Clinical Trial to Evaluate the Safety and Efficacy of SCAI-001 Compared to Restasis

Inclusion criteria

• Male and Female who over 19 years old
• Those who have dry eye symptoms (Dryness, Grittiness, soreness, irritation, watering, etc.)
• Those who meet below criteria at least one of two eyes;

• Those who have over than score 2 in corneal staining test-Oxford grading
• Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye)
• TBUT(Tear film break-up time) test result should be under 10sec.
• The corrected visual acuity is 0.2 or more.

Exclusion criteria

• Those who have clinically significant eye disease not related to dry eye syndrome
• Those who are in medication of systemic steroid or immunosuppressant 90days before screening visit
• Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period
• Those who have medical history with intraocular surgery 12months before screening visit
• Those who have diagnosed with glaucoma or have an intraocular pressure over than 21mmHg at least in one of the eyes
• Those who have medicated cyclosporine eye-drops 6weeks before screening visit
• Those who have underwent any eye correction surgery such as LASIK(Laser-assistant in situ keratomileusis) 12 months before screening visit
• Those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit
• Those who have received other investigational drugs/devices 30 days before screening visit
• Those who are inappropriate for participating in this study according to investigator's judgement