An Observational Multicenter Clinical Study to Assess the Long-Term Safety of the CyPass Micro-Stent in Patients With Primary Open Angle Glaucoma Who Have Completed Participation in the COMPASS Trial
Phase: NA
Conditions: Primary Open Angle Glaucoma (POAG)
Sponsor: Alcon Research

Short Title
COMPASS-XT
Long Title
AN OBSERVATIONAL MULTICENTER CLINICAL STUDY TO ASSESS THE LONG-
TERM SAFETY OF THE CYPASS MICRO-STENT IN PATIENTS WITH PRIMARY OPEN 
ANGLE GLAUCOMA WHO HAVE COMPLETED PARTICIPATION IN THE COMPASS 
TRIAL (TMI-09-01-E)
1
TITLE PAGE
Protocol Number: 
Sponsor Name & Address:
Test Product(s): 
Approvals:
GLD122b-C001 / NCT02700984
Alcon Research, Ltd.
6201 South Freeway 
Fort Worth, Texas 76134-2099
CyPass
See last page for electronic approvals to Archive
The approval signature of ‘Clinical Management’ on this protocol signifies that quality 
control processes verify this protocol was correctly pulled into the document management 
system from an external source and is the protocol utilized for the aforementioned study. 
Page 1 of 49

Page 2 of 49

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PROTOCOL TMI-09-01-E 
VERSION G 
 
 
 
AN OBSERVATIONAL MULTICENTER CLINICAL STUDY TO ASSESS THE LONG-TERM 
SAFETY OF THE CYPASS MICRO-STENT IN PATIENTS WITH PRIMARY OPEN ANGLE 
GLAUCOMA WHO HAVE COMPLETED PARTICIPATION IN THE COMPASS TRIAL 
(TMI-09-01-E) 

 
THE COMPASS TRIAL EXTENSION (COMPASS-XT) 
 
 
SPONSOR: 
 
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Page 3 of 49

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Page 5 of 49

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PROTOCOL TMI-09-01-E 
VERSION G 
 
AN OBSERVATIONAL MULTICENTER CLINICAL STUDY TO ASSESS THE LONG-TERM 
SAFETY OF THE CYPASS MICRO-STENT IN PATIENTS WITH PRIMARY OPEN ANGLE 
GLAUCOMA WHO HAVE COMPLETED PARTICIPATION IN THE COMPASS TRIAL 
(TMI-09-01-E)

THE COMPASS TRIAL EXTENSION (COMPASS-XT) 
 
1
PERSONNEL AND FACILITIES 
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STUDY SPONSOR: 
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Page 18 of 49

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Page 45 of 49

Page 46 of 49

P a g e 4 7 of 4 9

T R A N S C E N D C Y P A S S M
I C R O- ST E N T
P R O T O C O L T MI- 0 9- 0 1- E  V E R SI O N G
A L C O N L A B O R A T O RI E S , I N C. 
2 6  OC T O B E R 2 0 1 6
C O N FI D E N TI A L
P R O T O C O L T MI- 0 9- 0 1- E 
V E R SI O N G
A N O B S E R V A TI O N A L M U L TI C E N T E R C LI NI C A L S T U D Y T O A S S E S S T H E L O N G- T E R M 
S A F E T Y O F T H E C Y P A S S  MI C R O- S T E N T I N P A TI E N T S WI T H P RI M A R Y O P E N A N G L E 
G L A U C O M A W H O H A V E C O M P L E T E D P A R TI CI P A TI O N I N T H E C O M P A S S T RI A L 
( T MI- 0 9- 0 1- E)
T H E C O M P A S S T RI A L E X T E N SI O N ( C O M P A S S- X T) 
S P O N S O R : 
A L C O N L A B O R A T O RI E S
6 2 0 1 S O U T H F R E E W A Y
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I ha ve re vie we d a n d a p pr o v e t h e el e m e nts of t his cli ni c al st u d y pr ot o c ol.
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P a g e 4 8 of 4 9

TRANSCEND CYPASS MICRO-STENT
PROTOCOL TMI-09-01-E VERSION G
ALCON LABORATORIES, INC.
26 OCTOBER 2016
CONFIDENTIAL



PROTOCOL TMI-09-01-E
VERSION G
AN OBSERVATIONAL MULTICENTER CLINICAL STUDY TO ASSESS THE LONG-TERM 
SAFETY OF THE CYPASS MICRO-STENT IN PATIENTS WITH PRIMARY OPEN ANGLE 
GLAUCOMA WHO HAVE COMPLETED PARTICIPATION IN THE COMPASS TRIAL 
(TMI-09-01-E)
THE COMPASS TRIAL EXTENSION (COMPASS-XT)
SPONSOR:
ALCON LABORATORIES
6201 SOUTH FREEWAY
FORT WORTH, TX 76134-2099
I have reviewed and approve the elements of this clinical study protocol.
__________
__________________
___________________
, MD, 
Date
Page 49 of 49
10/28/20