UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035825
Receipt number R000040808
Scientific Title The examination of the efficacy of the quick tests for diagnosis in cases of conjunctivitis
Date of disclosure of the study information 2019/02/20
Last modified on 2019/02/09 12:42:27

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Basic information

Public title

The examination of the efficacy of the quick tests for diagnosis in cases of conjunctivitis

Acronym

The examination of the efficacy of the quick tests for diagnosis in cases of conjunctivitis

Scientific Title

The examination of the efficacy of the quick tests for diagnosis in cases of conjunctivitis

Scientific Title:Acronym

The examination of the efficacy of the quick tests for diagnosis in cases of conjunctivitis

Region

Japan


Condition

Condition

keratitis, conjunctivitis

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the improvement of the diagnostic accuracy for conjunctivitis by using two quick tests.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The detection rate with two quick tests for conjunctivitis

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

We perform two quick tests once on the same visit.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

eyes with relatively severe conjunctivitis

Key exclusion criteria

conjunctivitis with Stevens-Johnson syndrome and/or proliferative atopic keratoconjunctivitis
contact lens wearers
eyes with pretreatment

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroshi Fujishima

Organization

Tsurumi University Dental Hospital

Division name

Department of Ophthalmology

Zip code


Address

2-1-3 Tsurumi, Tsurumi-ku, Yokohama-shi, Kanagawa 230-8501 Japan

TEL

81455808500

Email

fujishima117@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Asako Kodama

Organization

Eiju General Hospital

Division name

Department of Ophthalmology

Zip code


Address

2-23-16 Higashiueno, Taito-ku, Tokyo 110-8645 Japan

TEL

81338338381

Homepage URL


Email

asa-chanyy_4747@kmh.biglobe.ne.jp


Sponsor or person

Institute

Tsurumi University Dental Hospital

Institute

Department

Personal name



Funding Source

Organization

We have no funding and conflicts of interest.

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


Address


Tel


Email



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

2019 Year 02 Month 20 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

Two quick tests improved the diagnostic accuracy for conjunctivitis and could diagnose more than 90% of cases.

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

2010 Year 01 Month 05 Day

Date of IRB


Anticipated trial start date

2010 Year 02 Month 01 Day

Last follow-up date

2010 Year 09 Month 30 Day

Date of closure to data entry

2010 Year 11 Month 30 Day

Date trial data considered complete

2010 Year 11 Month 30 Day

Date analysis concluded

2011 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 02 Month 09 Day

Last modified on

2019 Year 02 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040808


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name