Efficacy and Safety Study of ATs in Patients With Dry Eye Syndrome

Study Overview
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Brief Summary
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The purpose of this study is to determine whether artificial tears are safe and effective in the treatment of Dry Eye Syndrome.

Official Title
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A Phase II, Randomized, Double-Blind, Clinical Trial to Evaluate the Efficacy and Safety of DHP-101, DHP-300, DHP-500 in Patients With Dry Eye Syndrome

Conditions
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Dry Eye Syndromes, Keratoconjunctivitis Sicca

Intervention / Treatment
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* Drug: AT01
* Drug: AT02
* Drug: AT03
* Drug: AT04


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adults aged 18 years and over. Subjects should diagnosed as dry eye syndrome in both eyes or one eye, keratoconjunctivitis sicca (KCS), or should have at least a 3-month history diagnosed as dry eye syndrome due to Sjögren syndrome. Subjects must agree to discontinue all artificial tears from Screening for 2 weeks Subjects must discontinue lens wear one week before Screening and agree not to wear contact lenses during the entire study. Subjects who have taken Restasis® are eligible for inclusion if they have not used Restasis® during the 4 weeks prior to Screening Subjects must provide signed informed consent prior to participation in any study-related procedures Subjects who dose not Participate in same clinical trial within 6 month prior to Screening. Exclusion Criteria: Pregnancy or lactation. Females of childbearing potential who are not using systemic contraception,are not postmenopausal (≥ 1 year), or are not surgically sterilized. Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening. Any active inflammation of the eye not due to KCS Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication.

Ages Eligible for Study
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Minimum Age: 18 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: 1. Study Drugs<br> | Drug: AT01<br>* eye drop for 12 weeks<br>* Other names: DHP-101;|
| Experimental: 2. Study Drug<br> | Drug: AT02<br>* eye drop for 12 weeks<br>* Other names: DHP-300;|
| Experimental: 3. Study Drug<br> | Drug: AT03<br>* eye drop for 12 weeks<br>* Other names: DHP-500;|
| Placebo Comparator: 4. Placebo<br> | Drug: AT04<br>* eye drop for 12 weeks<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Break Up Time (TBUT) |  | 12weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluorescein staining, schirmer test, OSDI, VAS |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Syndromes, Keratoconjunctivitis Sicca, artificial tears, carboxymethylcellulose sodium, sodium hyaluronate