Comparison of Two Silicone Hydrogel Multifocal Contact Lenses
Phase: NA
Conditions: Visual Acuity
Sponsor: Johnson & Johnson Vision Care, Inc.

 
Johnson & Johnson Vision Care, Inc.
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CR-6344, v1.0
 
Page 1 of 259
JJVC Confidential 

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TABLE OF CONTENTS
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CR-6344, v1.0
 
Page 2 of 259
JJVC Confidential 

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CR-6344, v1.0
 
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TABLE OF CONTENTS
)LJXUH6WXG\)ORZFKDUW 
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TABLE OF CONTENTS
7DEOH7HVW$UWLFOHV 
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PROTOCOL TITLE, NUMBER, VERSION 
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JJVC Confidential 

 
AUTHORIZED SIGNATURES 
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1.3.
Summary of Findings from Nonclinical Studies 
1RW$SSOLFDEOH
1.4.
Summary of Known Risks and Benefits to Human Subjects 
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1.5.
Relevant Literature References and Prior Clinical Data Relevant to Proposed 
Clinical Study 
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2.
STUDY OBJECTIVES, ENDPOINTS AND HYPOTHESES 
2.1.
Objectives  
7KLV VWXG\ LV DQ HYDOXDWLRQ RI WKH OHQV ILW DQG KDQGOLQJ UHVSRQVH RI ERWK WKH $LU 2SWL[
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2.2.
Endpoints  
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2.3.
Hypotheses 
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7KHIROORZLQJK\SRWKHVHVZLOOEHWHVWHGWKURXJKRXWWKLVLQYHVWLJDWLRQ
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3ULPDU\+\SRWKHVHV
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EHLQJFHQWHUHGIRUWKHWHVWOHQVZLOOEHQRQLQIHULRUFRPSDUHGWRWKHFRQWUROOHQV$
QRQLQIHULRULW\PDUJLQRIRGGVUDWLRZLOOEHXVHG
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3.
TARGETED STUDY POPULATION 
3.1.
General Characteristics  
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3.2.
Inclusion Criteria 
3RWHQWLDOVXEMHFWVPXVWVDWLVI\DOOWKHIROORZLQJFULWHULDWREHHQUROOHGLQWKHVWXG\
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 7KHVXEMHFW¶VGLVWDQFHVSKHULFDOHTXLYDOHQWUHIUDFWLRQPXVWEHLQWKHUDQJHRI'
WR'RU'WR'LQHDFKH\H
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 7KHVXEMHFW¶V$''SRZHUPXVWEHLQWKHUDQJHRI'WR'
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UHDGLQJVSHFWDFOHVRYHUFRQWDFWOHQVHVPXOWLIRFDORUPRQRYLVLRQFRQWDFWOHQVHVHWF
RULIQRWUHVSRQGSRVLWLYHO\WRDWOHDVWRQHV\PSWRPRQWKH³3UHVE\RSLF6\PSWRPV
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3.3.
Exclusion Criteria 
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SDUWLFLSDWLQJLQWKHVWXG\
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OHQVZHDU
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ZKLFKPD\LQWHUIHUHZLWKFRQWDFWOHQVZHDU7KLVPD\LQFOXGHEXWQRWEHOLPLWHGWR
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6WHYHQV-RKQVRQV\QGURPHDQGLPPXQRVXSSUHVVLYHGLVHDVHVRUDQ\LQIHFWLRXV
GLVHDVHVHJKHSDWLWLVWXEHUFXORVLV
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VWDLQLQJWDUVDODEQRUPDOLWLHVRUEXOEDULQMHFWLRQRUDQ\RWKHUFRUQHDORURFXODU
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RIUHFXUUHQWFRUQHDOHURVLRQV
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 8VHRIDQ\RFXODUPHGLFDWLRQZLWKWKHH[FHSWLRQRIUHZHWWLQJGURSV
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3.4.
Enrollment Strategy 
6WXG\VXEMHFWVZLOOEHUHFUXLWHGIURP WKH ,QVWLWXWLRQFOLQLFDOVLWH¶VVXEMHFW GDWDEDVH DQGRU
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4.
STUDY DESIGN AND RATIONALE 
4.1.
Description of Study Design 
7KHFOLQLFDOVWXG\LVDUDQGRPL]HGFRQWUROOHGVLQJOHPDVNHGFURVVRYHUFOLQLFDOWULDO7KHUH
DUHWZRVWXG\WUHDWPHQWV$WRWDORIDSSUR[LPDWHO\VXEMHFWVZLOOEHHQUROOHGZLWK
P\RSLF DQG  K\SHURSLF HOLJLEOH VXEMHFWV WDUJHWHG WR FRPSOHWH WKH VWXG\ 7KH ILUVW 7HVW
DUWLFOHZLOOEHGLVSHQVHGIRUGD\DQGDQRSWLPL]DWLRQYLVLWZLOORFFXU7KHILQDOOHQVSDLU
ZLOO EH GLVSHQVHG IRU  GD\ DQG WKH DW WKH IROORZXS WKH ILQDO OHQV PHDVXUHPHQWV ZLOO
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OHQVZLOOWKHQEHILWDQGIROORZWKHVDPHVHTXHQFHDVWKHILUVWOHQV
4.2.
Study Design Rationale 
7KHVWXG\LVLQWHQGHGWRFRPSDUHWZRVWXG\OHQVW\SHVDQGWKHLQLWLDOSHUIRUPDQFHLQWHUPV
RI WKH PHFKDQLFDO OHQV ILW DQG KDQGOLQJ DIWHU D SHULRG RI OHQV GLVSHQVLQJ 7KH OHQVHV DUH
GLVSHQVHGWRGHWHUPLQHWKHKDQGOLQJUHVSRQVHVDQGWKHFRPSDULVRQLVPDGHDIWHUDWRWDORI
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7KH FURVVRYHU VWXG\ GHVLJQ ZDV FKRVHQ WR FRQWURO IRU YDULDEOHV WKDW PD\ LPSDFW WKH OHQV
SHUIRUPDQFHEHWZHHQVXEMHFWV$ZDVKRXWSHULRGEHWZHHQ3HULRGDQG3HULRGRIZHDULV
XVHGWRPLQLPL]HWKHFKDQFHRIFDUU\RYHUHIIHFWLQWKHVWXG\GDWD
4.3.
Enrollment Target and Study Duration 
$WRWDORIDSSUR[LPDWHO\HOLJLEOHVXEMHFWVZLOOEHHQUROOHGZLWKWDUJHWHGWRFRPSOHWH
WKHVWXG\7KHVWXG\ZLOOODVWDSSUR[LPDWHO\PRQWKV
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5.
TEST ARTICLE ALLOCATION AND MASKING 
5.1.
Test Article Allocation  
7KHVWXG\OHQVHVZLOOEHZRUQLQDELODWHUDODQGUDQGRPIDVKLRQXVLQJDîFURVVRYHUGHVLJQ
ZLWKOHQVW\SHVDQGSHULRGV8VLQJDFRPSXWHUJHQHUDWHGUDQGRPL]DWLRQVFKHPHSURYLGHG
E\WKHVWXG\ELRVWDWLVWLFLDQHDFKVXEMHFW ZLOOUDQGRPO\EHDVVLJQHGWR RQHRIWZRXQLTXH
VHTXHQFHV7HVW&RQWURORU&RQWURO7HVW5DQGRPL]DWLRQZLOOEHVWUDWLILHGE\VLWH
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3HUPXWHGEORFNUDQGRPL]DWLRQZLOOEHXVHGWRDYRLGELDVLQWKHDVVLJQPHQWRIVXEMHFWVWR
WUHDWPHQW DQG WR HQKDQFH WKH YDOLGLW\ RI VWDWLVWLFDO FRPSDULVRQV DFURVV WUHDWPHQW JURXSV
(DFKEORFNZLOOFRQWDLQWZRGLIIHUHQWOHQVWULDOVHTXHQFHV
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7KHRUGHURIOHQVZHDUZLOOEHEDVHGRQWKHUDQGRPL]DWLRQVFKHPHDVVLJQHGWRWKHVWXG\VLWH
7KHVWXG\VLWHZLOOIROORZWKHUDQGRPL]DWLRQVFKHPHSURYLGHGDQGZLOOFRPSOHWHHQUROOPHQW
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5.2.
Masking 
7KLVLVDVLQJOHPDVNHGVWXG\ZLWKWKHVXEMHFWVEHLQJPDVNHG7KHPDVNLQJZLOOEHSDUWLDODV
WKHVXEMHFWVZLOOKDYHGLIIHUHQWZHDUPRGDOLWLHVKRZHYHUWKHEUDQGQDPHRIWKHOHQVHVZLOO
QRWEHUHYHDOHGWRWKHVXEMHFW
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8QGHU QRUPDO FLUFXPVWDQFHV WKH PDVN VKRXOG QRW EH EURNHQ XQWLO DOO VXEMHFWV KDYH
FRPSOHWHGWKHVWXG\DQGWKHGDWDEDVHLVILQDOL]HG2WKHUZLVHWKHPDVNVKRXOGEHEURNHQ
RQO\ LI VSHFLILF HPHUJHQF\ WUHDWPHQWFRXUVH RI DFWLRQ ZRXOG EH GLFWDWHG E\ NQRZLQJ WKH
WUHDWPHQWVWDWXVRIWKHVXEMHFW,QVXFKFDVHVWKH,QYHVWLJDWRUPD\LQDQHPHUJHQF\FRQWDFW
WKHPHGLFDOPRQLWRU,QWKHHYHQWWKHPDVNLVEURNHQWKH6SRQVRUPXVWEHLQIRUPHGDVVRRQ
DVSRVVLEOH7KHGDWHWLPHDQGUHDVRQIRUWKHXQPDVNLQJPXVWEHGRFXPHQWHGLQWKHVXEMHFW
UHFRUG7KH,QYHVWLJDWRULVDOVRDGYLVHGQRWWRUHYHDOWKHVWXG\WUHDWPHQWDVVLJQPHQWWRWKH
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5.3.
Procedures for Maintaining and Breaking the Masking 
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QHFHVVDU\IRUWKHXUJHQWPHGLFDOWUHDWPHQWRIDVXEMHFW7KH6SRQVRUPXVWEHQRWLILHGEHIRUH
WKHPDVNLVEURNHQ
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Page 29 of 259
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CR-6344, v1.0
 
Page 33 of 259
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Page 37 of 259
JJVC Confidential 

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CR-6344, v1.0
 
Page 38 of 259
JJVC Confidential 

High and Low Contrast ETDRS Charts
0+&+&+&DQG/&/&
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Near, Bright Illuminance
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Distance, HC-1 Chart luminance
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Guillon-Poling, Near Chart 
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CR-6344, v1.0
 
Page 40 of 259
JJVC Confidential 

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CR-6344, v1.0
 
Page 41 of 259
JJVC Confidential 

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Page 43 of 259
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NOTE: In the event a lens is lost or 
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investigator site for replacement. As much 
as reasonably possible, a damaged lens 
should be returned to the investigational site 
and then returned to the Sponsor. If lens 
damage is present, complete the Product 
Quality Complaint Form. The lens will be 
stored in labeled vial with sterile saline and 
returned to the Sponsor.
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CR-6344, v1.0
 
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JJVC Confidential 

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as reasonably possible, a damaged lens 
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damage is present, complete the Product 
Quality Complaint Form. The lens will be 
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CR-6344, v1.0
 
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JJVC Confidential 

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CR-6344, v1.0
 
Page 48 of 259
JJVC Confidential 

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Product Quality Complaint Form. The lens 
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CR-6344, v1.0
 
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Near, Dim Illuminance (with Near goggles)
Reduced Guillon-Poling charts
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The room illuminance must be 
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Distance, HC-1 Chart luminance 
Acceptable Range 10.5-10.7 EV 
(181-208 cd/m2).
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Guillon-Poling, Near Chart 
Luminance Acceptable Range 10.8-
11.1 EV (223-274 cd/m2).
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Do not use the Mesopic filter for Dim 
luminance (Dim luminance will be 
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CR-6344, v1.0
 
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JJVC Confidential 

8.
SUBJECTS COMPLETION/WITHDRAWAL  
8.1.
Completion Criteria 
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JJVC Confidential 

9.
PRE-STUDY AND CONCOMITANT INTERVENTION/MEDICATION 
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Serious/Significant Adverse Events
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Non-Serious Adverse Events
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14.1. General Considerations 
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14.3. Analysis Populations 
Safety Population:
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Per-Protocol Population: 
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14.5. Primary Analysis  
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16.1. Access to Source Data/Document 
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APPENDIX B: PATIENT INSTRUCTION GUIDE  
 
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APPENDIX C: PACKAGE INSERT (APPROVED PRODUCT) 
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APPENDIX D: BINOCULAR OVER REFRACTION 
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APPENDIX E: PRESBYOPIC SYMPTOMS QUESTIONNAIRE 
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APPENDIX G: ALCON DAILIES TOTAL 1 MULTIFOCAL CONTACT LENS 
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JJVC Confidential 

APPENDIX H: ALCON AIR OPTIX MULTIFOCAL CONTACT LENS PLUS 
HYDRAGLYDE FITTING GUIDE 
 
 
 
 
 
 
 
 
 
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