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

Sponsor

Dhp Korea Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT00788229

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes Keratoconjunctivitis Sicca	Drug: AT01 Drug: AT02 Drug: AT03 Drug: AT04	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase II, Randomized, Double-Blind, Clinical Trial to Evaluate the Efficacy and Safety of DHP-101, DHP-300, DHP-500 in Patients With Dry Eye Syndrome

Study Start Date :

Nov 1, 2008

Actual Primary Completion Date :

Aug 1, 2009

Actual Study Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1. Study Drugs	Drug: AT01 eye drop for 12 weeks Other Names: DHP-101
Experimental: 2. Study Drug	Drug: AT02 eye drop for 12 weeks Other Names: DHP-300
Experimental: 3. Study Drug	Drug: AT03 eye drop for 12 weeks Other Names: DHP-500
Placebo Comparator: 4. Placebo	Drug: AT04 eye drop for 12 weeks Other Names: Saline

Outcome Measures

Primary Outcome Measures

Tear Break Up Time (TBUT) [12weeks]

Secondary Outcome Measures

Fluorescein staining, schirmer test, OSDI, VAS [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.