Tokyo, Oct. 31 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059589) titled 'Evaluation of the effects of a test food on Dry eye symptoms in healthy adults' on Oct. 30.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Miura Clinic, Medical Corporation Kanonkai

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the effects of test food consumption on symptoms of dry eye Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intake of the test food for 4 weeks Interventions/Control_2 - Intake of the placebo food for 4 weeks

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - (1) Healthy males from 20 to 64 years old. (2) Subjects who are concerned about dry eyes. (3) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing. Key exclusion criteria - (1) Subjects with a history of mental illness, diabetes,liver diseases, renal disease, gastrointestinal disease, cardiac disease, respiratory disease, peripheral vascular disease, or other serious disease. (2) Subjects with a history of ocular disease or eye surgery. (3) Subjects currently receiving ophthalmologic treatment. (4) Subjects using anti-inflammatory eye drops (e.g., steroids, cyclosporine, lifitegrast) or anti-allergic eye drops (e.g., olopatadine, epinastine, ketotifen). (5) Subjects taking prescription or over-the-counter medications including anticholinergics, antihistamines, antidepressants, beta-blockers, isotretinoin, etc. (6) Subjects who wear contact lenses. (7) Subjects with a history of gastrointestinal surgery. (8) Subjects with abnormal liver or kidney function test results. (9) Subjects currently undergoing treatment for any disease. (10) Subjects who are allergic to the foods in this study. (11) Females who are pregnant, breastfeeding, or planning to become pregnant during the study period (including those who may be pregnant). (12) Subjects with a tear film break-up time (BUT) of 5 seconds or less. (13) Subjects who engage in intense sports activities or are currently on a diet. (14) Subjects with extremely irregular dietary or lifestyle habits. (15) Subjects who cannot refrain from consuming health foods (including Foods for specified health uses, foods with functional claims, and supplements) or designated quasi-drugs during the study period. (16) Subjects who are continuously undergoing treatment with medications (including OTC and prescription drugs). (17) Subjects whose average daily alcohol consumption exceeds 40 g of pure alcohol. (18) Smokers. (19) Subjects who are currently participating in other clinical studies or are scheduled to participate in research at the start of this study. (20) Other subjects judged by the investigator or the investigator to be inappropriate for the examination. Target Size - 56

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 22 Day Date of IRB - 2025 Year 10 Month 23 Day Anticipated trial start date - 2025 Year 10 Month 30 Day Last follow-up date - 2025 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068072

Disclaimer: Curated by HT Syndication.