Initial Evaluation of Investigational Lenses Manufactured on a New Production Line
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

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CR-6283, v3.0 Amendment 2.0
Page 2 of 176
JJVC CONFIDENTIAL

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CR-6283, v3.0 Amendment 2.0
Page 3 of 176
JJVC CONFIDENTIAL

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CR-6283, v3.0 Amendment 2.0
Page 4 of 176
JJVC CONFIDENTIAL

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Page 5 of 176
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CR-6283, v3.0 Amendment 2.0
Page 6 of 176
JJVC CONFIDENTIAL

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CR-6283, v3.0 Amendment 2.0
Page 26 of 176
JJVC CONFIDENTIAL

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CR-6283, v3.0 Amendment 2.0
Page 28 of 176
JJVC CONFIDENTIAL

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CR-6283, v3.0 Amendment 2.0
Page 29 of 176
JJVC CONFIDENTIAL

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Page 30 of 176
JJVC CONFIDENTIAL

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Page 48 of 176
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Page 49 of 176
JJVC CONFIDENTIAL

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CR-6283, v3.0 Amendment 2.0
Page 56 of 176
JJVC CONFIDENTIAL

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Page 58 of 176
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Page 59 of 176
JJVC CONFIDENTIAL

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CR-6283, v3.0 Amendment 2.0
Page 60 of 176
JJVC CONFIDENTIAL

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CR-6283, v3.0 Amendment 2.0
Page 61 of 176
JJVC CONFIDENTIAL

VDPSOHV ZHUHVLPXODWHGEDVHGRQWKHKLVWRULFDOGDWD)RUHDFKUHSOLFDWHGVDPSOHDJHQHUDOL]HG
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CR-6283, v3.0 Amendment 2.0
Page 62 of 176
JJVC CONFIDENTIAL

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CR-6283, v3.0 Amendment 2.0
Page 63 of 176
JJVC CONFIDENTIAL

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PRGHOWRFRPSDUHWKH7HVW DQG&RQWUROOHQVHV7KHUHJUHVVLRQPRGHOZLOOLQFOXGHEDVHOLQH
&/8(FRPIRUWVFRUHVVHTXHQFHRIOHQVZHDUOHQVW\SHDQGILUVWRUGHUFDUU\RYHU HIIHFW DVIL[HG
HIIHFWV&OLQLFDOVLWHZLOOEHLQFOXGHGDVUDQGRPHIIHFWV2WKHUVXEMHFWFKDUDFWHULVWLFVVXFKDV
DJHJHQGHUUDFHDQGLULVFDWHJRU\ZLOOEHLQFOXGHGZKHQDSSURSULDWH
7KH0RGHO
/HWݕ௜௝௞௟ ݕͳ௜௝௞௟ ݕʹ௜௝௞௟ ݕ͵௜௝௞௟GHQRWHWKH&/8(&RPIRUWVFRUHIRUWKH݈௧௛VXEMHFWDWWKH
݇௧௛VLWHDVVLJQHGWRWKH݅௧௛OHQVXVLQJWKH݆௧௛VHTXHQFHDWSHULRGVDQG7KHOLNHOLKRRG
IRUݕ௜௝௞௟LVFRQVWUXFWHGDVIROORZV
ݕ௜௝௞௟a1ߤ௜௝௞௟ǡȈ) 
:KHUHߤ௜௝௞௟ ሺɊͳ௜௝௞௟ǡ Ɋʹ௜௝௞௟ǡ Ɋ͵௜௝௞௟ሻ்and Ȉ is a 3X3 varianceFRYDULDQFHPDWUL[+HUH
Ɋͳ௜௝௞௟ Ɋ଴ߨଵ ߚଵܮ݁݊ݏሾ௜ǡ௝ሿ ߚଶEDVHOLQHߚଷܵ݁ݍݑ݁݊ܿ݁௝
 ߛ௞
Ɋʹ௜௝௞௟ Ɋ଴ߨଶ ߚଵܮ݁݊ݏሾ௜ǡ௝ሿ ߚଶEDVHOLQH ߚଷܵ݁ݍݑ݁݊ܿ݁௝ ߚସܥܽݎݎݕͳሾ௜ǡ௝ሿߛ௞
Ɋ͵௜௝௞௟ Ɋ଴ߨଷ ߚଵܮ݁݊ݏሾ௜ǡ௝ሿ ߚଶEDVHOLQHߚଷܵ݁ݍݑ݁݊ܿ݁௝ ߚସܥܽݎݎݕͳሾ௜ǡ௝ሿ ߛ௞
,QWKLVPRGHOߨଵǡ ߨଶǡ ߨଷUHSUHVHQWWKHHIIHFWRISHULRGZLWKWKHFRQVWUDLQWߨଵ൅ߨଶ൅ߨଷ 
/HQVZLOOEHGHWHUPLQHGE\VHTXHQFHMWKHUHIRUHLLVGHQRWHGDVDIXQFWLRQRIM:HGHILQH
CR-6283, v3.0 Amendment 2.0
Page 64 of 176
JJVC CONFIDENTIAL

/HQV  IRU WKH &RQWURO OHQV DQG  ൌͳ IRU WKH 7HVW OHQV VHTXHQFH LV GHILQHG DV
6HTXHQFH IRUWKHRUGHU&RQWURO7HVW7HVWDQG6HTXHQFH IRURUGHU7HVW&RQWURO&RQWURO
7KHILUVWRUGHUFDUU\RYHUHIIHFWZLOOEHGHILQHGDVFDUU\ IRUWKH&RQWUROOHQVDQGFDUU\ IRU
WKH7HVWOHQV6RߚଵVWDQGVIRUWKHGLIIHUHQFHEHWZHHQWKH7HVW DQG&RQWUROOHQV DWSHULRG
ZLWK UHVSHFW WR &/8(FRPIRUW$SRVLWLYHߚଵLQGLFDWHVWKH 7HVW SHUIRUPHGEHWWHUWKDQWKH
&RQWURO
:HDVVXPHUDQGRPVLWHHIIHFWV DUHLQGHSHQGHQWDQGLGHQWLFDOO\GLVWULEXWHGLLGDVߛ௞a1
ߪ௦௜௧௘
ଶ
IRUVLWHIRUL  OHQVM  VHTXHQFHN     DQG VLWH 
For the ȕ coefficients, independent nonLQIRUPDWLYHSULRUV1ZLOOEHXVHG)RUWKH
YDULDQFHRIUDQGRPHIIHFWRIߪ௦௜௧௘
ଶ
DQLQGHSHQGHQWQRQLQIRUPDWLYHFRQMXJDWHSULRULQYHUVH
gamma(0.001, 0.001) will be used. For Ȉ, nonLQIRUPDWLYH FRQMXJDWH SULRUV LQYHUVH
ZLVKDUW6ZLOOEHXVHGZKHUH6LVD;YDULDQFHFRYDULDQFHPDWUL[RIݕ௜௝௞௟6WDUWLQJYDOXHV
IRUWKHPHDQDQGYDULDQFHRI&/8(VFRUHVZLOOEHDQGVLQFHVWDQGDUGGHYLDWLRQRI
&/8(LVQRUPDOL]HGWREHUHVSHFWLYHO\7KH0HWURSROLVVDPSOHUDOJRULWKPDVLPSOHPHQWHG
LQWKH6$667$70&0& SURFHGXUHZLOOEHXVHGWRHVWLPDWHWKHSRVWHULRUGLVWULEXWLRQ
RIWKHXQNQRZQSDUDPHWHUV ,QIHUHQFHV ZLOOEHPDGHEDVHGRQWKHSRVWHULRUFUHGLEOH
LQWHUYDOVIRUUHOHYDQWSDUDPHWHUV
+\SRWKHVLV7HVWLQJ
7KHQXOODQGDOWHUQDWLYH K\SRWKHVHVIRU&/8(FRPIRUWQRQLQIHULRULW\RIWKH7HVW OHQVUHODWLYH
WRWKH&RQWUROOHQVDUHDVIROORZV
ܪ௢ǣ ߚଵİ 
ܪ஺ǣ ߚଵ! 
1RQLQIHULRULW\ZLOOEHGHFODUHGLIWKHORZHUERXQGRIWKHVLGHGFUHGLEOHLQWHUYDORIWKH
GLIIHUHQFHEHWZHHQWKH7HVW OHQVDQGWKH&RQWUROOHQVLVJUHDWHUWKDQLH3ߚଵ! 5)  0.975. 
9LVLRQ6DWLVIDFWLRQLQ%ULJKW/LJKWLQJ
9LVLRQVDWLVIDFWLRQLQEULJKWOLJKWLQJZLOOEHDQDO\]HGXVLQJD%D\HVLDQPXOWLQRPLDOPRGHOIRU
RUGLQDOGDWD7KHUHJUHVVLRQPRGHOZLOOLQFOXGHVHTXHQFHRIOHQVZHDUOHQVW\SHSHULRGDQG
ILUVWRUGHUFDUU\RYHUHIIHFW&OLQLFDOVLWHDQGVXEMHFWQHVWHGZLWKLQFOLQLFDOVLWHZLOOEHLQFOXGHG
DVUDQGRPHIIHFWV2WKHUVXEMHFWFKDUDFWHULVWLFVVXFKDVDJHJHQGHUUDFHDQGLULVFDWHJRU\ZLOO
EHLQFOXGHGZKHQDSSURSULDWH
CR-6283, v3.0 Amendment 2.0
Page 65 of 176
JJVC CONFIDENTIAL

7KH0RGHO
/HWݕ௜௝௞௟௠ ݕ௜௝௞௟௠ଵ ݕ௜௝௞௟௠ଶ ݕ௜௝௞௟௠ଷ ݕ௜௝௞௟௠ସ ݕ௜௝௞௟௠ହGHQRWHWKHUDWLQJIRUWKH݉௧௛VXEMHFW
IURP WKH݈௧௛VLWH DVVLJQHG WR WKH݅௧௛VWXG\ OHQV LQ WKH݆௧௛SHULRG XVLQJ WKH݇௧௛VHTXHQFH
3RVVLEOHYDOXHVRIݕ௜௝௞௟௠DUHLIWKHVXEMHFWUDWLQJRIYLVLRQVDWLVIDFWLRQLQEULJKWOLJKWLQJ DUH
;DQGRWKHUZLVH[ IRU6WURQJO\$JUHHDQG; IRU6WURQJO\'LVDJUHHUHVSHFWLYHO\7KH
OLNHOLKRRGLVFRQVWUXFWHGDVIROORZV
ݕ௜௝௞௟௠a0XOWLQRPLDOܲ௜௝௞௟௠ଵ ܲ௜௝௞௟௠ଶ ܲ௜௝௞௟௠ଷ ܲ௜௝௞௟௠ସ ܲ௜௝௞௟௠ହ
ܲ௜௝௞௟௠ଵൌߛ௜௝௞௟௠ଵ
ܲ௜௝௞௟௠௑ൌߛ௜௝௞௟௠௑ߛ௜௝௞௟௠ሺ௑ିଵሻ2  n 4
ܲ௜௝௞௟௠ହൌͳ െ෍ܲ௜௝௞௟௠௑
௫ୀଵǡǤǤସ
/RJLW ߛ௜௝௞௟௠௑  ߠ௡ ߚଵܮ݁݊ݏ௜ሾ௝ǡ௞ሿ ߚଶܲ݁ݎ݅݋݀௝ଵ ߚଷܲ݁ݎ݅݋݀௝ଶ ߚସܵ݁ݍݑ݁݊ܿ݁௞
ߚହܥܽݎݎݕ௜ሾ௝ǡ௞ሿߛ௟ ߜ௠ሺ೗ሻ
:KHUHߠ௡LVWKHLQWHUFHSWIRUOHYHOVQ ܲ௜௝௞௟௠ଵൌሺߛ௜௝௞௟௠ଵൌͳሻZLWKUHVSHFWWRWKH
YLVLRQ VDWLVIDFWLRQ LQ EULJKW OLJKWLQJ LWHP :H DVVXPH WKH UDQGRP VXEMHFW HIIHFWV DUH
LQGHSHQGHQWLGHQWLFDOO\GLVWULEXWHGLLGDVߜ௠ሺ೗ሻa1ߪ௦௨௕௝௘௖௧
ଶ
IRUVXEMHFWPQHVWHGZLWKLQ
FOLQLFDOVLWHODQGWKHUDQGRPFOLQLFDOVLWHHIIHFWVDUHLLGDVߛ௟a1ߪ௦௜௧௘
ଶ
IRUL OHQV
M 3HULRGN 6HTXHQFHl=1, … 6LWH m=1, …݊௟VXEMHFWVLWH
,QWKLVPRGHOWKHOHQV,ZLOOEHGHWHUPLQHGE\WKHSHULRGMDQGVHTXHQFHNWKHUHIRUHLLVGHQRWHG
DVDIXQFWLRQRIMDQGN:HGHILQHܮ݁݊ݏ௜ IRUWKH&RQWUROOHQVDQGܮ݁݊ݏ௜ IRUWKH7HVWOHQV
7KHRGGVUDWLRIRUKDYLQJKLJKHUUDWLQJFDQEHZULWWHQDV25 ݁ఉଵ
,QGHSHQGHQWYDJXH1SULRUVIRUWKHUHJUHVVLRQFRHIILFLHQWVߚ௜i=1,…5. For ߠ௡ZHDUH
FRQVLGHULQJWKHIROORZLQJSULRUV
ʌ0(ș1) ~ N(0,100)
ʌș_șa1,ș!ș
ʌș_șa1,ș!ș
ʌ0(ș4| ș3) ~ N(0,100)I(ș>ș3)
)RU WKH YDULDQFH RI UDQGRP HIIHFWV LQGHSHQGHQW YDJXH QRUPDO SULRUV ZLOO DOVR EH XVHG
ߪ௉
ଶaLQYHUVHJDPPD  DQGߪ௦
ଶaLQYHUVHJDPPD  7KH 0HWURSROLV
VDPSOHDOJRULWKP DVLPSOHPHQWHGLQWKH6$66WDW0&0&3URFHGXUHZLOOEHXVHGWRHVWLPDWH
WKHSRVWHULRUGLVWULEXWLRQVRIWKHXQNQRZQSDUDPHWHUV,QIHUHQFHVZLOOEHPDGHEDVHGRQWKH
SRVWHULRUFUHGLEOHLQWHUYDOIRUWKHUHOHYDQWSDUDPHWHUV
CR-6283, v3.0 Amendment 2.0
Page 66 of 176
JJVC CONFIDENTIAL

+\SRWKHVLV7HVWLQJ
7KHQXOODQGDOWHUQDWLYHK\SRWKHVHVIRUVXSHULRULW\DUHDVIROORZV
ܪ௢ܱܴİ 
ܪ஺ܱܴ! 
:KHUH25UHSUHVHQWWKHRGGVUDWLRRIKDYLQJKLJKHUUDWLQJRIWKH7HVWOHQVFRPSDUHGWRWKH
&RQWUROOHQV1RQLQIHULRULW\ZLOOEHGHFODUHGLIWKHORZHUERXQGRIWKHVLGHGFUHGLEOH
FRQILGHQFHLQWHUYDOLVDERYHLH325 ݁ఉଵ!_\ 
3ULPDU\6DIHW\$QDO\VLV
/HQV)LW$FFHSWDQFH
/HQV ILW DFFHSWDQFH ZLOO EH DQDO\]HG XVLQJ D %D\HVLDQ /RJLVWLFUHJUHVVLRQ UDQGRPHIIHFWV
PRGHOWRHVWLPDWHWKHSURSRUWLRQRIVXEMHFWV’ H\HVZHDULQJWKH7HVW OHQVKDYLQJDFFHSWDEOHOHQV
ILWWLQJ 7KH UHJUHVVLRQ PRGHO ZLOO LQFOXGH SHULRG VHTXHQFH RI OHQV ZHDU DQG ILUVW RUGHU
FDUU\RYHUHIIHFW DVIL[HGHIIHFWV6LWHVXEMHFWQHVWHGZLWKLQVLWHDQGH\HZLWKLQVXEMHFWZLWKLQ
VLWHZLOOEHLQFOXGHGLQWKHPRGHODVUDQGRPHIIHFWV
/HWݕ௜௝௞௟௠ LIDQDFFHSWDEOHOHQVILWLVREVHUYHGIRUH\HVZHDULQJWKH7HVWOHQVRQO\DQG
ݕ௜௝௞௟௠ൌRWKHUZLVHIRUWKH݉௧௛VXEMHFWIURPWKH݈௧௛VLWHIRUWKH݅௧௛H\HLQWKH݆௧௛SHULRG
XVLQJWKH݇௧௛VHTXHQFH
୧୨୩୪୫̱ሺ୧୨୩୪୫ሻ 
 
୧୨୩୪୫ൌ
ሺܰݑ݉݁ݎܽݐ݋ݎሻ
ͳ ൅ሺܰݑ݉݁ݎܽݐ݋ݎሻ 
 
ܰݑ݉݁ݎܽݐ݋ݎ= Ⱦ଴൅ߚଵܮ݁݊ݏ௜ሾ௝ǡ௞ሿ൅Ⱦଷ݌݁ݎ݅݋݀௝ଵ൅Ⱦସ݌݁ݎ݅݋݀௝ଶ൅Ⱦହ୩൅Ⱦ଺ܥܽݎݎݕͳ௜ሾ௝ǡ௞ሿ൅
ɀ୪൅ߜ௠ሺ೗ሻ+ ߙ௝ሺ೘ሺ೗ሻሻ 
:HDVVXPHWKHUDQGRPVXEMHFWH\HHIIHFWVDUHLLGDVߙ௝ሺ೘ሺ೗ሻሻ̱ሺͲǡ ߪ݁ݕ݁
ʹ ሻIRUH\HQHVWHGZLWKLQ
VXEMHFWZLWKLQFOLQLFDOVLWHWKHUDQGRPHIIHFWIRUVXEMHFWDUHLLGDV ߜ௠ሺ೗ሻ̱ሺͲǡ ߪݏݑܾ݆݁ܿݐ
ʹ
ሻIRUVXEMHFW
QHVWHGZLWKLQFOLQLFDOVLWHDQGWKHUDQGRPFOLQLFDOVLWHHIIHFWVDUHLLGDVɀ୫a1ߪ௦௜௧௘
ଶ
 IRUL 
H\HM SHULRGN 6HTXHQFHO=1, … (Site) m=1, …݊௟VXEMHFWVLWH
)RUWKHȾ FRHIILFLHQWVLQGHSHQGHQWQRQLQIRUPDWLYHSULRUVሺͲǡ ͳͲͲͲͲሻZLOOEH XVHG)RUWKH
YDULDQFHRIUDQGRPHIIHFWV RIߪ௘௬௘
ଶɐୱ୳ୠ୨ୣୡ୲
ଶ
DQGɐୱ୧୲ୣ
ଶ
LQGHSHQGHQWQRQLQIRUPDWLYHFRQMXJDWH
SULRUV LQYHUVHJDPPD   ZLOO EH XVHG 7KH 0HWURSROLV+DVWLQJV DOJRULWKP DV
LPSOHPHQWHG LQ WKH 6$667$7  352& 0&0& SURFHGXUH ZLOO EH XVHG WR HVWLPDWH
SRVWHULRU GLVWULEXWLRQV RI WKH XQNQRZQ SDUDPHWHUV ,QIHUHQFHV ZLOO EH PDGH EDVHG RQ WKH
SRVWHULRUFUHGLEOHLQWHUYDOIRUWKHUHOHYDQWSDUDPHWHUV
CR-6283, v3.0 Amendment 2.0
Page 67 of 176

+\SRWKHVLV7HVWLQJ
:LWKUHVSHFWWR$FFHSWDEOHOHQVILWWKHQXOODQGDOWHUQDWLYHK\SRWKHVLV IRUVXSHULRULW\LV DV
IROORZV
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:KHUHSUHSUHVHQWVWKHSURSRUWLRQRIVXEMHFWH\HVWKDWDFKLHYHDFFHSWDEOHILWIRUWKH7HVW
OHQV
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LQWHUYDORIWKHSURSRUWLRQLVJUHDWHUWKDQ LHሺ ൐ͲǤͻͲሻ൒Ǥͻ͹ͷ
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3ULPDU\VDIHW\DQDO\VLV
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LQFOXGHEDVHOLQHVOLWODPSILQGLQJVOHQVW\SHSHULRGVHTXHQFHRIOHQVZHDUDQGILUVWRUGHU
FDUU\RYHUHIIHFW6LWHVXEMHFWQHVWHGZLWKLQVLWHDQGH\HZLWKLQVXEMHFWZLWKLQVLWHZLOOEH
LQFOXGHGLQWKHPRGHODVUDQGRPHIIHFWV
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VXEMHFWIURPWKH݉௧௛VLWHDVVLJQHGWRWKH݅௧௛VWXG\OHQVIRUWKH݆௧௛H\HLQWKH݇௧௛SHULRGXVLQJ
WKH ݈௧௛VHTXHQFH
୧୨୩୪୫୬̱ሺ୧୨୩୪୫୬ሻ 
 
୧୨୩୪୫୬ൌ
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ͳ ൅ሺܰݑ݉݁ݎܽݐ݋ݎሻ 
 
ܰݑ݉݁ݎܽݐ݋ݎ=Ⱦ଴൅ߚͳܮ݁݊ݏ݆݅ሾ݇ǡ݈ሿ൅Ⱦଶ	୪൅Ⱦଷ݌݁ݎ݅݋݀௞ଵ൅Ⱦସ݌݁ݎ݅݋݀௞ଶ൅
Ⱦହ୩൅Ⱦ଺ܥܽݎݎݕͳ݅ሾ݇ǡ݈ሿ൅ɀ୫൅ߜ݊ሺ݉ሻ൅ߙ௝ሺ೙ሺ೘ሻሻ 
:HDVVXPHWKHUDQGRPVXEMHFWH\HHIIHFWVDUHLLGDVߙ௝ሺ೙ሺ೘ሻሻ̱ሺͲǡ ߪ݁ݕ݁Ȁݏݑܾ݆݁ܿݐȀݏ݅ݐ݁
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