ID

43487

Description

ODM derived from http://clinicaltrials.gov/show/NCT00856622

Link

http://clinicaltrials.gov/show/NCT00856622

Keywords

Versions (3)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/16/14 4/16/14 - Julian Varghese
  3. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00856622 Ocular Hypertension

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
Description

Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205092
SNOMED CT 2011_0131
66459002
UMLS CUI 2011AA
C0238767
SNOMED CT 2011_0131
51440002
UMLS CUI 2011AA
C0339573
SNOMED CT 2011_0131
77075001
MedDRA 14.1
10036719
ICD-10-CM Version 2010
H40.11
ICD-9-CM Version 2011
365.11
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0206368
SNOMED CT 2011_0131
111514006
MedDRA 14.1
10037118
ICD-9-CM Version 2011
365.52
UMLS CUI 2011AA
C1411998
SNOMED CT 2011_0131
46168003
ICD-9-CM Version 2011
365.13
UMLS CUI 2011AA
C0028840
SNOMED CT 2011_0131
4210003
MedDRA 14.1
10030043
ICD-10-CM Version 2010
H40.0
ICD-9-CM Version 2011
365.04
Patients currently on IOP reducing therapy: IOP >= 25mmHg (two IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP >= 30mmHg (two IOP determinations at pre-study separated by at least one hour).
Description

Patients currently on IOP reducing therapy: IOP >= 25mmHg (two IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP >= 30mmHg (two IOP determinations at pre-study separated by at least one hour).

Data type

boolean

Alias
UMLS CUI 2011AA
C0150312
SNOMED CT 2011_0131
52101004
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0021888
SNOMED CT 2011_0131
41633001
LOINC Version 232
MTHU034775
UMLS CUI 2011AA
C0442797
SNOMED CT 2011_0131
260371004
UMLS CUI 2011AA
C0039798
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
History of acute angle closure or closed/barely open anterior chamber angle.
Description

History of acute angle closure or closed/barely open anterior chamber angle.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205178
SNOMED CT 2011_0131
272118002
UMLS CUI 2011AA
C0429528
SNOMED CT 2011_0131
251726002
UMLS CUI 2011AA
C0429524
SNOMED CT 2011_0131
251722000
Current use of contact lenses.
Description

Current use of contact lenses.

Data type

boolean

Alias
UMLS CUI 2011AA
C0521116
SNOMED CT 2011_0131
15240007
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
C0009836
SNOMED CT 2011_0131
57368009
LOINC Version 232
MTHU013784
Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
Description

Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.

Data type

boolean

Alias
UMLS CUI 2011AA
C1705869
SNOMED CT 2011_0131
422191005
UMLS CUI 2011AA
C1319234
SNOMED CT 2011_0131
404636007
Ocular inflammation/infection occurring within three months prior to pre-study visit.
Description

Ocular inflammation/infection occurring within three months prior to pre-study visit.

Data type

boolean

Alias
UMLS CUI 2011AA
C0239429
MedDRA 14.1
10015943
UMLS CUI 2011AA
C0015403
SNOMED CT 2011_0131
128351009
MedDRA 14.1
10015929
CTCAE 1105E
E11391
Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
Description

Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.

Data type

boolean

Alias
UMLS CUI 2011AA
C0020517
SNOMED CT 2011_0131
418634005
ICD-10-CM Version 2010
T78.40
UMLS CUI 2011AA
C0005026
SNOMED CT 2011_0131
64686009
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1705248
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
Description

Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205161
SNOMED CT 2011_0131
263654008
UMLS CUI 2011AA
C1299003
UMLS CUI 2011AA
C0348080
SNOMED CT 2011_0131
260905004
HL7 V3 2006_05
COND
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.
Description

Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.

Data type

boolean

Alias
UMLS CUI 2011AA
C0018801
SNOMED CT 2011_0131
155374007
MedDRA 14.1
10019279
ICD-9-CM Version 2011
428
CTCAE 1105E
E10124
UMLS CUI 2011AA
C0085610
SNOMED CT 2011_0131
49710005
MedDRA 14.1
10040741
ICD-10-CM Version 2010
R00.1
CTCAE 1105E
E10208
UMLS CUI 2011AA
C0264906
SNOMED CT 2011_0131
195042002
MedDRA 14.1
10003677
ICD-10-CM Version 2010
I44.1
UMLS CUI 2011AA
C0151517
SNOMED CT 2011_0131
27885002
MedDRA 14.1
10003673
ICD-10-CM Version 2010
I44.2
ICD-9-CM Version 2011
426.0
CTCAE 1105E
E10093
Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).
Description

Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0004096
SNOMED CT 2011_0131
195967001
MedDRA 14.1
10003553
LOINC Version 232
MTHU020815
ICD-10-CM Version 2010
J45
ICD-9-CM Version 2011
493
UMLS CUI 2011AA
C0024117
SNOMED CT 2011_0131
13645005
MedDRA 14.1
10009033
ICD-10-CM Version 2010
J44.9
ICD-9-CM Version 2011
496
Pregnancy, Gestation
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI 2011AA
C0549206
SNOMED CT 2011_0131
289908002
MedDRA 14.1
10036556
LOINC Version 232
MTHU035048
Women of childbearing potential who has not used adequate contraceptive methods during the last three months.
Description

Women of childbearing potential who has not used adequate contraceptive methods during the last three months.

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0420844
SNOMED CT 2011_0131
169450001
Inability to adhere to treatment/visit plan.
Description

Inability to adhere to treatment/visit plan.

Data type

boolean

Alias
UMLS CUI 2011AA
C1299582
SNOMED CT 2011_0131
371151008
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C1301732
SNOMED CT 2011_0131
397943006
Have participated in any other clinical study within one month prior to pre-study visit.
Description

Have participated in any other clinical study within one month prior to pre-study visit.

Data type

boolean

Alias
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C2348558
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
Item
Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
boolean
C0205092 (UMLS CUI 2011AA)
66459002 (SNOMED CT 2011_0131)
C0238767 (UMLS CUI 2011AA)
51440002 (SNOMED CT 2011_0131)
C0339573 (UMLS CUI 2011AA)
77075001 (SNOMED CT 2011_0131)
10036719 (MedDRA 14.1)
H40.11 (ICD-10-CM Version 2010)
365.11 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0206368 (UMLS CUI 2011AA)
111514006 (SNOMED CT 2011_0131)
10037118 (MedDRA 14.1)
365.52 (ICD-9-CM Version 2011)
C1411998 (UMLS CUI 2011AA)
46168003 (SNOMED CT 2011_0131)
365.13 (ICD-9-CM Version 2011)
C0028840 (UMLS CUI 2011AA)
4210003 (SNOMED CT 2011_0131)
10030043 (MedDRA 14.1)
H40.0 (ICD-10-CM Version 2010)
365.04 (ICD-9-CM Version 2011)
Patients currently on IOP reducing therapy: IOP >= 25mmHg (two IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP >= 30mmHg (two IOP determinations at pre-study separated by at least one hour).
Item
Patients currently on IOP reducing therapy: IOP >= 25mmHg (two IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP >= 30mmHg (two IOP determinations at pre-study separated by at least one hour).
boolean
C0150312 (UMLS CUI 2011AA)
52101004 (SNOMED CT 2011_0131)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0021888 (UMLS CUI 2011AA)
41633001 (SNOMED CT 2011_0131)
MTHU034775 (LOINC Version 232)
C0442797 (UMLS CUI 2011AA)
260371004 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
History of acute angle closure or closed/barely open anterior chamber angle.
Item
History of acute angle closure or closed/barely open anterior chamber angle.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205178 (UMLS CUI 2011AA)
272118002 (SNOMED CT 2011_0131)
C0429528 (UMLS CUI 2011AA)
251726002 (SNOMED CT 2011_0131)
C0429524 (UMLS CUI 2011AA)
251722000 (SNOMED CT 2011_0131)
Current use of contact lenses.
Item
Current use of contact lenses.
boolean
C0521116 (UMLS CUI 2011AA)
15240007 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C0009836 (UMLS CUI 2011AA)
57368009 (SNOMED CT 2011_0131)
MTHU013784 (LOINC Version 232)
Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
Item
Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
boolean
C1705869 (UMLS CUI 2011AA)
422191005 (SNOMED CT 2011_0131)
C1319234 (UMLS CUI 2011AA)
404636007 (SNOMED CT 2011_0131)
Ocular inflammation/infection occurring within three months prior to pre-study visit.
Item
Ocular inflammation/infection occurring within three months prior to pre-study visit.
boolean
C0239429 (UMLS CUI 2011AA)
10015943 (MedDRA 14.1)
C0015403 (UMLS CUI 2011AA)
128351009 (SNOMED CT 2011_0131)
10015929 (MedDRA 14.1)
E11391 (CTCAE 1105E)
Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
Item
Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
boolean
C0020517 (UMLS CUI 2011AA)
418634005 (SNOMED CT 2011_0131)
T78.40 (ICD-10-CM Version 2010)
C0005026 (UMLS CUI 2011AA)
64686009 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1705248 (UMLS CUI 2011AA)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
Item
Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
boolean
C0205161 (UMLS CUI 2011AA)
263654008 (SNOMED CT 2011_0131)
C1299003 (UMLS CUI 2011AA)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
CL411789 (UMLS CUI 2011AA)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.
Item
Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.
boolean
C0018801 (UMLS CUI 2011AA)
155374007 (SNOMED CT 2011_0131)
10019279 (MedDRA 14.1)
428 (ICD-9-CM Version 2011)
E10124 (CTCAE 1105E)
C0085610 (UMLS CUI 2011AA)
49710005 (SNOMED CT 2011_0131)
10040741 (MedDRA 14.1)
R00.1 (ICD-10-CM Version 2010)
E10208 (CTCAE 1105E)
C0264906 (UMLS CUI 2011AA)
195042002 (SNOMED CT 2011_0131)
10003677 (MedDRA 14.1)
I44.1 (ICD-10-CM Version 2010)
C0151517 (UMLS CUI 2011AA)
27885002 (SNOMED CT 2011_0131)
10003673 (MedDRA 14.1)
I44.2 (ICD-10-CM Version 2010)
426.0 (ICD-9-CM Version 2011)
E10093 (CTCAE 1105E)
Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).
Item
Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0004096 (UMLS CUI 2011AA)
195967001 (SNOMED CT 2011_0131)
10003553 (MedDRA 14.1)
MTHU020815 (LOINC Version 232)
J45 (ICD-10-CM Version 2010)
493 (ICD-9-CM Version 2011)
C0024117 (UMLS CUI 2011AA)
13645005 (SNOMED CT 2011_0131)
10009033 (MedDRA 14.1)
J44.9 (ICD-10-CM Version 2010)
496 (ICD-9-CM Version 2011)
Pregnancy
Item
Pregnancy, Gestation
boolean
C0549206 (UMLS CUI 2011AA)
289908002 (SNOMED CT 2011_0131)
10036556 (MedDRA 14.1)
MTHU035048 (LOINC Version 232)
Women of childbearing potential who has not used adequate contraceptive methods during the last three months.
Item
Women of childbearing potential who has not used adequate contraceptive methods during the last three months.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0420844 (UMLS CUI 2011AA)
169450001 (SNOMED CT 2011_0131)
Inability to adhere to treatment/visit plan.
Item
Inability to adhere to treatment/visit plan.
boolean
C1299582 (UMLS CUI 2011AA)
371151008 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C1301732 (UMLS CUI 2011AA)
397943006 (SNOMED CT 2011_0131)
Have participated in any other clinical study within one month prior to pre-study visit.
Item
Have participated in any other clinical study within one month prior to pre-study visit.
boolean
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C2348558 (UMLS CUI 2011AA)
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