Phase II Study of DA-6034 Eye Drops in Dry Eye Syndrome

Study Overview
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Brief Summary
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This study is to determine the efficacy and safety of 3% or 5% DA-6034 eye drops compared with placebo in dry eye syndrome.

Detailed Description
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Eligible subjects are randomly assigned to receive 3% DA-6034, 5% DA-6034 or Placebo. This study is conducted for 6 weeks(Run-in Period 2 weeks + Treatment Period 4 weeks).

Official Title
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Placebo Controlled, Dose-Response, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of DA-6034 Eye Drops in Patients With Dry Eye Syndrome

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: DA-6034 3%
* Drug: DA-6034 5%
* Drug: DA-6034 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age≥20 Dry eye symptoms(irritation, foreign body sensation, burning, mucus discharge, blurring, itching, photophobia, tird or heavy feeling, pain) for more than 6 months Fluorescein corneal staining score ≥ 4 and Schirmer test I ≤ 7mm in same eye Corrected vision ≥ 0.2 in both eye Have given a written, informed consent Exclusion Criteria: Ocular disorder that may confound interpretation of study results Current treatment for glaucoma or IOP over 25mmHg Ocular surgery history within 1 year Other malignancy history or uncontrolled severe disease within 5 years Use of systemic immunosuppressive therapies within 3 months Use of opthalmic cyclosporin, opthalmic steroid within 4 weeks Received any other investigational drugs within 4 weeks Subjects who are willing to wear contact lenses during study participation Pregnant or lactating women

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DA-6034 Low dose<br>DA-6034 3% | Drug: DA-6034 3%<br>* Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks<br>* Other names: DA-6034 Low dose;|
| Experimental: DA-6034 High dose<br>DA-6034 5% | Drug: DA-6034 5%<br>* Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks<br>* Other names: DA-6034 High dose;|
| Placebo Comparator: Placebo<br>DA-6034 Placebo | Drug: DA-6034 Placebo<br>* Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Fluorescein Corneal Staining(FCS) score | Change from baseline means the change between 0 weeks and 4 weeks. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Tear Break-Up Time(TBUT) | Change from baseline means the change between 0 weeks and 4 weeks. | 4 weeks | 
| Change from baseline of Lissamine Green Conjunctival Staining(LGCS) score | Change from baseline means the change between 0 weeks and 4 weeks. | 4 weeks | 
| Change from baseline of Schirmer Test I score | Change from baseline means the change between 0 weeks and 4 weeks. | 4 weeks | 
| Change from baseline of Ocular Surface Disease Index(OSDI) score | Change from baseline means the change between 0 weeks and 4 weeks. | 4 weeks | 

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