UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006395 |
|---|---|
| Receipt number | R000007588 |
| Scientific Title | The effect of diquafosol sodium ophthalmic solutions on the microbial flora of ocular surface |
| Date of disclosure of the study information | 2011/11/15 |
| Last modified on | 2011/09/22 18:43:09 |
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Basic information
Public title
The effect of diquafosol sodium ophthalmic solutions on the microbial flora of ocular surface
Acronym
The effect of eye drop on microbial flora
Scientific Title
The effect of diquafosol sodium ophthalmic solutions on the microbial flora of ocular surface
Scientific Title:Acronym
The effect of eye drop on microbial flora
Region
| Japan |
Condition
Condition
dry eye and prosthesis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of diquafosol sodium ophthalmic solutions on the microbial flora of patients with dry eye or prosthesis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
change of microbial flora
quantity of viable bacteria
analysis using 16 S rDNA clone library
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
ophthalmic solution
Interventions/Control_2
ophthalmic solution
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
dry eye, dry eye suspected, and patients with prosthesis
Key exclusion criteria
The patients who do not consent with this study.
Infectious disease
The patients who are anxious about this study.
The patients who has an allergy for diquafosol sodium ophthalmic solutions.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Eguchi |
Organization
Tokushima University Hospital
Division name
Ophthalmologhy
Zip code
Address
3-18-15, Kuramotocho,Tokushima-shi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokushima University Hospital
Division name
Ophthalmology
Zip code
Address
TEL
088-633-7163
Homepage URL
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Tokushima University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 11 | Month | 15 | 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
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
Preinitiation
Date of protocol fixation
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 22 | Day |
Last modified on
| 2011 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007588
