Efficacy and Safety of Hydrolysed Red Ginseng Extract on Dry Eye

A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Hydrolysed Red Ginseng Extract on Dry Eye

This study was conducted to investigate the effects of daily supplementation of Hydrolysed Red Ginseng Extract extract on dry eye.

This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 46 subjects were randomly divided into Hydrolysed Red Ginseng extract 10ml or placebo group. The investigators measured Ocular Surface Disease Index, tear break-up time, Visual analog scale, Schirmer's test, meibomian gland test and Fluorescein staining.

Inclusion Criteria:

• Adult men and women over 19years
• Ocular Surface Disease Index score is 13 scores and more at a screening
• Tear Break-Up Time is 10 seconds less or those who have positive in ocular staining test at a screening
• After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria:

• Those who have a body mass index(BMI) of less than 18.5 kg / m^2 or greater than 35 kg / m^2 at the screening

• Those who have clinically significant acute or chronic ophthalmologic, cardiovascular system, endocrine, immune, respiratory, liver biliary system, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders

• Those who couldn't control diabetes at screening

• Those with acute eye infections or inflammation within 1 month before screening

• Those who have ophthalmic surgery within 3 months before screening

• Those who use contact lens 1 month before screening

• Those who take a medication or health function food that affects your promotion of dry eye within 1 month prior to the screening

• Those who have received antipsychotic medication within 3 months before screening

• Those who alcoholic or drug abuse suspected

• Those who participated in other clinical trials within 3 months before screening

• Laboratory test by showing the following results

  • Aspartate Transaminase(AST), Alanine Transaminase(ALT) > Reference range 3 times upper limit
  • Serum Creatinine > 2.0 mg/dL

• Pregnancy or breastfeeding

• Those who don't accept the implementation of appropriate contraception of a childbearing woman

• Principal Investigator judged inappropriate for participation in the study because of Laboratory test results, etc.