UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032397 |
|---|---|
| Receipt number | R000036951 |
| Scientific Title | Investigation for the effect of Tapros ophthalmic solution monotherapy on the bacterial flora of conjunctival sacs |
| Date of disclosure of the study information | 2018/05/10 |
| Last modified on | 2019/10/31 08:43:23 |
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Basic information
Public title
Investigation for the effect of Tapros ophthalmic solution monotherapy on the bacterial flora of conjunctival sacs
Acronym
Investigation for the effect of Tapros ophthalmic solution monotherapy on the bacterial flora of conjunctival sacs
Scientific Title
Investigation for the effect of Tapros ophthalmic solution monotherapy on the bacterial flora of conjunctival sacs
Scientific Title:Acronym
Investigation for the effect of Tapros ophthalmic solution monotherapy on the bacterial flora of conjunctival sacs
Region
| Japan |
Condition
Condition
glaucoma, ocular hypertension
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate for the effect of Tapros ophthalmic solution monotherapy on the bacterial flora of conjunctival sacs
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Minimum inhibitory concentrations and Qac genes in staphylococcus epidermidis isolated from conjunctival sacs.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tapros ophthalmic solution monotherapy for a year
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
Glaucoma or ocular hypertension patients who have not used other IOP-lowering drugs.
Key exclusion criteria
1) patients who used antibiotic ophthalmic solutions within the last year
2) patients who is using ophthalmic solutions containing benzalkonium chloride
3) patients who doctors judged improper
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazunori |
| Middle name | |
| Last name | Miyata |
Organization
Miyata Eye Hospital
Division name
Ophthalmology
Zip code
8850051
Address
6-3 Kuraharacho, Miyakonojo-shi, Miyazaki, Japan
TEL
0986-22-1441
miyata@miyata-med.ne.jp
Public contact
Name of contact person
| 1st name | Jinhee |
| Middle name | |
| Last name | Lee |
Organization
Miyata Eye Hospital
Division name
Ophthalmology
Zip code
8850051
Address
6-3 Kuraharacho, Miyakonojo-shi, Miyazaki, Japan
TEL
0986-22-1441
Homepage URL
jri-tky@umin.ac.jp
Sponsor or person
Institute
Miyata Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
self-funding
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
Miyata Eye hospital
Address
Kurahara-cho-6-3
Tel
0986-22-1441
jri-tky@umin.ac.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
| 2018 | Year | 05 | Month | 10 | 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
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 26 | Day |
Last modified on
| 2019 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036951
