UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048578 |
|---|---|
| Receipt number | R000055356 |
| Scientific Title | Exploratory research for searching for the objective parameters related to study drug efficacy with the imaging data |
| Date of disclosure of the study information | 2022/08/04 |
| Last modified on | 2024/03/18 17:37:12 |
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Basic information
Public title
Exploratory research for searching for the objective parameters related to study drug efficacy with the imaging data
Acronym
Exploratory research for searching for the objective parameters related to study drug efficacy with the imaging data
Scientific Title
Exploratory research for searching for the objective parameters related to study drug efficacy with the imaging data
Scientific Title:Acronym
Exploratory research for searching for the objective parameters related to study drug efficacy with the imaging data
Region
| Japan |
Condition
Condition
Meibomian Gland Dysfunction
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using the image data obtained from patients with meibomian gland dysfunction who were prescribed the investigational drug, we will verify whether high-quality image data was obtained, and evaluate the feasibility whether it is possible to detect the effectiveness of the new ophthalmic solution based on the morphological changes with clinical information.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Morphological change of Meibomian gland and Lid margin before and after treatment
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
Patients who were administered an investigational drug including placebo at study sites during the study period, imaging data was taken, and clinical information was available.
Key exclusion criteria
Patients whose imaging data was not taken, or imaging data was not clear, or consent has not been obtained for its use.
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | Hisao |
| Middle name | |
| Last name | Shimada |
Organization
Santen Pharmaceutical Co. Ltd.
Division name
Ophthalmology Innovation center
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9339
clinical@santen.com
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shimizu |
Organization
Santen Pharmaceutical Co. Ltd.
Division name
Ophthalmology Innovation center
Zip code
530-8552
Address
4-20, Ofukacho, Kita-ku, Osaka
TEL
06-4802-9339
Homepage URL
clinical@santen.com
Sponsor or person
Institute
Santen Pharmaceutical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Santen Pharmaceutical Co. Ltd.
Address
4-20, Ofukacho, Kita-ku, Osaka
Tel
06-4802-9339
clinical@santen.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
| 2022 | Year | 08 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Due to the secondary use of clinical trial data, patient recruitment is not conducted to initiate this study, and the above "Anticipated trial start date" and "Last follow-up date" are the same as the protocol confirmation date.
Management information
Registered date
| 2022 | Year | 08 | Month | 04 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055356
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
