UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042916
Receipt number 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 19:47:07

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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 or person

Institute

Tsukazaki Hospital

Institute

Department

Personal name



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

Value
https://center6.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