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
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
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
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
