Clinical Trial: Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief 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.
Detailed Summary: 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).
Sponsor: Dong-A ST Co., Ltd.
Current Primary Outcome: Change from baseline of Fluorescein Corneal Staining(FCS) score [ Time Frame: 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline of Tear Break-Up Time(TBUT) [ Time Frame: 4 weeks ]Change from baseline means the change between 0 weeks and 4 weeks.
- Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score [ Time Frame: 4 weeks ]Change from baseline means the change between 0 weeks and 4 weeks.
- Change from baseline of Schirmer Test I score [ Time Frame: 4 weeks ]Change from baseline means the change between 0 weeks and 4 weeks.
- Change from baseline of Ocular Surface Disease Index(OSDI) score [ Time Frame: 4 weeks ]Change from baseline means the change between 0 weeks and 4 weeks.
Original Secondary Outcome: Same as current
Information By: Dong-A ST Co., Ltd.
Dates:
Date Received: January 19, 2012
Date Started: April 2012
Date Completion:
Last Updated: September 29, 2014
Last Verified: September 2014