UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057603 |
|---|---|
| Receipt number | R000065805 |
| Scientific Title | Disinfection test of the eyelid and ocular surface using ozone nano bubble water |
| Date of disclosure of the study information | 2025/04/20 |
| Last modified on | 2026/04/15 15:27:17 |
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Basic information
Public title
Disinfection test of the eyelid and ocular surface using ozone nano bubble water
Acronym
Disinfection test of the eyelid and ocular surface using ozone nano bubble water
Scientific Title
Disinfection test of the eyelid and ocular surface using ozone nano bubble water
Scientific Title:Acronym
Disinfection test of the eyelid and ocular surface using ozone nano bubble water
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In ophthalmic surgery, iodine preparations are usually used before surgery to prevent infection, and are used to disinfect the skin around the eyelids and the surface of the eye. However, while iodine preparations have a strong sterilizing effect, they are also known to be toxic to mucous membranes, and it has been reported that they can cause corneal damage after surgery. On the other hand, it is known that ozone water has a stronger sterilizing effect than iodine preparations, but does not have any cytotoxicity, and is beginning to be used as an alternative disinfectant to iodine. However, ozone water has a short half-life of about 20 minutes, and there is the issue that it cannot be made in advance. In order to solve this issue, ozone nano bubble water has been developed in recent years as ozone water that can be stored for long periods of time, and it is already being used in clinical applications in the dental field. In this study, we will disinfect the eyelid area and the surface of the eye using ozone nano bubble water, and examine its sterilizing effect and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bacterial detection rate in scraping cultures of the skin around the eyelids and the surface of the eye
Key secondary outcomes
Extent of corneal epithelial damage
Presence or absence of corneal irritation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Experimental group (right eye)
The skin around the eyelid is disinfected with ozone nanobubble water. After 2 minutes, oxybutocaine hydrochloride is instilled to anesthetize the surface of the eye, and then the eyelid is opened using an eyelid retractor. The surface of the eye is then disinfected with 150 mL of ozone nanobubble water.
Interventions/Control_2
Control group (left eye)
The skin around the eyelid is disinfected with povidone-iodine solution. After 2 minutes, oxybutocaine hydrochloride is instilled to anesthetize the surface of the eye, and the eyelid is then opened using an eyelid retractor. The surface of the eye is then disinfected with 150 mL of 40-fold diluted povidone-iodine.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
From April 1, 2024 to March 31, 2029, healthy individuals who have obtained informed consent at Kikuna Yuda Eye Clinic, Nihon University School of Medicine Itabashi Hospital, or Yokohama Minami Kyosai Hospital.
Key exclusion criteria
Those with eye diseases, those with dry eyes, pregnant women, women who are breastfeeding, those with iodine allergies, those with drug allergies
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Yuda |
Organization
Kikuna Yuda Eye Clinic
Division name
Ophthalmology
Zip code
222-0011
Address
4-3-11 Kikuna, Kohoku-ku, Yokohama City, Kanagawa Prefecture
TEL
045-435-3755
kyuda6482@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Yukari |
Organization
Nihon University School of Medicine Itabashi Hospital Ophthalmology
Division name
Ophthalmology
Zip code
173-8610
Address
30-1 Oyaguchi Kamimachi, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
yukari.yuto@nihon-u.ac.jp
Sponsor or person
Institute
Kikuna Yuda Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nihon University School of Medicine, Department of Ophthalmology, Visual Science (Nihon University School of Medicine Itabashi Hospital Ophthalmology)
Yokohama Minami Kyosai Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kikuna Yuda Eye Clinic
Address
4-3-11 Kikuna, Kohoku-ku, Yokohama City, Kanagawa Prefecture
Tel
03-3972-8111
yukari.yuto@nihon-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
きくな湯田眼科(神奈川県）、日本大学医学部附属板橋病院（東京都）、横浜南共済病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 20 | 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
Suspended
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 14 | Day |
Last modified on
| 2026 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065805
