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

Dong-A ST Co., Ltd.150 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

150

Conditions

Dry Eye Syndrome

Interventions

DA-6034 3%DRUG

Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks

DA-6034 5%DRUG

Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks

DA-6034 PlaceboDRUG

Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul St.Mary's hospital

Seoul, South Korea