Efficacy and Safety Study of Haporine-S for Treatment of Moderate to Severe Dry Eye Syndromes
NCT ID: NCT01804361
Last Updated: 2015-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
90 participants
INTERVENTIONAL
2013-03-31
2014-02-28
Brief Summary
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Detailed Description
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Primary outcome is the change of corneal staining score(Oxford scheme) at 12 weeks from baseline.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Haporine-S
Moderate to severe dry patients administered with with Haporine-S
Haporine-S
1 or 2 drops twice a day at 12 hour interval for 12 weeks
Restasis, Cyclosporine 0.05%
Moderate to severe dry eye patients with Restasis(cyclosporine 0.05%)
Restasis (cyclosporine 0.05%)
1 or 2 drops twice a day at 12 hour interval for 12 weeks
Interventions
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Haporine-S
1 or 2 drops twice a day at 12 hour interval for 12 weeks
Restasis (cyclosporine 0.05%)
1 or 2 drops twice a day at 12 hour interval for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
ALL
No
Sponsors
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BTO Pharm. Co., Ltd.
INDUSTRY
DH Bio Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hyo-Myung KIM, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital
Jong Suk SONG, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Hyung Keun LEE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yonsei University Gangnam Severance Hospital
Jong-Soo LEE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Busan National University Hospital
Mee Kum KIM, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Myoung-Joon KIM, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Busan National University Hospital
Busan, Busan, South Korea
Seoul National University Hospital
Seoul, Seoul, South Korea
Yonsei University Gangnam Severance Hospital
Seoul, Seoul, South Korea
Korea University Anam Hospital
Seoul, Seoul, South Korea
Asan Medical Center
Seoul, Seoul, South Korea
Korea University Guro Hospital
Seoul, Seoul, South Korea
Countries
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Other Identifiers
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1360-8040-3073-4190
Identifier Type: OTHER
Identifier Source: secondary_id
UMT-2012-DH-HS-01
Identifier Type: -
Identifier Source: org_study_id
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