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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036821
Receipt No. 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

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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
Institute Nojima Hospital
Institute
Department

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
URL(English) https://upload.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


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