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

Phase 2

Completed

• Conditions: Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Interventions: Drug: AT04; Drug: AT01; Drug: AT03; Drug: AT02

• Registration Number: NCT00788229
• Lead Sponsor: Dhp Korea Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-07
• Study First Submitted QC: 2008-11-07
• Study First Posted: 2008-11-10
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-01
• Last Update Posted: 2010-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4. Placebo	AT04	-
1. Study Drugs	AT01	-
3. Study Drug	AT03	-
2. Study Drug	AT02	-

Primary Outcome Measures

Name	Time	Method
Tear Break Up Time (TBUT)	12weeks

Secondary Outcome Measures

Name	Time	Method
Fluorescein staining, schirmer test, OSDI, VAS	12 weeks

Trial Locations

Locations (1)

Asan medical center; 🇰🇷 Seoul, 388-1 Pungnap-2dong, Songpa-gu, Korea, Republic of