UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of azithromycin eye drops on the findings around the eyelids of patients with blepharitis
Acronym	The efficacy of azithromycin eye drops on the blepharitis findings
Scientific Title	The efficacy of Azimycin 1% eye drops on the diagnosis and observation around the eyelids of patients with blepharitis
Scientific Title:Acronym	The efficacy of Azimycin 1% eye drops on the diagnosis and observation around the eyelids of patients with blepharitis
Region	Japan

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

Objectives
Narrative objectives1	To examine the effectiveness of azithromycin eye drops in blepharitis patients with meibomian gland dysfunction (MGD) symptoms
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The total-score variation of subjective and objective findings of blepharitis from baseline at 14th day of administration in subject eye
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1 Patients who understands the contents of the consent document and is able to consent in the document of the person. 2 Age of 20 years or older. 3 Patients who were defined as bacterial blepharitis at the administration start date, and with a score of 1 or more of eyelid redness/eyelid margin redness. 4 Patient who are judged to be needed to administration of azithromycin eye drops for treatment of blepharitis with MGD symptoms. 5 Patients who have all symptoms and findings shown below. Subjective symptoms Abnormal findings around openings of meibomian glands Plugging of meibomian glands 6 Patients who are judged to have symptoms of hypersecretory type MGD.
Key exclusion criteria	1. Patients who understands the contents of the consent document and is able to consent in the document of the person. 2. Age of 20 years or older. 3. Patients who were defined as bacterial blepharitis at the administration start date, and with a score of 1 or more of eyelid redness/eyelid margin redness. 4. Patient who are judged to be needed to administration of azithromycin eye drops for treatment of blepharitis with MGD symptoms. 5. Patients who have all symptoms and findings shown below. Subjective symptoms Abnormal findings around openings of meibomian glands Plugging of meibomian glands 6. Patients who are judged to have symptoms of hypersecretory type MGD. 1. Patients with suspected fungal, viral, or Acanthamoeba. 2. Patients with suspected allergic conjunctivitis. 3. History of recurrent corneal erosion. 4. Any corneal epithelial loss, specifically any corneal ulcer (except for superficial punctate keratitis). 5. Patients who need to use any antibiotic, anti-inflammatory drug, vasoconstrictors, antihistamine, anti-allergic drug, disinfectant, proteolytic enzyme, herbal medicine (systemic topical, or dermally around eyelid), or treatment for MGD symptom (warm compress or lid hygiene) during the study. 6. Patients who will change the therapeutic medication for dry eye during the study. 7. Use of any corticosteroid, nonsteroidal anti-inflammatory drug, immunosuppressant (systemic, topical, or dermally around eyelid) within 1 week of enrollment. 8. Patients use Azimycin 1% eye drops within the past 45 days. 9. History of eye lid surgery within the past 90 days. 10. Known hypersensitivity or adverse effect to azithromycin, other macrolides, or to any of the drug ingredients in the study medications. 11. Participation in any other clinical study within the past 90 days or planning to participation in other clinical studies. 12. In addition, patients who are judged to have a problem to join this study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Shimazaki
Organization	Shimazaki eye clinic/Tokyo Dental College Ichikawa General Hospital
Division name	Department of Ophthalmology
Zip code	100-0014
Address	Akasaka Tokyu Building 4F, 2-14-3, Nagata-cho, Chiyoda-ku, Tokyo 100-0014, Japan
TEL	03-3580-3518
Email	meishano1@gmail.com

Public contact
Name of contact person	1st name Jun Middle name Last name Shimazaki
Organization	Shimazaki eye clinic/Tokyo Dental College Ichikawa General Hospital
Division name	Department of Ophthalmology
Zip code	100-0014
Address	Akasaka Tokyu Building 4F, 2-14-3, Nagata-cho, Chiyoda-ku, Tokyo 100-0014, Japan
TEL	03-3580-3518
Homepage URL
Email	meishano1@gmail.com

Sponsor
Institute	Shimazaki eye clinic/Tokyo Dental College Ichikawa General 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	Satake Eye Clinic
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	Kitamachi Clinic
Address	1-1-3 Kitamachi, Musashino-city, Tokyo
Tel	03-6779-8166
Email	chi-pr-ec-kitamachi@cmicgroup.com

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	2021 Year 05 Month 31 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	2021 Year 04 Month 19 Day
Date of IRB	2021 Year 04 Month 21 Day
Anticipated trial start date	2021 Year 06 Month 07 Day
Last follow-up date	2021 Year 10 Month 31 Day
Date of closure to data entry	2022 Year 04 Month 30 Day
Date trial data considered complete	2022 Year 07 Month 31 Day
Date analysis concluded

Other
Other related information	Present study is conducted as a multi-center observational study. The patients who meet the selection criteria from June 2021 to October 2021 are incorporated

Management information
Registered date	2021 Year 05 Month 27 Day
Last modified on	2022 Year 10 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050650