Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome

Placebo Controlled, Dose-Response, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of DA-6034 Eye Drops in Patients With Dry Eye Syndrome

This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared with placebo in dry eye syndrome.

Eligible subjects are randomly assigned to receive 3% DA-6034, 5% DA-6034 or Placebo. This study is conducted for 6 weeks(Run-in Period 2 weeks + Treatment Period 4 weeks).

Inclusion Criteria:

1. Age≥20
2. Dry eye symptoms(irritation, foreign body sensation, burning, mucus discharge, blurring, itching, photophobia, tird or heavy feeling, pain) for more than 6 months
3. Fluorescein corneal staining score ≥ 4 and Schirmer test I ≤ 7mm in same eye
4. Corrected vision ≥ 0.2 in both eye
5. Have given a written, informed consent

Exclusion Criteria:

1. Ocular disorder that may confound interpretation of study results
2. Current treatment for glaucoma or IOP over 25mmHg
3. Ocular surgery history within 1 year
4. Other malignancy history or uncontrolled severe disease within 5 years
5. Use of systemic immunosuppressive therapies within 3 months
6. Use of opthalmic cyclosporin, opthalmic steroid within 4 weeks
7. Received any other investigational drugs within 4 weeks
8. Subjects who are willing to wear contact lenses during study participation
9. Pregnant or lactating women