UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020122 |
|---|---|
| Receipt number | R000023243 |
| Scientific Title | Evaluation of the eye drop bottles on the usability and visibility |
| Date of disclosure of the study information | 2015/12/08 |
| Last modified on | 2016/12/06 22:01:41 |
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Basic information
Public title
Evaluation of the eye drop bottles on the usability and visibility
Acronym
Evaluation of the eye drop bottles on the usability and visibility
Scientific Title
Evaluation of the eye drop bottles on the usability and visibility
Scientific Title:Acronym
Evaluation of the eye drop bottles on the usability and visibility
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence that the property of the eye drop bottles gives to the usability and visibility in glaucoma patients
Basic objectives2
Others
Basic objectives -Others
Usability
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall evaluation of scored usability and visibility of eye drop bottles
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 with glaucomatous visual field defect
2) Patients without experience of the use of eye drop bottles with the same design
Key exclusion criteria
Patients that cannot instill eye drops by themselves with disability
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiro Mizoue |
Organization
Ehime University
Division name
Ophthalmology
Zip code
Address
Shitsukawa, Toon-city, Ehime
TEL
089-960-5361
mizoue@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Kamao |
Organization
Ehime University
Division name
Ophthalmology
Zip code
Address
Shitsukawa, Toon-city, Ehime
TEL
089-960-5361
Homepage URL
t-kamao@m.ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
Institute
Department
Personal name
Funding Source
Organization
SENJU Pharmaceutical Co.,ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
南松山病院（愛媛県）Minami-matsuyama Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
case series
All glaucoma patients were examined who meet the selection criteria at Minami-matsuyama Hospital from December 2015 to March 2016.
Evaluation of scored usability and visibility of eye drop bottles using questionnare
Management information
Registered date
| 2015 | Year | 12 | Month | 08 | Day |
Last modified on
| 2016 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023243
