Trial | NCT01804361  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cyclosporine ...

  • Study Participants

    90
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.
Study Started
Mar 31
2013
Primary Completion
Feb 28
2014
Study Completion
Feb 28
2014
Last Update
Jul 22
2015
Estimate

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

Haporine-S Experimental

Moderate to severe dry patients administered with with Haporine-S

Restasis, Cyclosporine 0.05% Active Comparator

Moderate to severe dry eye patients with Restasis(cyclosporine 0.05%)

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
No Results Posted