UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007622 |
|---|---|
| Receipt number | R000008998 |
| Scientific Title | Pre-Operative Sterilization Study of Levofloxacin Ophthalmic Solution 1.5% |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2016/02/03 08:19:46 |
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Basic information
Public title
Pre-Operative Sterilization Study of Levofloxacin Ophthalmic Solution 1.5%
Acronym
Pre-Operative Sterilization Study of Levofloxacin Ophthalmic Solution
Scientific Title
Pre-Operative Sterilization Study of Levofloxacin Ophthalmic Solution 1.5%
Scientific Title:Acronym
Pre-Operative Sterilization Study of Levofloxacin Ophthalmic Solution
Region
| Japan |
Condition
Condition
Diseases necessary for intraocular Surgery
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study efficacy and safety of Levofloxacin Ophthalmic Solution 1.5% in Patients Scheduled for eye Surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Pre-Operative bacterial eradication rate of Levofloxacin Ophthalmic Solution 1.5%
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
Administration of antibacterial ophthalmic solution
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Fifteen and under children and 20 and upper adults
2.Patients scheduled for intraocular surgery
Key exclusion criteria
1.Patients with history of hypersensitivity or severe adverse effects on newquinolone antibiotics
2.Patients suspecting bacterium, fungus or virus infection
3.Patients administered antibiotics or immunosuppressants within 3 months prior to the study
4.Patients hospitalized other than ocular surgeries
5.Patients with uncontrollable underlying disorders or complications
6.Pregnant or breast-feeding women
7.Patients wearing contact lenses during the study
8.Patients having history of ocular surgery within 3 months prior to the study on the study eye
9. Patients whom investigators estimate are not eligible
Target sample size
80
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
0986-22-1441
miyata@miyata-med.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Terada |
Organization
Miyata eye Hospital
Division name
Miyata eye Hospital
Zip code
Address
6-3 Kurahara Miyakonojo Miyazaki 885-0051
TEL
0986-22-1441
Homepage URL
yukkkkkk@gk9.so-net.ne.jp
Sponsor or person
Institute
Miyata eye Hospital
Institute
Department
Personal name
Funding Source
Organization
Santen 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
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
| 2012 | Year | 04 | 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
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
| 2012 | Year | 02 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | 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
| 2012 | Year | 03 | Month | 30 | Day |
Last modified on
| 2016 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008998
