UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054946 |
|---|---|
| Receipt number | R000062774 |
| Scientific Title | Prospective Intervention Study on Eye Discomfort Caused by 222 nm Far-UVC Disinfectant Lamps |
| Date of disclosure of the study information | 2024/07/12 |
| Last modified on | 2025/01/31 18:39:19 |
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Basic information
Public title
Evaluation of conditions causing eye discomfort by 222 nm Far-UVC disinfectant lamps
Acronym
Evaluation of conditions causing eye discomfort by 222 nm Far-UVC
Scientific Title
Prospective Intervention Study on Eye Discomfort Caused by 222 nm Far-UVC Disinfectant Lamps
Scientific Title:Acronym
Prospective Intervention Study on Eye Discomfort Caused by 222 nm Far-UVC
Region
| Japan |
Condition
Condition
Eye discomfort
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the range of irradiation intensities and doses that do not cause discomfort in the eyes of normal subjects using a 222 nm Far-UVC germicidal lamp (Care 222).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eye discomfort reported by participants at 1 hour, 2 hours, 3 hours (immediately after the end of irradiation), 6 hours and 24 hours after the beginning of irradiation with 222 nm Far-UVC (answers based on a questionnaire).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A commercially available 222 nm Far-UVC disinfection lamp (Care222) or a dummy irradiation device (incorporating an optical LED in place of the 222 nm Far-UVC lamp) is irradiated to the eyes of the study subjects watching the movie at 3.0 micro-W/cm2 & 22 mJ/cm2. The irradiation duration was 3 hours, of which 2 hours were irradiated by the 222 nm Far-UVC disinfection lamp and 1 hour by the dummy irradiation device.
Interventions/Control_2
A commercially available 222 nm Far-UVC disinfection lamp (Care222) or a dummy irradiation device (incorporating an optical LED in place of the 222 nm Far-UVC lamp) is irradiated to the eyes of the study subjects watching the movie at 3.0 micro-W/cm2 & 11 mJ/cm2. The irradiation duration was 3 hours, of which 1 hours were irradiated by the 222 nm Far-UVC disinfection lamp and 2 hours by the dummy irradiation device.
Interventions/Control_3
A commercially available 222 nm Far-UVC disinfection lamp (Care222) or a dummy irradiation device (incorporating an optical LED in place of the 222 nm Far-UVC lamp) is irradiated to the eyes of the study subjects watching the movie at 1.0 micro-W/cm2 & 11 mJ/cm2. The irradiation duration was 3 hours, all with 222 nm Far-UVC disinfection lamps.
Interventions/Control_4
A commercially available 222 nm Far-UVC disinfection lamp (Care222) or a dummy irradiation device (incorporating an optical LED in place of the 222 nm Far-UVC lamp) is irradiated to the eyes of the study subjects watching the movie at 1.0 micro-W/cm2 & 5.5 mJ/cm2. The irradiation duration was 3 hours, of which 1.5 hours were irradiated by the 222 nm Far-UVC disinfection lamp and 1.5 hours by the dummy irradiation device.
Interventions/Control_5
A commercially available 222 nm Far-UVC disinfection lamp (Care222) or a dummy irradiation device (incorporating an optical LED in place of the 222 nm Far-UVC lamp) is irradiated to the eyes of the study subjects watching the movie at 0.5 micro-W/cm2 & 5.5 mJ/cm2. The irradiation duration was 3 hours, all with 222 nm Far-UVC disinfection lamps.
Interventions/Control_6
A dummy irradiation device (incorporating an optical LED instead of a 222 nm Far-UVC lamp) is irradiated to the eyes of the study subjects. The irradiation duration is 3 hours.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patient must be able to give his/her free and written consent to participate in the study.
Must be able to avoid excessive exposure to ultraviolet light (e.g., outdoor sports, swimming, mountain climbing, etc.) at each observation and within 48 hours prior to the time of exposure to ultraviolet light.
Visual acuity before enrollment and within 1 week of the scheduled irradiation must meet all of the following conditions
Corrected visual acuity of 0.9 or better in each eye
Naked eye visual acuity of 0.3 or better with both eyes open (the patient must be able to view images on a monitor during UVC irradiation).
The patient must not be undergoing treatment for ocular diseases that affect visual acuity.
No use of eye drops or topical facial skin medications
Key exclusion criteria
1) Daily contact lens wearer
2) Intend to wear contact lenses temporarily (e.g., during sports) within 1 week of irradiation.
3) Engaged in an occupation that exposes them to ultraviolet radiation on a daily basis (e.g., working outdoors, welding, etc.)
4) Have obvious ocular disorders (corneal erosion D score > 2 or conjunctival hyperemia score > 2) observed before enrollment and within 1 week of the scheduled irradiation
5) Has dry eye
6) Comorbid atopic dermatitis
7) Sun sensitivity
8) History or family history of hereditary tumors or melanoma
9) Currently participating in another clinical trial involving an intervention or will participate between the date of enrollment in this study and the end date of observation
10) Other patients deemed ineligible by the investigator of this study
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | |
| Last name | Kaidzu |
Organization
Shimane University Faculty of Medicine
Division name
Department of Ophthalmology
Zip code
6938501
Address
89-1 Enya, Izumo, Shimane
TEL
0853-20-2284
kecha@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Kaidzu |
Organization
Shimane University Faculty of Medicine
Division name
Department of Ophthalmology
Zip code
6938501
Address
89-1 Enya, Izumo, Shimane
TEL
0853-20-2284
Homepage URL
kecha@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane Univesity
Institute
Department
Personal name
Funding Source
Organization
Blueprint Biosecurity
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University Faculty of Medicine
Address
89-1 Enya, Izumo, Shimane
Tel
0853-20-2284
kecha@med.shimane-u.ac.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
| 2024 | Year | 07 | 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
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
| 2024 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 12 | Day |
Last modified on
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062774
