UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048726