UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001180 |
|---|---|
| Receipt number | R000001444 |
| Scientific Title | Correlation between a reduction of intraocular pressure and an increase of compliance with the eye drop guidance |
| Date of disclosure of the study information | 2008/06/09 |
| Last modified on | 2009/06/18 11:51:49 |
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Basic information
Public title
Correlation between a reduction of intraocular pressure and an increase of compliance with the eye drop guidance
Acronym
Effect of a guidance for eye drops on glaucoma treatment.
Scientific Title
Correlation between a reduction of intraocular pressure and an increase of compliance with the eye drop guidance
Scientific Title:Acronym
Effect of a guidance for eye drops on glaucoma treatment.
Region
| Japan |
Condition
Condition
glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of guidance for eye drops on the reduction of intraocular pressure and the patient compliance.
Basic objectives2
Others
Basic objectives -Others
non
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The intraocular pressure at the 3 months.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Period: for 3 months
To do the explanation of the disease and guidance for eye drops.
Interventions/Control_2
Period: for 3 months
To do the explanation of the disease.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Open-anglu glaucoma
Phase I >19 mmHg, Phase II >16 mmHg,
Phase III >14 mmHg.
2)Normal-tension glaucoma
More than 80% of IOP at pretreatment.
Key exclusion criteria
1)Patients have retinal diseases except optic neuropathy by glaucoma.
2)Patients who had attended other clinical trials 3 months before this IC.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sasamoto |
Organization
Sanyudo Hospital
Division name
Department of Ophthalmology
Zip code
Address
6-1-219, Chuou, Yonezawa-shi
TEL
0238-24-3700
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sasamoto |
Organization
Sanyudo Hospital
Division name
dept. Ophthalmology
Zip code
Address
6-1-219, Chuou, Yonezawa-shi
TEL
0238-24-3700
Homepage URL
http://www.sanyudo.or.jp
sasamoto@sanyudo.or.jp
Sponsor or person
Institute
Sanyudo Haspital
Institute
Department
Personal name
Funding Source
Organization
Sanyudo Haspital
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 06 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The intraocular pressure was decreased by the realization of glaucoma treatment and the training of eye drops in the glaucoma patients who had not reached the target intraocular pressure.
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
Completed
Date of protocol fixation
| 2007 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 06 | Month | 09 | Day |
Last modified on
| 2009 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001444
| 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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