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

Dhp Korea

Status and phase: Completed; Phase 2

Conditions: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Treatments: Drug: AT04; Drug: AT02; Drug: AT03; Drug: AT01

Study type: Interventional

Funder types: Industry

Identifiers

NCT00788229

dhpat02

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 4 patient groups, including a placebo group

1. Study Drugs

Experimental group

Treatment:

Drug: AT01

2. Study Drug

Experimental group

Treatment:

Drug: AT02

3. Study Drug

Experimental group

Treatment:

Drug: AT03

4. Placebo

Placebo Comparator group

Treatment:

Drug: AT04