Efficacy and Safety of AJU-S56 in Dry Eye Syndrome Patients

A Phase 2 Multicenter, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy and Safety of AJU-S56 in Patients With Dry Eye Disease

This study is planned to Evaluate the Efficacy and Safety of test drug (AJU-S56) compared to control drug(vehicle) in Patients with Dry Eye Disease.

Inclusion Criteria:

• Male and Female who over 19 years old
• Moderate to Severe Dry Eye Disease Patients
• Must meet all criteria listed below at least in one eye or both eyes. TCSS (National eye institute (NEI) scale)≥ 4 Schirmer test(without anesthesia) ≤ 10mm in 5 mins Tear break-up time ≤ 6 secs
• Written informed consent to participate in the trial

Exclusion Criteria:

• Those who have clinically significant eye disease not related to dry eye syndrome
• Those who have medical history with intraocular surgery 12months before screening visit
• Use of corticosteroid, beta blocker and anticholinergic agent within 4 weeks
• Participation in other studies within 4weeks of screening visit