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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042867
Receipt No. 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 2021/04/22

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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
Email 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
Email ksugi@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

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
Email 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 No longer recruiting
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
2021 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048726

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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