None listed
Conditions
Interventions
Dietary Supplement : 1) Study Product
Active Ingredient: WIN-1702 (Ethanol Extract Powder of Persimmon Leaf)
Appearance and Dosage Form: Hard Capsule
Content: 173 mg/capsule
Storage Condition: Sealed,
Sponsors
Whan In Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female adults aged 19 years or older 2) Individuals with intraocular pressure (IOP) = 21 mmHg in at least one eye 3) Individuals with a cup-to-disc (C/D) ratio of less than 0.5 4) Individuals with tear film break-up time (TBUT) of less than 10 seconds 5) Individuals who agree to participate in the study before its initiation and provide written informed consent (Informed Consent Form)
Exclusion criteria
Exclusion criteria: 1) Individuals currently under treatment for ocular diseases such as primary open-angle glaucoma (POAG), retinal diseases, or macular degeneration 2) Individuals with glaucomatous optic nerve changes or visual field defects 3) Individuals with a history of eye-related surgeries (excluding cataract surgery) or eye diseases (excluding dry eye disease) within 3 months prior to screening 4) Individuals with risk factors for vision loss (however, those with controlled diabetes or thyroid disease may be eligible) 5) Individuals with systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg (measured after 10 minutes of rest) or fasting blood glucose = 126 mg/dL at Visit 1 or Visit 2 6) Individuals who have used medications for IOP control or dry eye treatment within 3 months prior to screening 7) Individuals currently using medications that may affect IOP (e.g., steroids, bronchodilators, statins, anti-obesity drugs such as topiramate, phendimetrazine tartrate, mazindol, etc.) 8) Individuals currently using medications that may affect dry eye (e.g., treatments for autoimmune diseases) 9) Individuals who have worn contact lenses within 2 weeks prior to screening 10) Individuals who have consumed health functional foods or vitamins that may affect eye health within 1 week prior to screening 11) Individuals with cardiac diseases requiring drug therapy, surgery, or radiation therapy 12) Individuals sensitive or allergic to the investigational product 13) Pregnant or breastfeeding women, or women planning to become pregnant during the study period 14) Individuals who have participated in another clinical trial within 1 month prior to screening or plan to participate during the study period 15) Individuals deemed unsuitable by the investigator for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular Pressure;TBUT(Tear film Break-Up Time) | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Acuity;Central Corneal Thickness;Schirmer's test;Meiboscore;NIBUT(Non-Invasive tear Break-Up Time);NEI/Industry Grading System;OSDI(Ocular Surface Disease Index);Assessment of Improvement by the Investigator and the Subject Themselves | — |
Countries
Korea, Republic of
Contacts
Public ContactKuidong Kang
The Catholic University of Korea, Incheon St. Mary's Hospital
Outcome results
None listed