Clinical Trial: Efficacy and Safety Study of Haporine-S for Treatment of Moderate to Severe Dry Eye Syndromes

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy and Safety Study of Haporine-S in Subjects With Moderate to Severe Dry Eye, A Multicenter, Investigator(Assessor)Blind, Parallel Design, Non-inferiority Phase III

Brief Summary: The purpose of this study is to determine efficacy and safety of Haporine-S eye drop for the patients with moderate to severe dry eye disease in a multicenter phase III clinical trial.

Detailed Summary:

This study is to compare the efficacy and the safety of topical Haposine-S and Restasis® eye drop 0.05% for the patients with moderate to severe dry eye disease in a multicenter, investigator(assessor) blind, parallel design, non-inferiority phase III trial.

Primary outcome is the change of corneal staining score(Oxford scheme) at 12 weeks from baseline.


Sponsor: DH Bio Co., Ltd.

Current Primary Outcome: Corneal staining [ Time Frame: up to 12 weeks ]

Corneal fluorescein staining will be assessed at 0 day(baseline), 4 weeks and 12 weeks.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ocular Surface Disease Index(OSID) [ Time Frame: 0 day, 4 weeks and 12 weeks ]
    Ocular Surface Disease Index(OSID) will be assessed at 0 day, 4 weeks and 12 weeks.
  • Tear Breakup Time(TBUT) [ Time Frame: 0 day, 4 weeks and 12 weeks ]
    Tear Breakup Time(TBUT) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
  • Schirmer score [ Time Frame: 0 day, 4 weeks and 12 weeks ]
    Schirmer score will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
  • Drug compliance [ Time Frame: 0 day, 4 weeks and 12 weeks ]
    Drug compliance(conjunctival hyperemia and burning etc) will be assessed at 0 day(baseline), 4 weeks and 12 weeks.
  • DEWS(Dry Eye WorkShop) level [ Time Frame: 0 day, 4 weeks and 12 weeks ]
    Level on dry eye severity grading scheme of DEWS will be assessed at 0 day(baseline), 4 weeks and 12 weeks.


Original Secondary Outcome: Same as current

Information By: DH Bio Co., Ltd.

Dates:
Date Received: February 27, 2013
Date Started: March 2013
Date Completion:
Last Updated: July 20, 2015
Last Verified: July 2015