None listed
Conditions
Interventions
Dietary Supplement : This human intervention study is a randomized, double-blind, placebo-controlled, parallel-group trial consisting of an intervention group and a control group. Participants in the
Sponsors
Dankook Univeristy Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy adults aged 18 years or older. 2) Individuals who report symptoms such as foreign-body sensation, ocular pain, itching, decreased vision, or photophobia. 3) Individuals without structural abnormalities of the ocular surface, including conjunctival hyperemia, corneal erosion assessed using the National Eye Institute (NEI) scale, or meibomian gland abnormalities. 4) Individuals with a Schirmer I test result of 5 mm or greater. 5) Individuals with a tear film break-up time (TBUT) of 10 seconds or less.
Exclusion criteria
Exclusion criteria: 1) Individuals with allergic diseases that may affect the eyes, including allergic rhinitis, allergic conjunctivitis, or other allergic conditions such as urticaria. 2) Individuals with a history of ocular surgery within 6 months before Visit 1 or a history of ocular disease, excluding dry eye disease, within 3 months before Visit 1. 3) Individuals who have worn contact lenses within 1 month before Visit 1. 4) Individuals with a history of drug or alcohol abuse. 5) Individuals with an intraocular pressure greater than 21 mmHg. 6) Individuals who have used medications that may affect dry eye disease within 1 month before Visit 1, including dry eye treatments, diuretics, medications for autoimmune or thyroid diseases, antihistamines, beta-blockers, tricyclic antidepressants, or estrogen therapy. 7) Individuals who have consumed eye-health supplements or functional health foods within 1 week before Visit 1, including oils containing eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA), marigold flower extract, bilberry extract, lutein/zeaxanthin complex extract, or perilla extract. 8) Individuals with uncontrolled hypertension, defined as a systolic blood pressure of 160 mmHg or greater or a diastolic blood pressure of 100 mmHg or greater, measured after at least 10 minutes of rest. 9) Women who are pregnant or breastfeeding, or who plan to become pregnant during the study period. 10) Individuals with known sensitivity or allergy to any component of the investigational product. 11) Individuals who have participated in another interventional clinical trial, including a human intervention study, within 3 months before Visit 1, or who plan to participate in another interventional clinical trial after initiation of the present study. 12) Individuals considered by the investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Schirmer’s test for assessing tear secretion and dry eye severity;Eye Symptom Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| Corneal staining test for assessing corneal epithelial damage and inflammation;Conjunctival staining test for assessing conjunctival mucosal damage and tear film instability;Tear Break-Up Time;Non-Invasive Tear Break-Up Time;Ocular Surface Disease Index;Critical Flicker Fusion | — |
Countries
Korea, Republic of
Contacts
Public ContactKyongjin Cho
Dankook Univeristy Hospital
Outcome results
None listed