Efficacy and Safety Study of ATs in Patients With Dry Eye Syndrome
NCT ID: NCT00788229
Last Updated: 2010-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2008-11-30
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1. Study Drugs
AT01
eye drop for 12 weeks
2. Study Drug
AT02
eye drop for 12 weeks
3. Study Drug
AT03
eye drop for 12 weeks
4. Placebo
AT04
eye drop for 12 weeks
Interventions
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AT01
eye drop for 12 weeks
AT02
eye drop for 12 weeks
AT03
eye drop for 12 weeks
AT04
eye drop for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Dhp Korea Co., Ltd.
INDUSTRY
Responsible Party
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Dhp Korea Co., Ltd.
Principal Investigators
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Hungwon Tchah,, MD
Role: PRINCIPAL_INVESTIGATOR
Seoul asan medical center
Locations
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Asan medical center
Seoul, 388-1 Pungnap-2dong, Songpa-gu, South Korea
Countries
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Other Identifiers
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dhpat02
Identifier Type: -
Identifier Source: org_study_id
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