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

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.

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.

Inclusion Criteria:

• Male or female, age 20 or over
• Patients with moderate to severe dry eye(DEWS Level II or over)
• Be informed of the nature of the study and will give written informed consent

Exclusion Criteria:

• Being treated with steroidal eye drop or non-steroidal anti-inflammatory eye drop for dry eye
• Being treated with systemic steroid or immunosuppressive
• History of eyeball surgical operation within 6 months
• Wearing contact lenses during participation of the study
• Pregnancy or breastfeeding
• Use of cyclosporine eye drop within 2 weeks
• Intraocular pressure(IOP)> 25 mmHg
• History of punctal occlusion within 1 month or during participation of the study
• Hypersensitivity to the investigational products or be suspicious to them
• Patients whom the investigator considers inappropriate to participate in the study