Status:
COMPLETED
Efficacy and Safety Study of Haporine-S for Treatment of Moderate to Severe Dry Eye Syndromes
Lead Sponsor:
DH Bio Co., Ltd.
Collaborating Sponsors:
BTO Pharm. Co., Ltd.
Conditions:
Dry Eye Syndromes
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01804361
Start Date
March 1 2013
End Date
February 1 2014
Last Update
July 22 2015
Active Locations (6)
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1
Busan National University Hospital
Busan, Busan, South Korea, 602-739
2
Seoul National University Hospital
Seoul, Seoul, South Korea, 110-744
3
Yonsei University Gangnam Severance Hospital
Seoul, Seoul, South Korea, 135-720
4
Korea University Anam Hospital
Seoul, Seoul, South Korea, 136-705