Efficacy and Safety of HE10 for Dry Eye Syndrome

Multi-center, Randomized, Double-blind, Active Comparator- Controlled, Parallel Study Evaluating the Efficacy and Safety of HE10 in Subjects With Dry Eye Syndrome

The purpose of this study is to evaluate the efficacy and safety of HE10 eye drop for the patients with moderate to severe dry eye syndrome.

This study is to compare the efficacy and safety of HE10 and Restasis for patients with moderate to severe dry eye syndrome in multi-center, double-blind, randomized, active comparator-controlled, parallel design, non-inferiority Phase III clinical trial.

Inclusion Criteria:

• Corneal staining score of ≥2(Oxford grade)
• Schirmer test score (without anesthesia) < 10 mm/5 min in either eye
• Tear break-up time is 10 seconds or less
• Screening both eyes, the corrected visual acuity is 0.2 or more

Exclusion Criteria:

• Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status
• The patients with systemic or ocular disorders affected the test result
• Being treated with systemic steroid
• History of eyeball surgical operation within 3 months of screening visit
• Wearing contact lenses within 2 weeks of screening visit
• Be a use or used punctual plug within 1 month of screening vist
• Use of cyclosporine eye drop within 3 weeks
• Pregnancy or Breastfeeding
• Intraocular pressure > 25 mmHg
• Abnormal eyelid function : Disorders of the eyelids or eyelashes