A Study to Assess the Eye Moisturizing Effects of Enzymatic Decomposed Rooster Comb (INJUV(TM)) Oral Intake in Human

UMIN ID: UMIN000045484

Registered date:15/09/2021

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: N/A (healthy adults)
• Date of first enrollment: 2021/09/21
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Oral intake of the test product (4 weeks)

Outcome(s)

• Primary Outcome: DEQS,Visual Analogue Scale,BUT(Tear film break-up time),Schirmer's test
• Secondary Outcome: Visual acuity examination, Intraocular pressure examination,Refraction inspection,Anti-aging QOL common questionnaire

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: [1]Individuals receiving medical drugs for treatment of chronic diseases [2]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication such as headache, menstrual pain, common cold, etc. [3]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders [4]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.) [5]Individuals with history of gastrointestinal disorders except for appendicitis [6]Individuals who use artificial tears (eye drops) 6 times or more a day [7]Individuals diagnosed with presbyopia or aware of presbyopia [8]Individuals with eye disease, entropion of the eyelids, trichiasis [9]Individuals with a definitive diagnosis of dry eye [10]Individuals using eye drops to treat eye diseases [11]Individuals with refractive error and not properly corrected [12]Individuals undergoing LASIK surgery [13]Individuals with severe astigmatism [14]Individuals who are thought to have eye strain due to dysregulation such as neurosis [15]Individuals with >=30.0kg/m2 BMI [16]Individuals with drug or food allergies [17]Individuals who have a habit of continuing to take functional foods, health foods, and supplements for the purpose of improving eye function, or who plan to take them during the study period, now and within the past 3 months [18]Individuals who are currently or within the last 3 months taking health foods containing enzymatic decomposed rooster combs, hyaluronic acid, collagen, proteoglycans, elastin, or their precursors during the study period or individuals planning to take new those products [19]Individuals with alcohol intake exceeding 60g/day [20]Individuals who may significantly change their lifestyle during the study period [21]Individuals who work at night etc.

Related Information

• Primary Sponsor: LAIMU Corporation
• Source(s) of Monetary Support: LAIMU Corporation