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

NCT01804361 Phase 3 COMPLETED

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.

Details

Lead sponsor	DH Bio Co., Ltd.
Phase	Phase 3
Status	COMPLETED
Enrolment	90
Start date	2013-03
Completion	2014-02

Conditions

• Dry Eye Syndromes

Interventions

• Haporine-S
• Restasis (cyclosporine 0.05%)

Primary outcomes

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

Countries

South Korea