UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019650 |
|---|---|
| Receipt number | R000021039 |
| Scientific Title | Bacteriological analysis of the human conjunctival flora under a long-term instillation of ophthalmic solutions |
| Date of disclosure of the study information | 2015/11/05 |
| Last modified on | 2015/11/05 18:34:33 |
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Basic information
Public title
Bacteriological analysis of the human conjunctival flora under a long-term instillation of ophthalmic solutions
Acronym
Bacteriological analysis of the human conjunctival flora under a long-term instillation of ophthalmic solutions
Scientific Title
Bacteriological analysis of the human conjunctival flora under a long-term instillation of ophthalmic solutions
Scientific Title:Acronym
Bacteriological analysis of the human conjunctival flora under a long-term instillation of ophthalmic solutions
Region
| Japan |
Condition
Condition
Patients with glaucoma under topical ophthalmic treatment.
Patients with a long-term steroid instillation.
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Bacteriological analysis of the human conjunctival flora under a long-term instillation of ophthalmic solutions
Basic objectives2
Others
Basic objectives -Others
Analysis of the influence of ophthalmic topical treatment of the conjunctival flora
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Positive isolation rate of bacteria from the conjuncitiva.
Bacterial prevalence in the conjunctiva flora.
Antibiotic susceptibility of isolated bacteria
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Glaucoma patients treated with ophthalmic solutions for reduction of intraocular pressurein more than one year, or
2) Patients treated with steroid ophthalmic solutions more than three months.
Key exclusion criteria
"1) Patients with a history of antibiotics administration within two weeks prior to the study,
2) Patients suspecting any infectious ocular diseases, and/ or
3) Patients whom investigators considered not to be are eligible. "
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Miyata |
Organization
Miyata eye Hospital
Division name
Miyata eye Hospital
Zip code
Address
6-3 Kurahara Miyakonojo Miyazaki 885-0051
TEL
0986221441
miyata@miyata-med.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryohei Nejima |
Organization
Miyata eye Hospital
Division name
Miyata eye Hospital
Zip code
Address
6-3 Kurahara Miyakonojo Miyazaki 885-0051
TEL
0986221441
Homepage URL
nejima@miyata-med.ne.jp
Sponsor or person
Institute
Miyata eye Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2015 | Year | 11 | Month | 05 | 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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | 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
Patients were continuously enrolled for this study at Miyata Eye Hospital between February and September 2014, which were received continuous monotherapy with prostaglandin analogs for glaucoma for at least 1 year.
Management information
Registered date
| 2015 | Year | 11 | Month | 05 | Day |
Last modified on
| 2015 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021039
