None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women, 18 to 65 years old 2. Dry eye syndrome in one or both eyes (ICD-10:H04.1) with: 2-1. Refractive surgery within 24 months and dry eye symptoms (for example, ocular itching, foreign body sensation, burning, pain and dryness, visual disturbance, ocular redness, and/or a sensation of tearing) of at least moderate severity 2-2. VAS score = 40 2-3. TBUT =10 seconds and Schirmer-I test results = 10 mm/5 minutes 3. Voluntary participation and written informed consent
Exclusion criteria
Exclusion criteria: 1. Dry eye symptoms due to eyelid or eyelash defects 2. Acute infection of the eyelid, eyeball or periorbital area 3. Skin disease such as Stevens-Johnson syndrome and/or pemphigoid 4. Vitamin A deficiency 5. Any external injury to the orbital or periorbital area 6. A history of eye surgery within the past six months (except refractive surgery) 7. Impaired blinking due to facial palsy 8. History of punctal plug or punctal occlusion surgery 9. Pregnancy, lactation, or plans to conceive 10. Exclusion at the investigator’s discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular Surface Disease Index (OSDI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale (VAS);Tear Film Break up Time (BUT);Quality of Life (QOL);Fluorescein stained corneal surface digital photography;Schirmer-I test with anesthesia;Experience about durg or other therapeutic modalities;General assessment | — |
Countries
Korea, Republic of
Contacts
Korea Institute of Oriental Medicine