UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050584 |
|---|---|
| Receipt number | R000057619 |
| Scientific Title | Effect of lid hygiene on pollen allergy |
| Date of disclosure of the study information | 2023/03/15 |
| Last modified on | 2023/03/15 08:45:57 |
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Basic information
Public title
Effect of lid hygiene on pollen allergy
Acronym
Effect of lid hygiene on pollen allergy
Scientific Title
Effect of lid hygiene on pollen allergy
Scientific Title:Acronym
Effect of lid hygiene on pollen allergy
Region
| Japan |
Condition
Condition
pollen allergy
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of lid hyginen on pollen allergy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
symptom
Key secondary outcomes
lid findings, ocular surface findings
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
lid hygiene
Interventions/Control_2
no treatment
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
people who have pollen allergy
Key exclusion criteria
people who have a habit of lid hygiene
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Kawashima |
Organization
Senju Clinic
Division name
Ophthalmology
Zip code
1200026
Address
1-14, Senju Asahi-cho, Adachi-ku, Tokyo.
TEL
03-5284-8862
motoko326@gmail.com
Public contact
Name of contact person
| 1st name | Motoko |
| Middle name | |
| Last name | Kawashima |
Organization
Senju Clinic
Division name
Ophthalmology
Zip code
1200026
Address
1-14, Senju Asahi-cho, Adachi-ku, Tokyo.
TEL
03-5284-8862
Homepage URL
motoko326@gmail.com
Sponsor or person
Institute
Senju Clinic
Institute
Department
Personal name
Funding Source
Organization
Mediproduct
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Haneginomori Eye Clinic
Address
4 Chome-26-4 Daita, Setagaya City, Tokyo
Tel
03-6265-8777
mail@hanegi-eye.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
| 2023 | Year | 03 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 04 | 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
| 2023 | Year | 03 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057619
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
