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OpenTrials
Completed

NCT Number: NCT00788229

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asan medical center

Seoul, 388-1 Pungnap-2dong, Songpa-gu, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AT01

Drug

eye drop for 12 weeks

Other names: DHP-101

AT02

Drug

eye drop for 12 weeks

Other names: DHP-300

AT03

Drug

eye drop for 12 weeks

Other names: DHP-500

AT04

Drug

eye drop for 12 weeks

Other names: Saline

Primary outcomes

  1. Tear Break Up Time (TBUT)

    Time frame: 12weeks

Secondary outcomes

  1. Fluorescein staining, schirmer test, OSDI, VAS

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Dhp Korea Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 10, 2008
Registry last updated
Apr 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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