Efficacy and Safety Study of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome

Study Overview
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Brief Summary
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A multicenter, Placebo controlled, Restasis® referenced, Randomized, Double blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Adult Patients with Dry Eye Syndrome

Official Title
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A Multicenter, Placebo Controlled, Restasis® Referenced, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of HU00701/HU007 Eye Drops in Patients With Dry Eye Syndrome

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: HU00701
* Drug: HU007
* Drug: Restasis
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age over 19 Corneal staining score(Oxford grading) > 2 or Schirmer test < 10mm/5min (If Schirmer test = 0mm/5min, Nasal stimulation schirmer test > 3mm/5min) Volunteer who went through menopause more than 1 years ago before screening or has surgical menopause Volunteer who has negative result of pregnancy test or use effective contraception Exclusion Criteria: Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status The patients with systemic or ocular disorders affected the test result Being treated with systemic steroid Wearing contact lenses within 3 days of screening visit Pregnancy or Breastfeeding

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: HU00701<br>HU00701(Cyclosporine 0.01% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks | Drug: HU00701<br>* Cyclosporine 0.01% + 3% trehalose<br>|
| Experimental: HU007<br>HU007(Cyclosporine 0.02% + 3% trehalose) 1 drop b.i.d at 12 hour interval for 12 weeks | Drug: HU007<br>* Cyclosporine 0.02% + 3% trehalose<br>|
| Active Comparator: Restasis<br>Restasis(Cyclosporine 0.05%) 1 drop b.i.d at 12 hour interval for 12 weeks | Drug: Restasis<br>* Cyclosporine 0.05%<br>|
| Placebo Comparator: Placebo(without main component)<br>Placebo 1 drop b.i.d at 12 hour interval for 12 weeks | Drug: Placebo<br>* Vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from Baseline of Corneal staining score - Oxford grading |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from Baseline of Corneal staining score - Oxford grading |  | Week 4, 8 | 
| change from Baseline of Strip meniscometry assessment |  | Week 4, 8, 12 | 
| change from Baseline of Tear film break-up time |  | Week 4, 8, 12 | 
| change from Baseline of Standard patient evaluation of eye dryness questionnaire |  | Week 4, 8, 12 |