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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00788229
Recruitment Status : Completed
First Posted : November 10, 2008
Last Update Posted : April 2, 2010
Sponsor:
Information provided by:

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  (Clinical Trial)
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 : November 2008
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Tear Break Up Time (TBUT) [ Time Frame: 12weeks ]

Secondary Outcome Measures :
  1. Fluorescein staining, schirmer test, OSDI, VAS [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788229


Locations
Korea, Republic of
Asan medical center
Seoul, 388-1 Pungnap-2dong, Songpa-gu, Korea, Republic of, 138-736
Sponsors and Collaborators
Dhp Korea Co., Ltd.
Investigators
Principal Investigator: Hungwon Tchah,, MD Seoul asan medical center
More Information

Responsible Party: Donghwa Han / The director of Laboratory, Dhp Korea Co., Ltd.
ClinicalTrials.gov Identifier: NCT00788229     History of Changes
Other Study ID Numbers: dhpat02
First Posted: November 10, 2008    Key Record Dates
Last Update Posted: April 2, 2010
Last Verified: April 2010

Keywords provided by Dhp Korea Co., Ltd.:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
artificial tears
carboxymethylcellulose sodium
sodium hyaluronate

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Disease
Pathologic Processes
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases