UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039106 |
|---|---|
| Receipt number | R000044599 |
| Scientific Title | Study of the treatment protocol for blepharitis |
| Date of disclosure of the study information | 2020/01/09 |
| Last modified on | 2023/09/15 11:21:40 |
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Basic information
Public title
Study of the treatment protocol for blepharitis
Acronym
Study of the treatment protocol for blepharitis
Scientific Title
Study of the treatment protocol for blepharitis
Scientific Title:Acronym
Study of the treatment protocol for blepharitis
Region
| Japan |
Condition
Condition
blepharitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the pathogenic bacteria in blepharitis and to examine a treatment protocol of clinical practice for blepharitis with azithromycin ophthalmic solution 1% administration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Healing rate will be assessed at day 7 and 14.
Key secondary outcomes
Bacteria isolated from lid margin and clinical symptoms and signs at initial visit.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Male or female blepharitis patients who is 16 year old or older.
2 Patients with a total score of 4 or more of signs(eyelid redness/eyelid margin redness, eyelash discharge, and conjunctival hyperemia) and symptoms (foreign body sensation, lacrimation) and a score of 1 or more of eyelid redness/eyelid margin redness, and a score of 1 or more of symptoms.
3 Patients who can administer eye drops properly.
4 Patients who understands the contents of the consent document and is able to consent in the document of the person.
Key exclusion criteria
1 Younger than 16 years old.
2 Patients with eyelid diseases (including entropion, eyelid tumor) other than blepharitis.
3 Patients with extraocular inflammatory diseases (including bacterial, fungal, viral, and allergic) other than blepharitis.
4 Patients with severe ocular surface disease.
5 Patients who use of any antibiotic, steroid or immunosuppressant (systemic or topical) within 2 week of enrollment.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | Nejima |
Organization
Miyata Eye Hospital
Division name
Ophthalmology
Zip code
8850051
Address
6-3 Kurahara, Miyakonojo, Miyazaki, 885-0051, Japan
TEL
0986-22-1441
nejima@miyata-med.ne.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Nejima |
Organization
Miyata Eye Hospital
Division name
Ophthalmology
Zip code
8850051
Address
6-3 Kurahara, Miyakonojo, Miyazaki, 885-0051, Japan
TEL
0986-22-1441
Homepage URL
nejima@miyata-med.ne.jp
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
Ishizuchi Eye Clnic
Tane Memorial Eye Hospital
Hattori Clinic
Horikiri Eye Clinic
Matsumoto Eye Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Miyata Eye Hospital IRB
Address
6-3 Kurahara, Miyakonojo, Miyazaki, 885-0051, Japan
Tel
0986-22-1441
ushihama@miyata-med.ne.
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
| 2020 | Year | 01 | 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
Completed
Date of protocol fixation
| 2019 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 01 | Month | 09 | Day |
Last modified on
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044599
| Research Plan | |
|---|---|
| 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 |
