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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042916
Receipt No. R000048985
Scientific Title Comparison of the number of drops per container of Nevanac and Diclod
Date of disclosure of the study information 2021/01/05
Last modified on 2021/01/05

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Basic information
Public title Comparison of the number of drops per container of Nevanac and Diclod
Acronym Comparison of the number of drops per container of Nevanac and Diclod
Scientific Title Comparison of the number of drops per container of Nevanac and Diclod
Scientific Title:Acronym Comparison of the number of drops per container of Nevanac and Diclod
Region
Japan

Condition
Condition A person who can apply eye drops by oneself with comprehension
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of the number of drops per container of Nevanac and Diclod
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A dose of quantity and number of instillations
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
99 years-old >=
Gender Male and Female
Key inclusion criteria a person who can apply eye drops and be healthy
Key exclusion criteria a person who cannot apply eye drops
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Kazuaki
Middle name
Last name Nishimura
Organization Tsukazaki Hospital
Division name ophthalmology
Zip code 671-1277
Address 68-1 Waku,Aboshi-ku,Himeji-shi,Hyogo,Japan
TEL 0792-98-8555
Email k.nishimura@tsukazaki-eye.net

Public contact
Name of contact person
1st name Kazuaki
Middle name
Last name Nishimura
Organization Tsukazaki Hospital
Division name ophthalmology
Zip code 671-1277
Address 68-1 Waku,Aboshi-ku,Himeji-shi,Hyogo,Japan
TEL 0792-98-8555
Homepage URL
Email k.nishimura@tsukazaki-eye.net

Sponsor
Institute Tsukazaki Hospital
Institute
Department

Funding Source
Organization nothing
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 Tsukazaki Hospital
Address 68-1 Waku,Aboshi-ku,Himeji-shi,Hyogo,Japan
Tel 0792-98-8555
Email k.nishimura@tsukazaki-eye.net

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
2021 Year 01 Month 05 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 30
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 Completed
Date of protocol fixation
2015 Year 08 Month 01 Day
Date of IRB
2015 Year 08 Month 26 Day
Anticipated trial start date
2015 Year 08 Month 26 Day
Last follow-up date
2020 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information select who are healthy and random

Management information
Registered date
2021 Year 01 Month 05 Day
Last modified on
2021 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048985

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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