UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062483 |
|---|---|
| Receipt number | R000071467 |
| Scientific Title | An Exploratory Evaluation Study on Changes in Indicators Related to Concentration and Attentional States During Eye Drop Use |
| Date of disclosure of the study information | 2026/08/05 |
| Last modified on | 2026/08/05 18:01:50 |
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Basic information
Public title
An Exploratory Study on Changes in Concentration and Attentional States During Eye Drop Use
Acronym
An Exploratory Study on Changes in Concentration and Attentional States During Eye Drop Use
Scientific Title
An Exploratory Evaluation Study on Changes in Indicators Related to Concentration and Attentional States During Eye Drop Use
Scientific Title:Acronym
An Exploratory Evaluation Study on Changes in Indicators Related to Concentration and Attentional States During Eye Drop Use
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct an exploratory evaluation of changes in indicators related to concentration and attentional states during eye drop use.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Analysis of Electroencephalogram (EEG) and Behavioral Data Such as Reaction Time During Eye Drop Use
Key secondary outcomes
Administration of Questionnaires on Eye-Related Items and Daily Life
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Medicine |
Interventions/Control_1
Use within the indicated dosage and administration
Interventions/Control_2
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Male and female subjects aged 20 to 50 years
Individuals who routinely use menthol-containing eye drops and have no reluctance to use them, or those who do not routinely use menthol-containing eye drops but have no reluctance to use them
Individuals with no history of experiencing severe irritation, ocular abnormalities, allergic symptoms, or other adverse reactions caused by the use of menthol-containing eye drops
Individuals with uncorrected vision (naked eye) or those wearing hard contact lenses
Subjects who agree to refrain from using any other eye drops on the test day
Subjects who agree to remove earrings and other earlobe accessories on the test day
Key exclusion criteria
Individuals with visual or hearing impairments
Individuals with neurological disorders such as epilepsy
Individuals with severe psychiatric disorders such as schizophrenia
Individuals with known allergies to any ingredients of the study eye drops
Individuals with other uncontrolled physical or mental conditions
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Ideriha |
Organization
SandBox Inc.
Division name
Research Division
Zip code
162-0066
Address
B1F, 12-12 Ichigaya Daimachi, Shinjuku-ku, Tokyo
TEL
080-4365-4099
ideriha@sandbox-vr.com
Public contact
Name of contact person
| 1st name | Seri |
| Middle name | |
| Last name | Yomochi |
Organization
SandBox Inc.
Division name
General Affairs Division
Zip code
162-0066
Address
B1F, 12-12 Ichigaya Daimachi, Shinjuku-ku, Tokyo
TEL
050-1808-2565
Homepage URL
info@sandbox-vr.com
Sponsor or person
Institute
SandBox Inc.
Institute
Department
Personal name
Funding Source
Organization
ROHTO Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sandbox Institutional Review Board
Address
12-12 Ichigaya Daimachi, Shinjuku-ku, Tokyo
Tel
080-4365-4099
akihito@sandbox-vr.com
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
株式会社SandBox（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 05 | Day |
Last modified on
| 2026 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071467
