UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013696 |
|---|---|
| Receipt number | R000015935 |
| Scientific Title | Glaucoma Research on Adherence to Fixed Combination Eye Drops study |
| Date of disclosure of the study information | 2014/04/11 |
| Last modified on | 2014/04/11 17:29:09 |
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Basic information
Public title
Glaucoma Research on Adherence to Fixed Combination Eye Drops study
Acronym
GRACE study
Scientific Title
Glaucoma Research on Adherence to Fixed Combination Eye Drops study
Scientific Title:Acronym
GRACE study
Region
| Japan |
Condition
Condition
primary open angle glaucoma,pseudo-exfoliation glaucoma,ocular hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze factors affecting glaucoma treatment adherence in Japanese glaucoma patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy
To analyze factors affecting glaucoma treatment adherence
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
give the patients adherence guidance for both tolerability and effect of glaucoma treatment after 1 month follow up
Interventions/Control_2
give the patients adherence guidance for only tolerability of glaucoma treatment after 1 month follow up
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients under treatment without glaucoma fixed combination eye drops.
2.Patients needed treatment of glaucoma fixed combination drugs.
3.Patients agreee with this study.
Key exclusion criteria
1.Changes of any glaucoma treatment under this study.
2.No recording at forgotten administration of glaucoma treatment in the questionaire.
3.Patients who are judged to be inappropriate for participation in the study for other reason by the doctor in charge.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Araie |
Organization
Kanto Central Hospital of The Mutual Aid Association of Public School
Division name
Director
Zip code
Address
6-25-1,Kamiyoga,Setagaya,Tokyo,Japan
TEL
03-3429-1171
araie-tky@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toyoaki Tsumura |
Organization
Fussa Hospital
Division name
department of ophthalmology
Zip code
Address
1-6-1,Kamidaira,Fussa,Tokyo,Japan
TEL
042-551-1111
Homepage URL
tsumura@fussahsp.jp
Sponsor or person
Institute
Glaucoma EyeDrops Adherence Council
Institute
Department
Personal name
Funding Source
Organization
Pfizer Japan Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
shinwa Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
関東中央病院（東京都）山梨大学附属病院（山梨県）、東海大学八王子病院（東京都）、中野総合病院（東京都）、吉川眼科クリニック（東京都）、前田眼科クリニック（東京都）、公立福生病院（東京都）、その他１０７４施設
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://pfizerpro.jp/cs/sv/grace/graceC_D/generalcontents/1259683469382/?f=rec2&aid=promo_contents
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2011 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 01 | Month | 19 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 11 | Day |
Last modified on
| 2014 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015935
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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