Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere
Phase: NA
Conditions: Ametropia
Sponsor: CooperVision, Inc.



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$FN=KLA?9LAGF9D .AL=K

!@9.1= ;2 &5?1>
/@AK OADD := 9 KAF?D= ;=FL=J AFN=KLA?9LAGF9D KAL= AF (=PA;G ALQ /9J?=L  KM:B=;LK

:A1>?53-?;= %1/=@5?91:?
/@AK KLM<Q OADD := ;GF<M;L=< 9L L@= AFN=KLA?9LGJ_K HJAN9L= HJ9;LA;= DG;9L=< 9L GFKMDLGJAG *HLGEULJA;G
,M=J=L9JG  
 GDGFA9 -GE9	 M9M@LUEG; AM<9< <= (UPA;G V<A?G +GKL9D  /@=
$FN=KLA?9LGJK OADD := J=IMAJ=< LG >MD>AD L@= >GDDGOAF? ;JAL=JA9
x
'A;=FK=< GHLGE=LJAKL OAL@ 9L D=9KL LOG Q=9JK G> ;GFL9;L D=FK >ALLAF? =PH=JA=F;=
x
 PH=JA=F;=< $FN=KLA?9LGJK O@G OADD := LJ9AF=< AF "GG< DAFA;9D +J9;LA;= "+ :Q L@= HJAF;AH9D
AFN=KLA?9LGJ
x
$F
G>>A;= =E9AD GJ >9P
x
2ADDAF?F=KK LG >GDDGO L@= KLM<Q HJGLG;GD 9F< LG ;G
GH=J9L= OAL@ L@= KLM<Q EGFALGJK
/@AK ;DAFA;9D KLM<Q AK <=KA?F=< LG := AF ;GF>GJE9F;= OAL@ L@= =L@A;9D HJAF;AHD=K AF L@= =;D9J9LAGF G>
#=DKAFCA	 OAL@ L@= $# ?MA<=DAF=K >GJ "GG< DAFA;9D +J9;LA;= "+ 9F< 9DD L@= 9HHDA;9:D= DG;9D
?MA<=DAF=K

 L@A;K -=NA=O  .L9L=E=FL G> GEHDA9F;=

%181A-:? &?-:0-=0>  @50185:1>
/@AK AEHD=E=FL9LAGF <G;ME=FL @9K :==F <=N=DGH=< AF 9;;GJ<9F;= OAL@ L@= >GDDGOAF?
x
$.*  DAFA;9D $FN=KLA?9LAGF G> (=<A;9D =NA;=K
x
$# #9JEGFAR=< /JAH9JLAL= "MA<=DAF= >GJ "GG< DAFA;9D +J9;LA;=
x
=;D9J9LAGF G> #=DKAFCA

:>?5?@?5;:-8 %1A51B ;-=0
/@AK KLM<Q OADD := ;GF<M;L=< AF 9;;GJ<9F;= OAL@ $FKLALMLAGF9D -=NA=O G9J< J=?MD9LAGFK 0. !-
+9JL  GJ 9HHDA;9:D= $  J=?MD9LAGFK GHA=K G> 9DD $-$  ;GJJ=KHGF<=F;= OAL@ L@=
AFN=KLA?9LGJKHGFKGJ OADD := C=HL GF >AD= /@= KLM<Q OADD ;GEE=F;= MHGF 9HHJGN9D >JGE L@= >GDDGOAF?
 L@A;K GEEALL== GEAKAVF <= SLA;9 <= D9 ! .$ N=FA<9 <= DGK 9JJAGK FG 	 'GK -=Q=K $RL9;9D9	

;:2501:?5-8
7
7<@A "$" +"*)%$ % %#( %$)". (&' $ +' )"). (&'

/D9DF=H9FLD9  <G <= (UPA;G +  /=D=H@GF= FME:=J 


 9F< =E9AD 9<<J=KK
;=LA;9>=KA?E9AD;GE

85:5/-8 '=5-8 %135>?=-?5;:
/@AK KLM<Q OADD := J=?AKL=J=< OAL@ ;DAFA;9D LJA9DK?GN AF 9;;GJ<9F;= OAL@ K=;LAGF  G> L@= !GG< 9F<
JM? <EAFAKLJ9LAGF ! ;L O@A;@ E9F<9L=K L@= J=?AKLJ9LAGF G> ;=JL9AF ;DAFA;9D LJA9DK G> <JM?K 9F<
E=<A;9D <=NA;=K

:2;=910 ;:>1:?
$F>GJE=< ;GFK=FL	
	 K@9DD := G:L9AF=< AF OJALAF? >JGE L@= KM:B=;L 9F< L@= HJG;=KK K@9DD :=
<G;ME=FL=< :=>GJ= 9FQ HJG;=<MJ= KH=;A>A; LG L@= ;DAFA;9D AFN=KLA?9LAGF AK ;9JJA=< GML

+GL=FLA9D -AKCK 9F< =F=>ALK LG #ME9F .M:B=;LK
/@=J= E9Q := <AJ=;L :=F=>ALK LG L@= KM:B=;LK AF L@AK KLM<Q KM;@ 9K AEHJGN=< NAKAGF	 ;GE>GJL	
;GFN=FA=F;=	 9F< ;GKE=LA; 9<N9FL9?=
+9JLA;AH9LAGF AF 9 KLM<Q E9Q ;GFLJA:ML= LG K;A=FLA>A; J=K=9J;@
AF>GJE9LAGF L@9L E9Q := MK=< AF L@= <=N=DGHE=FL G> F=O ;GFL9;L D=FK HJG<M;LK $F 9<<ALAGF	 KM:B=;LK
OADD J=;=AN= 9F =P9EAF9LAGF G> L@= >JGFL H9JL G> L@=AJ =Q=K 9F< E9Q @9N= L@= GHHGJLMFALQ LG LJQ 9 <A>>=J=FL
LQH= G> KG>L ;GFL9;L D=FK=K 9F<GJ <A>>=J=FL D=FK ;9J= HJG<M;LK 9L FG ;GKL LG L@=E /@= ;GFL9;L D=FK
E9L=JA9DK MK=< AF L@AK KLM<Q 9J= ;GEE=J;A9DDQ 9N9AD9:D= AFL=F<=< >GJ <9ADQ O=9J )*/ =PL=F<=< O=9J
KAEAD9J LG L@= 9N=J9?= O=9JAF? LAE= G> 
 @GMJK >GJ <9ADQ O=9J D=FK=K
/@AK KLM<Q AK ;GFKA<=J=< LG := 9 FGF
KA?FA>A;9FL JAKC KLM<Q :9K=< GF 0FAL=< .L9L= !GG< 9F< JM?
9<EAFAKLJ9LAGF ! 9F< $FL=JF9LAGF9D .L9F<9J<K *J?9FAR9LAGF $.* ?MA<=DAF=K :=;9MK= L@= KLM<Q
<=NA;=K MK=< 9K AFL=F<=< AF L@AK KLM<Q <9ADQ O=9J <GF_L J=HJ=K=FL 9 HGL=FLA9D >GJ K=JAGMK JAKC LG L@=
@=9DL@	 K9>=LQ GJ O=D>9J= G> L@= KM:B=;L	 9F<  AL AK FGL 9F AEHD9FL	  AL AK FGL MK=< LG KMHHGJL GJ
KMKL9AF @ME9F DA>=	  AL AK FGL G> KM:KL9FLA9D AEHGJL9F;= AF <A9?FGKAF?	 ;MJAF?	 EALA?9LAF? GJ LJ=9LAF?
<AK=9K= GJ GL@=JOAK= HJ=N=FLK AEH9AJE=FL G> @ME9F @=9DL@	  <G=K FGL HJ=K=FL 9 HGL=FLA9D >GJ K=JAGMK
JAKC LG L@= @=9DL@	 K9>=LQ GJ O=D>9J= G> L@= KM:B=;L
GEHDA;9LAGFK L@9L E9Q G;;MJ <MJAF? L@= O=9JAF? G> ;GFL9;L D=FK=K AF;DM<= <AK;GE>GJL	 <JQF=KK	 9;@AF?
GJ AL;@AF? =Q=K	 =P;=KKAN= L=9JAF?	 <AK;@9J?=	 @QH=J=EA9 9F< N9JA9:D= GJ :DMJJ=< NAKAGF (GJ= K=JAGMK
JAKCK E9Q AF;DM<= H@GLGH@G:A9	 AJALAK	 ;GJF=9D =<=E9 GJ =Q= AF>=;LAGF DL@GM?@ ;GFL9;L D=FK
J=D9L=<
AF>=;LAGFK 9J= N=JQ AF>J=IM=FL	 L@= HGKKA:ADALQ <G=K =PAKL /@= AF;A<=F;= G> AF>=;LAGF <M= LG <9Q
O=9J
KG>L D=FK=K AK  DEGKL 9DO9QK 9F AF>=;LAGF OADD G;;MJ GFDQ AF GF= =Q= /@AK JAKC AK 9KKME=< :Q

EADDAGF E=JA;9FK O@G ;MJJ=FLDQ O=9J ;GFL9;L D=FK=K
-GMLAF= ;DAFA;9D HJG;=<MJ=K AF;DM<AF? 9MLG
J=>J9;LAGF	 9MLG
C=J9LGE=LJQ	 NAKM9D 9;MALQ	 9FL=JAGJ G;MD9J
@=9DL@ 9KK=KKE=FL	 9F< ;GFL9;L D=FK >ALLAF? OADD := MK=< $F 9<<ALAGF	 @A?@ E9?FA>A;9LAGF AE9?AF? G> L@=
D=FK >AL E9Q := E9<= MKAF?  EE GJ <A?AL9D ;9E=J9K	 AF NANG ;GF>G;9D EA;JGK;GHQ	 9F<GJ KH=;MD9J
EA;JGK;GHQ +9LA=FLK OADD := EGFALGJ=< AF L@= ;DAFA; <MJAF? L@= KLM<Q LG J=<M;= A> FGL =DAEAF9L= L@=
G;;MJJ=F;= G> 9<N=JK= GJ HGL=FLA9D 9<N=JK= =N=FLK +9LA=FLK OADD := ?AN=F AFKLJM;LAGFK >JGE L@= KLM<Q
AFN=KLA?9LGJ J=?9J<AF? =9JDQ KQEHLGEK 9F< KA?FK G> 9<N=JK= =N=FLK 9F< L@=AJ ;GFL9;L AF>GJE9LAGF

;:2501:?5-8
7
7<@A "$" +"*)%$ % %#( %$)". (&' $ +' )"). (&'


(9L=JA9DK 9F< (=L@G<K

#-=?5/5<-:?>
#9:ALM9D KG>L ;GFL9;L D=FK O=9J=JK O@G ;MJJ=FLDQ O=9J KH@=J= D=FK=K >GJ <AKL9F;= NAKAGF ;GJJ=;LAGF 9F<
HJGNA<= OJALL=F AF>GJE=< ;GFK=FL 9F< E==L L@= HJGLG;GD =FLJ9F;= ;JAL=JA9 .M:B=;LK OADD := J=;JMAL=<
>JGE L@= AFN=KLA?9LGJ_K HJAN9L= HJ9;LA;= <9L9:9K=K O@G 9?J== LG NGDMFL9JADQ H9JLA;AH9L= AF L@= KLM<Q
 DD KM:B=;LK OADD := K;J==F=< LG <=L=JEAF= KLM<Q =DA?A:ADALQ  9;@ KM:B=;L OADD :=
?AN=F 9 MFAIM= $ FME:=J <<ALAGF9DDQ	 9DD KM:B=;LK EMKL E==L L@= KLM<Q AF;DMKAGF 9F< =P;DMKAGF
;JAL=JA9 DAKL=< :=DGO
:/8@>5;: /=5?1=5-
 H=JKGF AK =DA?A:D= >GJ AF;DMKAGF AF L@= KLM<Q A> @=K@=

$K 9L D=9KL  Q=9JK G> 9?= 9F< @9K >MDD D=?9D ;9H9;ALQ LG NGDMFL==J

#9K J=9< 9F< KA?F=< 9F AF>GJE9LAGF ;GFK=FL D=LL=J

.=D>
J=HGJLK @9NAF? 9 >MDD =Q= =P9EAF9LAGF AF L@= HJ=NAGMK LOG Q=9JK

FLA;AH9L=K :=AF? 9:D= LG O=9J L@= KLM<Q D=FK=K >GJ L@= J=IMAJ=< LAE= G> L@= KLM<Q

$K OADDAF? 9F< 9:D= LG >GDDGO AFKLJM;LAGFK 9F< E9AFL9AF L@= 9HHGAFLE=FL K;@=<MD=

#9K J=>J9;LAN= 9KLA?E9LAKE FG @A?@=J L@9F 
 

9F := >AL OAL@ L@= 9N9AD9:D= D=FK H9J9E=L=JK KH@=J=  LG 
 .== /9:D= 

9F 9;@A=N= :AFG;MD9J <AKL9F;= NAKAGF G> 9L D=9KL  .F=DD=F DG?(-  OAL@ L@= KLM<Q
;GFL9;L D=FK=K
C/8@>5;: =5?1=5-
 H=JKGF OADD := =P;DM<=< >JGE L@= KLM<Q A> @=K@=
 $K H9JLA;AH9LAF? AF 9FQ ;GF;MJJ=FL ;DAFA;9D GJ J=K=9J;@ KLM<Q
 #9K 9FQ CFGOF 9;LAN= G;MD9J <AK=9K= 9F<GJ AF>=;LAGF L@9L ;GFLJ9AF<A;9L=K ;GFL9;L D=FK O=9J
 #9K 9 KQKL=EA; ;GF<ALAGF L@9L AF L@= GHAFAGF G> L@= AFN=KLA?9LGJ E9Q 9>>=;L 9 KLM<Q GML;GE= N9JA9:D=
 $K MKAF? 9FQ KQKL=EA; GJ LGHA;9D E=<A;9LAGFK L@9L AF L@= GHAFAGF G> L@= AFN=KLA?9LGJ E9Q 9>>=;L
;GFL9;L D=FK O=9J GJ 9 KLM<Q GML;GE= N9JA9:D=
 #9K CFGOF K=FKALANALQ LG L@= <A9?FGKLA; KG<AME >DMGJ=K;=AF MK=< AF L@= KLM<Q
 .=D>
J=HGJLK 9K HJ=?F9FL	 D9;L9LAF? GJ HD9FFAF? 9 HJ=?F9F;Q 9L L@= LAE= G> =FJGDE=FL
 #9K MF<=J?GF= J=>J9;LAN= =JJGJ KMJ?=JQ GJ AFLJ9G;MD9J KMJ?=JQ
 !GJ L@= HMJHGK=K G> L@AK KLM<Q	 9;LAN= G;MD9J <AK=9K= AK <=>AF=< 9K AF>=;LAGF GJ AF>D9EE9LAGF O@A;@ J=IMAJ=K
L@=J9H=MLA; LJ=9LE=FL (AD< A=	 FGL ;GFKA<=J=< ;DAFA;9DDQ J=D=N9FL DA< 9:FGJE9DALA=K :D=H@9JALAK	 E=A:GEA9F
?D9F< <QK>MF;LAGF	 H9HADD9=	 ;GJF=9D 9F< ;GFBMF;LAN9D KL9AFAF? 9F< <JQ =Q= 9J= FGL ;GFKA<=J=< 9;LAN= G;MD9J
<AK=9K= )=GN9K;MD9JAR9LAGF 9F< ;GJF=9D K;9JK 9J= L@= J=KMDL G> HJ=NAGMK @QHGPA9	 AF>=;LAGF GJ AF>D9EE9LAGF 9F<
9J= L@=J=>GJ= FGL 9;LAN=

;:2501:?5-8
7
7<@A "$" +"*)%$ % %#( %$)". (&' $ +' )"). (&'

x
(=9KMJ= @A?@ ;GFLJ9KL <AKL9F;= NAKM9D 9;MALQ 9F< GHLAEAR= L@= HJ=K;JAHLAGF A> F==<=<
x
 N9DM9L= D=FK >AL 
D=FK >AL 9;;=HL9F;=
x
*J<=J >AF9D !& 
 )5>5?  1:> 05><1:>5:3 5? !&   A-8@-?1
x
x
1:> 25? ->>1>>91:?
¾
*N=J9DD >AL 9;;=HL9F;=  [ ` 9F< J=9KGF A> "J9<=  GJ D=KK
 )5>5?  
 95:@?1> A-8@-?1 !& 
x
x
1:> 5? >>1>>91:?
¾
¾
*N=J9DD >AL 9;;=HL9F;=  [ ` 9F< J=9KGF A> "J9<=  GJ D=KK
¾
-=EGN= !& 
 )5>5? - 1:> 05><1:>5:3 5? !&   A-8@-?1
x
x
1:> 5? >>1>>91:?
¾
¾
*N=J9DD >AL 9;;=HL9F;=  [ ` 9F< J=9KGF A> "J9<=  GJ D=KK

;:2501:?5-8
7
7<@A "$" +"*)%$ % %#( %$)". (&' $ +' )"). (&'


%1<;=?5:3 0A1=>1 A1:?>
DD HGL=FLA9D &1=5;@> -:0 (:-:?5/5<-?10 0A1=>1 1A5/1 221/?> L@9L 9J= J=D9L=< GJ HGKKA:DQ J=D9L=<
LG KM:B=;L H9JLA;AH9LAGF AF L@= AFN=KLA?9LAGF OADD := J=HGJL=< LG L@= +JAF;AH9D $FN=KLA?9LGJ 9F< L@= KHGFKGJ
OAL@AF  @GMJK G> L@= AFN=KLA?9LGJ :=;GEAF? 9O9J= G> L@= =N=FL /@= +JAF;AH9D $FN=KLA?9LGJ OADD J=HGJL
L@= =N=FL LG L@=  $- 9K KGGF 9K HGKKA:D= :Q >9P	 E9AD<=DAN=JQ	 H@GF=	 GJ =E9AD	 :ML OAL@AF 
:MKAF=KK <9QK G> :=;GEAF? 9O9J= G> L@= HJG:D=E  # !  #!# %#" &  ! !#
#( # # 
&53:525/-:? -:0 !;:&53:525/-:? 0A1=>1 A1:?> OADD := J=HGJL=< LG L@= KHGFKGJ 9K KGGF 9K
HGKKA:D=	 :ML FG D9L=J L@9F  OGJCAF? <9QK 9>L=J L@= G;;MJJ=F;=
.HGFKGJ ;GFL9;L <=L9ADK 9J=

5>/;:?5:@-?5;: 2=;9 ?41 &?@0D
DD <AK;GFLAFM9LAGFK OADD := >MDDQ <G;ME=FL=< GF L@= 9HHJGHJA9L= -!  PAL 9F< <N=JK=  N=FL >GJEK 9K
F==<=< +9JLA;AH9FLK OADD := >GDDGO=< MFLAD J=KGDMLAGF AF EGKL AFKL9F;=K 9F< 9J= >J== G> L@= GH@L@9DEA;
AFK=JL J=D9L=< ;GEHDA;9LAGFK GJ GL@=J G;MD9J H9L@GDG?Q 2@=F HGKKA:D= KLM<Q D=FK=K AFNGDN=< AF 9F
<N=JK=  N=FL OADD := J=LMJF=< LG L@= KHGFKGJ AF 9 F=O LA?@LDQ K=9D=< ;GFL9;L D=FK ;9K= 9F< D9:=D=<
OAL@ L@= KM:B=;L A<=FLA>A;9LAGF 9F< KLGJ=< AF 0FAKGD FGF
HJ=K=JN=< K9DAF=
 .L9LAKLA;9D F9DQKAK

	
 &?-?5>?5/-8 -:-8D>5>
.MEE9JQ KL9LAKLA;K OADD := HJG<M;=<	 =?	 E=9F	 KL9F<9J< <=NA9LAGF	 :Q L@= HJAF;AH9D AFN=KLA?9LGJ
A>>=J=F;=K :=LO==F D=FK=K OADD := ;GEH9J=< MKAF? +9AJ=< L
L=KLK +9AJ=< L
L=KLK 9F9DQKAK G> N9JA9F;=
>GJ FGJE9D AFL=JN9D;GFLAFMGMK <9L9	 2AD;GPGF_K KA?F=< J9FCK L=KL >GJ FGF
FGJE9D GJ<AF9D <9L9	 ;@A
KIM9J=K L=KL >GJ FGEAF9D <9L9 GEE=FLK J=?9J<AF? L@= ;DAFA;9D J=D=N9F;= G> <A>>=J=F;=K AF KM:B=;LAN=
J9LAF?K OADD := :9K=< GF L@= ;GF;DMKAGF :Q )9N9K;M=K
GJF9?G =L 9D	 +9H9K	 =L 9D L@9L GF 9 K;9D=
G> 
	 <A>>=J=F;=K ?J=9L=J GJ =IM9D LG  HGAFLK OGMD< ?=F=J9DDQ J=HJ=K=FL 9 <A>>=J=F;= L@9L 9 H9LA=FL
OGMD< FGLA;=  IMAN9D=F;= L=KLAF? OADD := ;GF<M;L=< >GJ J9LAF?K G> ;GE>GJL	 MKAF? (AFL9:   N9DM=
G> [  9F<   OADD := MK=< 9K L@= E9J?AFK >GJ =IMAN9D=F;=  IMAN9D=F;= L=KLAF? G> NAKM9D 9;MALQ OADD :=
;GF<M;L=< MKAF? 9F =IMAN9D=F;= E9J?AF G>  DG?(-

 AFGEA9D L=KL OADD := MK=< LG =N9DM9L= D=FK HJ=>=J=F;= IM=KLAGFK DD H9JLA;AH9FLK O@G 9J= =N9DM9L=<
AF L@= KLM<Q OADD := MK=< AF L@= 9F9DQKAK $F L@= =N=FL G> EAKKAF? <9L9 AF<ANA<M9D FME:=J G> HGAFLK OADD
:= =P;DM<=< AF L@= 9F9DQKAK 9F< FGL =PLJ9HGD9L=< >JGE L@= ;GDD=;L=< <9L9 /@= ;JALA;9D 9DH@9 D=N=D >GJ
KL9LAKLA;9D KA?FA>A;9F;= OADD := K=L 9L H d 	 OAL@ 9<BMKLE=FL >GJ EMDLAHD= ;GEH9JAKGFK

;:2501:?5-8
7
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;:2501:?5-8
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;:2501:?5-8
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;:2501:?5-8
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;:2501:?5-8
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;:2501:?5-8
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;:2501:?5-8
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;:2501:?5-8
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;:2501:?5-8
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;:2501:?5-8
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;:2501:?5-8
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