UMIN-CTR Clinical Trial

Basic information
Public title	Questionnaire survey on participation in treatment for general consumers
Acronym	Questionnaire survey on participation in treatment
Scientific Title	Questionnaire survey on participation in treatment for general consumers
Scientific Title:Acronym	Questionnaire survey on participation in treatment
Region	Japan

Condition
Condition	Glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The intention to participate in the selection of therapeutic agents and the intention to continue eye drops and the intention to continue to visit a hospital by participating in the selection of therapeutic agents will be investigated in general consumers who have not been diagnosed with glaucoma, assuming that they have been diagnosed with glaucoma for the first time.
Basic objectives2	Others
Basic objectives -Others	Intention to participate in the selection of therapeutic agens Intention to adhere to instillation and continue visiting hospitals by participating in the selection of therapeutic agents
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Intention to participate in the selection of therapeutic agents Intention to adhere to instillation and continue visiting hospitals by participating in the selection of therapeutic agents
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	General consumers over the age of 40 who have never been diagnosed with glaucoma
Key exclusion criteria	Those who previously diagnosed with glaucoma Those who have relatives diagnosed with glaucoma Medical professionals (doctors, pharmacists, nurses, etc.) Those engaged in the manufacturing of pharmaceuticals and medical products Person engaged in drug marketing
Target sample size	100

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, Development Management Department, Japan Business
Zip code	530-8552
Address	4-20, Ofukacho, Kita-ku, Osaka
TEL	06-4802-9603
Email	clinical@santen.co.jp

Public contact
Name of contact person	1st name Etsuyo Middle name Last name Miyamoto
Organization	Santen Pharmaceutical Co., Ltd.
Division name	Japan Medical Affairs, Development Management Department, Japan Business
Zip code	530-8552
Address	4-20, Ofukacho, Kita-ku, Osaka
TEL	06-4802-9603
Homepage URL
Email	clinical@santen.co.jp

Sponsor
Institute	Santen Pharmaceutical Co., Ltd.
Institute
Department

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	Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address	1, 3, Kichijoji Kita-cho, Musashino-shi, Tokyo
Tel	070-5011-8550
Email	shingo-namiki@cmicgroup.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	2020 Year 06 Month 19 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	108
Results	More than 70 percent of the subjects answered that they would like to be involved in drug selection when they are diagnosed with glaucoma for the first time and decide on a treatment, and they indicated higher treatment compliance and intention to continue hospital visits when they involved in drug selection. From these facts, it is considered desirable for patients to be involved in the drug selection in in order to improving adherence.
Results date posted	2021 Year 04 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 02 Month 27 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	2020 Year 01 Month 27 Day
Date of IRB	2020 Year 02 Month 07 Day
Anticipated trial start date	2020 Year 02 Month 22 Day
Last follow-up date	2022 Year 02 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Questionnaire survey in the venue Subjects were recruited from a research panel living in Kansai area.

Management information
Registered date	2020 Year 06 Month 19 Day
Last modified on	2021 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046609