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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Haporine-S
* Drug: Restasis (cyclosporine 0.05%)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Haporine-S<br>Moderate to severe dry patients administered with with Haporine-S | Drug: Haporine-S<br>* 1 or 2 drops twice a day at 12 hour interval for 12 weeks<br>|
| Active Comparator: Restasis, Cyclosporine 0.05%<br>Moderate to severe dry eye patients with Restasis(cyclosporine 0.05%) | Drug: Restasis (cyclosporine 0.05%)<br>* 1 or 2 drops twice a day at 12 hour interval for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining | Corneal fluorescein staining will be assessed at 0 day(baseline), 4 weeks and 12 weeks. | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Index(OSID) | Ocular Surface Disease Index(OSID) will be assessed at 0 day, 4 weeks and 12 weeks. | 0 day, 4 weeks and 12 weeks | 
| Tear Breakup Time(TBUT) | Tear Breakup Time(TBUT) will be assessed at 0 day(baseline), 4 weeks and 12 weeks. | 0 day, 4 weeks and 12 weeks | 
| Schirmer score | Schirmer score will be assessed at 0 day(baseline), 4 weeks and 12 weeks. | 0 day, 4 weeks and 12 weeks | 
| Drug compliance | Drug compliance(conjunctival hyperemia and burning etc) will be assessed at 0 day(baseline), 4 weeks and 12 weeks. | 0 day, 4 weeks and 12 weeks | 
| DEWS(Dry Eye WorkShop) level | Level on dry eye severity grading scheme of DEWS will be assessed at 0 day(baseline), 4 weeks and 12 weeks. | 0 day, 4 weeks and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Syndromes