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 ]
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