UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036821
Receipt number R000041826
Scientific Title The effect of iodine compounds on patients with adenoviral keratoconjunctivitis.
Date of disclosure of the study information 2019/06/01
Last modified on 2019/05/22 17:21:47

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Basic information

Public title

The effect of iodine compounds on patients with adenoviral keratoconjunctivitis.

Acronym

The effect of iodine on adenoviral keratoconjunctivitis.

Scientific Title

The effect of iodine compounds on patients with adenoviral keratoconjunctivitis.

Scientific Title:Acronym

The effect of iodine on adenoviral keratoconjunctivitis.

Region

Japan


Condition

Condition

adenoviral keratoconjunctivitis

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the effect of iodine compounds on patients with adenoviral keratoconjunctivitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The copy number of polymerase chain reaction copy number.

Period of recovery.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Topical iodine, 2 weeks.

Interventions/Control_2

conventional treatment, topical antibiotics

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patient with acute adenoviral keratoconjunctivitis.

Key exclusion criteria

The patient who has been treated elsewhere

Pregnancy

Presence of an ocular inflammation or infection other than adenoviral keratoconhunctivitis

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Kazuki
Middle name
Last name Matsuura

Organization

Nojima Hospital

Division name

Department of Ophthalmology

Zip code

682-0863

Address

Sezakimachi, Kurayoshi, 2514-1, Japan

TEL

0858-22-6231

Email

mastu224@ncn-k.net


Public contact

Name of contact person

1st name Kazuki
Middle name
Last name Matsuura

Organization

Nojima Hospital

Division name

Department of Ophthalmology

Zip code

682-0863

Address

Sezakimachi, Kurayoshi, 2514-1, Japan

TEL

0858-22-6231

Homepage URL


Email

mastu224@ncn-k.net


Sponsor or person

Institute

Nojima Hospital

Institute

Department

Personal name



Funding Source

Organization

Division of Ophthalmology and Visual Science, Faculty of Medicine, Tottori university

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nojima Hospital

Address

Sezakimachi, Kurayoshi, 2514-1, Japan

Tel

0858-22-6231

Email

matsu224@ncn-k.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

2019 Year 06 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

50

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

No longer recruiting

Date of protocol fixation

2017 Year 09 Month 01 Day

Date of IRB

2017 Year 06 Month 01 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2019 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 05 Month 22 Day

Last modified on

2019 Year 05 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041826


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name