Tokyo, Jan. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060466) titled 'A study to evaluate the effects of continuous consumption of the test food on visual function and QOL' on Jan. 26.

Study Type: Interventional

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

Primary Sponsor: Institute - Nippon Shinyaku Co., Ltd.

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

Objective: Narrative objectives1 - To evaluate the efficacy of 12-week consumption of the test food, compared with a placebo, in healthy men and women with a tendency toward ocular dryness, using lacrimal secretion volume as the indicator.

1. To evaluate the efficacy of 12-week consumption of the test food, compared with a placebo, in healthy men and women with a tendency toward ocular dryness, using a dryness Visual Analogue Scale (VAS), the Dry Eye related Quality of life Score (DEQS), and blood pentosidine levels as indicators.

2. To evaluate the safety of 12-week consumption of the test food, compared with a placebo, in healthy men and women with a tendency toward ocular dryness. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Test food Interventions/Control_2 - Duration: 12 weeks Test product: Placebo

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Individuals aged 20 or more and less than 65

4. Healthy individuals

5. Individuals whose monocular visual acuity is 1.0 or better with the unaided eye or corrected eye (whichever is worse)

6. Individuals who do not wear contact lenses or who wear contact lenses but can change to glasses during this study (between the date of consent and the final examination)

7. Individuals who are aware of dry eye-like symptoms in daily life (e.g., eye strain, a gritty sensation, a feeling of dryness, or ocular discomfort)

8. Individuals with a Break Up Time (BUT) > 5 seconds in both eyes at Scr

9. Individuals with low lacrimal secretion volume at Scr Key exclusion criteria - Individuals who 1. receive treatment or have a history of malignant tumor, heart failure, or myocardial infarction

2. have a pacemaker or an implantable cardioverter defibrillator

3. receive treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases

4. take Foods for Specified Health Uses or Foods with Functional Claims, particularly those who take or plan to take such foods or supplements that claim to improve eye-related functions

5. receive treatment for eye conditions

6. have diseases related to the lacrimal glands or Meibomian glands, such as dry eye

7. have undergone eye surgery within 1 year before Scr, or plan to undergo eye surgery during this study

8. have used eye drops, including over-the-counter (OTC), within 2 weeks before Scr

9. are unable to discontinue the use of eye drops, including OTC, during this study

10. use or plan to use cholinergic agents, anticholinergic agents, or herbal medicines used to alleviate dry eye symptoms

11. are diagnosed with presbyopia

12. have undergone laser in situ keratomileusis

13. have hay fever or allergic conjunctivitis

14. have a history or currently have drug or food allergies

15. plan to make significant changes in their lifestyle (e.g., diet, sleep, or exercise)

16. work night shifts or other rotating shifts

17. have a history or currently have dependence on alcohol, hypnotics, central analgesics, or psychotropic drugs

18. have a history or currently have psychiatric disorders

19. take medicines (including herbal medicines) or supplements

20. are pregnant, lactating, or planning to become pregnant during this study

21. have participated in other clinical studies within 28 days before informed consent, or plan to participate in another study during this study

22. are judged as ineligible to participate in this study by the physician Target Size - 80

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 01 Month 14 Day Date of IRB - 2026 Year 01 Month 14 Day Anticipated trial start date - 2026 Year 01 Month 26 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069179

Disclaimer: Curated by HT Syndication.