Axis Orientation Comparison of Two Silicone Hydrogel Toric Contact Lenses
Phase: NA
Conditions: Astigmatism
Sponsor: Alcon Research

Page 1 of 54
Title
Axis Orientation Comparison of Two
Silicone Hydrogel Toric Contact Lenses
Protocol Number:
Development Stage of 
Project:
Sponsor Name and 
Address:
Test Product:
Investigator Agreement:
CLC127-C001 / NCT03392532
Development
Alcon Research, Ltd. and its affiliates (“Alcon”)
6201 South Freeway
Fort Worth, Texas 76134-2099
AIR OPTIX plus HydraGlyde for Astigmatism soft contact 
lenses (LID009941)
I have read the clinical study described herein, and recognize its 
confidentiality. I agree to conduct this study in accordance with 
the ethical principles contained within the Declaration of 
Helsinki, and the described study in compliance with the 
protocol, Good Clinical Practice (GCP), ISO 14155, 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 Study Sponsor.
Principal Investigator:
Signature
Date
Name and professional 
position:
Address:
Template version 1.0, approved 09 JUNE 2017
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Table of Contents
Axis Orientation Comparison of Two Silicone Hydrogel Toric Contact Lenses.......................1
Table of Contents .......................................................................................................................2
List of Tables..............................................................................................................................4
List of Figures............................................................................................................................5
1
GLOSSARY OF TERMS ....................................................................................................6
2
LIST OF ACRONYMS AND ABBREVIATIONS ...........................................................10
3
PROTOCOL SUMMARY.................................................................................................11
4
PROTOCOL AMENDMENTS .........................................................................................18
4.1
Amendments......................................................................................................19
5
INTRODUCTION.............................................................................................................19
5.1
Rationale and Background ................................................................................19
5.2
Purpose of the Study..........................................................................................20
5.3
Risks and Benefits.............................................................................................20
6
STUDY OBJECTIVES......................................................................................................21
6.1
Primary Objective(s) .........................................................................................21
6.2
Secondary Objective(s) .....................................................................................21
22
6.4
Safety Objective(s)............................................................................................22
7
INVESTIGATIONAL PLAN ............................................................................................22
7.1
Study Design .....................................................................................................22
7.2
Rationale for Study Design ...............................................................................23
7.3
Rationale for Duration of Treatment/Follow-Up...............................................23
7.4
Rationale for Choice of Control Product...........................................................23
7.5
Data Monitoring Committee..............................................................................24
8
STUDY POPULATION ....................................................................................................24
8.1
Inclusion Criteria...............................................................................................24
8.2
Exclusion Criteria..............................................................................................25
8.3
Rescreening of Subjects ....................................................................................26
9
TREATMENTS ADMINISTERED...................................................................................26
9.1
Investigational Product(s)..................................................................................26
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9.2
Other Medical Device or Medication Specified for Use During the Study ......30
9.3
Treatment Assignment / Randomization ...........................................................30
9.4
Treatment masking ............................................................................................30
9.5
Accountability Procedures.................................................................................32
9.6
Changes to concomitant medications, treatments/ procedures..........................33
10 STUDY PROCEDURES AND ASSESSMENTS.............................................................33
10.1
Informed Consent and Screening ......................................................................34
10.2
Description of Study Procedures and Assessments...........................................34
10.2.1
Demographics....................................................................................34
10.2.2
Medical History.................................................................................34
10.2.3
Investigational Product compliance ..................................................35
10.2.4
Adverse Event Collection: Safety Assessment..................................35
10.2.5
Slit-Lamp Biomicroscopy: Safety Assessment .................................35
10.2.6
Device Deficiencies: Safety Assessment...........................................35
10.2.7
Additional Study Assessments: Effectiveness and Safety Assessments
...........................................................................................................35
10.3
Unscheduled Visits ............................................................................................36
10.4
Discontinued Subjects .......................................................................................36
10.4.1
Screen Failures ..................................................................................36
10.4.2
Discontinuations................................................................................36
10.4.3
Schedule of Procedures and Assessments for Subjects Discontinued 
from Investigational Product .............................................................37
10.5
Clinical Study Termination................................................................................37
10.5.1
Follow-up of subjects after study participation has ended ................37
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES ...................................................38
11.1
General Information ..........................................................................................38
11.2
Monitoring for Adverse Events .........................................................................40
11.3
Procedures for Recording and Reporting ..........................................................41
11.4
Return product analysis .....................................................................................43
11.5
Unmasking of the Study Treatment...................................................................43
11.6
Follow-Up of Subjects with Adverse Events.....................................................43
11.7
Pregnancy in the Clinical Study........................................................................44
12 ANALYSIS PLAN ............................................................................................................44
12.1
Subject Evaluability...........................................................................................44
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12.2
Analysis Sets .....................................................................................................44
12.2.1
Safety Analysis Set............................................................................44
12.2.2
Full Analysis Set................................................................................45
12.2.3
Per Protocol Analysis Set ..................................................................45
12.3
Demographic and Baseline Characteristics.......................................................45
12.4
Effectiveness Analyses ......................................................................................45
12.4.1
Analysis of Primary Effectiveness Endpoint(s).................................45
12.4.1.1
Statistical Hypotheses........................................................46
12.4.1.2
Analysis Methods ..............................................................46
46
47
47
12.5
Handling of Missing Data .................................................................................47
12.6
Safety Analyses .................................................................................................47
12.7
Interim Analyses and Reporting........................................................................48
12.8
Sample Size Justification...................................................................................48
13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS ...............................49
13.1
Subject Confidentiality......................................................................................49
13.2
Completion of Source Documents and Case Report Forms..............................49
13.3
Data Review and Clarifications.........................................................................50
13.4
Sponsor and Monitoring Responsibilities .........................................................51
13.5
Regulatory Documentation and Records Retention ..........................................52
13.6
Quality Assurance and Quality Control.............................................................52
14 ETHICS .............................................................................................................................52
15 REFERENCES ..................................................................................................................54
15.1
References applicable for all clinical studies ....................................................54
15.1.1
US references applicable for clinical studies.....................................54
15.2
References for this clinical study ......................................................................54
List of Tables
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol ...........................10
Table 3–1
Schedule of Study Procedures and Assessments .............................................17
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Table 6–1
Primary Objective(s)........................................................................................21
22
Table 6–3
Safety Objective(s)...........................................................................................22
Table 9–1
Test Product .....................................................................................................26
Table 9–2
Control Product................................................................................................28
Table 9–3
Unmasked Individuals Associated with the Study...........................................30
List of Figures
Figure 7–1
Flowchart of Study Visit ..................................................................................23
Figure 11–1
Categorization of All Adverse Events..............................................................38
Figure 11-2
Categorization of All Serious Adverse.............................................................38
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1
GLOSSARY OF TERMS
Names of test product(s)
Throughout this document, test product will be referred to as 
AOHG toric
Name of Control Product(s)
AIR OPTIX® for Astigmatism soft contact lenses (AO toric)
Adverse Device Effect
Adverse event related to the use of an investigational 
medical device (test product) or control product. Note: This 
definition includes adverse events resulting from insufficient 
or inadequate instructions for use, deployment, 
implantation, installation, or operation; any malfunction; 
and use error or intentional misuse of the test product or 
control product.
Adverse Event
Any untoward medical occurrence, unintended disease or 
injury, or untoward clinical signs (including abnormal 
laboratory findings) in subjects, users or other persons, 
whether or not related to the investigational medical device 
(test product). Note: For subjects, this definition includes 
events related to the test product, the control product, or the 
procedures involved. For users or other persons, this 
definition is restricted to events related to the test product.
Requirements for reporting Adverse Events in the study can 
be found in Section 11.
Anticipated Serious 
Adverse Device Effect
Serious adverse device effect which by its nature, incidence, 
severity, or outcome has been identified in the risk 
management file.
Device Deficiency
Inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safety, or performance. Note: 
This definition includes malfunctions, use errors, and 
inadequate labeling.
Requirements for reporting Device Deficiencies in the study 
can be found in Section 11.
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Pa ge 7 of 5 4
E nr olle d S u bject
A n y  s u bject w h o si g ns a n i nf or me d c o nse nt f or m f or 
partici pati o n i n t he st u d y.
I nter ve nti o nal Cli nical Trial
A researc h trial t hat pr os pecti vely assi g ns, w het her 
ra n d o ml y or n ot, h u ma n partici pa nts or gr o u ps of h u ma ns t o 
o ne or m ore healt h -relate d i nter ve nti o ns t o e val uate t he 
eff ects o n healt h o utc o mes, a n d/ or a researc h trial i n w hic h 
dia g n ostic or m o nit ori n g pr oce d ures be y o n d sta n dar d of care 
are c o n d ucte d a n d ge nerate o utc o mes f or use i n a nal ysis of
data.
I n vesti gati o nal Pr o d uct
Is defi ne d as a pre ve ntati ve ( vacci ne), a t hera pe utic ( dr u g or 
bi ol o gic), de vice, dia g n ostic, or palliati ve use d as a test or 
c o ntr ol pr o d uct i n a cli nical trial, i ncl u di n g a pr o d uct wit h a 
mar keti n g a ut h orizati o n w he n use d or asse m ble d 
(f or m ulate d or pac ka ge d) i n a wa y differe nt fr o m t he 
a ut h orize d f or m, or w he n use d f or a n u na ut h orize d 
i n dicati o n, or w he n use d t o gai n f urt her i nf or mati o n a b o ut 
t he a ut h orize d f or m.
Malf u ncti o n
Fail ure of a me dical de vice t o perf or m i n acc or da nce wit h its 
i nte n de d p ur p ose w he n use d i n acc or da nce wit h t he 
i nstr ucti o ns f or use or cli nical i n vesti gati o n pla n.
N o n -seri o us A d verse E ve nt
A d verse e ve nt t hat d oes n ot meet t he criteria f or a seri o us 
a d verse e ve nt.
Ra n d o mize d S u bjects
A n y  s u bject w h o is assi g ne d a ra n d o mize d treat me nt.
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 seri o us a d verse e ve nt.
Seri o us A d verse E ve nt 
( S A E)
A d verse e ve nt t h at 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.
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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7

Pa ge 8 of 5 4
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 urre 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 pit alizati o n.
N ote: Pl a n ne d h os pit aliz ati o n f or a 
pre-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 
seri o us a dverse eve nt. 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 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 ar e a dverse 
eve nts. If a c o m plic ati o n prol o n gs 
h os pit aliz ati o n or f ulfills a ny ot her seri o us 
criteri a, t he eve nt is seri o us. W he n i n d o u bt as 
t o w het her “ h os pit aliz ati o n ” occ urre 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 onse 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 birt h defect.
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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7

Page 9 of 54
Refer to Section 11 for additional SAEs.
Significant Non-Serious 
Adverse Event
Is a symptomatic, device-related, non-sight threatening 
adverse event that warrants discontinuation of any contact 
lens wear for greater than or equal to 2 weeks.
Refer to Section 11 for additional Significant Non-Serious 
AEs.
Unanticipated Serious 
Adverse Device Effect 
(USADE)
Serious adverse device effect which by its nature, incidence, 
severity or outcome has not been identified in the risk 
management file.
Use Error
Act or omission of an act that results in a different medical 
device response than intended by manufacturer or expected 
by user. Note: This definition includes slips, lapses, and 
mistakes. An unexpected physiological response of the 
subject does not in itself constitute a use error.
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2
LIST OF ACRONYMS AND ABBREVIATIONS
Table 2–1
List of Acronyms and Abbreviations Used in This Protocol
Abbreviation
Definition
ADE
Adverse device effect
AE
Adverse event
AO toric
AIR OPTIX for Astigmatism soft contact lenses
AOHG toric
AIR OPTIX plus HYDRAGLYDE for Astigmatism soft contact lenses 
(LID009941)
BCVA
Best corrected visual acuity
CE
Conformité Européene or European Conformity
CFR
Code of Federal Regulations
CI
Confidence interval
CRF
Case report form
CSM
Clinical site manager
CTT
Clinical trial team
D
Diopter
D/C
Discontinue
DC
Diopters cylinder
DEP
Deviations and evaluability plan
EOBO
Polyxyethylene-polyoxybutylene
eCRF
Electronic case report form
EDC
Electronic data capture
FAS
Full Analysis Set
FDA
Food and Drug Administration
GCP
Good Clinical Practice
IB
Investigator’s brochure
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
IRT
Interactive response technology
ISO
International Organization of Standardization
LCSM
Lead clinical site manager
LID
Lens identification
min
Minute
mm
Millimeter
MOP
Manual of procedures
N
Number
N/A
Not applicable
OU
Both eyes
PMA
Premarket approval
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Pa ge 11 of 5 4
A b bre vi ati o n
Defi niti o n
P P
Per p r ot oc ol anal ys is set
pt
P oi nt
S A D E
Seri o us a d verse de vice effect
S A E
Seri o us ad verse eve nt
S D
Sta n dar d de viati o n
S L E
Slit -la m p e xa mi nati o n
U S
U nite d States
U S A D E
U na ntici pate d seri o us a d verse de vice effect
V A
Vis ual ac uit y
3
P R O T O C O L  S U M M A RY
T his is a pr os pecti ve, ra n d o mize d, bilateral cr oss o ver, d o u ble -mas ke d , c o ntr olle d st u d y. T he 
st u d y p o p ulati o n will i ncl u de a p pr o xi matel y 3 5 s u bjects i n 1 U S site, wit h a p ote ntial 2 n d U S 
site bei n g a d de d if necessar y t o meet t he tar get e nr oll me nt. T he st u d y will c o nsist of 
v ol u nteer s u bjects wit h n or mal e y es ( ot her t ha n c orrecti o n f or refracti ve err or) w h o are at 
least 1 8 years of a ge , are a da pte d wearers of s oft c o ntact le nses , a n d ha ve at least 3 m o nt hs of 
s oft c o ntact le ns weari n g e x perie nce .
T w o pairs of t oric c o ntact le nses ( A O H G t oric a n d A O t oric) will be e val uate d d uri n g 1 of fice 
visit i n t his cr oss o ver st u d y. S u bjects will be ra n d o ml y  assi g ne d i n a 1: 1 ma n ner t o eit her 
recei ve A O H G t oric or A O t oric le nses f or use d uri n g Peri o d 1 of t he st u d y.   F or Peri o d 2, t he 
c o ntact le nses t hat were n ot all ocate d f or use i n Per i o d 1 will t he n be assi g ne d per t he 
s pecifie d se q ue nce gr o u p:
Se q ue nce Gr o u p
1)
A O H G t oric → A O t oric
2)
A O t oric → A O H G t oric
S u bjects will wear Pair 1 assi g ne d st u d y le nses bilaterall y f or a p pr o xi matel y 3 0 mi n bef ore 
cr ossi n g o ver i nt o Pair 2 assi g ne d st u d y le nses bilaterall y f or a p pr o xi matel y 3 0 mi n. T here 
will be a 3 0 ( + 1 5) mi n was h o ut peri o d bet wee n re m o val of Pair 1 a n d i nserti o n of Pair 2 
st u d y le nses.
T he f oll o wi n g assess me nts will be perf or me d m o n oc ularl y i n t he ri g ht a n d left e ye f or Pair 1 
a n d Pair 2 le nses (see secti o n 1 0 f or details):

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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
A xis orie ntati o n 1 0 mi n after le ns i nserti o n

Pa ge 1 2 of 5 4
O nce Pair 2 le nses are re m o ve d, t he st u d y e xit pr oce d ures will be perf or me d f or eac h s u bject.
I n vesti g ati o n al 
pr o d uct t y pe
De vice
St u d y t y pe
I nter ve nti o nal
I n vesti g ati o n al 
pr o d ucts
Test Pr o d uct : A O H G t oric le nses 
C o ntr ol Pr o d uct: A O t oric le nses 
P ur p ose a n d 
r ati o n ale
T he o verall p ur p ose of t his n o n- dis pe nse st u d y is t o e val uate t he 
r otati o nal c haracteristics of t he A O H G t oric le ns, b y assessi n g le ns 
orie ntati o n as t he pri mar y varia ble c o m pare d t o t he c o m merciall y 
a vaila ble A O t oric le ns.
O bjecti ve(s)

T he pri mar y  effecti ve ness o bjecti ve of t his st u d y is t o 
e val uate t he perce nta ge of A O H G t oric le nses t hat orie nt 
wit hi n ± 3 0 de grees fr o m t he 9 0° a xis (i deal l ocati o n), 
1 0 mi n after le ns i nserti o n.

 
 
 

T he safet y o bjecti ve is t o descri be t he safety pr ofile of t he 
i n vesti gati o nal pr o d ucts t hr o u g h e val uati o n of 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.
E n d p oi nt(s)
Pri mar y  Effecti ve ness

Perce nt of le nses wit h a xis orie ntati o n wit hi n 
± 3 0 de grees fr o m t he 9 0° a xis (i deal l ocati o n), 1 0 mi 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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7

Pa ge 1 3 of 5 4
after le ns i nserti o n
Safet y

A Es

Bi o micr osc o p y fi n di n gs

De vice deficie ncies
Assess me nt(s) 
Effecti ve ness

A xis orie ntati o n 1 0 mi n after le ns i nserti 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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7

Pa ge 1 4 of 5 4
Safet y

A Es

Bi o micr osc o p y

De vice Deficie ncies
St u d y Desi g n
T his is a pr os pecti ve, ra n d o mize d, bilateral cr oss o ver, d o u ble -
mas ke d , c o ntr olle d st u d y. S u bject partici pati o n i n t he st u d y  will be 
a p pr o xi matel y 2 h o urs d uri n g 1 visit w here s u bjects will bilaterall y  
wear t he 1 st st u d y le ns fr o m t he assi g ne d le ns se q ue nce ( Pair 1) f or 
a p pr o xi matel y 3 0 mi n bef ore cr ossi n g o ver i nt o t he 2 n d st u d y le ns 
of t he assi g ne d le ns se q ue nce ( Pair 2) bilaterall y f or a p pr o xi matel y  
3 0 mi n. T here will be a 3 0 ( + 1 5) mi n was h o ut peri o d bet wee n
re m o val of Pair 1 a n d i nserti o n of Pair 2 st u d y le nses.
S u bject p o p ul ati o n
Vo l u nteer s u bjects a ge d 1 8 or o ver w h o are a da pte d s oft c o ntact 
le ns 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 lea st 3 da ys per 
wee k a n d at least 8 h o urs per da y .
Ke y i ncl usi o n 
criteri a
( See Secti o n 8. 1 f or a 
c o m plete list of 
i ncl usi o n criteria)

S uccessf ul wear of s oft c o ntact le nses f or visi o n c orrecti o n 
i n b ot h e yes d uri n g t he past 3 m o nt hs f or a mi ni m u m of 
3 da y s per wee k a n d 8 h o urs per d a y .

S u bjects m ust ha ve ≥ 0. 7 5 D c or neal or ma nifest 
asti g matis m.

Re q uiri n g c o ntact le ns s p here p o wer fr o m - 0. 5 0 t o - 8. 0 0 D; 
c yli n der p o wer less t ha n or e q ual t o - 2. 2 5 D C; a n d f or 
c yli n der p o wers greater t ha n -1. 0 0 D C, a xis s h o ul d be 
wit h i n ± 3 0 ° fr o m 9 0° or 1 8 0° a xis (i.e., bet wee n 6 0° t o 
1 2 0° or 3 0° t o 1 5 0° i ncl usi 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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7

Pa ge 1 5 of 5 4

Best s pectacle c orrecte d V A 2 0/ 2 5 or better i n eac h e y e.
Ke y e xcl usi o n 
criteri a
( See Secti o n 8. 2 f or a 
c o m plete list of 
e xcl usi o n criteria)

A n y  a nteri or se g me nt i nfecti o n, i nfla m mati o n, or 
a b n or malit y or disease (i ncl u di n g sys te mic) t hat 
c o ntrai n dicates c o ntact le ns wear, as deter mi ne d b y t he 
I n vesti gat or.

Hist or y  of oc ular or i ntra oc ular s ur ger y w hic h c o ntact le ns 
wear c o ul d be c o ntrai n dicate d, as deter mi ne d b y t he 
I n vesti gat or, i ncl u di n g refracti ve s ur ger y a n d/ or irre g ular 
c or nea.

Bi o micr osc o p y fi n di n gs at baseli ne t hat are m o derate 
( Gra de 3) or hi g her a n d/ or c or neal vasc ularizati o n t hat is 
mil d ( G ra de 2) or hi g her; prese nce of c or neal i nfiltrates

C urre nt or hist or y  of her petic keratitis i n eit her e ye.

E y e i nj ur y wit hi n 1 2 wee ks i m me diatel y pri or t o e nr olli n g 
i n t his trial.

Hist or y  of i nt olera nce or h yperse nsiti vit y  t o a ny 
c o m p o ne nt of t he st u d y le nses.

A n y  cli nicall y si g nifica nt c or neal t hi n ni n g dis or der s uc h as 
kerat o gl o b us, kerat oc o n us or pell uci d mar gi nal 
de ge nerati o n
D at a a n al ysis a n d 
s a m ple size 
j ustific ati o n
T o a d dress t he pri mar y  
 effecti ve ness
e n d p oi nts, c ollecte d 1 0 mi n after le ns i nserti o n, pla n ne d a nal ys es 
are s u m marize d bel o w:
E n d p oi nt
C o m paris o n
Statistical Met h o d
Pri mar y
Perce nta ge of A O H G 
t oric le nses orie nti n g 
wit hi n ± 3 0 de grees of 
t he 9 0º a xis
T hres h ol d = 9 0 %
Descri pti ve statistics
Si nce o nl y  o ne e n d p oi nt will be teste d i nfere ntiall y, t here is 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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7

Pa ge 1 6 of 5 4
c o ncer n f or m ulti plicit y. 
N o i nfere ntial testi n g will be carrie d o ut f or safet y e n d p oi nts.
Sa m ple size calc ulati o n/i nter pretati o n f or pri mar y 
 
 effecti ve ness e n d p oi nts are s u m marize d bel o w.
E n d p oi nt
Ass u m pti o ns
P o wer
N
Pri mar y
Perce nta ge of 
A O H G t o ric 
le nses orie nti n g 
wit hi n 
± 3 0 de grees of 
t he 9 0º a xis
N ot a p plica ble  
N ot a p plica ble
9 5 % co nfi de nce 
i nter val f or 
pr o p orti o n will 
e xte n d 0. 1 0 fr o m 
0. 9 0
3 0
Ke y w or ds

H Y D R A G L Y D E

Asti g matis m

A xis orie ntati o n

A O H G t oric

A O t oric
Ass oci ate d m ateri als
N o le ns care pr o d ucts will be use d. Re- wetti n g dr o ps will n ot be 
per mitte d. 
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7

Pa ge 1 7 of 5 4
Ta ble 3 – 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
B aseli ne/
Scree ni n g
E x p os ure P air 
1 – Peri o d 1
E x p os ure P air 
2 – Peri o d 2
E xit
I nf or me d C o nse nt

-
-
-
D e 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 i nf or mati o n 
( bra n d, p o wer, a xis) * 

-
-
-
V A w/ ha bit ual c orrecti o n 
( S nelle n dista nce) *

-
-

Ma nifest refracti o n *

-
-
-
B C V A ( S nelle n dista nce 
wit h ma nifest refracti o n) *

-
-
-
Bi o micr osc o p y #

-
-

Fit st u d y le nses
-


-
A xis orie ntati o n 1 0 ( + 2) mi n 
after i nserti o n 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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7

Pa ge 1 8 of 5 4
Pr oce d ure/ Assess me nt
B aseli ne/
Scree ni n g
E x p os ure P air 
1 – Peri o d 1
E x p os ure P air 
2 – Peri o d 2
E xit
A d verse E ve nts 




De vice deficie ncies 




E xit F or m
()
()
()

() if a p plica ble; 
* S o urce o nl y
 
 
1 Data w ill be use d f or deri vi n g pri mar y effecti ve ness e n d p oi nt. 
# PI m a y c h o ose t o ta ke p h ot o gra p h or vi de o of slit la m p o bser vati o ns
4
P R O T O C O L  AM E N D M E N T S
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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
M o dificati o n of t he pr ot oc ol i s pr o hi bite d wit h o ut pri or writte n a gree me nt i n t he f or m of a 
pr ot oc ol a me n d me nt. All a me n d me nts m ust be create d b y t he St u d y S p o ns or a n d m ust be 
a p pr o ve d b y t he I RB/I E C a n d gl o bal a n d re gi o nal Healt h A ut h orities, as a p plica ble, pri or t o 
i m ple me ntati o n e xce pt w he n re q uire d t o miti gate i m me diate safet y ris ks or w he n t he c ha n ges 
i n v ol ve o nl y l o gistical or a d mi nistrati ve re visi o ns. 

Page 19 of 54
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 must sign 
the approved, revised informed consent (re-consent), as required by the IRB/IEC.
4.1
Amendments
There are no amendments. This is the first version of the protocol.
5
INTRODUCTION
5.1
Rationale and Background
Soft toric contact lenses were introduced into clinical practice over 40 years ago
(Holden 1975) Since then, toric lens technology has continued to grow, with improvements in 
design, lens formulation, and reproducibility in order to enhance vision and contact lens wear 
experience. Patients who do not wish to wear spectacles or undergo refractive surgery for the 
correction of refractive errors may opt for contact lenses. Contact lenses are often described 
in terms of material (eg, hydrogel, silicone hydrogel), modality (daily wear or extended wear) 
and replacement schedule (daily disposable, planned replacement, or conventional). All 
contact lenses intended to be reused must be cleaned and disinfected with solutions designed 
for this purpose and compatible with the lens polymer.
Alcon launched a monthly replacement lens known as AIR OPTIX for Astigmatism soft 
contact lenses (AO toric) in 2009. AO toric lenses are indicated for the optical correction of 
astigmatism of up to 6 D in people with healthy eyes with or without refractive ametropia 
(myopia or hyperopia). AO toric lenses are made from a fluoro-silicone hydrogel lens 
material consisting of 33% water and 67% lotrafilcon B. When placed on eye, the lenses 
glide over the cornea and serve as a refracting medium to focus light rays on the retina. These 
lenses use the Precision 8|4 design which helps minimize the interaction between the lens and 
the lower lid to provide improved comfort. The lenses also feature a patented surface 
treatment to help resist deposits. The lenses, immersed in phosphate buffered saline solution, 
are provided sterile in individual blister packs. AO toric lenses carry the European 
Conformity (CE)-mark and have US FDA 510(k) marketing clearance for daily wear and 
premarket approval (PMA) for extended wear (for up to 6 nights of continuous wear) with 
removal for disposal, or cleaning and disinfection.
Recently, Alcon introduced AIR OPTIX plus HYDRAGLYDE (AOHG sphere), a spherical 
lens, into the global markets. The AOHG sphere lens is comprised of the same lotrafilcon B 
material with a packaging saline that was designed to incorporate wetting agents for 
improved lens surface wettability, lubricity, and longer lasting lens surface moisture out of 
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Page 20 of 54
package compared to packaging saline without any wetting agents. The goal of the AOHG 
toric lens project is to upgrade the packaging saline of commercial AO toric lenses (which 
currently consists of isotonic, sodium-phosphate buffered saline) to that currently used in the 
AOHG sphere lens.
This non-dispense clinical trial will evaluate the on-eye performance of the lotrafilcon B toric 
lens packaged in the AOHG packaging saline (AOHG toric lens).
5.2
Purpose of the Study
The overall purpose of this non-dispense study is to evaluate the rotational characteristics of 
the AOHG toric lens, by assessing lens orientation as the primary variable and comparing it 
to the commercially available AO toric lens.
At the end of the study, a clinical study report will be prepared in accordance with applicable 
regulatory requirements and standards.
There are no immediate plans to submit the results of this development study for publication; 
however, the results may be offered for publication if they are of scientific interest, or if the 
results relate to a product that is subsequently approved or cleared for marketing.
5.3
Risks and Benefits
Contact lenses may offer improved peripheral vision and the convenience of not wearing
spectacles; however, this study will only use a few select contact lens powers and subjects 
may require spectacles for vision correction. There is no intended clinical benefit to the 
subject; however, subjects will receive study visit assessments free of change (that will not 
substitute for a regular eye exam). Material properties and design characteristics of AOHG 
toric lenses are features consistent with successful contact lens wear. Based upon nonclinical 
data and documented rationale for applicability of test results, and clinical and market 
experience with similar contact lens materials and packaging saline, AOHG toric lenses are 
assessed to be non-toxic and biocompatible for on-eye use. 
AO toric lenses are indicated for daily and extended wear (up to 6 nights) use; further details 
on any known potential risks and benefits can be found in the package insert. 
A summary of the known potential risks and benefits associated with AOHG toric lenses can 
be found in the IB. Any risks to subjects in this trial are minimized by compliance with the 
eligibility criteria and study procedures, and through close supervision by a licensed clinician 
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Page 21 of 54
during exposure to the study lenses. In general, the risks with AOHG toric lenses are 
anticipated to be similar to other marketed frequent replacement soft contact lenses. 
There may also be unknown risks with the use of AOHG toric lens. During clinical exposure, 
qualified investigational site personnel will verify that the dispensed lenses demonstrate 
adequate centration and movement on the eye. In this study, the duration of the planned 
clinical exposure of the investigational AOHG toric lens is approximately 30 minutes. Site 
personnel will educate subjects on proper hygiene and lens care, handling, and compliance 
with use of the study contact lens, as applicable. Site personnel will advise the subjects to 
remove contact lenses and/or alert site staff for prompt follow-up if there are symptoms such 
as ocular discomfort, foreign body sensation, excessive tearing, vision changes, or 
hyperemia. 
Refer to the IB for additional information.
6
STUDY OBJECTIVES
6.1
Primary Objective(s)
The overall objective of the study is to evaluate the rotational characteristics of the AOHG 
toric lens.
Table 6–1
Primary Objective(s)
Objective(s)
Endpoint(s)
Evaluate the percentage of AOHG toric 
lenses that orient within ±30 degrees from 
the 90º axis (ideal location), 10 min after 
lens insertion
Percent of lenses with axis orientation 
within ±30 degrees from the 90° axis (ideal 
location), 10 min after lens insertion
6.2
Secondary Objective(s)
Not applicable
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Pa ge 2 2 of 5 4
6. 4
S afet y O bjecti ve(s)
Ta ble 6 – 3
S afet y O bjecti ve(s)
O bjecti ve(s)
E n d p oi nt(s)
D escri be t he safet y pr ofile of t he 
i n vesti gati o nal pr o d ucts

A Es

Bi o micr osc o p y fi n di n gs

De vice deficie ncies
7
I N V E S TI G ATI O N A L  P L A N
7. 1
St u d y Desi g 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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
T his is a pr os pecti ve, ra n d o mize d, bilateral cr oss o ver, d o u ble -mas ke d , c o ntr olle d st u d y.
T he st u d y  p o p ulati o n will i ncl u de a p pr o xi matel y 3 5 s u bjects t o be e nr olle d at 1- 2 sites a n d 
will c o nsist of v ol u nteer s u bjects wit h n or mal e y es ( ot her t ha n c orrecti o n f or refracti ve err or) 
w h o are at least 1 8 ye ars of a ge, are a da pte d wearers of s oft c o ntact le nses , a n d ha ve at least 
3 m o nt hs of s oft c o ntact le ns weari n g e x perie nce .
S u bjects will be ra n d o ml y assi g ne d i n a 1: 1 ma n ner t o eit her recei ve A O H G t oric or A O t oric 
le nses f or bilateral wear d uri n g Peri o d 1 of t he st u d y. F or Peri o d 2, t he c o ntact le nses t hat 
were n ot all ocate d f or use i n Peri o d 1 will t he n be assi g ne d per t he s pecifie d se q ue nce gr o u p:
Se q ue nce Gr o u p
1)
A O H G t oric → A O t oric
2)
A O t oric → A O H G t oric

Page 23 of 54
Subjects will be expected to attend 1 office visit. The total expected duration of the subject’s 
participation is approximately 2 hours with approximately 30 minutes of exposure to each 
study lens.
The study is expected to take approximately 4 weeks for completion. The study outline is 
provided in Figure 7-1 (below):
Figure 7–1
Flowchart of Study Visit
7.2
Rationale for Study Design
In this study, the on-eye performance of the investigational AOHG toric lens and the 
commercially available AO toric lens will be assessed in a prospective, double-masked, 
bilateral crossover design with approximately 30 minutes of exposure to each study lens.  The 
study design as well as the exposure duration of study lenses is supported by the nonclinical 
and clinical data presented in the IB.
7.3
Rationale for Duration of Treatment/Follow-Up
The duration of exposure to the investigational products was chosen to address the objective 
of this study, and is aligned with AO toric fitting guidelines for initial fit assessment 
following lens insertion.
7.4
Rationale for Choice of Control Product
AO toric lenses were chosen as the control product to address the study objectives. Both 
AOHG toric and AO toric lenses are fluoro-silicone hydrogel lenses consisting of 33% water 
and 67% lotrafilcon B, and are prescribed for monthly wear. AO toric lenses are indicated for 
the optical correction of astigmatism of up to 6D or less in people with healthy eyes with or 
without refractive ametropia (myopia or hyperopia).
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Page 24 of 54
7.5
Data Monitoring Committee
Not applicable
8
STUDY POPULATION
The study population consists of adult male and female subjects (aged 18 and over) with 
non-diseased eyes, who require optical correction for astigmatism. It is aimed to enroll 
approximately 35 subjects in 1 US site, with a potential 2nd US site being added if necessary
to meet target enrollment. Site-specific targets may vary based upon individual site 
capabilities. Estimated time needed to recruit subjects for the study is approximately 4 weeks. 
The intended study population consists of volunteer subjects aged 18 or over who are adapted 
soft contact lens wearers, have at least 3 months of contact lens wearing experience, and who 
wear their habitual lenses at least 3 days per week and at least 8 hours per day.
Subjects must require contact lens sphere power from -0.50 to -8.00 D; cylinder power less 
than or equal to -2.25 DC; and for cylinder powers greater than -1.00 DC, axis should be 
between 60° to 120° or 30° to 150° inclusive. Because an approximately 10% screening 
failure rate is expected, approximately 35 subjects are expected to be enrolled to obtain a 
target of 30 completed subjects.
8.1
Inclusion Criteria
Written informed consent must be obtained before any study specific assessment is 
performed. Upon signing informed consent, the subject is considered enrolled in the study.
Subjects eligible for inclusion in this study must fulfill all of the following criteria:
1.
Subject must be at least 18 years of age and must be able to understand and sign an 
IRB/IEC approved Informed Consent form.
2.
Willing and able to attend the single study visit as required per protocol.
3.
Successful wear of soft contact lenses for vision correction in both eyes during the past 3 
months for a minimum of 3 days per week and 8 hours per day.
4.
Subjects must have ≥ 0.75 D corneal or manifest astigmatism.
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Page 25 of 54
5.
Requiring contact lens sphere power from -0.50 to -8.00 D; cylinder power less than or 
equal to -2.25 DC; and for cylinder powers greater than -1.00 DC, axis should be within 
± 30 ° from 90° or 180° axis (i.e., between 60° to 120° or 30° to 150° inclusive).
6.
Distortion-free keratometric readings at baseline.
7.
Best spectacle corrected visual acuity 20/25 or better in each eye.
8.2
Exclusion Criteria
Subjects fulfilling any of the following criteria are not eligible for participation in this study.
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 ocular or intraocular surgery, including refractive surgery which contact 
lens wear could be contraindicated, as determined by the Investigator and/or irregular 
cornea. 
4.
Biomicroscopy findings at baseline that are moderate (Grade 3) or higher and/or 
corneal vascularization that is mild (Grade 2) or higher; presence of corneal 
infiltrates
5.
Current or history of pathologically dry eye in either eye that, in the opinion of the 
Investigator, would preclude contact lens wear.
6.
Current or history of herpetic keratitis in either eye.
7.
Eye injury within 12 weeks immediately prior to enrolling in this trial.
8.
History of intolerance or hypersensitivity to any component of the study lenses.
9.
Any clinically significant corneal thinning disorder such as keratoglobus, 
keratoconus or pellucid marginal degeneration
10.
Enrollment of site staff or family/household members of the site staff who are listed 
on the study personnel log as having a role in the execution of this study.
11.
Participation of the subject in a clinical trial within the previous 30 days or currently 
enrolled in any clinical trial.
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Pa ge 2 6 of 5 4
8. 3
Rescree ni n g of S u bjects
Rescree ni n g of s u bjects is n ot all o we d i n t his st u d y.
9
T R E A T M E N T S A D MI NI S T E R E D
9. 1
I n vesti g ati o n al Pro d uct(s)
Te st Pro d uct(s):
AI R O P TI X pl us H Y D R A G L Y D E f or Asti g matis m 
s oft c o ntact le nses
C o ntr ol Pr o d uct(s):
AI R O P TI X f or Asti g matis m s oft c o ntact le nses
Ta ble 9 – 1
Te st Pro d uct
Test Pr o d uct
AI R O P TI X pl us H Y D R A G L Y D E f or Asti g matis m s oft c o ntact 
le nses ( A O H G t oric) - LI D 0 0 9 9 4 1
Ma n ufact urer
Alc o n La b orat ories, I nc.
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
U S A
I n dicati o n f or use 
a n d i nte n de d 
p ur p ose i n t he 
c urre nt st u d y 
T he i nte n de d use of t his c o ntact le ns is f or visi o n c orrecti o n.
Li mite d para meters are a vaila ble f or use i n t his n o n -dis pe nsi n g 
st u d y i n acc or da nce wit h t he st u d y o bjecti ve.
Pr o d uct descri pti o n 
a n d para meters 
a vaila ble f or t his 
st u d y

Material: l otrafilc o n B

Water c o nte nt : 3 3 %

P o wer ra n ge:
o
S p here: - 1. 0 0 D, - 3. 0 0 D a n d - 5. 0 0 D
o
C y li n der: -1. 2 5 D C
o
A xis a vaila bilit y : 9 0 & 1 8 0

Base c ur ve ( m m): 8. 7 m m (tar get)

Dia meter ( m m): 1 4. 5 m m (tar get)

Ot her: A d diti o nal details ca n be f o u n d i n t he I B
F or m ulati o n
Silic o ne H y dr o gel. A d diti o nal details ca n be f o u n d i n t he I B f or 
A O H G t oric.
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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7

Pa ge 2 7 of 5 4
Usa ge

Wear:
o
Dail y  Wear f or t his st u d y
o
Bilateral

Re place me nt peri o d: N/ A f or t his n o n -dis pe nse st u d y

E x p os ure: A p pr o xi matel y 3 0 mi n utes

Le ns Care: N/ A

A d diti o nal details ca n be f o u n d i n t he M O P
N u m ber/ A m o u nt of 
p r o d uct t o be 
p r o vi de d t o t he 
s u bject
O ne pair of test st u d y le nses will be pr o vi de d t o t he s u bject at a 
si n gle visit t o be w or n f or i n-office use o nl y. T he test le nses will be 
re m o ve d after a p pr o xi matel y 3 0 mi n utes of le ns wear. 
T he test le nses will n ot be dis pe nse d t o s u bject t o ta ke h o me. 
Re place me nt le nses are all o we d o nl y  if t here is a de vice deficie nc y 
(e g, t or n le ns).
Pac ka gi n g 
descri pti o n
Blister c o ntai ni n g p h os p hate b uf fere d sali ne s ol uti o n wit h wetti n g 
a ge nts
La beli n g descri pti o n

Le ns 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 de vice state me nt
-
S p o ns or i nf or mati o n

Pr o vi de d i n b o xes of 4 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 c ol or c o de d 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
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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7

Pa ge 2 8 of 5 4
St ora ge c o n diti o ns
St ore d at r o o m te m perat ure.
A d diti o nal 
i nf or mati o n
N/ A
S u p pl y
Refer t o t he M O P f or a detaile d descri pti o n
Ta ble 9 – 2
C o ntr ol Pr o d uct
C o ntr ol Pr o d uct(s)
AI R O P TI X f or Asti g matis m s oft c o ntact le nses ( A O t oric)
Ma n ufact urer
Alc o n La b orat ories, I nc.
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
U S A
I n dicati o n f or Use 
T he i nte n de d use of t his c o ntact le ns is f or visi o n c orrecti o n.
Li mi te d para meters are a vaila ble f or use i n t his n o n-dis pe nsi n g 
st u d y i n acc or da nce wit h t he st u d y o bjecti ve.
Pr o d uct descri pti o n 
a n d para meters 
a vaila ble f or t his 
st u d y

Material:
l otrafilc o n B

Water c o nte nt: 3 3 %

P o wer ra n ge:
o
S p here: -1. 0 0 D, -3. 0 0 D a n d - 5. 0 0 D
o
C y li n der: -1. 2 5 D C
o
A xis a vaila bilit y : 9 0 & 1 8 0

Base c ur ve ( m m): 8. 7 m m (tar get)

Dia meter ( m m): 1 4. 5 m m (tar get)

Ot her: A d diti o nal details ca n be f o u n d i n t he I B
F or m ulati o n
Silic o ne H y dr o gel. A d diti o nal details ca n be f o u n d i n t he I B f or A O 
t oric.
Usa ge

Wear:
o
Dail y  Wear f or t his st u d y
o
Bilateral

Re place me nt peri o d: N/ A f or t his n o n -dis pe nse 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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7

Pa ge 2 9 of 5 4

E x p os ure: A p pr o xi matel y  3 0 mi n utes

Le ns Care: N/ A

A d diti o nal details ca n be f o u n d i n t he M O P
N u m ber/ A m o u nt of 
Pr o d uct t o be 
Pr o vi de d t o t he 
s u bject
O ne pair of c o ntr ol st u d y le nses will be pr o vi de d t o t he s u bject at a 
si n gle visit t o be w or n f or i n-office use o nl y. T he c o ntr ol le nses will 
be re m o ve d after a p pr o xi matel y  3 0 mi n utes of le ns wear. 
T he c o ntr ol le nses will n ot be dis pe nse d t o s u bject t o ta ke h o me. 
Re place me nt le nses are all o we d o nl y  if t here is a de vice deficie nc y 
(e g, t or n le ns).
Pac ka gi n g 
descri pti o n
Blister c o ntai ni n g p h os p hate b uf fere d sali ne s ol uti o n wit h wetti n g 
a ge nts
La beli n g descri pti o n

Le ns F oil la bel i ncl u des:
-
material na me a n d i de ntifier
-
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
-
S p o ns or i nf or mati o n

Pr o vi de d i n b o xes of 6 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 c ol or c o de d 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
St ora ge c o n diti o ns
St ore d at r o o m te m perat ure.
A d diti o nal 
i de ntif yi n g 
i nf or mati o n
N/ A
S u p pl y
Refer t o t he M O P f or a detaile d descri pti 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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7

Page 30 of 54
9.2
Other Medical Device or Medication Specified for Use During the 
Study
No other medical devices or medications are required to be used in conjunction with the 
investigational products during the clinical study.
9.3
Treatment Assignment / Randomization
Subjects will be randomized in a 1:1 ratio to receive treatment in crossover sequence AOHG 
toric then AO toric or AO toric then AOHG toric, respectively.
Only after signing the ICF, a subject will be assigned a subject number by the electronic data 
capture system. 
A randomization list will be generated using a validated system that automates the random 
assignment of treatment arms to randomization numbers in the specified ratio. Subjects will 
be assigned treatment according to the randomization list uploaded in the iMedidata 
BALANCE system. The randomization list will be generated and maintained by the Study 
Sponsor.
At Visit 1, all eligible subjects will be randomized via the EDC/IRT integration system to one 
of the lens sequences. The Investigator or delegate will access the respective system after 
confirming that the subject meets all the eligibility criteria. A randomization number will be 
automatically assigned to the subject according to the subject randomization list but will not 
be communicated to the site user. The EDC/IRT integration system will inform the site user 
of the treatment assignment to be dispensed to the subject.
9.4
Treatment masking
This study is double-masked, with subjects randomized to use AOHG toric and AO toric
lenses (in a crossover fashion) for the duration of the approximately 30 minute treatment 
period for each lens pair. All study team members (at the site and the Study Sponsor) are 
masked to the assigned sequence with the exception of those mentioned in Table 9-3.
Table 9–3
Unmasked Individuals Associated with the Study
Unmasked Individual
Extent of Unmasking
Rationale
Unmasked Study
Coordinator(s)
The Unmasked Study
Coordinator(s) will manage IP 
inventory, as well as IP 
administration. This individual 
will have access to IP supply, 
The Unmasked Study
Coordinator(s) will be
unmasked to allow for
processing of IP shipment,
storage, and dispensing, as
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Page 31 of 54
Unmasked Individual
Extent of Unmasking
Rationale
accountability logs, and other 
documents or supplies 
pertaining to IP. The unmasked 
coordinator will also assist with 
device deficiency and adverse 
event reporting.
well as accountability for all
IP.
LCSM
The LCSM will have access to 
IP supply, accountability logs, 
and other documents or 
supplies pertaining to IP. This 
individual assists with masked 
and unmasked data reviews.
The LCSM will be 
unmasked to allow for 
oversight of the CSM, in 
conjunction with all IP 
accountability tasks.
CSM
CSM will have access to IP 
supply, accountability logs, and 
other documents or supplies 
pertaining to IP accountability. 
This individual monitors 
unmasked and masked study 
data.
The CSM will be unmasked
to allow for performance of
IP accountability, 
management of device 
deficiencies and related AE 
lens returns, and any other 
IP related tasks.
Unmasked Data
Manager(s)
The Unmasked Data
Manager(s) will have access to 
restricted fields in RAVE that 
would contain unmasking data.
The Unmasked Data
Manager(s) will be 
unmasked to allow for 
review of all restricted data.
IRT Manager
The IRT manager will be 
unmasked to allow for system 
programming, testing, and to 
allow for technical oversight of 
the system.
The IRT manager is 
unmasked to all aspects of 
the trial for system 
development purposes.
Randomization Specialist
The Randomization Specialist 
will be unmasked to allow for 
generation of the randomization 
list and uploading of that list 
into the IRT system.
Generates and therefore has 
full knowledge of treatment 
codes but otherwise is 
operationally not associated 
with the CTT or any 
decision making aspects 
related to clinical trial 
design, execution, or 
reporting.
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Pa ge 3 2 of 5 4
T his le vel of mas ki n g will be mai ntai ne d t hr o u g h o ut t he c o n d uct of t he st u d y . U n mas ki n g 
will occ ur o nl y  after all pla n ne d st u d y d ata ha ve bee n vali date d, a n d t he data base l oc ke d. 
Mas ke d st u d y  pers o n nel m ust a v oi d see ki n g i nf or mati o n t hat ma y c o m pr o mise mas ki n g. 
U n mas ke d st u d y  pers o n nel m ust n ot disse mi nate i nf or mati o n t hat is p ote ntiall y u n mas ki n g t o 
a n y mas ke d pers o n nel. T he mas ke d a n d u n mas ke d site pers o n nel m ust c o or di nate all st u d y  
acti vities as necessar y t o pr otect mas ki n g a n d mi ni mize bias d uri n g t he st u d y. 
I n t he e ve nt of a me dical e mer ge nc y w here t he k n o wle d ge of s u bject treat me nt is re q uire d, a n 
i n di vi d ual In vesti gat or will ha ve t he a bilit y  t o u n mas k t he treat me nt assi g n me nt f or a s pecific 
s u bject after c o ntacti n g a n a p pr o priate St u dy S p o ns or re prese ntati ve if ti me all o ws. 
U n mas ki n g m ust be d o ne acc or di n g t o t he i nstr ucti o ns pr o vi de d f or t he st u d y I RT s yste m.
9. 5
Acc o u nt a bilit y Pr oce d ures
U p o n recei pt of t he I Ps, t he I n vesti gat or or dele gate m ust c o n d uct a n i n ve nt or y . D uri n g t he 
st u d y, u n mas ke d desi g nate d st u d y  staff m ust pr o vi de t he I Ps t o t he s u bjects i n acc or da nce 
wit h t heir ra n d o mizati o n assi g n me nt. 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 I P  dis pe nsati o n a n d c ollecti o n f or eac h s u bject. T his rec or d m ust be ma de 
a vaila ble t o t he st u d y m o nit or f or t he p ur p oses of verif yi n g t he acc o u nti n g of I P  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 ust be rec or de d al o n g wit h a n e x pla nati o n. All I Ps se nt t o t he I n vesti gat or m ust be 
acc o u nte d f or b y St u d y S p o ns or pers o n nel, a n d i n n o case be use d i n a n u na ut h orize d 
sit uati o n.
It is t he I n vesti gat or’s res p o nsi bilit y t o e ns ure t hat:

All st u d y  pr o d ucts are acc o u nte d f or a n d n ot use d i n a n y u na ut h orize d ma n ner

All use d f oils a n d u n use d s u p plies are retai ne d b y desi g nate d u n mas ke d staff

All u n use d pr o d ucts are a vaila ble f or ret ur n t o t he St u d y S p o ns or , as directe d

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
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, 
u n less ot her wise directe d b y t he Sp o ns or. Refer t o Secti o n 11 of t h is 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.
T he I n vesti gat or is res p o nsi ble f or pr o per dis p ositi o n of all u n use d I Ps at t he c o ncl usi o n of 
t he st u d y, acc or di n g t o t he i nstr ucti o ns pr o vi de d i n t he M O P.

Pa ge 3 3 of 5 4
9. 6
C h a n ges t o c o nc o mit a nt me dic ati o ns, tr e at me nts/ pr oce d ures
C ha n ges i n c o nc o mita nt treat me nts d uri n g Vi sit 1 are n ot all o we d u nless nee de d f or t he 
pr o per me dical care a n d treat me nt of t he s u bject f or a s peci fic me dical c o n diti o n.
After t he s u bject is e nr olle d i nt o t he st u d y , t he I n vesti gat or m ust i nstr uct t he s u bject t o n otif y 
t he st u d y site a b o ut:

A n y  ne w me dicati o ns 

Alterati o ns i n d ose or d ose sc he d ules f or c urre nt me dicati o ns, 

A n y  me dical pr oce d ure or h os pitalizati o n t hat occ urre d or is pla n ne d

A n y  n o n-dr u g t hera pies (i ncl u di n g p h ys ical t hera p y a n d bl o o d tra nsf usi o ns). 
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.
1 0 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
S u bjects will be e x pecte d t o atte n d o nl y  1 office visit w hic h i ncl u des 2 differe nt st u d y 
peri o ds, 3 0 mi n utes eac h. S u bjects will wear Pair 1 assi g ne d st u d y le nses bilaterall y  f or 
a p pr o xi matel y 3 0 mi n bef ore cr ossi n g o ver i nt o Pair 2 assi g ne d st u d y le nses bilaterall y f or 
a p pr o xi matel y 3 0 mi n. T here will be a 3 0 mi n ute ( + 1 5 mi n) was h o ut peri o d bet wee n re m o val 
of Pair 1 a n d i nserti o n of Pair 2 st u d y  le nses.
All st u d y  pr oce d ures a n d assess me nts will be c o n d ucte d d uri n g t he 1 office visit bef ore 
s u bject is e xite d at t he e n d of t he si n gle visit.
D uri n g Peri o d 1, t he st u d y pr oce d ures will be c o n d ucte d i n t he f oll o wi n g or der:

S u bjects will i nsert t he first pair of le nses i n t he ra n d o mize d se q ue nce, bei n g i nstr ucte d 
t o al wa ys be gi n wit h t he ri g ht le 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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
T he f oll o wi n g assess m e nts will t he n be perf or me d m o n oc ularl y i n t he ri g ht a n d left 
e ye:

Page 34 of 54
o
Axis orientation 10 min after lens insertion.
 
The procedures described above will be repeated for the second pair of study lenses in the 
randomized sequence for Period 2.
10.1 Informed Consent and Screening
The Investigator or delegate must explain the purpose and nature of the study, and have the 
subject read, sign, and date the IRB/IEC-approved informed consent document. The subject 
must sign the ICF BEFORE any study-specific procedures or assessments can be performed, 
including study-specific screening procedures. Additionally, have the individual obtaining 
consent from the subject and a witness, if applicable, sign and date the informed consent 
document. 
The Investigator or delegate must provide a copy of the signed document to the subject and 
place the original signed document in the subject’s chart, or provide documentation as 
required by local regulations.
10.2 Description of Study Procedures and Assessments
Detailed descriptions of assessments and procedures are provided in the MOP. The 
Investigator is responsible for ensuring responsibilities for all procedures and assessments are 
delegated to appropriately qualified site personnel.
10.2.1 Demographics
Obtain demographic information including age, race, ethnicity, and sex.
10.2.2 Medical History
Collect medical history information, including information on all medications used within the 
past 30 days. Include herbal therapies, vitamins, and all over-the-counter as well as 
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Pa ge 3 5 of 5 4
prescri pti o n me dicati o ns. T hr o u g h o ut t he s u bject’ s partici pati o n, 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.
1 0. 2. 3 I n vesti g ati o n al Pro d uct c o m pli a nce
Re vie w s u bject c o m plia nce wit h t he I P  usa ge a n d a dj u nct pr o d uct usa ge a n d c ollect all use d 
a n d u n use d st u d y IPs.
1 0. 2. 4 A d verse E ve nt C ollecti o n: S afet y Assess me nt
Assess a n d rec or d a n y a d verse e ve nts 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 si g nat ure of i nf or me d 
c o nse nt .
1 0. 2. 5 Slit -L a m p Bi o micr osc o p y: S afet y Assess me nt
S L E of t he c or nea, iris/a nteri or c ha m ber a n d le ns m ust be p erf or me d i n b ot h e y es bef ore 
i nstillati o n of a n y dia g n ostic e ye dr o ps.
1 0. 2. 6 De vice Deficie ncies: S afet y Assess me nt
Assess a n d rec or d a n y De vice Deficie ncies t hat are re p orte d or o bser ve 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 e nr oll me nt. Re q uire me nts 
f or re p orti n g de vice deficie ncies i n t he st u d y ca n be f o u n d i n Secti o n 11.
1 0. 2. 7 A d diti o n al St u d y Assess me nts : Effe cti ve ness a n d S afet y 
Assess me nt s
T he f oll o wi n g are a d diti o nal st u d y  assess me nts. Refer t o t he M O P f or f urt her details.

B C V A ( S nelle n dista nce wit h ma nifest refracti o n)


A xis orie ntati 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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
 

Pa ge 3 6 of 5 4




1 0. 3 U nsc he d ule d Vi sits
T h is is a si n gle visit st u d y d uri n g w hic h t he s u bject will be e nr olle d, scree ne d, ra n d o mize d,
e x p ose d t o st u d y pr o d ucts, a n d e xite d d uri n g t he sa me st u d y  visit. N o u nsc he d ule d visits are 
e x pecte d f or t his st u d y .  
1 0. 4 Disc o nti n ue d S u bjects
1 0. 4. 1 Scree n F ail ures
S u bjects w h o were e xcl u de d fr o m t he st u dy after si g ni n g t he i nf or me d c o nse nt , n ot meeti n g 
i ncl usi o n/e xcl usi o n criteria, a n d pri or t o ra n d o mizati o n t o pr o d uct/ dis pe nse (e x p os ure) of 
st u d y pr o d uct will be c o nsi dere d a scree n fail ure .
T he I n vesti gat or m ust d oc u me nt t he reas o n f or scree n fail ure i n t he s u bject’ s case hist or y 
s o urce d oc u me nts.
S u bject n u m bers m ust n ot be re- use d.
1 0. 4. 2 Disc o nti n u ati 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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
Disc o nti n ue d s u bjects are i n di vi d uals w h o v ol u ntaril y  wit h dra w or are wit h dra w n fr o m t he 
st u d y b y t he I n vesti gat or after si g ni n g t he i nf or me d c o nse nt, i ncl u di n g scree n fail ures.
S u bject n u m bers of disc o nti n ue d s u bjects m ust n ot be re -use d.
S u bjects ma y disc o nti n ue fr o m st u d y  or st u d y treat me nt 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 st u d y treat me nt at a n y ti me if, i n t he o pi ni o n of t he 
I n vesti gat or, c o nti n ue d treat me nt p oses a ris k t o t heir healt h.
F or s u bjects 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 m plete all E xit pr oc e d ures 
acc or di n g t o Ta ble 3- 1, Sc he d ule of St u d y Pr oce d ures a n d Assess me nts, if t he s u bject is 
willi n g a n d a ble, a n d if , i n t he o pi ni o n of t he I n vesti gat or it is safe f or t he s u bject t o d o s o.
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.

Pa ge 3 7 of 5 4
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 n y t hera pies a n d/ or me dical pr oce d ures t hat ma y be 
nee de d t o mai ntai n t heir healt h.
1 0. 4. 3 Sc he d ule of Pr oce d ures a n d Assess me nts f or S u bjects Disc o nti n ue d 
fr o m I n vesti g ati o n al Pr o d uct 
Ot her t ha n scree n fail ures, if a s u bject disc o nti n ues fr o m t he st u d y  t he s u bject s h o ul d u n der g o 
a n Earl y E xit visit. Refer t o Ta ble 3- 1, Sc he d ule of St u d y  Pr oce d ures a n d assess me nts.
1 0. 5 Cli nic al St u d y Te r mi n ati o n
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.
If t he cli nical st u dy is pre mat urel y ter mi nate d or s us p e n de d b y 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 nstructi 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. 

T he I n vesti gat or (s) m ust:
o
Pr o m ptl y  n otif y t he I RB/I E C 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.
A n I n vesti gat or ma y ter mi nate t he site’s partici pati o n i n t he st u d y f or reas o na ble ca use.
1 0. 5. 1 F oll o w -u p of s u bjects after st u d y p artici p ati o n h as e n de d 
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
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.

Page 38 of 54
11 ADVERSE EVENTS AND DEVICE DEFICIENCIES
11.1 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 and figures below for categories of AEs and SAEs.
Figure 11–1
Categorization of All Adverse Events
Figure 11-2
Categorization of All Serious Adverse
Alcon - Business Use Only 
 
Effective Date:  
Document:  
Version:  
Status:  
Printed By: 
Print Date:  
Effective
1.0; CURRENT; Most-Recent; Effective
TDOC-0054499
Protocol - Clinical
17-Nov-2017

Pa ge 3 9 of 5 4
S pecific E ve nts Rele v a nt t o t his Pr ot oc ol
Seri o us A dverse Eve nts
I n a d diti o n t o re p orti n g all A E s (seri o us a n d n o n-seri o us) meeti n g t he defi niti o ns, t he 
I n vesti gat or m ust re p ort a n y occ urre nce of t he f oll o wi n g as a n S A E:

A n oc ular i nfecti o n i ncl u di n g a pres u me d i nfecti o us ulcer wit h a n y of t he f oll o wi n g 
c haracteristics:
o
Ce ntral or parace ntral l ocati o n
o
Pe netrati o n of B o w ma n’ s me m bra ne
o
I nfiltrates > 2 m m dia meter
o
Iritis
o
I ncrease i n i ntra oc ular press ure
o
C ult ure p ositi ve f or micr o or ga nis ms
o
I ncreasi n g size or se verit y at s u bse q ue nt ti me p oi nts

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 
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 ne al s urface area
Si g nific a nt N o n -Seri o us A dverse Eve nts
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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
A si g nifica nt n o n-seri o us A E is a de vice-relate d, n o n- si g ht t hreate ni n g a d verse e ve nt 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 ves ti 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 d verse E ve nt:

Pa ge 4 0 of 5 4

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 ( Refer t o M O P  f or gra di n g 
scales) [ Gra di n g scale is base d u p o n I S O 1 1 9 8 0: 2 0 1 2 u nless s pecifie d differe ntl y  i n 
M O P]

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 
that persists f or 2 or m ore wee ks

Ne o vasc ularizati o n sc ore greater t ha n or e q ual t o G ra de 2 ( Refer t o M O P  f or gra di n g 
scales) [ Gra di n g scale is base d u p o n I S O 1 1 9 8 0: 2 0 1 2 u nless s pecifie d differe ntl y  i n 
M O P]
T he a b o ve e ve nts are base d u p o n t he cate g ories pr o vi de d i n t he I S O 1 1 9 8 0 a n d t he U S F D A  
Pre mar ket N otificati o n ( 5 1 0( k)) G ui da nce D oc u me nt f or Dail y Wear C o ntact Le nses .
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 
associate d wit h patie nt har m (ie, A D E or S A D E); h o we ver , n ot all A D Es or S A D Es are d ue 
t o a de vice deficie nc y. T he I n vesti gat or s h o ul d deter mi ne t he a p plica ble cate g or y liste d i n t he 
De vice Deficie nc y  e C R F f or t he i de ntifie d or s us pect de vice deficie nc y a n d re p ort a n y 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/s ol uti o n cl o u d y

Le ns s urface/e d ge defect

To r n le ns d uri n g ha n dli n g/i n pac k

Pac ka gi n g deficit (e g, misla bele d pr o d uct, ta m pere d seal, lea ki n g b ottle/c o ntai ner)

S us pect pr o d uct c o nta mi nati o n

Lac k of perf or ma nce
1 1. 2 M o nit ori n g f or A d verse E ve nts
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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
At t he st u d y 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 E s b y  as ki n g t he sta n dar d q uesti o ns:

Pa ge 4 1 of 5 4

“ Ha ve y o u ha d a n y healt h pr o ble ms si nce e nr olli n g i n t he st u d y? ”

“ 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 e nr olli n g i n t he st u d y? ”
C ha n ges i n a ny pr ot oc ol -s pecific p ar a meters a n d/ or q uesti o n n aires e val uate d d uri n g t he 
st u d y are t o be re vie we d b y t he I n vesti gat or. A n y u nt o war d ( u nfa v ora ble a n d u ni nte n de d) 
c ha n ge i n a pr ot oc ol -specific p ar a meter or q uesti o n n air e 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 1. 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 E s i n t he st u d y a n d s h o ul d be rec or de d in 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 E s if t he I n vesti 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 defici e 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 vice deficie ncies t o t he St u d y  S p o ns or 
i m me diatel y as f oll o ws:

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 vesti 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 Deficie ncy e C R F m ust be i ncl u de d wit h pr o d uct ret ur ns.

A d diti o nal rele va nt i nf or mati o n after i nitial re p orti n g m ust be e ntere d i nt o t he e C R F as 
s o o n as t he data bec o me a vaila ble.

D oc u me nt a n y c ha n ges t o c o nc o mita nt me dicati o ns o n t he a p pr o priate e C R Fs.

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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
D oc u me nt all rele va nt i nf or mati o n fr o m Disc har ge S u m mar y , A ut o ps y  Re p ort,

Pa ge 4 2 of 5 4

Certificate of Deat h , etc, if a p plica ble, i n narrati ve secti o n of t he Seri o us A dverse 
Eve nt a n d A dverse Device Effect e C R F.
N ote: S h o ul d t he E D C s yste m bec o me n o n - o perati o nal, t he site m ust c o m plete t he 
a p pr o priate pa per Seri o us A dverse Eve nt a n d A dverse Device Effect a n d/ or Device Deficie ncy
F or m. T he c o m plete d f or m is e maile d t o t he St u d y S p o ns or t o
acc or di n g t o t he ti meli nes o utli ne d a b o ve; h o we ver, t he 
re p orte d i nf or mati o n m ust be e ntere d i nt o t he E D C s yste m o nce it bec o mes o perati o nal.
St u d y  S p o ns or re prese ntati ves ma y be c o ntacte d f or a n y pr ot oc ol relate d q uesti o n 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 IR B/I E C.
I nte nsit y a n d C a us alit y Assess me nts
W here a p pr o priate, t he I n vesti gat or m ust assess t he i nte nsit y  (se verity) of t he A E 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)
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.
Se vere
A n A E is se vere if t he si g n or s y m pt o m is i nca pacitati n g a n d res ults i n t he 
s u bject’s i na bilit y t o w or k or e n ga ge i n t heir us ual acti vities.
F or e ver y  AE i n t he st u d y , t he I n vesti gat or m ust assess t he ca usalit y ( Relate d or N ot Relate d 
t o t he me dical de vice or st u d y pr oce d ure). A n assess me nt of ca usalit y  will als o be perf or me d 
b y  St u d y S p o ns or utilizi n g t he sa me defi niti o ns, as s h o w n bel o w:
C a us ality
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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
Relate d
A n A E classifie d as relate d ma y  be eit her definitel y  relate d or p ossi bly relate d 
w here a direct ca use a n d ef fect relati o ns hi p wit h t he me dical de vice or st u d y 

Page 43 of 54
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.
11.4 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 must be 
returned and must include the Complaint # which will be provided by Study Sponsor after the 
case is entered in the Study Sponsor’s Global Product Complaint Management System 
(GPCMS).
11.5 Unmasking of the Study Treatment
Masked information on the identity of the assigned medical device should not be disclosed 
during the study (See Section 9.4). 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.
11.6 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 
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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 post-market 
vigilance procedures) 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.
11.7 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. Pregnancy is not reportable as an AE; 
however, complications may be reportable and will be decided on a case–by-case basis.
12 ANALYSIS PLAN
Continuous variables will be summarized using the number of observations, mean, standard 
deviation (SD), median, minimum and maximum, as well as confidence intervals (CI) or 
confidence limits where applicable. Categorical variables will be summarized with counts 
and percentages from each category. Any deviations to the 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.
12.1 Subject Evaluability
Final subject evaluability must be determined prior to breaking the code for masked lens 
sequence assignment and locking the database, based upon the Deviations and Evaluability 
Plan.
12.2 Analysis Sets
12.2.1 Safety Analysis Set
Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis.
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As such, the safety analysis set will include all subjects/eyes exposed to any study lenses
evaluated in this study. For treatment-emergent safety analyses, subjects/eyes will be
categorized under the actual study lenses exposed in the corresponding lens sequence.
12.2.2 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.
12.2.3 Per Protocol Analysis Set
The per protocol (PP) analysis set is a subset of FAS and excludes all data/subjects which 
have met any of the critical deviation or evaluability criteria identified in the DEP.
12.3 Demographic and Baseline Characteristics
Demographic and baseline characteristics will be summarized by lens sequence and overall. 
Counts and percentages will be presented for categorical variables such as sex, age group, 
race, and ethnicity. N, mean, SD, median, minimum, and maximum will be presented for 
continuous variables such as age.
12.4 Effectiveness Analyses
This study defines 1 primary, 
 effectiveness 
endpoints. All effectiveness evaluations will use the FAS as the primary analysis set. 
Supportive analyses of the primary 
 effectiveness endpoints will be 
conducted using the PP Analysis Set only if the number of subjects excluded from the PP
Analysis Set exceeds 5% of the FAS.
12.4.1 Analysis of Primary Effectiveness Endpoint(s)
The primary endpoint is the percent of AOHG toric with axis orientation within ±30 degrees 
from the 90° axis (ideal location), 10 min after lens insertion. This percentage is calculated 
for the binary variable derived based on axis location of each lens, as defined below:
Yes – if the absolute difference between the axis location and 90 is less than or equal 
to 30 (ie, lens axis located between the 60° and 120° axis inclusive)
No – otherwise
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12.4.1.1 Statistical Hypotheses
No inferences are to be made on the primary effectiveness endpoint; therefore no hypotheses 
are formulated. 
12.4.1.2 Analysis Methods
Frequency and percentage of lenses classified as ‘Yes’ will be provided for AOHG toric and 
AO toric, and a two-sided CI will be calculated. 
A threshold of 90% (as a minimum) has been established for this endpoint based upon 
historical data. Therefore, percent of ‘Yes’ for AOHG toric lenses will be compared 
numerically to 90%.
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1 2. 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 ysis. N o i m p utati o n 
f or missi n g val ues will be carrie d o ut f or t he pri mar y 
 effecti ve ness 
a nal ys es.
1 2. 6 S afet y A n al ys es
T he safet y e n d p oi nts are: 

A d verse e ve nts

Bi o micr osc o p y Fi n di n g

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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
De vic e Deficie ncies

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There are no safety hypotheses planned in this study. The focus of the safety analysis will be 
a comprehensive descriptive assessment of occurrence of adverse events as well as the other 
listed parameters.
All AEs occurring from the time a subject signs informed consent to study exit will be 
accounted for in the reporting. Safety analyses will be conducted using the safety analysis set 
on a treatment-emergent basis. Descriptive summaries (counts and percentages) for ocular 
and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities 
Preferred Terms. AEs leading to study discontinuation, significant non-serious AEs, and 
SAEs will be identified. Individual subject listings will be provided, as necessary. 
Individual subject listings will be provided for AEs that occur after signing informed consent 
but prior to exposure to IP.
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 (Baseline / Screening assessment time point during Visit 1) to subsequent assessment 
at the Exit will be presented. A supportive listing will be generated which will include all 
biomicroscopy data from all assessment time points for these eyes experiencing the increase.
Two listings (prior to exposure of study lenses and treatment-emergent) of device 
deficiencies, as recorded on the Device Deficiency Form, will be provided. Additionally, each 
device deficiency category will be tabulated.
No inferential testing will be done for safety analysis.
12.7 Interim Analyses and Reporting
There are no plans to conduct an interim analysis and no criteria by which the study would be 
terminated early based upon statistical determination
12.8 Sample Size Justification
Although inferential testing is not planned for the primary effectiveness endpoint, expected 
precision of the observed results is provided. A two-sided 95% confidence interval for a 
single proportion will extend approximately 0.10 from the observed value when the expected 
proportion is 0.90, with a sample size of 30.
 
 
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13 DATA HANDLING AND ADMINISTRATIVE REQUIREMENTS
13.1 Subject Confidentiality
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 Study Sponsor will collect a copy 
of the enrollment log without any identifying subject information. All documents submitted 
to the Study Sponsor will identify the subjects exclusively by number and demographic 
information. No other personally identifying information will be transmitted to the Study 
Sponsor.
The Study Sponsor may release anonymized study data to external researchers for purposes 
of future research directly related to the study objectives, or future research that is beyond the 
scope of the current study objectives. The Informed Consent Form explains this to study 
subjects. Anonymization means that all identifiable information will be removed from the 
dataset and all links to the subjects in the study will be removed. Anonymization of the data 
will maintain confidentiality of the subjects who participate in the study so that they cannot 
be identified by external researchers. The anonymized data set will contain records from all 
of the subjects in the current study, but the anonymization process might change the data set 
in some ways, so external researchers will be informed that they might not be able to 
duplicate some of the results from this study.
13.2 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 CRFs exist and are accessible for verification by the site monitor, 
and all discrepancies shall be appropriately documented via the query resolution process. Site
monitors are appointed by the Study Sponsor and are independent of study site staff.
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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 i ncl u de t he f oll o wi n g i nf or mati o n f or eac h s u bject:

S u bject i de ntificati o n ( na me, se x, race/et h nicit y)

D oc u me ntati o n of s u bject eli gi bilit y

Date of i nf or me d c o nse nt

Dates of visits

D oc u me ntati o n t hat pr ot oc ol s pecific pr oce d ures were perf or me d

Res ults of st u d y  para meters, as re q uire d by t he pr ot oc ol

I P acc o u nta bilit y rec or ds

D oc u me ntati o n of A Es a n d ot her safet y para meters (if a p plica ble)

Rec or ds re gar di n g me dical hist ories a n d t he use of c o nc o mita nt t hera pies pri or t o a n d 
d uri n g t he st u d y

Date of st u d y 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 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 at t he site will c o m plete t he C R Fs. T he C R Fs m ust be c o m plete 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 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 In 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 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 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. 
1 3. 3 D at a Re vie w a n d Cl arific ati 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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
A re vie w of C R F data t o t he s u bject’s s o urce data will be c om 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. After t he C R Fs ha ve bee n c o m plete d, 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 C R F.

Page 51 of 54
13.4 Sponsor and Monitoring Responsibilities
The Study Sponsor will designate a monitor to conduct the appropriate site visits at the 
appropriate intervals according to the study monitoring plan. The clinical investigation will 
be monitored to ensure that the rights and well-being of the subjects are protected, the 
reported data are accurate, complete, and verifiable from the source documents, and the study 
is conducted in compliance with the current approved protocol (and amendments[s], if 
applicable), with current GCP, and with applicable regulatory requirements.
The site may not screen subjects or perform the informed consent process on any subject until 
it receives a notification from an appropriate Study Sponsor representative that the site may 
commence conducting study activities. Monitoring will be conducted periodically while the 
clinical study is ongoing. Monitoring methods may include site visits, telephone, written and 
fax correspondence. Close-out visits will take place after the last visit of the last subject at the 
site.
A Coordinating Investigator may be identified by the Study Sponsor to review and endorse 
the final study report. In cases where a Coordinating Investigator is engaged, the Study 
Sponsor will select the Coordinating Investigator based upon their experience, qualifications, 
active study participation, and their willingness and availability to take on this role.
Additionally, Alcon may have an expert Alcon Observer present during the planned study 
visit to make technical observations during the visit. The assessments made by the sponsor 
representative(s) will be considered optional and will not impact subject evaluability. The 
Investigator and the Alcon Observer(s) will make and record their observations separately.
The Alcon Observer must be supervised by the Investigator or designee to ensure the Alcon 
Observer’s presence or activities do not bias the outcome of the study, affect the quality of 
the research data, and/or compromise the rights and welfare of the subject. The Alcon
Observer will not intervene with the standard of care provided to study subjects or make 
safety-related decisions or assessments. The activities of Alcon Observer(s) will be described 
in the ICF.
The Alcon Observer(s) will perform a technical assessment through the biomicroscope of
each treatment pair of contact lenses, on some or all subjects, using the investigative site’s
biomicroscope (slit-lamp). The Alcon Observer will remain masked to the investigational 
product until after database lock. The Alcon Observer will record general observations 
related to lens fit and surface characteristics made during the slit-lamp examination onto a 
eCRF in a separate database with access only provided to internal Alcon personnel.
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Pa ge 5 2 of 5 4
1 3. 5 Re g ul at or y D oc u me nt ati o n a n d Rec or ds Rete nti o n
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 by t he St u d y 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 st u d y m o nit ori n g. Fi na ncial i nf or mati o n is t o be ke pt se paratel y. 
A d diti o nall y , t he I n vesti gat or m ust kee p st u d y rec or ds a n d s o urce d oc u me nts c o nsiste nt wit h 
t he ter ms of t he cli nical st u d y a gree me nt wit h t he St u d y S p o ns or. If t he I n vesti gat or retires, 
rel ocates, or f or a ny ot her reas o n wit h dra ws fr o m res p o nsi bilit y of kee pi n g t he st u d y rec or ds, 
t he n t he St u d y S p o ns or m ust be n otifie d a n d s uita ble arra n ge me nts ma de f or rete nti o n of 
st u d y rec or ds a n d s o urce d oc u me nts nee de d t o c o m pl y wit h nati o nal a n d i nter nati o nal 
re g ulati o ns.
1 3. 6 Q u alit y Ass ur a nce a n d Q u alit y C o ntr ol
T he St u d y  S p o ns or will sec ure a gree me nt fr o m all i n v ol ve d parties t o e ns ure direct access t o 
all st u d y relate d sites, s o urce data a n d d oc u me nts, a n d re p orts f or t he p ur p ose of m o nit ori n g 
a n d a u diti n g b y t he St u d y S p o ns or , a n d i ns pecti o n b y d o mestic a n d f orei g n re g ulat or y  
a ut h orities. Q ualit y c o ntr ol will be a p plie d t o eac h sta ge of data ha n dli n g t o e ns ure t hat all 
data are relia ble a n d ha ve bee n pr ocesse d c orrectl y . A gree me nts ma de b y t he St u d y  S p o ns or 
wit h t he I n vesti gat or/I nstit uti o n a n d a n y ot her parties i n v ol ve d i n t he cli nical st u d y will be 
pr o vi de d i n writi n g as part of t he pr ot oc ol or as a se parate a gree me nt.
1 4 E T HI C S
T his cli nical st u d y  m ust be c o n d ucte d i n acc or da nce wit h t he et hical pri nci ples c o ntai ne d 
wit hi n: 

T he D eclarati o n of H e lsi n ki, a n d i n c o m plia nce wit h t he IC H E 6 G C P  C o ns oli date d 
G ui deli ne, I S O 1 4 1 5 5: 2 0 1 1, a n d t he a p plica ble U S F D A  2 1 C F R Re g ulati o ns. 

S O Ps of t he St u d y  S p o ns or a n d c o ntract researc h or ga nizati o ns partici pati n g i n t he 
c o n d uct of t he cli nical st u d y a n d all ot her a p plica ble re g ulati 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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
N otificati o ns a n d ti meli nes f or re p orti n g pr ot oc ol de viati o ns s h o ul d be base d u p o n
a p plica ble Et hics C o m mittee re q uire me nts
T he I n vesti gat or m ust e ns ure t hat all pers o n nel i n v ol ve d i n t he c o n d uct of t he st u d y  are 
q ualifie d t o perf or m t heir assi g ne d res p o nsi bilities t hr o u g h rele va nt e d ucati o n, trai ni n g, a n d 
e x perie nce. T he I n vesti gat or a n d all cli nical st u d y staff m ust c o n d uct t he cli nical st u d y i n 
c o m plia nce wit h t he pr ot oc ol. De viati o ns fr o m t his pr ot oc ol, re g ulat or y  re q uire me nts a n d/ or 
G C P  m ust be rec or de d a n d re p orte d t o t he S p o ns or pri or t o data base l oc k. If nee de d, 

Page 53 of 54
corrective and preventive action should be identified, implemented, and documented within 
the study records. Use of waivers to deviate from the clinical protocol is prohibited.
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 IRB/IEC. The Investigator must provide documentation of the IRB/IEC 
approval to the Study Sponsor. The approval must be dated and must identify the applicable 
protocol, amendments (if any), informed consent form, assent form (if any), all applicable 
recruiting materials, written information for subject, and subject compensation programs. The 
IRB/IEC must be provided with a copy of the IB, package insert for AO toric, any periodic 
safety updates, and all other information as required by local regulation and/or the IRB/IEC. 
At the end of the study, the Investigator must notify the IRB/IEC about the study’s 
completion. The IRB/IEC also must be notified if the study is terminated prematurely. 
Finally, the Investigator must report to the IRB/IEC on the progress of the study at intervals 
stipulated by the IRB/IEC.
Voluntary informed consent must be obtained in writing from every subject and the process 
shall be documented before any procedure specific to the clinical investigation is applied to 
the subject. The Investigator must have a defined process for obtaining consent. Specifically, 
the Investigator, or their delegate, must explain the clinical study to each potential subject and 
the subject must indicate voluntary consent by signing and dating the approved informed 
consent form. The subject must be provided an opportunity to ask questions of the 
Investigator, and if required by local regulation, other qualified personnel. The Investigator 
must provide the subject with a copy of the consent form written in a language the subject 
understands. The consent document must meet all applicable local laws and provide subjects 
with information regarding the purpose, procedures, requirements, and restrictions of the 
study, along with any known risks and potential benefits associated with the IP and the study, 
the available compensation, and the established provisions for maintaining confidentiality of 
personal, protected health information. Subjects will be told about the voluntary nature of 
participation in the study and must be provided with contact information for the appropriate 
individuals should questions or concerns arise during the study. The subject also must be told 
that their records may be accessed by appropriate authorities and Sponsor-designated 
personnel. The Investigator must keep the original, signed copy of the consent (file in 
subject’s medical records) and must provide a duplicate copy to each subject according to 
local regulations. 
The Study Sponsor assures that the key design elements of this protocol will be registered on 
www.clinicaltrials.gov as required by current regulations and, if applicable, other public 
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data bases as re q uire d b y l ocal c o u ntr y re g ulati o ns. I n a d diti o n, res ults of t his st u d y will be 
ma de p u blicl y  a vaila ble o n w w w.cli nicaltrials. g o v re gar dless of o utc o me as re q uire d by 
c urre nt re g ulati o ns a n d, if a p plica ble, i n ot her p u blic data bases as re q uire d b y  l ocal c o u ntr y 
re g ulati o ns.
1 5 R E F E R E N C E S
1 5. 1 Refere nces a p p lic a ble f or all cli nic al st u dies

I S O 11 9 8 0: 2 0 1 2 O p ht hal mic o ptics - C o ntact le nses a n d c o ntact le ns care pr o d ucts -
G ui da nce f or cli nical i n vesti gati o ns

I S O 1 4 1 5 5: 2 0 1 1 Cli nical i n vesti gati o n of me dical de vices f or h u ma n s u bjects - G o o d 
cli nical practice
1 5. 1. 1 U S refere nces a p plic a ble f or cli nic al st u dies

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 Par t 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 5. 2 Refere nces f or t his cli nic al 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 4 4 9 9
P r o t o c o l  -  C l i n i c a l
1 7- N o v- 2 0 1 7
H ol de n B A. T he pri nci ples a n d practice of c orrecti n g asti g matis m wit h s oft c o ntact le nses. 
A ust J O pt o m. 1 9 7 5 A u g; 5 8: 2 7 9 - 9 9.

                                                                                                                
                                                                                     
Date/Time 
(mm/dd/yyyy GMT):
Signed by:
Justification:
11/17/2017 20:37:29
11/17/2017 20:04:07
11/17/2017 19:51:36
11/17/2017 19:45:30
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Status:  
Printed By: 
Print Date:  
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