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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039106
Receipt No. R000044599
Scientific Title Study of the treatment protocol for blepharitis
Date of disclosure of the study information 2020/01/09
Last modified on 2020/01/09

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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
Email 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
Email nejima@miyata-med.ne.jp

Sponsor
Institute Miyata Eye Hospital
Institute
Department

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
Email 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 Open public recruiting
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
2020 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044599

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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