UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042867 |
|---|---|
| Receipt number | R000048726 |
| Scientific Title | Prospective interventional study of ocular safety for 222 nm UVC room disinfection lamp |
| Date of disclosure of the study information | 2020/12/28 |
| Last modified on | 2022/01/06 19:51:30 |
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Basic information
Public title
Study of ocular safety for 222 nm UVC room disinfection lamp
Acronym
Study of ocular safety for 222 nm UVC room disinfection lamp
Scientific Title
Prospective interventional study of ocular safety for 222 nm UVC room disinfection lamp
Scientific Title:Acronym
Study of ocular safety for 222 nm UVC room disinfection lamp
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the ocular safety for 222 nm UVC room disinfection lamp
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Grade of Corneal erosion and conjunctival hypermia at 24 hour,1 month, 3 months and 6 months after ultraviolet irradiation
Key secondary outcomes
Visual acuity, refractive power, corneal cell density, skin erythema, adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Ultraviolet of 222 nm at 22 mJ / cm2 are irradiated.
Interventions/Control_2
Ultraviolet of 222 nm at 50 mJ / cm2 are irradiated.
Interventions/Control_3
Ultraviolet of 222 nm at 50 mJ / cm2 are irradiated.
Interventions/Control_4
Ultraviolet of 222 nm at 75 mJ / cm2 are irradiated.
Interventions/Control_5
Ultraviolet of 222 nm at 75 mJ / cm2 are irradiated.
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Those who obtained document consent by their own voluntary intention about participation in this trial
2)Avoiding exposure for ultraviolet within 48 hours.
3)Corrected visual acuity 0.04
4)Not being treated for eye diseases that affect eyesight.
.5)Do not use eye drops or topical medication for facial skin
Key exclusion criteria
1)People wearing contact lens.
2)Engaged in out door work that are exposed UV(field work, welding, etc.).
3)Anyone with abnormalities in the cornea.(corneal eroion D score > 2, or congestion score >2.)
4)Patient with dryeye.
5)Patient with atopic dermatitis.
6)Patient with sun sensitivity.
7)Participating in clinical trials involving other interventions or will participate between the enrollment of this study and the end of observation.
8)Others who are judged inappropriate by the doctor in charge of this trial.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Tanito |
Organization
Shimane University
Division name
Ophthalmology
Zip code
6930021
Address
89-1, Enya-Cho, Izumo city, Shimane prefecture, Japan
TEL
0853202284
mtanito@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazunobu |
| Middle name | |
| Last name | Sugihara |
Organization
Shimane University
Division name
Ophthalmology
Zip code
6930021
Address
89-1, Enya-Cho, Izumo city, Shimane prefecture, Japan
TEL
0853202284
Homepage URL
ksugi@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Ushio Inc
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review boards at Faculty of Medicine, Shimane University
Address
89-1, Enya-Cho, Izumo city, Shimane prefecture, Japan
Tel
0853-20-2259
kenkyu@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
| 2020 | Year | 12 | Month | 28 | 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
Main results already published
Date of protocol fixation
| 2020 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 28 | Day |
Last modified on
| 2022 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048726
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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