UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037770 |
|---|---|
| Receipt number | R000043073 |
| Scientific Title | Persistence rate of out-patients visit in glaucoma patients (Collect additional data) |
| Date of disclosure of the study information | 2019/08/22 |
| Last modified on | 2020/10/16 15:40:07 |
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Basic information
Public title
Persistence rate of out-patients visit in glaucoma patients (Collect additional data)
Acronym
Persistence rate of out-patients visit in glaucoma patients (Collect additional data)
Scientific Title
Persistence rate of out-patients visit in glaucoma patients (Collect additional data)
Scientific Title:Acronym
Persistence rate of out-patients visit in glaucoma patients (Collect additional data)
Region
| Japan |
Condition
Condition
Glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the effect of anti-dropout tool, intraocular pressure (IOP) change between pre and post of persisting visit are investigate, and discuss the IOP change after dropout.
Basic objectives2
Others
Basic objectives -Others
To estimate the effect of anti-dropout tool, intraocular pressure (IOP) change between pre and post of persisting visit are investigate, and discuss the IOP change after dropout.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraocular pressure change between pre and post persisting visit
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Twenty eight patients who persisted over 180-days continuous visit in the phase 2 of preceding glaucoma persistence rate study conducted by Santen
Key exclusion criteria
Not applicable
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Kiyotaka |
| Middle name | |
| Last name | Hori |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs Group, Development Management Department, Japan Business
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
clinical@santen.co.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Otsuka |
Organization
Santen Pharmaceutical Co., Ltd.
Division name
Japan Medical Affairs Group, Development Management Department, Japan Business
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9337
Homepage URL
clinical@santen.co.jp
Sponsor or person
Institute
Santen Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Santen 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
Non-Profit Organization MINS Institutional Review Board
Address
ST Shibuya Building 1-15-14, Dogenzaka, Shibuya-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2019 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
28
Results
The glaucoma patient visit persistence support system has proven to be effective in maintaining the persistence of the patients visits for newly diagnosed glaucoma.
Intraocular pressure after the implementation of this support system was significantly lower than at the time of the first visit, suggesting the usefulness of this system for the treatment of glaucoma.
(Ganka. 2020, 62(8), 801-807)
Results date posted
| 2020 | Year | 10 | Month | 16 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Under submission
Date of the first journal publication of results
| 2020 | Year | 08 | Month | 19 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a retrospective study about persistence rate of out-patients visit. We collect and analyze patients information of newly visiting glaucoma patients between April 2017 and May 2017 until November 2017.
Management information
Registered date
| 2019 | Year | 08 | Month | 22 | Day |
Last modified on
| 2020 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043073
| 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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| Registered date | File name |
