Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear
Phase: NA
Conditions: Refractive Error
Sponsor: Alcon Research

Page 1 of 44
a Novartis company
Title:
Clinical Performance of a Silicone Hydrogel for Daily Disposable Wear
Protocol Number:
Sponsor Name and 
Address:
Test Product(s):
CLE383-C003 / NCT03095027  
Alcon Research, Ltd.
6201 South Freeway
Fort Worth, Texas 76134-2099
Daily Disposable T2 Soft Contact Lenses (DD T2 Contact 
Lenses)
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:
[Include professional 
position]
[May be entered into the document or written/typed in later]
Address:
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Pa ge 2 of 4 4
1
P R O T O C O L  S Y N O P SI S
Trial S p o ns or
Alc o n Researc h, Lt d.
6 2 0 1 S o ut h Free wa y
F ort W ort h, Te xas 7 6 1 3 4 - 2 0 9 9
Na me of Test Pr o d uct
Dail y  Dis p osa ble T 2 S oft C o ntact Le nses ( D D T 2)
Na me of C o ntr ol Pr o d uct
C o o per V isi o n® M y Da y ® (ste nfilc o n A) Dail y Dis p osa ble 
C o ntact Le nses (M Y D A Y )
Title of Trial
Cli nical Perf or ma nce of a Silic o ne H y dr o gel f or Dail y  
Dis p osa ble Wear
Pr ot oc ol N u m ber
C L E 3 8 3 -C 0 0 3
N u m ber of Sites
C o u ntr y
~ 3
U S
Pla n ne d D urati o n of 
E x p os ure 
~ 1 2 d a y s t otal d urati o n

Test Pr o d uct: 6 da y s ( ± 1 da y)

C o ntr ol Pr o d uct: 6 da y s ( ± 1 da y)
N u m ber of S u bjects 
Tar get t o c o m plete: 4 4
Pla n ne d t o e nr oll: ~ 5 4
St u d y  P o p ulati o n
V ol u nteer s u bjects a ge d 1 8 or o ver w h o are s oft c o ntact le ns 
wearers (e xcl u di n g pre vi o us or c urre nt M Y D A Y
wearers), 
ha ve at least 3 m o nt hs of c o ntact le ns weari n g e x perie nce, 
a n d w h o wear t heir ha bit ual le nses at least 5 da y s per wee k 
a n d at least 8 h o urs per da y. T o q ualif y, s u bjects m ust 
re q uire c o ntact le nses i n a p o wer ra n ge fr o m -1. 5 0 D
t o -4. 0 0 D.
O bjecti ve (s)
T he pri mar y  o bjecti ve of t his st u d y is t o de m o nstrate 
n o ni nferi orit y  i n vis ual ac uit y of D D T 2 w he n c o m pare d t o 
M Y D A Y . 
 
 
E n d p oi nts
Pri mar y  Effecti ve ness

Vis ual ac uit 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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7

Pa ge 3 of 4 4
Safet y

A Es

De vice deficie ncies

Bi o micr osc o p y
Assess me nts
Effecti ve ness

V A ( S nelle n dista nce )




 


 
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7

Pa ge 4 of 4 4
Safet y

A Es

De vice deficie ncies

Bi o micr osc o p y
St u d y  Desi g n
Pr os pecti ve
Si n gle -mas ke d 
(trial s u bject)
Si n gle -mas ke d 
(I n vesti gat or)
D o u ble- mas ke d
O pe n -la bel
Ot her
Si n gle gr o u p
Parallel gr o u p
Cr oss o ver
Ot her
C o ntralateral
Bilateral
M o n oc ular le ns wear
Ra n d o mize d
Test Pr o d uct Details
Pri mar y  
c o m p o ne nt/ material
Pr o d uct Na me
D D T 2
FI D N o.
1 2 2 8 1 9
Ma n ufact urer
Alc o n
Ot her 
T he le nses will be a vaila ble i n
-1. 5 0 D t o -4. 0 0 D ( 0. 2 5 D 
ste ps)
C o ntr ol Pr o d uct Details
Pri mar y  
c o m p o ne nt/ material
ste nfilc o n A
Pr o d uct Na me
M Y D A Y
Ma n ufact urer
C O O P E R VI SI O N
Ot her 
T he le nses will be a vaila ble 
i n - 1. 5 0 D t o -4. 0 0 D ( 0. 2 5 D 
ste ps)
I ncl usi o n Criteria
1.
S u bject m ust be at least 1 8 y ears of a ge. 
2.
S u bject m ust be a ble t o u n dersta n d a n d m ust si g n a n I CF 
t hat has bee n a p pr o ve d b y a n I RB. 
3.
S uccessf ul wear of s p herical s oft c o ntact le nses i n b ot h 
e yes f or a mi ni m u m of 5 da ys per wee k a n d 8 h o urs per 
da y  d uri n g t he past 3 m o nt hs.
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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7

Page 5 of 44
4. Manifest cylinder ≤ 0.75 D in each eye.
5. BCVA 20/25 or better in each eye.
Exclusion Criteria
1. Any anterior segment infection, inflammation, or 
abnormality or disease (including systemic) that 
contraindicates contact lens wear, as determined by the 
Investigator.
2. Any use of systemic or ocular medications for which 
contact lens wear could be contraindicated, as 
determined by the Investigator.
3. History of refractive surgery or plan to have refractive 
surgery during the study or irregular cornea in either eye.
4. Ocular or intraocular surgery (excluding placement of 
punctal plugs) within the previous 12 months or planned 
during the study.
5. Biomicroscopy findings at screening that are moderate 
(Grade 3) or higher and/or corneal vascularization that is 
mild (Grade 2) or higher.
6. Current or history of pathologically dry eye in either eye 
that, in the opinion of the Investigator, would preclude 
contact lens wear.
7. Current or history of herpetic keratitis in either eye.
8. Eye injury in either eye within twelve weeks 
immediately prior to enrollment for this trial.
9. Any previous or current wear of MYDAY.
10. Habitually wearing monovision or multifocal lenses 
during the last 3 months.
11. Current or history of intolerance, hypersensitivity or 
allergy to any component of the study products.
12. Wearing habitual contact lenses in an extended wear 
modality (routinely sleeping in lenses for at least 1 night 
per week) over the last 3 months prior to enrollment.
13. Any use of topical ocular medications and artificial tear 
or rewetting drops that would require instillation during 
contact lens wear.
14. The Investigator, his/her staff, family members of the 
Investigator, family members of the Investigator’s staff, 
or individuals living in the households of the 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Pa ge 6 of 4 4
af ore me nti o ne d pers o ns ma y  n ot partici pate i n t he st u d y. 
1 5. Partici pati o n of t he s u bject i n a cli nical trial wit hi n t he 
pre vi o us 3 0 da y s or c urre ntl y e nr olle d i n a ny cli nical 
trial.
Ass ociate d Materials
L u bricati o n/re -wetti n g dr o ps will n ot be per mitte d.
Ta ble 1 - 1
Sc he d ule of St u d y Pr oce d ur es a n d Assess me nts
Pr oce d ure/ Assess me nt
Visit 1, D a y 1: 
B aseli ne/ Dis pe nse 
St u d y Le ns 1
Visit 2, Wee k 1:
6 D a ys (± 1 d a y ) 
F oll o w -u p St u d y 
Le ns 1 / Dis pe nse 
St u d y Le ns 2
Visit 3, Wee k 2: 
6 D a ys ( ± 1 D a y ) 
F oll o w -u p St u d y 
Le ns 2 / E xit
I nf or me d C o nse nt

-
-
De m o gra p hics

-
-
Me dical Hist or y

-
-
C o nc o mita nt Me dicati o ns



I ncl usi o n/ E xcl usi o n

-
-
Ha bit ual le ns 
( bra n d, p o wer) 

-
-
V A w/ ha bit ual c orrecti o n 
(O D, O S, S nelle n dista nce)



Bi o micr osc o p y



Dis pe nse st u d y  le nses


-
V A w/ st u d y le nses (O D, 
O S, S nelle n dista nce 1)



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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7

Pa ge 7 of 4 4
Pr oce d ure/ Assess me nt
Visit 1, D a y 1: 
B aseli ne/ Dis pe nse 
St u d y Le ns 1
Visit 2, Wee k 1:
6 D a ys (± 1 d a y ) 
F oll o w -u p St u d y 
Le ns 1 / Dis pe nse 
St u d y Le ns 2
Visit 3, Wee k 2: 
6 D a ys ( ± 1 D a y ) 
F oll o w -u p St u d y 
Le ns 2 / E xit
A E s 



De vice deficie ncies 



E xit F or m
()
()
()
() assess me nt perf or me d as necessar y, e g, decrease of VA b y 2 li nes or m ore wit h i n vesti gati o nal pr o d uct (I P)
1
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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7
Pri mar y effecti ve ness e n d p oi nt

Page 8 of 44
1.1
Abbreviations
Abbreviation
Definition
ADE
Adverse device effect
AE
Adverse event
ASADE
Anticipated serious adverse device effect
BCVA
Best corrected visual acuity
CFR
Code of Federal Regulations
D
Diopter(s)
DD
Daily disposable
DD T2 
Daily Disposable T2 Soft Contact Lenses
DEP
Deviations and Evaluability Plan
eCRF
Electronic case report form
EDC
Electronic data capture
FAS
Full analysis set
FDA
US Food and Drug Administration
FID
Formulation identification
GCP
Good Clinical Practice
IB
Investigator’s brochure
ICF
Informed consent form
IEC
Independent ethics committee
IP
Investigational product
IRB
Institutional review board
ISO
International Organization for Standardization
LogMAR
Logarithm of the minimum angle of resolution
mm
Millimeter
MYDAY
COOPERVISION MYDAY (stenfilcon A) Daily Disposable Contact 
Lenses
N/A
Not applicable
OD
Right eye
OS
Left eye
OU
Both eyes
PP
Per protocol
pt
Point
Rx
Prescription
SAE
Serious adverse event
SADE
Serious adverse device effect
SiHy
Silicone hydrogel
US
United States
USADE
Unanticipated serious adverse device effect
VA
Visual acuity
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Page 9 of 44
2
TABLE OF CONTENTS
1
PROTOCOL SYNOPSIS ....................................................................................................2
1.1
Abbreviations ......................................................................................................8
2
TABLE OF CONTENTS.....................................................................................................9
List of Tables............................................................................................................................11
List of Figures..........................................................................................................................11
3
INTRODUCTION.............................................................................................................12
3.1
Study Rationale and Purpose.............................................................................12
3.2
Trial Objective...................................................................................................12
3.3
Risks and Benefits.............................................................................................13
3.4
Subject Population.............................................................................................13
3.5
Outline of Study ................................................................................................14
4
TREATMENTS ADMINISTERED...................................................................................14
4.1
Identity of Study Treatments .............................................................................14
4.2
Accountability Procedures.................................................................................15
5
STUDY PROCEDURES AND ASSESSMENTS.............................................................16
5.1
Visits and Examinations ....................................................................................16
5.1.1
Visit 1 (Day 1) – Baseline/Dispense Study Lens 1............................16
5.1.2
Visit 2 (6 Days ± 1 Day) – Follow-up Study Lens 1 / Dispense Study 
Lens 2 ................................................................................................18
5.1.3
Visit 3 (6 Days ± 1 Day) - Follow-up Study Lens 2 / Exit Visit .......20
21
5.2
Unscheduled Visits ............................................................................................21
5.3
Discontinued Subjects .......................................................................................22
5.4
Clinical Study Termination................................................................................22
6
ANALYSIS PLAN ............................................................................................................23
6.1
Subject Evaluability...........................................................................................23
6.2
Analysis Data Sets.............................................................................................23
6.2.1
Safety Analysis Set............................................................................23
6.2.2
Full Analysis Set................................................................................24
6.2.3
Per Protocol Analysis Set ..................................................................24
6.3
Demographic and Baseline Characteristics.......................................................24
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Page 10 of 44
6.4
Effectiveness Analyses ......................................................................................24
6.4.1
Primary Effectiveness........................................................................24
6.4.1.1
Statistical Hypotheses........................................................24
6.4.1.2
Analysis Methods ..............................................................25
6.4.2
Secondary Effectiveness....................................................................25
6.4.2.1
Statistical Hypotheses........................................................25
6.4.2.2
Analysis Methods ..............................................................25
.25
26
26
6.5
Subgroup Analyses ............................................................................................26
6.6
Handling of Missing Data .................................................................................27
27
6.8
Safety Analysis ..................................................................................................27
6.9
Interim Analyses................................................................................................28
28
7
ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................28
7.1
General Information ..........................................................................................30
7.2
Monitoring for Adverse Events .........................................................................33
7.3
Procedures for Recording and Reporting ..........................................................34
7.4
Return product analysis .....................................................................................36
7.5
Follow-Up of Subjects with Adverse Events.....................................................36
7.6
Pregnancy in the Clinical Study........................................................................36
8
CONFIDENTIALITY, BIAS AND MASKING................................................................36
8.1
Subject Confidentiality and Methods Used to Minimize Bias..........................36
8.2
Unmasking of the Study Treatment...................................................................37
9
DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................37
9.1
Completion of Source Documents and Case Report Forms..............................37
9.2
Data Review and Clarifications.........................................................................38
9.3
Regulatory Documentation and Records Retention ..........................................38
10 ETHICS AND COMPLIANCE.........................................................................................39
10.1
Compliance........................................................................................................39
10.2
Institutional Review Board (IRB) .....................................................................39
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Page 11 of 44
11 PROTOCOL AMENDMENT HISTORY..........................................................................40
12 REFERENCES ..................................................................................................................40
12.1
References applicable for all clinical trials: ......................................................40
12.1.1
US references applicable for clinical trials:.......................................41
12.2
References for this clinical trial.........................................................................41
13 Appendix............................................................................................................................42
13.1
MYDAY Package Insert....................................................................................42
List of Tables
Table 1-1
Schedule of Study Procedures and Assessments ...............................................6
List of Figures
Figure 7–1
Categorization of All AEs................................................................................31
Figure 7-2
Categorization of All Serious Adverse Events.................................................31
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Page 12 of 44
3
INTRODUCTION
3.1
Study Rationale and Purpose
Daily disposable (DD) lenses are worn for a full day, during waking hours, and then thrown 
away after usage. This modality of contact lens wear is generally preferable by certain 
subsets of the contact lens wearing population including, but not limited to, patients who 
have environmental allergies, patients who have excessive deposition of their non-DD lenses, 
younger patients where the eye care professional and/or the parent are unsure of the patient’s 
ability to remove and clean a set of lenses on a daily basis, or patients who simply prefer not 
to use a daily cleaning and storage regimen.
New silicone hydrogel (SiHy) materials continue to be developed and each of these contains 
a unique set of properties. A new DD SiHy lens, known here as DD T2, has been developed 
that combines high oxygen transmissibility with a low modulus of elasticity.
In this clinical trial, the overall lens performance of the study lenses including VA
 
 be assessed in a crossover design. The study lenses will be worn 
bilaterally and in a DD wear modality for approximately 1 week.
DD T2 is intended for the optical correction of refractive myopia in persons with non-
diseased eyes.
The purpose of this study is to obtain on-eye performance data to inform contact lens product 
development. There are no immediate plans to submit the results of this study for publication; 
however, the results may be offered for publication if they are of scientific interest, or if the 
results relate to a product that is subsequently approved or cleared for marketing. The design 
of this study is justified based upon preclinical and clinical testing, as described within the 
Investigator’s Brochure (IB).
3.2
Trial Objective
The primary objective of this study is to demonstrate noninferiority in VA of DD T2 when 
compared to MYDAY. 
 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Page 13 of 44
3.3
Risks and Benefits
Contact lenses may offer improved peripheral vision and the convenience of not wearing 
spectacles. Material properties and design characteristics of DD T2 are features consistent 
with successful contact lens wear.
Based upon nonclinical testing and documented rationale for applicability of test results, DD 
T2 are assessed to be non-toxic and biocompatible for on-eye use. 
MYDAY is for daily wear use under a DD wear modality; further details on any known 
potential risks and benefits can be found in the package insert. Refer to Appendix, Section 13.
DD T2 and MYDAY are not intended for use with a cleaning/disinfecting solution, and the 
biocompatibility with lens care solutions and any associated clinical effects are unknown.
A summary of the known potential risks and benefits associated with DD T2 can be found in 
the IB. Risks are minimized by compliance with the eligibility criteria and study procedures, 
and through close supervision by a licensed clinician during exposure to the study lenses. The 
potential harms associated with on-eye exposure to the new lens materials include toxicity 
response, blurred vision and ocular discomfort. In general, the risks with DD T2 are 
anticipated to be similar to other marketed DD soft contact lenses. 
Site personnel will educate subjects on proper hygiene and lens handling, and compliance 
with the use of contact lenses according to the protocol. Subjects should be instructed not to 
wear contact lenses while sleeping or swimming. Site personnel will also advise the subjects 
to remove contact lenses and return for prompt follow-up of symptoms, such as ocular 
discomfort, foreign body sensation, excessive tearing, vision changes, or hyperemia.
3.4
Subject Population
The study population includes approximately 54 subjects to be enrolled at approximately
3 sites, with approximately 18 subjects enrolled per site. The study population will consist of 
subjects with normal eyes (other than the need for optical correction for myopia), who are 
adapted, existing wearers of soft contact lenses (excluding previous or current MYDAY
wearers) in both eyes. To qualify, subjects must require contact lenses in a power range from 
-1.50 D to -4.00 D. 
Subjects must be screened according to the full list of inclusion/exclusion criteria in Section 1
of this protocol. Rescreening of subjects is not allowed in this study.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Pa ge 1 4 of 4 4
3. 5
O utli ne of St u d y
T his will be a m ulti -site, pr os pecti ve, ra n d o mize d, cr oss o ver, d o u ble -mas ke d st u d y  
c o m pari n g 2 c o ntact le nses w or n i n a dail y wear , dail y dis p osa ble m o dalit y f or a p pr o xi matel y 
6 da y s eac h. T he e x pecte d d urati o n of s u bject p artici pati o n i n t he st u d y is a p pr o xi matel y 
2 wee ks, wit h 3 sc he d ule d visits. T he st u d y  is e x pecte d t o be c o m pleted i n a p pr o xi matel y  
1 m o nt h . T he ef fecti ve ness a n d safety assess me nts al o n g wit h t heir c ollecti o n ti me p oi nts are 
prese nte d i n Ta ble 1 - 1. 
4
T R E A T M E N T S A D MI NI S T E R E D
S u b jects will be ra n d o mize d i n a 1: 1 ma n ner t o recei ve t reat me nt i n a cr oss o ver se q ue nce: 
Te st pr o d uct t he n C o ntr ol pr o d uct or C o ntr ol pr o d uct t he n Te st pr o d uct, res pecti vel y.
4. 1
I de ntit y of St u d y Tr e at me nts
D E S C RI P TI O N O F  TE S T  AN D C O N T R O L  P R O D U C T S
T E S T
C O N T R O L
Le ns
D D T 2
M Y D A Y
Material
ste nfilc o n A
Wa ter C o nte nt
5 1 %
5 4 %
Base C ur ve ( m m)
8. 3
8. 4 
Dia meter ( m m)
1 4. 2
1 4. 2
R x p o wers ( D) t o be 
a vaila ble i n t his st u d y
-1. 5 0 t o - 4. 0 0 ( 0. 2 5 ste ps)
- 1. 5 0 t o - 4. 0 0 ( 0. 2 5 ste ps)
Pac ka gi n g, La beli n g, a n d 
S u p pl y

Blister f oil pac k

F oil la bel i ncl u des:
-
material na me a n d 
i de ntifier
-
base c ur ve
-
dia meter
-
ma n ufact uri n g 
pr ot oc ol n u m ber
-
pac ki n g s ol uti o n
-
p o wer
-
l ot n u m ber
-
e x pirati o n date
-
c o nte nt state me nt
-
i n vesti gati o nal 

Blister f oil pac k

C o m mercial f oil wit h 
Half O ver -la bel
-
material na me
-
base c ur ve
-
dia meter
-
pac ki n g s ol uti o n
-
p o wer
-
l ot n u m ber
-
e x pirati o n date
-
c o nte nt state me nt
-
i n vesti gati o nal 
de vice state me nt
-
c o u ntr y of ori gi 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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7

Pa ge 1 5 of 4 4
de vice state me nt
-
s p o ns or 
i nf or mati o n
-
c o u ntr y of ori gi n.

Pr o vi de d i n b o xes of 1 0 
le nses per p o wer per b o x, 
i de ntifie d wit h t he 
f oll o wi n g:
-
a la bel stati n g t he 
pr ot oc ol n u m ber
-
material i de ntifier
-
p o wer
-
a n i n vesti gati o nal 
use o nl y  state me nt
-
trac ki n g n u m ber.

Le nses s h o ul d be st ore d at 
r o o m te m perat ure.

Pr o vi de d i n b o xes of 1 0 
le nses per p o wer per b o x, 
i de ntifie d wit h t he 
f oll o wi n g:
-
a la bel stati n g t he 
pr ot oc ol n u m ber
-
material i de ntifier
-
p o wer
-
a n i n vesti gati o nal 
use o nl y  state me nt
-
trac ki n g n u m ber.

Le nses s h o ul d be st ore d 
at r o o m te m perat ure. 
Usa ge

Wear: 
o
Dail y  Wear 
o
Bilateral, Cr oss o ver

Re place me nt peri o d: D D

E x p os ure: At least 8 h o urs per da y , 5 da ys per wee k o ver 
t he st u d y d urati o n, 6-d a y ( ± 1 da y) wi n d o w per pr o d uct

Le ns Care: N/ A
4. 2
Acc o u nt a bilit y Pr oce d ures
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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7
U p o n recei pt of t he st u d y le nses, t he I n vesti gat or or dele gate will c o n d uct a n i n ve nt or y . 
Desi g nate d st u d y staff will pr o vi de t he st u d y le nses t o t he s u bjects i n acc or da nce wit h t heir 
ra n d o mizati o n sc he d ule. T hr o u g h o ut t he st u d y, t he I n vesti gat or or dele gate m ust mai ntai n 
rec or ds of st u d y treat me nt dis pe nsatio n a n d c ollecti o n f or eac h s u bject. T his rec or d m ust be 
ma de a vaila ble t o t he st u d y  m o nit or f or t he p ur p oses of verif yi n g t he acc o u nti n g of cli nical 
s u p plies. A n y discre pa ncies a n d/ or deficie ncies bet wee n t he o bser ve d dis p ositi o n a n d t he 
writte n acc o u nt m u st be rec or de d al o n g wit h a n e x pla nati o n. 
It is t he I n vesti gat or’s res p o nsi bilit y t o e ns ure t hat:

Pa ge 1 6 of 4 4

All st u d y  pr o d ucts are acc o u nte d f or a n d n ot use d i n a n y u na ut h orize d ma n ner

All use d f oils a n d u n use d s u p plies are ret ur ne d b y eac h s u bject

All u n use d pr o d u cts are a vaila ble f or ret ur n t o t he St u d y  S p o ns or, as directe d

A n y  st u d y le nses ass ociate d wit h a de vice deficie nc y  or wit h a n y  pr o d uct-relate d 
a d verse e ve nt [ie, A D E or S A D E ] are ret ur ne d t o t he St u d y S p o ns or f or i n vesti gati o n. 
Refer t o Secti o n 7 . 3 of t hi s pr ot oc ol f or a d diti o nal i nf or mati o n o n t he re p orti n g of 
de vice deficie ncies a n d A Es a n d t he ret ur n of st u d y pr o d ucts ass ociate d wit h t hese 
e ve nts.
5
S T U D Y  P R O C E D U R E S A N D A S S E S S M E N T S
5. 1
Vi sits a n d E x a mi n ati o ns
5. 1. 1
Vi sit 1 ( D a y 1) – B aseli ne/ Dis pe nse St u d y Le ns 1
1
E x plai n t he p ur p ose a n d nat ure of t he st u d y, a n d ha ve t he s u bject rea d, si g n, a n d date 
t he IR B -a p pr o ve d i nf or me d c o nse nt d oc u me nt. A d diti o nall y , ha ve t he i n di vi d ual 
o btai ni n g c o nse nt fr o m t he s u bject a n d a wit ness, if a p plica ble, si g n a n d date t he 
i nf or me d c o nse nt d oc u me nt. Pr o vi de a p h ot oc o py of t he si g ne d d oc u me nt t o t h e 
s u bject a n d place t he ori gi nal si g ne d d oc u me nt i n t he s u bject’s c hart. After si g ni n g 
t he IC F , a s u bject will be assi g ne d a s u bject n u m ber b y t he E D C s yste m. A si g ne d 
i nf or me d c o nse nt d oc u me nt defi nes t he p oi nt of e nr oll me nt.
2
O btai n de m o gra p hic i nf or ma ti o n a n d me dical hist or y, i ncl u di n g i nf or mati o n o n all 
me dicati o ns use d wit hi n t he past 3 0 da y s. I ncl u de her bal t hera pies, vita mi ns, a n d all 
o ver -t he-c o u nter as well as prescri pti o n me dicati o ns.
3
4
Perf or m S nelle n V A wit h ha bit ual c orrecti o n .
O D , O S, dista nce o nl y,  c o ntact le nses*
Rec or d ha bit ual le ns i nf or mati o n ( bra n d, p o wer).
* Rec or d i n S o urce D oc u me nt o nly.
5
6
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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7

Pa ge 1 7 of 4 4
7
Perf or m slit -la m p bi o micr osc o py ( wit h o ut c o ntact le nses) t o e val uate t he f oll o wi n g:
Li m bal h y pere mia
B ul bar h y p ere mia
C or neal stai ni n g
C o nj u ncti val stai ni n g
C or neal vasc ularizati o n
C or neal e pit helial e de ma
C or neal str o mal e de ma
C o nj u ncti val c o m pressi o n/i n de nti o n
C he m osis
Pal pe bral c o nj u ncti val o bser vati o ns
C or neal i nfiltrates
Ot her fi n di n gs
8
 
9 
Re vie w i ncl usi o n/e xcl usi o n criteria t o deter mi ne if t he s u bject q ualifies t o be
ra n d o mize d i nt o t he st u d y. If s u bject q ualifies, re q uest ra n d o mizati o n.
1 0
Base d u p o n t he ra n d o mize d treat me nt se q ue nce assi g n me nt, ha ve t he s u bject i nsert 
t he a p pr o priate st u d y le nses.  

Kee p all li d di n g f oils of le nses use d d uri n g le ns fit pr ocess f or st u dy le ns 
acc o u nt a bility.

F oll o w pr oce d ures t o m ai nt ai n m aski n g.
1 1
 
 
1 2
E val uate t he st u d y le nses b y perf or mi n g t he f oll o wi n g:
S nelle n V A wit h st u d y  le nses ( O D a n d O S, at dista nce) * *

O ver -refracti o n if necessar y t o deter mi ne t he best c o ntact le ns-c orrecte d V A
a n d fi nal st u d y le ns p o wer(s)
* * V A w/st u dy le nses m ust be 2 0/ 4 0 O U or better f or s u bject t o le ave t he office
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7

Pa ge 1 8 of 4 4
1 3
 
 
 
1 4
1 5
Assess a n d rec or d a n y A Es a n d de vice deficie ncies re p orte d or o bser ve d d uri n g t he 
st u d y visit.
N ote: A Es a n d device deficie ncies m ust be rec or de d f or all e nr olle d s u bjects fr o m t he ti me of 
si g n at ure of i nf or me d c o nse nt i ncl u di n g t h ose t h at scree n f ail.
1 6
Dis pe nse st u d y  le nses a n d i nstr uct t he s u bject o n le ns wear. 
1 7
Sc he d ule Visit 2 t o ta ke place 6 da y s (± 1 da y ) after Visit 1. 
5. 1. 2
Vi sit 2 (6 D a y s ± 1 D a y) – F oll o w- u p St u d y Le ns 1 / Dis pe nse St u d y 
Le ns 2
1
O btai n i nf or mati o n o n a n y  c ha n ges i n me dical healt h a n d/ or t he use of 
c o nc o mita nt me dicati o ns.
2
Rec or d a n y de vice deficie ncies or A Es 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 dicati o n d osi n g si nce t he 
pre vi o us visit(s).
3
Re vie w s u bject c o m plia nce wit h le ns wear .
4
 
5
E val uate t he st u d y le nses b y perf or mi n g t he f oll o wi n g:
S nelle n V A wit h st u d y  le nses ( O D a n d O S, at dista nce)
N ote: Perf or m B C V A if t here is a decre ase of V A by 2 li nes or m ore wit h I P
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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7

Pa ge 1 9 of 4 4
6
 
 
 
7
8
Ha ve s u bject re m o ve st u d y le nses.
9
Perf or m slit -la m p bi o micr osc o py ( wit h o ut c o ntact le nses) t o e val uate t he 
f oll o wi n g:
Li m bal h y pere mia
B ul bar h y p ere mia
C or neal stai ni n g
C o nj u ncti val stai ni n g
C or neal vasc ularizati o n
C or neal e pit helial e de ma
C or neal str o mal e de ma
C o nj u ncti val c o m pressi o n/i n de nti o n
C he m osis
Pal pe bral c o nj u ncti val o bser vati o ns
C or neal i nfiltrates
Ot her fi n di n gs
1 0 
Base d u p o n t he ra n d o mize d treat me nt se q ue nce assi g n me nt, ha ve t he s u bject 
i nsert t he a p pr o priate st u d y le nses t o be e val uate d.

Kee p all li d di n g f oils of le nses use d d uri n g le ns fit pr ocess f or st u dy le ns 
acc o u nt a bility.

F oll o w pr oce d ures t o m ai nt ai n m aski n g.
1 1
 
 
1 2
E val uate t he st u d y le nses b y perf or mi n g t he f oll o wi n g:
S nelle n V A wit h st u d y le nses ( O D a n d O S, at dista nce) *

O ver -refracti o n if necessar y t o deter mi ne t he best c o ntact le ns-c orrecte d 
V A a n d fi nal st u d y le ns p o wer(s)
* V A w/st u dy le nses m ust be 2 0/ 4 0 O U or better f or s u bject t o le ave t he office
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7

Pa ge 2 0 of 4 4
1 3
 
 
 
1 4
1 5 
Sc he d ule Visit 3 t o ta ke place 6 da y s ± 1 d a y  after Visit 2.
5. 1. 3
Vi sit 3 (6 D a y s ± 1 D a y) - F oll o w -u p St u d y Le ns 2 / 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 de vice deficie ncies or A Es 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 dica ti o n d osi n g si nce t he pre vi o us 
visit(s) .
3
Re vie w s u bject c o m plia nce wit h le ns wear a n d a dj u nct pr o d uct usa ge. 
4
 
5
E val uate t he st u d y le nses b y perf or mi n g t he f oll o wi n g:
S nelle n V A  wit h st u d y le nses ( O D a n d O S, at dista nce)
N ote: Perf or m B C V A if t here is a decre ase of V A by 2 li nes or m ore wit h I P
6
 
 
 
7
8
Ha ve s u bject re m o ve t he 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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7

Pa ge 2 1 of 4 4
9
Perf or m slit -la m p bi o micr osc o py ( wit h o ut c o ntact le nses) t o e val uate t he f oll o wi n g:
Li m bal h y pere mia
B ul bar h y p ere mia
C or neal stai ni n g
C o nj u ncti val stai ni n g
C or neal vasc ularizati o n
C or neal e pit helial e de ma
C or neal str o mal e de ma
C o nj u ncti val c o m pressi o n/i n de nti o n
C he m osis
Pal pe bral c o nj u ncti val o bser vati o ns
C or neal i nfiltrates
Ot her fi n di n gs
1 0 
Perf or m S nelle n V A wit h ha bit ual c orrecti o n * .
O D , O S, dista nce o nl y
O ver -refracti o n ( o nly nee de d if V A is re d uce d)
* Rec or d i n s o urce d oc u me nt o nly
1 1
E xit t he s u bject fr o m t he st u d y .
5. 2
U nsc he d ule d Vi sits
A 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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7
If a s u bject visit occ urs bet wee n a n y re g ularl y sc he d ule d visits t he n t his visit m ust be 
d oc u me nte d as a n U nsc he d ule d V isit. D uri n g all u nsc he d ule d visits, t he I n vesti gat or m ust 
c o n d uct t he f oll o wi n g pr oce d ures: 

Pa ge 2 2 of 4 4

C ollect A E a n d De vice Deficie nc y i nf or mati o n

Assess a n d r ec or d c ha n ges i n me dical c o n diti o n or c o nc o mita nt me dicati o n 

Asse ss a n d rec or d V A s

Perf or m b i o micr osc o py (assess me nts wit h or wit h o ut le nses, as a p plica ble)
T he I n vesti gat or ma y  perf or m a d diti o nal pr oce d ures f or pr o per dia g n osis a n d treatme nt of t he 
s u bject. T he I n vesti gat or m ust d oc u me nt t his i nf or mati o n i n t he s u bject’ s case hist or y s o urce 
d oc u me nts.
If d uri n g a n U nsc he d ule d Visit t he s u bject is disc o nti n ui n g t he st u d y le nses or disc o nti n ui n g 
fr o m t he st u d y, t he I n vesti gat or m ust c o n d uct E xit pr oce d ures acc or di n g t o Ta ble 1 - 1:
Sc he d ule of St u d y  Pr oce d ures a n d Assess me nts , as p ossi ble.
5. 3
Disc o nti n ue d S u bjects
Disc o nti n ue d s u bjects are t h ose w h o wit h dra w or are wit h dra w n fr o m t he st u d y  after sig ni n g 
t he i nf or me d c o nse nt, i ncl u di n g scree n failures . S u bjects ma y  disc o nti n ue fr o m t he st u d y at 
a n y ti me f or a n y reas o n. S u bjects ma y als o be disc o nti n ue d fr o m t he st u d y at a n y ti me if, i n 
t he o pi ni o n of t he I n vesti gat or, t heir c o nti n ue d partici pati o n p oses a ris k t o t heir healt h. 
Disc o nti n ue d s u bjects will n ot be re place d (ie, t heir s u bject n u m bers will n ot be 
re-assi g ne d/re -use d).
S h o ul d a s u bject e x hi bit a n y  cli nicall y rele va nt si g ns, sy m pt o ms, or ot her cli nical 
o bser vati o ns t hat p ossi bl y  c o ul d be ass ociate d wit h s us pecte d se nsiti vit y or i nt olera nce t o o ne 
of t he st u d y  treat me nts, t he I n vesti gat or m ust d oc u me nt t h ose o bser vati o ns o n a n A E F or m.
A n y  s u bject w h o e xits earl y fr o m t he st u d y m ust u n der g o all pr oce d ures o utli ne d at Visit 3, 
as a p plica ble .
T he I n vesti gat or m ust d oc u me nt t he reas o n f or st u d y  or treat me nt disc o nti n uati o n i n t he 
s u bject’s case hist or y s o urce d oc u me nts.
To  e ns ure t he safety of all s u bjects w h o disc o nti n ue earl y,  In vesti gat ors m ust assess eac h 
s u bject a n d, if necessar y, a d vise t he m of a ny t hera pies a n d/ or me dical pr oce d ures t hat m a y  be 
nee de d t o mai ntai n t heir healt h.
5. 4
Cli nic al St u d y Te r mi n ati o n
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7
T he St u d y  S p o ns or reser ves t he ri g ht t o cl ose t he i n vesti gati o nal site or ter mi nate t he st u d y i n 
its e ntiret y at a n y ti me, f or reas o na ble ca use.

Pa ge 2 3 of 4 4
If t he cli nical st u dy is pre mat urel y ter mi na te d or s us pe n de d by t he St u d y S p o ns or: 

T he St u d y  S p o ns or m ust:
o
I m me diatel y n otif y t he I n vesti gat or(s) a n d s u bse q ue ntl y pr o vi de 
i nstr ucti o ns f or st u d y ter mi nati o n.
o
I nf or m t he I n vesti gat or a n d t he re g ulat or y a ut h orities of t he 
ter mi nati o n/s us pe nsi o n a n d t he reas o n(s) f or t he ter mi nati o n/s us pe nsi o n, 
as a p plica ble . 

T he I n vesti gat or m ust:
o
Pr o m ptl y  n otif y t he I RB of t he ter mi nati o n or s us pe nsi o n a n d of t he 
reas o ns. 
o
Pr o vi de s u bjects wit h rec o m me n dati o ns f or p ost -st u d y treat me nt o pti o ns 
as nee de d.
T he I n vesti gat or ma y  ter mi nate a site’s partici pati o n i n t he st u d y f or reas o na ble ca use.
6
A N A L Y SI S P L A N
C o nti n u o us varia bles will be s u m marize d usi n g t he n u m ber of o bser vati o ns, mea n, sta n dar d 
de viati o n, me dia n, mi ni m u m, a n d ma xi m u m. Cate g orical varia bles will be s u m mari ze d wit h 
c o u nts a n d perce nta ges fr o m eac h cate g or y. A n y de viati o ns t o t his a nal y sis pla n will be 
u p date d d uri n g t he c o urse of t he st u d y as part of a pr ot oc ol a me n d me nt or will be detaile d i n 
t he cli nical st u d y re p ort.
6. 1
S u bject E v al u a bilit y
T he fi nal s u bject e val ua bilit y will be deter mi ne d pri or t o brea ki n g t he c o de f or mas ke d 
treat me nt (le ns) se q ue nce assi g n me nt a n d l oc ki n g t he data base, base d u p o n t he De viati o ns 
a n d E val ua bilit y Pla n ( D E P).
6. 2
A n al ysis D at a Sets
6. 2. 1
S afet y A n al ysis Set
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7
Safet y  a nalys es will be c o n d ucte d usi n g t he safet y a nal ys is set o n a treat me nt-e mer ge nt basis. 
As s uc h, t he safet y  a nalysis set will i ncl u de all s u bjects/e yes e x p ose d t o a n y st u d y le nses 
e val uate d i n t his st u d y. F or treat me nt-e mer ge nt safet y a nal ys es, s u bjects/e yes will be 
cate g orized u n der t he act ual st u d y  le nses e x p ose d. 

Page 24 of 44
6.2.2
Full Analysis Set
The full analysis set (FAS) is the set of all randomized subjects who are exposed to any study 
lenses evaluated in this study. 
6.2.3
Per Protocol Analysis Set
The per protocol (PP) analysis set is a subset of FAS and excludes all data which have met 
any of the critical deviation or evaluability criteria identified in the DEP. 
6.3
Demographic and Baseline Characteristics
Demographic information (age, sex, ethnicity, race) will be summarized on the safety, full, 
and PP analysis sets. Baseline data pertaining to habitual lens (lens brand, power, 
 
) will be summarized on the full and PP analysis sets. 
6.4
Effectiveness Analyses
This study defines one primary effectiveness endpoint, 
 
 The FAS will serve as the primary set for all 
effectiveness analyses. 
 
 
 
 
6.4.1
Primary Effectiveness
The primary objective of this study is to demonstrate noninferiority in VA of DD T2 when 
compared to MYDAY.
The primary endpoint is VA (logMAR) at Dispense and Week 1, Follow-Up. 
6.4.1.1
Statistical Hypotheses
The null and alternative hypotheses are formulated in terms of the predefined margin of 0.05 
for noninferiority: 
H0: µ(DDT2) - µ(MYDAY) ≥  0.05
Ha: µ(DDT2) - µ(MYDAY) <  0.05
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Page 25 of 44
where µ(DDT2) and µ(MYDAY) denote the mean VA for DD T2 and MYDAY, respectively. 
6.4.1.2
Analysis Methods
A mixed effect repeated measures model will be utilized to test these hypotheses. The model 
will include terms for lens, visit, lens by visit interaction, period, and sequence. Within-
subject correlation due to eye and the crossover will also be accounted for in the model. Lens 
difference (DD T2 minus MYDAY) and the corresponding one-sided 95% upper confidence 
limit will be computed. Noninferiority in VA will be declared if upper confidence limit is less 
than 0.05.
6.4.2
Secondary Effectiveness
Not applicable.
6.4.2.1
Statistical Hypotheses
Not applicable.
6.4.2.2
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-0053428
Protocol - Clinical
07-Mar-2017

Page 26 of 44
6.5
Subgroup Analyses
It is not expected that demographic or baseline characteristics will have an impact on the 
results in this study. No subgroup analyses are planned.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Page 27 of 44
6.6
Handling of Missing Data
All data obtained in evaluable subjects/eyes will be included in the analysis. No imputation 
for missing values will be carried out for the primary analysis.
6.8
Safety Analysis
The safety endpoints for this study are AEs, biomicroscopy findings, and device deficiencies. 
Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be 
presented by Medical Dictionary for Regulatory Activities Preferred Terms. AEs leading to 
study discontinuation, significant nonserious AEs, and SAEs will be identified. Individual 
subject listings will be provided, as necessary. 
Individual subject listings will be provided for AEs that occur after signing informed consent 
but prior to exposure to study lenses. This listing will include the following variables: lens 
sequence assigned, Investigator, subject, age, sex, eye (if ocular), in addition to relevant data 
describing the AE.  
Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy 
parameter, counts and percentages of eyes that experience an increase of ≥ 2 grades from 
baseline (Visit 1) to any subsequent visit within the specific crossover period will be 
presented. A supportive listing will be generated which will include all biomicroscopy data 
from all visits within the affected period for these eyes experiencing the increase, with the 
following variables: lens, Investigator, subject, age, sex, visit, eye, parameter, baseline value, 
and value at the visit.
Two listings (prior to exposure of study lenses and treatment-emergent) of device 
deficiencies, as recorded on the Device Deficiency Form, will be provided. Additionally, each 
device deficiency category will be tabulated. Each listing will include the following 
variables: lens, Investigator, subject, age, sex, in addition to relevant data describing the 
device deficiency and associated ADE, if any. 
No inferential testing will be done for safety analysis. 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Page 28 of 44
6.9
Interim Analyses
There are no plans to conduct an interim analysis and no criteria by which the study would be 
terminated early based upon statistical determination. 
7
ADVERSE EVENTS AND DEVICE DEFICIENCIES
Terms and Definitions
Adverse Event (AE)
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device (test article). Note: For subjects, 
this definition includes events related to the test article, the control 
article, or the procedures involved. For users or other persons, 
this definition is restricted to events related to the test article.
Adverse Device 
Effect (ADE)
AE related to the use of an investigational medical device (test 
article) or control article. Note: This definition includes AEs
resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation; any 
malfunction; and use error or intentional misuse of the test article 
or control article.
Anticipated Serious 
Adverse Device 
Effect (ASADE)
Serious ADE which by its nature, incidence, severity or outcome 
has been identified in the risk management file.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Pa ge 2 9 of 4 4
De vice Deficie nc y
I na de q uac y of a me dical de vice wit h res pect t o its i de ntit y, q ualit y, 
d ura bilit y, relia bilit y, safet y, or perf or ma nce. N ote: T his defi niti o n 
i ncl u des m alf u ncti o ns, use errors, a n d i n a de q u ate l a beli n g.
Malf u ncti o n
Fail ure of a me dical de vice t o meet its perf or ma nce s pecificati o ns 
or ot her wise perf or m as i nte n de d. Perf or ma nce s pecificati o ns 
i ncl u de all clai ms ma de i n t he la beli n g of t he de vice. T he i nte n de d 
perf or ma nce of t he de vice refers t o t he i nte n de d use f or w hic h t he 
de vice is la bele d or mar kete d.
N o nseri o us A d verse 
E ve nt
A E t hat d oes n ot meet t he criteria f or an S A E .
Seri o us A d verse 
E ve nt ( S A E)
A E t hat le d t o a n y of t he f oll o wi n g:

Deat h.

A 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 
i m pair me nt t o a b o d y str uct ure or a b o d y f u ncti o n.
c)
i n-patie nt h os pitalizati o n or pr ol o n ge d h os pitalizati o n.
N ote: Pl a n ne d h os pit aliz ati o n f or a pr e-existi n g c o n diti o n, 
wit h o ut seri o us deteri or ati o n i n he alt h, is n ot c o nsi der e d 
a n S A E . I n ge ner al, h os pit aliz ati o n si g nifies t h at t he 
i n divi d u al re m ai ne d at t he h os pit al or e merge ncy w ar d f or 
o bser v ati o n a n d/ or tre at me nt ( us u ally i nv olvi n g a n 
over ni g ht st ay) t h at w o ul d n ot h ave bee n a p pr o pri ate i n t he 
p hysici a n's office or a n o ut -p atie nt setti n g. C o m plic ati o ns 
t h at occ ur d uri n g h os pit aliz ati o n are a dverse eve nts. If a 
c o m plic ati o n prol o n gs h os pit ali z ati o n or f ulfills a ny ot her 
seri o us criteri a, t he eve nt is seri ous. W h e n i n d o u bt as t o 
w het her “ h os pit aliz ati o n ” occ urr e d, t he eve nt s h o ul d be 
c o nsi dere d seri o us.
d)
a me dical or s ur gical i nter ve nti o n t o pre ve nt a) or b). 
e)
a n y i n direct har m as a c o nse q ue nce of i nc orrect dia g n ostic 
test res ults w he n use d wit hi n ma n ufact urer’s i nstr ucti o ns 
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7

Pa ge 3 0 of 4 4
f or use.

Fetal distress, fetal deat h, or a c o n ge nital a b n or malit y  or birt h 
defect.
Refer t o Secti o n 7. 1 f or a d diti o n al S A Es.
Seri o us A d verse 
De vice Ef fect 
( S A D E)
A D E t hat has res ulte d i n a n y of t he c o nse q ue nces c haracteristic of 
a n S A E .
Si g nifica nt 
N o n seri o us A d verse 
E ve nt
A si g nifica nt n o nseri o us A E is a s ym pt o matic, de vice -relate d, n o n-
si g ht t hreate ni n g A E t hat warra nts disc o nti n uati o n of a n y c o ntact 
le ns wear f or greater t ha n or e q ual t o 2 wee ks.
Refer t o Secti o n 7 f or a d diti o n al Si g nific a nt N o nseri o us A Es.
U na ntici pate d 
Seri o us A d verse 
De vice Ef fect 
( U S A D E)
Seri o us a d verse de vice effect w hic h b y its nat u re, i nci de nce, 
se verity or o utc o me has n ot bee n i de ntifie d i n t he ris k ma na ge me nt 
file.
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 defi 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.
7. 1
Ge ner al I nf or m 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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7
A n A E is 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). 

Pa ge 3 1 of 4 4
Fi g ur e 7 – 1
C ate g oriz ati o n of All A Es
Fi g ur e 7- 2
C ate g oriz ati o n of All Seri o us A d verse E ve nts 
Seri o us A dverse Eve nts
I n a d diti o n t o re p orti n g all A Es (seri o us a n d n o nseri o us) meeti n g t he defi niti o ns, t he 
I n vesti gat or m ust re p ort a n y occ urre nce of t he f oll o wi n g as a n S A E:

A n oc ular i nfecti o n i ncl u di n g a pres u me d i nfecti o us ulcer wit h a n y of t he f oll o wi n g 
c haracteristics: 
o
Ce ntral or parace ntral l ocati o n
o
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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7
Pe netrati o n of B o w ma n’ s me m bra ne

Pa ge 3 2 of 4 4
o
I nfiltrates > 2 m m dia meter
o
Iritis
o
I ncrease i n i ntra oc ular press ure
o
C ult ure p ositi ve f or micr o or ga nis ms
o
I ncreasi n g size or se verit y at s u bse q ue nt visits

A n y  ce ntral or parace ntral c or neal e ve nt (s uc h as ne o vasc ularizati o n) t hat res ults i n 
per ma ne nt o pacificati o n

H y p o p y o n

H y p he ma

Ne o vasc ularizati o n wit hi n t he ce ntral 6 m m of t he c or nea

Per ma ne nt visi o n l oss as defi ne d b y l oss of 2 or m ore li nes of B C VA fr o m e nr oll me nt 
visit t hat fails t o res ol ve

U veitis (a nteri or , i nter me diate, or p osteri or)

C or neal a brasi o n affecti n g ≥5 0 % of c or neal s urface area
Si g nific a nt N o n seri o us A dverse Eve nts
A si g nifica nt n o n-seri o us A E is a s ym pt o matic, de vice -relate d, n o n-si g ht t hreate ni n g A E t hat 
warra nts disc o nti n uati o n of a n y c o ntact le ns wear f or greater t ha n or e q ual t o 2 wee ks. I n 
a d diti o n, t he In vesti gat or m ust re p ort a n y  occ urre nce of t he f oll o wi n g as a Si g nifica nt 
N o n seri o us A E :

Peri p heral n o n - pr o gressi ve n o n-i nfecti o us ulcers

All s y m pt o matic c or neal i nfiltrati ve e ve nts

C or neal stai ni n g sc ore greater t ha n or e q ual t o G ra de 3 [ Gra di n g scale is base d u p o n 
I S O 11 9 8 0: 2 0 1 2 u nless ot her wise s pecifie d]

Te m p orar y  visi o n l oss as defi ne d b y l oss of 2 or m ore li nes of B C VA fr o m e nr oll me nt 
visit t hat persists f or 2 or m ore wee ks

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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7
Ne o vasc ularizati o n sc ore greater t ha n or e q ual t o G ra de 2 [ Gra di n g scale is base d u p o n 
I S O 11 9 8 0: 2 0 1 2 u nless ot her wise s pecifie d]

Pa ge 3 3 of 4 4
T he a b ove eve nts ar e b ase d u p o n t he c ate g ories pr ovi de d i n t he I S O 11 9 8 0 a n d t he U S F D A  
Pr e m arket N otific ati o n (5 1 0(k )) G ui d a nce D oc u me nt f or D aily W e ar C o nt act Le nses a n d 
C o nt act Le ns C ar e Pro d ucts.
Device Deficie ncies
A de vice deficie nc y  is i na de q uac y of a me dical de vice wit h res pect t o its i de ntit y, q ualit y, 
d ura bilit y, relia bilit y, safet y, or perf or ma nce. A de vice deficie nc y  ma y or ma y n ot be 
ass ociate d wit h patie nt har m (ie, A D E or S A D E); h o we ve r, n ot all A D Es or S A D Es are d ue 
t o a de vice deficie nc y. T he I n vesti gat or s h o ul d deter mi ne t he a p plica ble cate g or y liste d i n t he 
De vice Deficie nc y  e C R F f or t he i de ntifie d or s us pect de vice deficie nc y a n d re p ort a ny patie nt 
har m se paratel y. E xa m ples of de vice deficie ncies i ncl u de t he f oll o wi n g: 

Fail ure t o meet pr o d uct s pecificati o ns (e g, i nc orrect le ns p o wer/ dia meter/ base 
c ur ve/c ol or)

Le ns cl o u d y

Le ns s urface/e d ge defect 

To r n le ns d uri n g ha n dli n g/i n pac k

Pac ka gi n g deficit (e g, misla bele d pr o d uct )

S us pect p r o d uct c o nta mi nati o n

Lac k of perf or ma nce
7. 2
M o nit ori n g f or A d verse E ve nts
At eac h visit, after t he s u bject has ha d t he o p p ort u nit y  t o s p o nta ne o usly me nti o n a n y 
pr o ble ms, t he I n vesti gat or s h o ul d i n q uire a b o ut A Es b y  as ki n g t he sta n dar d q uesti o ns:

“ Ha ve y o u ha d a n y healt h pr o ble ms si nce y o ur last st u d y  visit?”

“ Ha ve t here 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?”
A d diti o nall y , cha 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 air es 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 air e res p o nse
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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7
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 orted 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. 

Pa ge 3 4 of 4 4
7. 3
Pr oce d ures f or Rec or di n g a n d Re p orti n g
A Es are c ollecte d fr o m t he ti me of i nf or me d c o nse nt .A n y pre -e xisti n g me dical c o n diti o ns or 
si g ns/s ym pt o ms prese nt i n a s u bject pri or t o t he start of t he st u d y  (ie, bef ore i nf or me d 
c o nse nt is si g ne d) are n ot c o nsi dere d A Es i n t he st u d y  a n d s h o ul d be rec or de d i n t he Me dical 
Hist or y  secti o n of t he e C R F.
I n a d diti o n, te m p orar y le ns a ware ness or vis ual c ha n ges d uri n g t he fitti n g pr ocess are n ot 
c o nsi dere d A Es if t he I n vesti gat or assesses t hat t he s y m pt o m(s) ca n reas o na bl y  res ol ve wit hi n 
t he a ntici pate d a da ptati o n peri o d. 

A D Es or S A Es are d oc u me nte d o n t he Seri o us A dverse Eve nt a n d A dverse Device 
Effect e C R F wit hi n 2 4 h o urs of t he I n ves ti gat or’s or site’s a ware ness. 

De vice deficie ncies are d oc u me nte d o n t he Device Deficie ncy e C R F wit hi n 2 4 h o urs 
of t he 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 Effect 
a n d/ or Device Defic ie ncy e C R F m ust be i ncl u de d wit h pr o d uct ret ur ns.

A d diti o nal rele va nt i nf or mati o n after i nitial re p orti n g m ust be e ntere d i nt o t he e C R F as 
s o o n as t he data bec o me a vaila ble.

D oc u me nt a n y c ha n ges t o c o nc o mita nt me dicati o ns o n t he a p pr o priate e C R Fs.

D oc u me n t all rele va nt i nf or mati o n fr o m Disc har ge S u m mar y, A ut o ps y  Re p ort,

Certificate of Deat h , etc, if a p plica ble, i n narrati ve secti o n of t he Seri o us A dverse 
Eve nt a n d A dverse Device Effect e C R F.
N ote: S h o ul d t he E D C s yste m bec o me n o n -o perati o nal, t he site m ust c o m plete t he 
a p pr o priate pa per Seri o us A dverse Eve nt a n d A dverse Device Effect a n d/ or Device Deficie ncy
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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7
F or m. T he c o m plete d f or m is e maile d t o t he St u d y  S p o ns or at
ft w. me dical _safety @ alc o n.c o m acc or di n g t o t he ti meli nes o utli ne d a b o ve; h o we ver, t he 
re p orte d i nf or mati o n m ust be e ntere d i nt o t he E D C s yste m o nce it bec o mes o perati o nal.
A n y  AEs a n d de vice deficie ncies f or n o n -st u d y mar kete d de vices/ pr o d ucts 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 de vice’s/ 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.

Page 35 of 44
Further, depending upon the nature of the AE or device deficiency being reported, the Study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC.
Intensity and Causality Assessments
Where appropriate, the Investigator must assess the intensity (severity) of the AE based upon 
medical judgment with consideration of any subjective symptom(s), as defined below:
Intensity (Severity)
Mild
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom.
Moderate
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities.
Severe
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities.
For every AE in the study, the Investigator must assess the causality (Related or Not Related 
to the medical device or study procedure). An assessment of causality will also be performed 
by Study Sponsor utilizing the same definitions, as shown below:
Causality
Related
An AE classified as related may be either definitely related or possibly related 
where a direct cause and effect relationship with the medical device or study 
procedure has not been demonstrated, but there is a reasonable possibility that 
the AE was caused by the medical device or study procedure.
Not Related
An AE classified as not related may either be definitely unrelated or simply 
unlikely to be related (ie, there are other more likely causes for the AE).
The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
seriousness and/or causality. The Study Sponsor will notify the Investigator of any AEs that 
are upgraded from nonserious to serious or from unrelated to related.
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Page 36 of 44
7.4
Return product analysis
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. These 
products should be returned to the Sponsor at the end of the study, unless instructed otherwise 
by the Sponsor. 
7.5
Follow-Up of Subjects with Adverse Events
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study. 
The Investigator should provide the Study Sponsor with any new safety information (which 
includes new AEs and changes to previously reported AEs) that may affect the safety 
evaluation of the device. For AEs that are unresolved/ ongoing at time of subject exit from 
study, any additional information received at follow-up should be documented in the eCRFs 
up to study completion (ie, database lock). 
Any additional data received up to 1 month after subject discontinuation or exit must be 
documented and available upon the Study Sponsor’s request. All complaints received after 
this time period will be considered and processed as spontaneous and should be 
communicated to the medical device’s manufacturer as per local requirements.
The Investigator should also report complaints on non-Alcon products directly to the 
manufacturer as per the manufacturer’s instructions or local regulatory requirements.
7.6
Pregnancy in the Clinical Study
Women of childbearing potential or women who are pregnant at the time of study entry are 
not excluded from participation. Pregnancy should be included in the Medical History section 
of the eCRF when a pregnant woman enters the study or if a woman becomes pregnant 
during the study. Pregnancy is not reportable as an AE; however, complications may be 
reportable and will be decided on a case–by-case basis. 
8
CONFIDENTIALITY, BIAS AND MASKING
8.1
Subject Confidentiality and Methods Used to Minimize Bias
The Investigator must ensure that the subject’s anonymity is maintained throughout the
course of the study. In particular, the Investigator must keep an enrollment log with
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Page 37 of 44
confidential identifying information that corresponds to the subject numbers and initials of
each study participant. At the end of the clinical study, the Sponsor will collect a copy of the
enrollment log without any identifying subject information. All documents submitted to the
Sponsor will identify the subjects exclusively by number and demographic information. No
other personally identifying information should be transmitted to the Sponsor.
This study is double-masked with subjects randomized to use both DD T2 and MYDAY (in a 
randomized sequence) for the duration of the 2-week treatment period. The Investigator, 
 and Sponsor personnel (other than site monitors, lead clinical site manager, 
person responsible for generating the randomization schedule, and unmasked clinical data 
managers) involved in reporting, obtaining, and/or reviewing the clinical evaluations will be 
masked to the identity of the contact lens being administered. This level of masking will be 
maintained throughout the conduct of the study. Unmasking will occur only after all planned 
study data have been validated, and the database locked. Masked study personnel must avoid 
seeking information that may compromise masking. Unmasked study personnel must not 
disseminate information that is potentially unmasking to any masked personnel. The masked 
and unmasked site personnel must coordinate all study activities as necessary to protect 
masking and minimize bias during the trial.
8.2
Unmasking of the Study Treatment
Masked information on the identity of the assigned medical device should not be disclosed 
during the study. If the treatment code needs to be broken in the interest of subject safety, the 
Investigator is encouraged to contact an appropriate Study Sponsor representative prior to 
unmasking the information if there is sufficient time. Dependent upon the individual 
circumstances (ie, medical emergency), the code may be broken prior to contact with the 
Study Sponsor. The Study Sponsor must be informed of all cases in which the code was 
broken and of the circumstances involved. Additionally, the Study Sponsor may be required 
to unmask the information in order to fulfill expedited regulatory reporting requirements.
9
DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS
9.1
Completion of Source Documents and Case Report Forms
The nature and location of all source documents will be identified to ensure that original data 
required to complete the eCRFs exist and are accessible for verification by the site monitor, 
and all discrepancies shall be appropriately documented via the query resolution process. 
Study monitors are appointed by the Study Sponsor and are independent of study site staff. If 
electronic records are maintained, the method of verification must be determined in advance 
of starting the study. 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Pa ge 3 8 of 4 4
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 nta ti o n t hat pr ot oc ol s pecific pr oce d ures were perf or me d

Res ults of st u d y  para meters, as re q uire d by t he pr ot oc ol

I P acc o u nta bilit y rec or ds

D oc u me ntati o n of A Es a n d ot her safet y para meters (if a p plica ble)

Rec or ds re gar di n g me dical hist ories a n d t he use of c o n c o mita nt t hera pies pri or t o a n d 
d uri n g t he st u d y

Date of st u d y c o m pleti o n a n d reas o n f or early disc o nti n uati o n, if a p plica ble
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 e C R F are c o nsiste nt wit h t he ori gi nal s o urce data.
O nl y desi g nate d i n di vi d uals ma y  c o m plete t he e C R Fs. T he e C R Fs will be s u b mitte d at 
re g ular i nter vals f oll o wi n g t he cli nical st u d y 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. T he Pri nci pal I n vesti gat or 
is res p o nsi ble f or re vie wi n g a n d certif yi n g t hat t he e C R Fs are acc urate a n d c o m plete. T he 
o nl y  s u bject i de ntifiers rec or de d o n t he e C R Fs will be s u bject n u m ber, a n d s u bject 
de m o gra p hic i nf or mati o n.
9. 2
D at a Re vie w a n d Cl arific ati o ns
U p o n c o m pleti o n of t he e C R Fs, a tar gete d re vie w of t he e C R F data t o t he s u bject’s s o urce 
data will be c o m plete d b y  t he site m o nit or t o e ns ure c o m plete ness a n d acc urac y . A d diti o nal 
data clarificati o ns a n d/ or a d diti o ns ma y  be nee de d as a res ult of t he data clea ni n g pr ocess.
Data clarificati o ns are d oc u me nte d a n d are part of eac h s u bject’ s e C R Fs.
9. 3
Re g ul at or y D oc u me nt ati o n a n d Rec o r ds Rete nti 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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7
T he I n vesti gat or is re q uire d t o mai ntai n u p- t o-date, c o m plete re g ulat or y  d oc u me ntati o n as 
i n dicate d b y t he S p o ns or a n d t he I n vesti gat or’s files will be re vie we d as part of t he o n g oi n g 

Page 39 of 44
study monitoring. Financial disclosure is not subject to regulatory inspection and should be 
kept separately. 
Additionally, the Investigator must keep study records and source documents until the 
Sponsor provides written approval for their destruction. If the Investigator retires, relocates, 
or for any other reason withdraws from responsibility of keeping the study records, the 
Sponsor must be notified and suitable arrangements made for retention of study records and 
source documents needed to comply with national and international regulations (generally 
2 years after discontinuing clinical development or after the last marketing approval).
10 ETHICS AND COMPLIANCE
This trial will be conducted in accordance with the ethical principles that have their origin in 
the Declaration of Helsinki and the referenced directives, regulations, guidelines, and/or 
standards.
10.1 Compliance
The Investigator must ensure that all personnel involved in the conduct of the study are 
qualified to perform their assigned responsibilities through relevant education, training, and 
experience. The Investigator and all clinical study staff must conduct the clinical study in 
compliance with the protocol. Deviations from this protocol, regulatory requirements and/or 
GCP must be recorded and reported to the Sponsor prior to database lock. If needed, 
corrective and preventive action should be identified, implemented, and documented within
the study records.
10.2 Institutional Review Board (IRB)
This trial requires IRB approval prior to initiation. This protocol, subject informed consent, 
and subsequent amendments will be reviewed and approved by an IRB.
Before clinical study initiation, this protocol, the ICF (and assent form, if applicable), any 
other written information given to subjects, and any advertisements planned for subject 
recruitment must be approved by an IRB. The Investigator must provide documentation of 
the IRB approval to the Study Sponsor. The approval must be dated and must identify the 
applicable protocol, amendments (if any), ICF, assent form (if any), all applicable recruiting 
materials, written information for subject, and subject compensation programs. The IRB must 
be provided with a copy of the IB, any periodic safety updates, and all other information as 
required by local regulation and/or the IRB. At the end of the study, the Investigator must 
notify the IRB about the study’s completion. The IRB also must be notified if the study is 
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Pa ge 4 0 of 4 4
ter mi nate d pre mat urel y. Fi nall y, t he I n vesti gat or m ust re p ort t o t he I RB o n t he pr o gress of t he 
st u d y at i nter vals sti p ulate d b y t he I R B.
Vo l u ntar y i nf or me d c o nse nt m ust be o btai ne d fr o m e ver y s u bject (a n d/ or le gal re prese ntati ve, 
as a p plica ble) pri or t o t he i nitiati o n of a n y  scree ni n g or ot her st u d y-relate d pr oce d ures. T he 
I n vesti gat or m ust ha ve a defi ne d pr ocess f or obtai ni n g c o nse nt. S pecificall y, t he I n vesti gat or, 
or dele gate, m ust e x plai n t he cli nical st u d y  t o eac h p ote ntial s u bject a n d t he s u bject m ust 
i n dicate v ol u ntar y c o nse nt b y si g ni n g a n d dati n g t he a p pr o ve d i nf or me d c o nse nt f or m. T he 
s u bject m ust be pr o vi de d a n o p p ort u nit y t o as k q uesti o ns of t he I n vesti gat or, a n d if re q uire d 
b y  l ocal re g ulati o n, ot her q ualifie d pers o n nel. T he I n vesti gat or m ust pr o vi de t he s u bject wit h 
a c o p y of t he c o nse nt f or m writte n i n a la n g ua ge t he s u bject u n dersta n ds. T he c o nse nt 
d oc u me nt m ust meet all a p plica ble l ocal la ws a n d pr o vi de s u bjects wit h i nf or mati o n 
re gar di n g t he p ur p ose, pr oce d ures, re q uire me nts, a n d restricti o ns of t he st u d y, al o n g wit h a n y 
k n o w n ris ks a n d p ote ntial be nefits ass ociate d wit h t he I P,  t he a vaila ble c o m pe nsati on, a n d t he 
esta blis he d pr o visi o ns f or mai ntai ni n g c o nfi de ntialit y  of pers o nal, pr otecte d healt h 
i nf or mati o n. S u bjects will be t ol d a b o ut t he v ol u ntar y nat ure of partici pati o n i n t he st u d y a n d 
m ust be pr o vi de d wit h c o ntact i nf or mati o n f or t he a p pr o priate i n di vi d uals s h o ul d q uesti o ns or 
c o ncer ns arise d uri n g t he st u d y. T he s u bject als o m ust be t ol d t hat t heir rec or ds ma y be 
accesse d b y a p pr o priate a ut h orities a n d S p o ns or -desi g nate d pers o n nel. T he I n vesti gat or m ust 
kee p t he ori gi nal, si g ne d c o p y  of t he c o nse nt a n d m ust pr o vi de a d u plicate c o p y  t o eac h 
s u bject acc or di n g t o l ocal re g ulati o ns. F oll o wi n g t his st u d y , t he s u bject will ret ur n t o t heir 
e ye care pr ofessi o nal f or t heir r o uti ne e ye care a n d c o ntact le nses.
1 1 P R O T O C O L  AM E N D M E N T HI S T O R Y
Versi o n
Brief Descri pt i o n a n d R ati o n ale
1
I nitial Versi o n of t his d oc u me nt
1 2 R E F E R E N C E S
1 2. 1 Refere nces a p plic a ble f or all cli nic al tri als:

I S O 11 9 8 0: 2 0 1 2 O p ht hal mic o ptics - C o ntact le nses a n d c o ntact le ns care pr o d ucts -
G ui da nce f or cli nical i n vesti gati o ns

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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7
I S O 1 4 1 5 5: 2 0 11 Cli nical i n vesti gati o n of me dical de vices f or h u ma n s u bjects - G o o d 
cli nical practice

Pa ge 4 1 of 4 4
1 2. 1. 1 U S refere nces a p plic a ble f or cli nic al tri als:

2 1 C F R Part 1 1 - Electr o nic Rec or ds; Electr o nic Si g nat ures

2 1 C F R Part 5 0 - Pr otecti o n of H u ma n S u bjects

2 1 C F R Part 5 6 - I nstit uti o nal Re vie w B oar ds

2 1 C F R Part 8 1 2 - I n vesti gati o nal De vice E xe m pti o ns

2 1 C F R Part 5 4 - Fi na ncial Discl os ure b y Cli nical I n vesti gat ors

T he Calif or nia Bill of Ri g hts
1 2. 2 Refere nces f or t his cli nic al tri al
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
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 2 8
P r o t o c o l  -  C l i n i c a l
0 7- Mar- 2 0 1 7
N ot a p plica ble.

Page 42 of 44
13 Appendix
13.1 MYDAY Package Insert
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Page 43 of 44
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

Page 44 of 44
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017

                                                                                                                
                                                                                     
Date/Time 
(mm/dd/yyyy GMT):
Signed by:
Justification:
03/07/2017 03:02:55
03/06/2017 14:59:19
03/04/2017 00:05:07
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0053428
Protocol - Clinical
07-Mar-2017