None listed
Conditions
Interventions
Dietary Supplement : Participants who voluntarily provide written informed consent and report symptoms of ocular fatigue and dryness will undergo screening assessments to determine their eligibility b
Sponsors
NVP Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those aged 19 years or older and 65 years or younger 2) Those who use electronic devices (e.g., monitors, mobile phones) for an average of 4 hours or more per day 3) Those with a total score of 20 or higher on the subjective eye fatigue questionnaire 4) Those whose tear break-up time (TBUT) is less than 10 seconds 5) Those who agreed to participate in the study before the start of the clinical trial and provided written informed consent (Informed Consent Form)
Exclusion criteria
Exclusion criteria: 1) Those currently undergoing treatment for severe diseases related to the cardiovascular, immune, respiratory, gastrointestinal/hepatobiliary, renal/urinary, nervous, musculoskeletal, psychiatric, infectious, or malignant systems 2) Those diagnosed with allergic conditions that may affect the eyes, such as allergic rhinitis or allergic conjunctivitis 3) Those who have received a vaccination (e.g., influenza, COVID-19, herpes zoster) that may affect immune function within 2 months prior to Visit 1 4) Those who were diagnosed with COVID-19 within 2 months prior to Visit 1 5) Those with a history of eye-related surgery within 6 months or eye-related diseases (excluding dry eye) within 3 months prior to Visit 1 6) Those who have worn contact lenses an average of 3 or more times per week within 2 weeks prior to Visit 1 7) Those with a history of drug or alcohol abuse 8) Current smokers or individuals who have smoked within 6 months prior to Visit 1 9) Those with intraocular pressure (IOP) exceeding 21 mmHg 10) Those who have taken medications that may affect dry eye (e.g., dry eye treatments, diuretics, treatments for autoimmune or thyroid diseases, antihistamines, beta-blockers, tricyclic antidepressants, estrogen hormone therapies, etc.) within 1 month prior to Visit 1 11) Those who have taken eye health-related supplements or functional foods (e.g., oils containing EPA and DHA, marigold flower extract, bilberry extract, lutein-zeaxanthin complex, perilla leaf extract, etc.) within 1 week prior to Visit 1 12) Those who have taken antibiotics or intestinal regulators within 2 weeks prior to Visit 1 13) Those who have taken or consumed probiotics, prebiotics, or lactic acid bacteria products regularly (4 or more times per week) within 2 weeks prior to Visit 1 14) Individuals with uncontrolled hypertension (systolic BP =160 mmHg or diastolic BP =100 mmHg, measured after 10 minutes of rest) 15) Individuals with uncontrolled diabetes (fasting blood glucose =180 mg/dL) 16) Those with thyroid-stimulating hormone (TSH) levels =0.1 µIU/mL or =10 µIU/mL 17) Those with creatinine levels =2 times the upper limit of normal (ULN) at the testing institution 18) Those with AST (GOT) or ALT (GPT) levels =3 times the ULN at the testing institution 19) Pregnant or lactating women, or those planning to become pregnant during the study period 20) Those with irregular lifestyles such as night shift workers 21) Those who are hypersensitive or allergic to any ingredients of the investigational product 22) Those who have participated in another interventional clinical trial (including human intervention trials) within 3 months prior to Visit 1, or plan to participate in another interventional trial during the study period 23) Those who, in the opinion of the investigator, are deemed unsuitable for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TBUT(Tear film Break-Up Time);ESQ(Eye Strain Questionnaire) | — |
Secondary
| Measure | Time frame |
|---|---|
| NPC(Near Point Convergence);NPA(Near Point Accommodation); CFF(Critical Flicker Fusion frequency);OSDI(Ocular Surface Disease Index);Schirmer's I test;Cytokine(IL-1ß, IL-6, IL-10, TNF-a), MMP-9;Fecal flora;Adverse Events;Clinical pathological examination (hematologic/hematochemical examination, urine test);Vital signs (blood pressure, pulse), body measurements (weight) | — |
Countries
Korea, Republic of
Contacts
Public ContactChoul yong Park
Dongguk University Ilsan Hospital
Outcome results
None listed