UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037713 |
|---|---|
| Receipt number | R000043014 |
| Scientific Title | The safety and efficacy of AZM eye drops on patients with MGD -multi-center study |
| Date of disclosure of the study information | 2019/09/09 |
| Last modified on | 2019/08/17 11:51:12 |
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Basic information
Public title
The safety and efficacy of azimycin 1% eye drops on patients with posterior blepharitis multi-center study
Acronym
The efficacy of azimycin eye drops on MGD -multi-center study-
Scientific Title
The safety and efficacy of AZM eye drops on patients with MGD -multi-center study
Scientific Title:Acronym
The efficacy of AZM eye drops on MGD -multi-center study
Region
| Japan |
Condition
Condition
posterior blepharitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In four clinics, to evaluate the safety and efficacy of azimycin 1% eye drops for patients with posterior blepharitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ocular symptoms, lid margin abnormalities,quality and quantity of meibum, tear film breakup time, meiboscore
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
azmycin eyed drops plus warming eyelid/warming eyelids
Interventions/Control_2
warming eyelids
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) age is more than 18 years old
2) both gender is available
3) consent form is available
4) those who were defined as meibomian gland dysfunction
5) those who were defined as hyper-secretory MGD
6) Lid margin abnormalities
7) ocular symptoms
8) plugging and hypo-secretory MGD
Key exclusion criteria
StevensJohnson syndrome
acute ocular inflammation
ocular surface andor eye lid abnormalities
allergic conjunctivitis
CL wear
Ocular surgery history within 3 months
systemic diseases which might interfere with tear function
inappropriate characters
9) ocular diseases except cataract or refractive error
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Reiko |
| Middle name | |
| Last name | Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
3370042
Address
Saitama City
TEL
0486865588
ritoh@za2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | Arita |
| Last name | Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
3370042
Address
Saitama City
TEL
0486865588
Homepage URL
ritoh@za2.so-net.ne.jp
Sponsor or person
Institute
Itoh Clinic
Institute
Department
Personal name
Funding Source
Organization
Lid and meibomian gland working group
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Itoh Clinic
Address
626-11, Minaminakano, Minuma-ku
Tel
0486865588
ritoh@za2.so-net.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 | 09 | Month | 09 | 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
| 2019 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2020 | 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
| 2019 | Year | 08 | Month | 17 | Day |
Last modified on
| 2019 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043014
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
