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

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DH Bio Co., Ltd.
• Collaborator: BTO Pharm. Co., Ltd.
• Treatments: Cyclosporine; Cyclosporins

Criteria

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