Overview

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.