Tokyo, Aug. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062483) titled 'An Exploratory Study on Changes in Concentration and Attentional States During Eye Drop Use' on Aug. 5.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - SandBox Inc.
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To conduct an exploratory evaluation of changes in indicators related to concentration and attentional states during eye drop use.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Use within the indicated dosage and administration
Eligibility:
Age-lower limit - 20
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 Size - 40
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071467
Disclaimer: Curated by HT Syndication.