Tokyo, March 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060945) titled 'Effects of Bathing with Carbon Dioxide Bath Additives on Dry Eye Symptoms and Eye Strain' on March 16.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Earth Corporation
Condition:
Condition - Dry eye, Eye strain
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the effects of bathing with inorganic salt-containing carbon dioxide bath additives on periocular blood flow, dry eye-related findings (tear dynamics, meibomian gland function), and subjective symptoms.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Carbonated bath: Whole-body bathing for 15 minutes in 39 degrees Celsius water containing inorganic salt-containing carbon dioxide bath additives. Single intervention.
Interventions/Control_2 - Warm water bath (Control): Whole-body bathing for 15 minutes in 39 degrees Celsius plain tap water. Single intervention.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - 1. Adults aged 18 to 59 years.
2. Participants with chronic dry eye symptoms (J-OSDI score >= 13).
3. Participants without a regular bathing habit (bathing in a tub < 4 times per week).
4. Participants who understand the study and provide written informed consent.
Key exclusion criteria - 1. Participants currently receiving treatment for ocular diseases (e.g., infections, severe corneal disorders).
2. Participants with serious systemic diseases (e.g., severe heart disease, skin disease).
3. Pregnant or lactating women.
4. Others deemed inappropriate by the principal investigator.
Target Size - 10
Recruitment Status:
Recruitment status - Main results already published
Date of protocol fixation - 2025 Year 01 Month 10 Day
Date of IRB - 2025 Year 01 Month 17 Day
Anticipated trial start date - 2025 Year 04 Month 01 Day
Last follow-up date - 2025 Year 04 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069745
Disclaimer: Curated by HT Syndication.