UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000036473 |
|---|---|
| Receipt number | R000041562 |
| Scientific Title | The effect of the combination of intraocular pressure lowering drugs on the bacterial flora of the conjunctiva |
| Date of disclosure of the study information | 2019/04/12 |
| Last modified on | 2020/10/13 17:54:45 |
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Basic information
Public title
The effect of the combination of intraocular pressure lowering drugs on the bacterial flora of the conjunctiva
Acronym
The effect of the combination of intraocular pressure lowering drugs on the bacterial flora of the conjunctiva
Scientific Title
The effect of the combination of intraocular pressure lowering drugs on the bacterial flora of the conjunctiva
Scientific Title:Acronym
The effect of the combination of intraocular pressure lowering drugs on the bacterial flora of the conjunctiva
Region
| Japan |
Condition
Condition
ocular hypertension and glaucoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the combination of intraocular pressure lowering drugs on the bacterial flora of the conjunctiva
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The species of the bacteria and the sensitivity of staphylococcus epidermidis isolated from the conjunctiva before and one year after the addition of brimonidine.
Key secondary outcomes
1. The transition of the species of the bacteria and the sensitivity of staphylococcus epidermidis isolated from the conjunctiva.
2. The transition of the expression of gene of qacA/B, C/D from the isolated staphylococcus epidermidis.
3. The antibacterial effect of 0.1% brimonidine on the isolated staphylococcus epidermidis.
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
People who have been treated with prostaglandin analog alone for ocular hypertension or glaucoma and are necessary to add brimonidine.
Key exclusion criteria
1. People who have used intraocular pressure lowering drugs other than prostaglandin analog.
2. The use of antibacterial drug within three months from the initiation of brimonidine.
3. The use of eye drops with BAC within three months from the initiation of brimonidine.
4. People who have active ocular infection.
5. People who have severe underlying medical problems or complications.
6. People who are judged as improper for this study from the investigators.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Iwasaki |
Organization
Miyata Eye Hospital
Division name
Ophthalmology
Zip code
8850051
Address
6-3, Kurahara-cho, Miyakonojo, Miyazaki, Japan
TEL
0986-22-1441
tkyiwasaki@gmail.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Iwasaki |
Organization
Miyata Eye Hospital
Division name
Ophthalmology
Zip code
8850051
Address
6-3, Kurahara-cho, Miyakonojo, Miyazaki, Japan
TEL
0986-22-1441
Homepage URL
tkyiwasaki@gmail.com
Sponsor or person
Institute
Miyata Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
SENJU PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyata Eye hospital
Address
6-3, Kurahara-cho, Miyakonojo, Miyazaki, Japan
Tel
0986-22-1441
ushihama@miyata-med.ne.jp
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 | 04 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The species of the bacteria and the sensitivity of staphylococcus epidermidis isolated from the conjunctiva before, 3 months, 6 months, 9 months and one year after the addition of brimonidine were examined.
Management information
Registered date
| 2019 | Year | 04 | Month | 11 | Day |
Last modified on
| 2020 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041562
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
