Trial | NCT00788229  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    72
The purpose of this study is to determine whether artificial tears are safe and effective in the treatment of Dry Eye Syndrome.
Study Started
Nov 30
2008
Primary Completion
Aug 31
2009
Study Completion
Aug 31
2009
Last Update
Apr 02
2010
Estimate

Drug AT01

eye drop for 12 weeks

  • Other names: DHP-101

Drug AT02

eye drop for 12 weeks

  • Other names: DHP-300

Drug AT03

eye drop for 12 weeks

  • Other names: DHP-500

Drug AT04

eye drop for 12 weeks

  • Other names: Saline

1. Study Drugs Experimental

2. Study Drug Experimental

3. Study Drug Experimental

4. Placebo Placebo Comparator

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.
No Results Posted