nts:

Perf or m a slit-la m p bi o micr osc o pic e xa m t o e val uate t he f oll o wi n g:
o
Li m bal h y pere mia
o
B ul bar h y pere mia
o
Ot her fi n di n gs
N ote: Visit 2 Sli t-l a m p ex a m d oes N O T nee d t o be c o n d ucte d if st u dy le nses were 
dis pe nse d at Visit 1, or if ne w st u dy le nses are bei n g dis pe nse d ( o n t he d ay of Visit 2 
Dis pe nse 2) as a res ult of refit fr o m t he Visit 3 F oll o w - u p 1 visit.
4
Dis pe nse st u d y  c o ntact le ns acc or di n g t o ra n d o mizati o n sc he me, if a p plica ble.
5
6
7
Perf or m dista nce l o g M A R B C V A f or eac h e ye wit h ma nifest refracti o n ( as 
necess ary ).

O D

O S
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. Rec or d 
o nly i n s o urce d oc u me nt.
8
9
1 0
T he PI  will 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.
1 1
Sc he d ule Vi sit 3 F oll o w-u p 1/ E xit Vi sit, t o ta ke place after 1 0 ± 3 da y s of le ns wear 
i n 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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7

Pa ge 3 7 of 5 4
1 0. 2. 2. 3
V isit 3 – ( 1 0 ± 3 d a ys after Visit 2) F oll o w -u p 1 / E xit Vi sit
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 A Es or de vice deficie ncies t hat are o bser ve d or re p orte d, 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 dic ati o n d osi n g.
3
4
5
Perf or m dista nce B C V A f or eac h e y e wit h ma nifest refracti o n ( as necess ary ).

O D

O S
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. Rec or d 
o nly i n s o urce d oc u me nt.
6
7
8
9
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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7

Pa ge 3 8 of 5 4
1 0
C o n d uct a n o p ht hal mic e xa mi nati o n of b ot h e y es c o nsisti n g of t he f oll o wi n g
assess me nts:

Perf or m a slit-la m p bi o micr osc o pic e xa m t o e val uate t he f oll o wi n g:
o
Li m bal h y pere mia
o
B ul bar h y p ere mia
o
Ot her fi n di n gs
1 1
1 2
Assess o pti mal prescri pti o n . If s u bject nee ds a ne w pre scri pti o n, t he n c o n d uct V isit 2 
Dis pe nse 2 ( S ecti o n 1 0. 2. 2. 2) usi n g y o ur assi g ne d fitti n g g ui de .
1 3
E xit t he s u bject fr o m t he st u d y  if a ne w prescri pti o n is n ot nee de d. If s u bject is N O T 
bei n g e xite d fr o m t he st u d y, sc he d ule s u bject t o ret ur n f or Visit 3 E xit Vi sit after 
1 0 ± 3 da y s of le ns wear i n re -dis pe nse d st u d y  le nses. N o a d diti o nal dis pe nsati o n of 
st u d y le nses will be all o we d after 1 refit.
1 4
1 0. 3
U nsc he d ule d Vi sits
A n y  visit t hat occ urs bet wee n t he re g ularly sc he d ule d visits m ust be d oc u me nte d i n t he 
U nsc he d ule d V isit pa ges of t he electr o nic Case Re p ort F or m ( eC R F). It is p ossi ble a s u bject 
ma y  ha ve re m o ve d t heir le nses pri or t o atte n di n g a n u nsc he d ule d visit. D uri n g all 
u nsc he d ule d visits, t he f oll o wi n g pr oce d ures s h o ul d be c o n d ucte d: 
1.
O btai n a n u p date o n ge neral healt h a n d a n y  c ha n ges i n c o nc o mita nt me dicati o ns si nce
t he pre vi o us visit.
2.
Perf or m B C VA 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. Rec or d
o nly i n s o urce d oc u me nt
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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7
3.

Pa ge 3 9 of 5 4
4.
C o n d uct a n o p ht hal mic e xa mi nati o n of b ot h e y es c o nsisti n g of t he f oll o wi n g 
assess me nts:

Perf or m a slit-la m p bi o micr osc o pic e xa m t o e val uate t he f oll o wi n g:
o Li m bal h y pere mia
o B ul bar h y p ere mia
o Ot her fi n di n gs
5.
Assess o pti mal prescri pti o n (as necess ary ). If s u bject nee ds a ne w pre scri pti o n, t he n 
c o n d uct Visit 2 Dis pe nse 2 ( Secti o n 1 0. 2. 2. 2) usi n g y o ur assi g n e d fitti n g g ui de .  
6.
7.
T he PI  will assess a n d rec or d a n y AEs 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.
If t he s u bject is disc o nti n ui n g at t he u nsc he d ule d visit, t he E xit f or m s h o ul d als o be 
c o m plete d a n d t he Earl y E xit visit eC R Fs s h o ul d be use d rat her t ha n t he eC R Fs fr o m t he
U nsc he d ule d V isit.
1 0. 4
Disc o nti n ue d S u bjects
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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7
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 Visit 1. 
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 ny 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 In vesti gat or , t heir c onti 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 ha t 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 I Ps, 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 for m.
A n y  s u bject w h o e xits earl y fr o m t he st u d y m ust u n der g o all pr oce d ures o utli ne d at Vi sit 3. 
A d diti o nall y, t he E xit for m m ust be c o m plete d a n d t he reas o n f or disc o nti n uati o n m ust be 
i de ntifie d.
Fi nall y , t o e ns ure t he safet y of all s u bjects w h o disc o nti n ue early,  In vesti gat ors s h o ul d assess 
eac h s u bject a n d, if necessar y, a d vise t he m of a ny t hera pies a n d/ or me dical pr oce d ures t hat 
mi g ht be nee de d t o mai ntai n t heir healt h.

Pa ge 4 0 of 5 4
1 0. 5
Cli nic al St u d y Te r mi n ati o n
If t he cli nical st u dy is pre mat urel y ter mi nate d or s us pe n de d, t he S p o ns or will 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 uspe 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. T he I n vesti gat or s h o ul d pr o m ptl y  n otif y t he I E C/IR B of t he 
ter mi nati o n or s us pe nsi o n a n d of t he reas o ns. T he 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. 
Reas o ns f or t he cl os ure of a n i n vesti gati o nal site or ter mi nati o n of a st u d y ma y  i ncl u de: 

S uccessf ul c o m pleti o n of t he st u d y

T he st u d y ’s e nr oll me nt g oals are met

T he I n vesti gat or fails t o c o m pl y  wit h t he pr ot oc ol or G C P g ui deli nes

Safet y  c o ncer ns

S uf ficie nt data s u g gesti n g lac k of effecti ve ness

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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7
I na de q uate recr uit me nt of s u bjects b y t he I n vesti gat or
T he I n vesti gat or als o ma y ter mi nate t he st u d y at his/ her site f or reas o na ble ca use. If t he 
S p o ns or ter mi nates t he st u d y f or safet y reas o ns, it will i m me diatel y n otif y t he I n vesti gat or(s) 
b y  tele p h o ne a n d s u bse q ue ntl y will pr o vi de writte n c o nfir mati o n of a n d i nstr ucti o ns f or st u d y 
ter mi nati o n.

Page 41 of 54
11
ANALYSIS PLAN
Continuous variables will be summarized using the number of observations, mean, standard 
deviation, median, minimum and maximum, as well as confidence intervals or confidence 
limits where applicable. Categorical variables will be summarized with counts and 
percentages from each category. Any deviations to this analysis plan will be updated during 
the course of the study as part of a protocol amendment or will be detailed in the clinical 
study report.
11.1
Subject Evaluability
The final subject evaluability will be determined prior to breaking the code for the
assignment of fitting guide and/or lens and locking the database, based upon the DEP.
11.2
Analysis Data Sets
11.2.1
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 study lenses
evaluated in this study, except for the trial lenses used for parameterization and fitting at 
Visit 1. For treatment-emergent safety analyses, subjects/eyes will be categorized under the 
actual study lenses exposed.
11.2.2
Full Analysis Set
The FAS will include:
1. all randomized subjects to AOA MF or DACP MF as well as subjects assigned to DT1 
MF and
2. who are exposed to study lenses including those used for parametrization and fitting at 
Visit 1.
11.2.3
Per Protocol Analysis Set
The PP analysis set will include:
1. all randomized subjects to AOA MF or DACP MF as well as subjects assigned to DT1 
MF and
2. all data/subjects which have not met any of the critical deviation or non-evaluable 
criteria identified in the DEP.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053461
Protocol - Clinical
21-Mar-2017

Page 42 of 54
11.3
Demographic and Baseline Characteristics
Demographic information (age, sex, ethnicity, race) will be summarized on the safety, full, 
and PP analysis sets. Baseline characteristics on habitual lens 
 
 
 will be 
summarized on the full and PP analysis sets.
11.4
Effectiveness Analyses
This study defines one primary endpoint, 
 All effectiveness evaluations will use the FAS as the primary analysis 
set. Supportive analyses of the primary 
 effectiveness endpoint will be 
conducted using the PP analysis set only if the number of subjects excluded from PP analysis 
set exceeds 5% of FAS.
For all planned inferential analyses, alternative models/methods may be considered if 
convergence cannot be achieved.
11.4.1
Primary Effectiveness
The primary objective of this study is to demonstrate noninferiority of the alternative fitting 
guide when compared to the current fitting guide in fitting.
The corresponding endpoint is the number of trial lenses needed to fit each eye at the 
Screening/Fitting visit (Visit 1), derived from the number of on-eye lens prescriptions. 
11.4.1.1
Statistical Hypotheses
The null and alternative hypotheses are formulated as follows:
H0: µ(AFG) – µ(CFG) ≥ 0.5
Ha: µ(AFG) – µ(CFG) < 0.5
where µ(AFG) and µ(CFG) denote the mean number of trial lenses used to achieve fit in each eye 
using the alternative and current fitting guide, respectively, at the Screening/ Fitting visit. All 
Alcon MF lenses are to be included. 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053461
Protocol - Clinical
21-Mar-2017

Page 43 of 54
11.4.1.2
Analysis Methods
A mixed effect repeated measures model will be utilized to test these hypotheses, including 
terms for fitting guide, 
 
 Correlation between eyes will be accounted for in this analysis. 
Fitting guide difference (Alternative minus Current) and the corresponding one-sided 95% 
upper confidence limit (UCL) will be computed. Noninferiority in fitting will be declared if 
UCL < 0.5 at Visit 1. 
 
11.4.2
Secondary Effectiveness
No secondary effectiveness objective is defined for this study.
11.4.2.1
Statistical Hypotheses
Not applicable.
11.4.2.2
Analysis Methods
Not applicable.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053461
Protocol - Clinical
21-Mar-2017

Page 44 of 54
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053461
Protocol - Clinical
21-Mar-2017

Pa ge 4 5 of 5 4
1 1. 5
H a n dli n g of Missi n g D at a
All data o btai ne d i n e val ua ble s u bjects / e yes will be i ncl u de d i n t he a nal y sis. N o i m p utatio n 
f or missi n g val ues will be carrie d o ut f or t he effecti ve ness a nal ys is.
1 1. 6  
M ulti plicit y
A se q ue ntial gate kee pi n g strate g y will be i m ple me nte d t o c o ntr ol testi n g of m ulti ple 
eff ecti ve ness e n d p oi nts. T heref ore, t he o verall t y p e I err or will be c o ntr olle d at o ne -si de d 
0. 0 5 wit h t he f oll o wi n g testi n g or der: 

N o ni nferi orit y of pri mar y e n d p oi nt

1 1. 7
S afet y A n al ysis
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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7
T he safet y e n d p oi nts f or t his st u d y are A Es, b i o micr osc o py fi n di n gs, a n d de vice deficie ncies. 
Descri pti ve s u m maries (c o u nts a n d perce nta ges) f or oc ular a n d n o n oc ular A Es will be 
prese nte d b y Me dical Dicti o nar y  f or Re g ulat or y Acti vities Preferre d T er ms. In a d diti o n t o a n 
o verall prese ntati o n of A Es, r e p orts will be ge nerate d f or seri o us A Es. A Es lea di n g t o st u d y  
disc o nti n uati o n will be i de ntifie d. I n di vi d ual s u bject listi n gs will be pr o vi de d, as necessar y . 

Page 46 of 54
Individual subject listings will be provided for AEs that occur after signing informed consent 
but prior to exposure to study lens not used for lens parametrization and fitting at Visit 1.
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 to any subsequent visit will be presented. Baseline is defined as Visit 2. 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 not used for lens parametrization and fitting at 
Visit 1, and treatment-emergent) of device deficiencies will be provided. Additionally, each 
device deficiency category will be tabulated. 
No inferential testing will be done for safety analysis.
11.8
Health Economics
Not applicable.
11.9
Interim Analyses
Not applicable.
11.10
Sample Size Justification
Sample size calculation for the primary effectiveness hypothesis on fit success is based upon
results 
 With an assumed common standard deviation of 0.6 and 
expected difference of 0.25, a sample size of 80 (160 eyes) in each group will provide 83% 
power for a noninferiority margin of 0.5, at one-sided α=0.05, based upon a two group t-test.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053461
Protocol - Clinical
21-Mar-2017

Page 47 of 54
12
ADVERSE EVENTS AND DEVICE DEFICIENCIES
12.1
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 article). Refer to the 
Glossary of Terms for categories of AEs and SAEs.
Figure 12–1
Categorization of All Adverse Events
Figure 12-2
Categorization of All Serious Adverse Events
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053461
Protocol - Clinical
21-Mar-2017

Pa ge 4 8 of 5 4
1 2. 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 uestio 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 bee 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?”
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.
1 2. 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 ve sti gat or assesses t hat t he s ym 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. 
F or eac h rec or de d e ve nt, t he A D Es a n d S A Es d oc u me ntati o n m ust i ncl u de: date of 
occ urre nce, se verit y, treat me nt (if a p plica ble), o utc o me, a n d assess me nts of t he seri o us ness 
a n d ca usalit y. In a d diti o n, t he I n vesti gat or m ust d oc u me nt all de vice deficie ncies re p orte d or 
o bser ve d wit h test a n d c o ntr ol articles o n t he De vice Deficie nc y e C R F. T he site m ust s u b mit 
all a vaila ble i nf or mati o n o n A D Es, S A Es, a n d de vi ce deficie ncies t o t he S t u d y S p o ns or 
i m me diatel y as f oll o ws:

All S A Es m ust be re p orte d i m me diatel y  ( wit hi n 2 4 h o urs) of t he I n ve sti gat or’s or 
site’s a ware ness.

A D Es t hat d o n ot meet seri o us ness criteria a n d de vice deficie ncies m ust be re p orte d 
wit hi n 1 0 ca le n dar da ys of t he I n 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 Ef fect 
a n d/ or Device Deficie ncy
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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7
e C R F m ust be i ncl u de d wit h pr o d uct ret ur ns. [ Refer t o 
C L K 0 2 7 -P 0 0 1 M O P  f or i nstr ucti o ns o n pr o d uct ret ur ns .]

Pa ge 4 9 of 5 4

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 D isc 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 A d verse De vice 
Ef fect (f or relate d A Es) a n d Seri o us A d verse E ve nt 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 
ap 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 fa xe d or e maile d t o t he St u d y S p o ns or at 
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 sys te m o nce it 
bec o mes o perati o nal.
A n y  AEs a n d de vice deficie ncies f or n o n -st u d y mar kete d pr o d ucts (ie, ha bit ual c o ntact le ns 
care pr o d ucts ) use d c o nc o mita ntl y  d uri n g t he st u d y will be c o nsi dere d a n d pr ocesse d as 
s p o nta ne o us (f oll o wi n g t he p ost mar ket vi gila nce pr oce d ures) a n d s h o ul d be c o m m u nicate d t o 
t he pr o d uct’s ma n ufact urer as per l ocal re q uire me nts.
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 a n d t heir 
c o ntact i nf or mati o n is pr o vi de d i n t he Ma n ual of Pr oce d ures
t hat acc o m pa nies t his pr ot oc ol.
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 re p ort all A Es a n d de vice deficie ncies t hat c o ul d ha v e 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 I E C/I RB.
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 base 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 ym 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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7
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 n terfere nce wit h t he s u bject’s us ual acti vities.

Page 50 of 54
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 is 
upgraded from non-serious to serious or from unrelated to related.
12.4
Return Product Analysis
Study Sponsor representatives and their contact information are provided in the MOP that 
accompanies this protocol. 
Alcon products associated with device deficiencies and/or product related AEs should be 
returned and must include the Complaint # which will be provided by Study Sponsor after the 
case is entered in the Study Sponsor’s Global Product Complaint Management System. To 
maintain study team masking, device deficiency and ADE returns may be collected by the 
end of the study along with all other supplies returns.
12.5
Unmasking of the Study Treatment
Masked information on the identity of the assigned fitting guide should not be disclosed to 
the subject during the study [See Section 9.4 for additional detail on study masking]. 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
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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.
12.6
Follow-Up of Subjects with Adverse Events
The PI 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 PI 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. All complaints received after 
this time period will be considered and processed as spontaneous (following the postmarket 
vigilance procedures) and should be communicated to Alcon as the medical device’s 
manufacturer per local requirements.
12.7
Pregnancy in the Clinical Trial
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.
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Pa ge 5 2 of 5 4
1 3
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
1 3. 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 eC R Fs e xist a n d are accessi ble f or verificati o n b y  t he site m o nit or. 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 me 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

Tr ial me dicati o n 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:  
1 . 0 ;  C U R R E N T ;  M o s t - R e c e n t ;  E f f e c t i v e
T D O C - 0 0 5 3 4 6 1
P r o t o c o l  -  C l i n i c a l
2 1- Mar- 2 0 1 7
Date of trial c o m pleti o n a n d reas o n f or earl y disc o nti n uati o n, if a p plica ble
It is re q uire d t hat t he a ut h or of a n e ntr y i n t he s o urce d oc u me nts be i de ntifia ble. Direct access 
t o s o urce d oc u me ntati o n ( me dical rec or ds) m ust be all o we d f or t he p ur p ose of verif yi n g t hat 
t he data rec or de d o n t he eC R F are c o nsiste nt wit h t he ori gi nal s o urce data. 
Electr o nic C R Fs will be pr o vi de d t o t he sites; o nl y  desi g nate d i n di vi d uals ma y c om plete t he 
eC R Fs. T he eC R Fs will be s u b mitte d at re g ular i nter vals base d u p o n t he cli nical trial visit 
sc he d ule. It is e x pecte d t hat all data re p orte d will ha ve c orres p o n di n g e ntries i n t he s o urce 
d oc u me nts a n d t hat t he PI will re vie w t he re p orte d data a n d certif y t hat t he eC R Fs are 
acc urate a n d c o m plete. N o s u bject i de ntifiers s h o ul d be rec or de d o n t he eC R Fs be y o n d 
s u bject n u m ber, a n d de m o gra p hic i nf or mati o n.

Page 53 of 54
13.2
Data Review and Clarifications
The eCRF data will be reviewed against the subject’s source data by the study monitors to 
ensure completeness and accuracy. After monitoring has occurred at the clinical sites and the 
eCRFs have been submitted, additional data clarifications and/or additions may be needed. 
Data clarifications and/or additions are documented and are part of each subject’s eCRFs.
13.3
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 information 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 latest marketing approval).
13.4
Clinical Trial Results
Any information other than that which is disclosed upon registration should not be discussed 
with persons outside the study. The protocol, study data, and information related to the study 
or to Alcon’s products or research programs that is provided by Alcon (Confidential 
Information) is to be kept confidential, and not disclosed directly or indirectly to any third 
party other than those involved in the study who have a need to know.
All data and discoveries arising out of the study, patentable or non-patentable, shall be the 
sole property of Alcon, Inc. Alcon reserves the right of prior review of any publication or 
presentation of information related to the study. Alcon may use these data now and in the 
future for presentation or publication at Alcon’s discretion or for submission to government 
regulatory agencies.
The existence of this clinical study is confidential and should not be discussed with persons 
outside of the study. You shall hold confidential, and not disclose directly or indirectly to any 
third party other than those persons involved in the study who have a need to know, the 
protocol, the data arising out of the study, and any other information related to the study or to
Alcon’s products or a research program that is provided by Alcon to you (the “Confidential
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Information”). All such persons must be instructed not to further disseminate this information 
to others. You shall not use the Confidential Information for any purpose other than the study.
The foregoing obligations of confidence and non-use assumed by you shall not apply to: 
(a) information which at the time of disclosure is in the public domain; (b) information which 
thereafter lawfully becomes part of the public domain other than through disclosure by or 
through you; (c) information which, as evidenced by your written records, was known by you 
prior to Alcon’s disclosure; (d) information which is lawfully disclosed to you by a third party 
not under any obligation of confidence to Alcon; or (e) information which is required to be 
disclosed by law or government regulatory agency, provided reasonable advance notice of 
such disclosure is given to Alcon.
In signing this protocol, you agree to the release of the data from this study and acknowledge 
the above confidentiality and publication policy. The provisions of this Statement shall 
survive the completion of the study.
14
REFERENCES
Not applicable.
15
APPENDIX
There are no appendices for this protocol. Please refer to the MOP.
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Date/Time 
(mm/dd/yyyy GMT):
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Justification:
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