NCT01804361

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

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 Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: DH Bio Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	Haporine-S	1 or 2 drops twice a day at 12 hour interval for 12 weeks
DRUG	Restasis (cyclosporine 0.05%)	1 or 2 drops twice a day at 12 hour interval for 12 weeks

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-03-05
• Last updated: 2015-07-22

Locations

6 sites across 1 country: South Korea