UMIN-CTR Clinical Trial

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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048578
Receipt No. 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 2022/08/04

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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
Email 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
Email clinical@santen.com

Sponsor
Institute Santen Pharmaceutical Co. Ltd.
Institute
Department

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
Email 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
2022 Year 08 Month 04 Day


Link to view the page
URL(English) 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


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