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

Study Overview
=================
Brief Summary
-----------------
A multicenter, Randomized, Double blind, Restasis®-controlled Non-inferiority, Moisview® Eye Drops-controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients with Dry Eye Syndrome

Official Title
-----------------
A Multicenter, Randomized, Double Blind, Restasis®-Controlled Non-inferiority, Moisview® Eye Drops-controlled Superiority, Phase III Study to Evaluate the Efficacy and Safety of HU007 Eye Drops in Patients With Dry Eye Syndrome

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Drug: HU007
* Drug: Restasis
* Drug: Moisview


Participation Criteria
=================
Eligibility Criteria
-----------------
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 or who has negative result of pregnancy test or use effective contraception Exclusion Criteria: The patients with systemic or ocular disorders affected the test result Current or recent patients used dry eye syndrome medications (topical or systemic) that may affect the status Being treated with systemic steroid Wearing contact lenses within 72 hr of screening visit Pregnancy or Breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HU007<br>Cyclosporine 0.02%, trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks | Drug: HU007<br>* cyclosporine 0.02%, trehalose 3%<br>|
| Active Comparator: Restasis<br>Cyclosporine 0.05% 1 drop b.i.d at 12hr interval for 12 weeks | Drug: Restasis<br>* cyclosporine 0.05%<br>|
| Active Comparator: Moisview<br>trehalose 3% 1 drop b.i.d at 12hr interval for 12 weeks | Drug: Moisview<br>* trehalose 3%<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from Baseline in Corneal staining(Oxford grading) score |  | Week 4,8 | 
| change from Baseline of Conjunctival staining(Oxford grading) score |  | Week 4,8,12 | 
| 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 | 
| arrival time of 100% clearence in Corneal staining test |  | Week 0-12 | 
| The number of total rescue drug usage |  | Week 0-12 |