UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054379 |
|---|---|
| Receipt number | R000062011 |
| Scientific Title | Clinical study on the effect of a desktop humidifier on tear film |
| Date of disclosure of the study information | 2024/05/12 |
| Last modified on | 2024/05/12 22:35:44 |
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Basic information
Public title
Safety and efficacy of photocatalytic micro-mist desktop humidifier for dry eye caused by digital environment
Acronym
Clinical Study on the Influence of a Desktop Humidifier on tear film
Scientific Title
Clinical study on the effect of a desktop humidifier on tear film
Scientific Title:Acronym
Effect of a desktop humidifier on tear film
Region
| Japan |
Condition
Condition
dry eye
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effect of micro-mist from a desktop humidifier on the tear film of VDT workers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Immediately before humidifier, immediately after 1-hour VDT work with humidifier, 1.5 hours after humidifier and VDT work
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Humidifier mist for 1 hour for VDT workers
Interventions/Control_2
VDT work without mist
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects of this study will be those whose written consent to participate in this study has been obtained and who meet all of the following criteria
1) Age: 18 years old or older, but not older than 70 years old at the time consent is obtained
2) Gender: Not applicable
3) Able to fill out the consent form in their own handwriting
Key exclusion criteria
Any of the following will be excluded from the study.
Exclusion Criteria
1) Patients with acute ocular or eyelid disease
2) Patients with obvious eyelid or ocular surface disease (eyelid congenital anomalies, entropion, ectropion, Sjogren's syndrome)
3) Anti-glaucoma eye drops
4) Previous ocular surgery within 3 months, Intense pulsed light (IPL) therapy, LipiFlow, Botox injections
5) Ocular allergy symptoms at the time of examination
6) Deemed ineligible by the principal investigator or research associate
Target sample size
32
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
626-11, Minaminakano, Minumaku, Saitama City, Saitama
TEL
0486865588
ritoh@za2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Arita |
Organization
Itoh Clinic
Division name
Ophthalmology
Zip code
3370042
Address
626-11, Minaminakano, Minumaku, Saitama City, Saitama
TEL
0486865588
Homepage URL
ritoh@za2.so-net.ne.jp
Sponsor or person
Institute
Itoh Clinic
Institute
Department
Personal name
Funding Source
Organization
Kaltech Corporation
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
Yamauchi Clinic
Address
1-15-19, Jiyugaoka, Meguroku, Tokyo
Tel
03-3723-7717
fujii.tetsuya@neues.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2023-09-00202
Org. issuing International ID_1
Yamauchi Clinic
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
伊藤医院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 12 | 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
31
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
| 2023 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 10 | 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
| 2024 | Year | 05 | Month | 12 | Day |
Last modified on
| 2024 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062011
