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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040646
Receipt No. R000046392
Scientific Title Questionnaire survey on the usability of eye drop aid Just in in patients with glaucoma
Date of disclosure of the study information 2020/08/01
Last modified on 2020/08/03

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Basic information
Public title Questionnaire survey on the usability of eye drop aid Just in in patients with glaucoma
Acronym Questionnaire survey on the usability of eye drop aid
Scientific Title Questionnaire survey on the usability of eye drop aid Just in in patients with glaucoma
Scientific Title:Acronym Questionnaire survey on the usability of eye drop aid
Region
Japan

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

Objectives
Narrative objectives1 To assess the usability and utility of Just in in glaucoma patients
Basic objectives2 Others
Basic objectives -Others Usability of Just in
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Usability of Just in
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 Glaucoma patients visiting the ophthalmology department of Kobe University Hospital.
Self-instillation
Key exclusion criteria Those with best corrected visual acuity less than 0.1 for both eyes
Those who had undergone intraocular surgeries within 1 month (for glaucoma filtrating surgeries, within three months).
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Mari
Middle name
Last name Sakamoto
Organization Kobe University Graduate School of Medicine
Division name Department of Surgery, Division of Ophthalmology
Zip code 650-0017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City
TEL 078-382-6048
Email mariwsakamoto@people.kobe-u.ac.jp

Public contact
Name of contact person
1st name Yasutaka
Middle name
Last name Takagi
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 Kobe University
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 Kobe University Graduate School of Medicine IRB
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe City
Tel 078-382-6669
Email kansatsu@med.kobe-u.ac.jp

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 神戸大学医学部附属病院/ Kobe University Hospital

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 01 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 Open public recruiting
Date of protocol fixation
2020 Year 05 Month 26 Day
Date of IRB
2020 Year 07 Month 20 Day
Anticipated trial start date
2020 Year 08 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Questionnaire survey in patients with glaucoma

Management information
Registered date
2020 Year 06 Month 04 Day
Last modified on
2020 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046392

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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