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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dhp Korea Co., Ltd.

Criteria

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.