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

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A ST Co., Ltd.
• Treatments: Ophthalmic Solutions; Tetrahydrozoline

Criteria

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