Status:
COMPLETED
Efficacy and Safety Study of ATs in Patients With Dry Eye Syndrome
Lead Sponsor:
Dhp Korea Co., Ltd.
Conditions:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether artificial tears are safe and effective in the treatment of Dry Eye Syndrome.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00788229
Start Date
November 1 2008
End Date
August 1 2009
Last Update
April 2 2010
Active Locations (1)
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1
Asan medical center
Seoul, 388-1 Pungnap-2dong, Songpa-gu, South Korea, 138-736