UMIN-CTR Clinical Trial

Basic information
Public title	The safety and efficacy of azimycin 1% eye drops on patients with posterior blepharitis
Acronym	The efficacy of azimycin eye drops on patients with posterior blepharitis
Scientific Title	The safety and efficacy of AZM eye drops on MGD
Scientific Title:Acronym	The efficacy of AZM eye drops on MGD
Region	Japan

Condition
Condition	posterior blepharitis
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of AZM eye drops on patients with meibomian gland dysfunction (MGD) (posterior blepharitis)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Ocular symptom, lid margin abnormalities, tear film breakup time, lipid layer thickness, non-invasive tear film breakup time, tear osmolarity, meiboscore
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and 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	azimycin eyed drop plus warming eyelid
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) 18 years old older 2) both gender 3) informed consent available 4) those who were diagnosed with obstructive MGD 5) those who were diagnosed with seborrheic MGD 6) Ocular symptoms 7) lid margin abnormalities 8) plugging
Key exclusion criteria	1) Stevens-Johnson syndrome 2) acute inflammation 3) lid margin abnormalities 4) allergy 5) CL wear 6) Ocular surgery history within 3 monmths 7) systemic dieseases which might interfere with tear function 8) inappropriate charater 9) ocular diseases except cataract and/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
Email	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	626-11, Minaminakano, Minuma-ku
TEL	+81486865588
Homepage URL
Email	ritoh@za2.so-net.ne.jp

Sponsor
Institute	Itoh Clinic
Institute
Department

Funding Source
Organization	Lid and meibomian gland working group
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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	0486865588048
Email	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
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043015