UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044348 |
|---|---|
| Receipt number | R000050650 |
| Scientific Title | The efficacy of Azimycin 1% eye drops on the diagnosis and observation around the eyelids of patients with blepharitis |
| Date of disclosure of the study information | 2021/05/31 |
| Last modified on | 2022/10/28 15:21:12 |
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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
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
meishano1@gmail.com
Sponsor or person
Institute
Shimazaki eye clinic/Tokyo Dental College Ichikawa General 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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050650
| 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 |
