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 ]

Change from baseline means the change between 0 weeks and 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